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Information for patients with Immune Thrombocytopenia (ITP) scheduled for Covid-19 vaccination. (Published 27th January 2022 but still current as of October 2022)

Information for patients with Immune Thrombocytopenia (ITP) scheduled for Covid-19 vaccination. (Published 27th January 2022 but still current as of October 2022)

I have ITP.  Can I receive the Covid-19 vaccine?

Yes.  ITP is not a contra-indication to the Covid-19 vaccine. 

Is it correct that thrombocytopenia can develop following Covid-19 vaccine?

In one study, it was estimated that approximately one new case of ITP occurred for every 100,000 doses of first AstraZeneca vaccine.  The association was not observed with first Pfizer vaccine.  Furthermore, there is no indication yet that thrombocytopenia following Covid-19 vaccine is any more common than after Covid-19 infection itself.

Another rare complication observed following the AstraZeneca vaccine was vaccine-induced immune thrombotic thrombocytopenia (VITT).  This condition leads to blood clotting and low platelets, typically presenting 5-30 days post-vaccine.  ITP was not identified as a risk factor for VITT, and VITT was almost exclusively reported after adenoviral vectors (AstraZeneca, Johnson & Johnson), rather than the mRNA vaccines (Pfizer, Moderna) now being offered in the UK.  

If I have ITP, could my platelet count fall after the Covid-19 vaccine?

Some people with ITP will have a significant fall in platelet count after the vaccine (studies suggest about 1 in 15).  In most cases, this will either resolve without treatment or respond to standard treatment.  This effect does not appear to be specific to one particular type of Covid-19 vaccine and no other risk factors have been identified. 

I am receiving immune suppression for my ITP, should I still have the vaccine?

Yes.  The vaccine may give you less protection if your immune system is weakened by treatments such as rituximab, steroids or mycophenolate.  For this reason, a 3rd Covid-19 vaccine has been offered, at least 8 weeks after the second, to those on such treatments, and subsequently a booster (4th) vaccine, from 3 months after the 3rd dose.

Can I prepare for my vaccine?

Yes.  It is now recommended that your platelet count is checked 2-5 days after vaccination.  Once you know your vaccination date, book a full blood count (FBC) check through your haematology department or GP.  An additional FBC may be required if the platelet count is falling or bleeding symptoms develop. If you choose not to check the platelet count at 2-5 days, observe for unusual or increased bruising or bleeding and have your platelet count checked if this occurs.

If your platelet count is likely to be less than 50, ask for a thin needle (23 or 25 gauge) and press firmly at the injection site for 2 minutes without rubbing to reduce the chance of a bruised muscle.

My ITP presented or relapsed after Covid-19 vaccine.  Can I have further Covid-19 vaccines?

The risk of a further platelet count drop appears higher in these circumstances, but the platelet count still does not fall in the majority of cases. You can have further Covid-19 vaccines, however discuss your individual circumstances with your haematologist first, and your post-vaccine platelet count should be monitored.

 

Patient information on behalf of the UK ITP Forum.  Version 1 (27th January 2022).  Authors: Drs Q Hill, V McDonald, N Cooper, S Pavord.

Covid Vaccine and Children (12 to 18s) By Dr John Grainger

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Covid Vaccine and Children

The guidance published by the UK ITP Forum is equally applicable to children as adults and can be found via this link – UK ITP Forum Vaccine Guidance.

In brief we are strongly recommending COVID vaccination for children with ITP who are currently eligible. Platelet fluctuations are not uncommon following vaccinations occcuring in about 7% however the risk of an acute drop would appear to be significantly higher with actual COVID infection. COVID infections seem inevitable in school and college for the unvaccinated. Infections can still occur in the vaccinated but are less frequent and generally much milder. Currently we have not seen any severe infections in our paediatric ITP locally in Manchester.

For those children with more unstable ITP or whom are on active medication to support platelet levels we would recommend discussion with the local ITP team. We are generally recommending a check FBC 2-7 days post vaccine especially for those on medication.

At the time of vaccination, if the platelet count is less than 30, we recommend taking a cotton wool ball and pressing firmly to site of vaccination for 5  minutes to minimise any bleeding.

Regarding children under 12years of age, this is now common practice in several other countries such as USA. I will reserve comment until I hear more from the vaccination committee regarding benefit.

Dr John Grainger -  MBChB MD MRCP FRCPath - ITPSA Medical Advisor

15th December 2021

Covid-19 and the Omicron variant – an update by Professor Adrian Newland

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Covid-19 and the Omicron variant – an update

The Omicron variant of the SARS-CoV-2 virus, which causes Covid-19 infection, was first detected in early November in South Africa and has now been identified world-wide.  Although the numbers detected in the UK remain small they are rising fast, with numbers doubling every two to three days, and it is predicted that it could become the dominant variant, taking over from Delta in the next few weeks.

Early evidence suggests that Omicron spreads more easily with more people becoming infected from contact, however, data from South Africa suggests that it causes a milder infection than past variants. Even though it spreads more quickly it has not been associated with any major increase in hospitalisations or in deaths.  We will see if this is confirmed as numbers increase over the next few weeks.

While double vaccinations provide some protection against infection this is probably half that seen with the currently dominant Delta variant.  However, evidence suggests that the third, booster dose brings this protection to over 90%.  In the UK almost 22 million people have had the booster dose, a third of the population, and the government has broadened eligibility to all those over 18 and shortened the interval between the second and third dose to only three months. 

Those who have been vaccinated may still contract the infection but this appears to be a much milder form of the disease and is rarely associated with admission to hospital.  It is best, however, to continue to take precautions against infection.  The government has brought in a number of public health measures, asking people to work from home where possible, wear masks in public places, including transport,  and be able to show proof of vaccination or a negative Covid-19 test for entry into certain venues.  I would add that a more widespread use of masks would be desirable and where possible to maintain social distancing, although these have not been recommended by the government.  Both the lateral flow test (LFT) and the PCR tests will both identify the Omicron variant and in the run up to the Christmas period regular use of the LFT at home can add reassurance to continue meeting with friends and relatives.

It is worth pointing out that infection with the Delta variant remains a significant problem with high hospitalisation rates with severe disease in those with conditions such as diabetes, high blood pressure and who are obese.   This may also apply to those who are immune suppressed but ITP itself is not an independent risk.  Currently over 90% of those who require admission to Intensive Care Units (ICUs) are unvaccinated and nearly a half of those who require ventilation support are dying with an increasing number of under 40s are being affected.  This has put an enormous burden on the NHS and is preventable.  There are few medical reasons for not being vaccinated and we should encourage everyone to have this simple and safe procedures. The risks from the infection are far greater.

Professor Adrian Newland  12/12/2021

Press release - JCVI issues advice on third dose vaccination for severely immunosuppressed

Press release

JCVI issues advice on third dose vaccination for severely immunosuppressed

The JCVI is advising that people with severely weakened immune systems should have a third vaccine dose as part of their primary COVID-19 vaccination schedule.

To read the press release click this link (this link will take you to the UK Government website: https://www.gov.uk/government/news/jcvi-issues-advice-on-third-dose-vaccination-for-severely-immunosuppressed

What is ITP and what are the risks of a fall in the platelet count post Covid-19 vaccination? - Professor A C Newland 10/06/2021

What is ITP and what are the risks of a fall in the platelet count post Covid-19 vaccination?

The background rate in the normal population of immune thrombocytopenia (ITP) in adults is around 6 per 100,000.  Although the hallmark of ITP is a low platelet count and an increased risk of bleeding it is also associated with a small increased risk of thrombosis – in general an increase of around 20% over the general population where the risk is 1 per thousand per year, so that increase looks large but in real terms still small.  Thrombosis is increased by certain things like age, surgery, obesity, diabetes and these increase the risk in both ITP and in the normal population; in the elderly with ITP (over 60) and post-surgery or any procedure this may increase 3 fold.

Thrombocytopenia following vaccinations is well recognised and has been calculated at around 10 per million (these in general are the standard childhood vaccinations, such as MMR) and are usually mild and transient.  It is no surprise that a similar response would be seen following vaccination against Covid-19 and in view of the intense rate of vaccination over the last 5 months any reactions would be highlighted.  By early June over 68 million doses had been administered and thrombocytopenia has been described with both commonly used vaccines.

The rate with the Pfizer vaccine is around 10 per million vaccinations with around 165 cases of thrombocytopenia reported and following the Astra Zeneca vaccine around 20 per million vaccinations with around 874 reported. These may not all be ITP but have been reported as thrombocytopenia.  If you compare that with the likelihood of thrombocytopenia (ITP) occurring in the normal population (at 60 per million) over the first 5 months of this year we would have expected around 535 new diagnoses.  So it is difficult to be certain whether all these are vaccine related or chance associations, although the close association of some to the vaccine suggests that many are likely to be related.  The Moderna  vaccine has not been given to sufficient numbers in the UK to produce meaningful figures.  To make matters rather more complicated around one third of adults with ITP are normally picked up incidentally and have no bleeding  problems.  In ITP the platelet count may fall post vaccine (in around 5%) so we do not know in patients who present post vaccine whether this was a new problem or highlighting and underlying disorder.

The good news is, however, that treatment is not always required and if it is the count usually responds quickly and is not associated with long-term disease.  It is uncertain how to proceed with the 2nd vaccination when there is a reaction to the first and this must be considered on an individual basis.  We have had patients who have had both of the same without recurrence but most doctors would suggest swapping to the alternate.

The ITP Support Association has been surveying platelet counts in their members with ITP post Covid-19 vaccination.  The survey covers the 220 people who completed the survey from the end of February 2021 to 12th May 2021.  Of that total 41 ITP Patients received a pre and post vaccine Platelet Count, split, almost 50/50 between Pfizer and Astra Zeneca.  Nine patients in all had a reduction in their platelet count of greater than 30; 2 and 7 respectively.  In none was the fall sufficiently severe to require hospitalisation.  Interestingly 7 patients showed an increased count.  Probably a non-specific reaction to the vaccine along with the other, non-specific, reactions reported in about 1 in 10 with both vaccines used mainly in the UK.   None of this group fell into the category of Vaccine induced thrombocytopenia and thrombosis (VITT) that is associated with the cerebral venous sinus thrombosis syndrome and is clearly a separate entity.

In a similar study from the USA of 52 consecutive patients 15% had no worsening of ITP symptoms but no count measured; 73% had no new symptoms and no change in platelet count.  However, 12% had a drop in the platelet count but all either bounced back or responded to treatment and the majority were above 30 x109 /L within 3 days.  The changes in platelet count occurred independent of remission status, concurrent ITP treatment or vaccine type.

Professor A C Newland 10/06/2021

Prof Adrian Newland commented for the Science Media Centre on the JCVI announcement on using an alternate vaccine to O/AZ in the under 40's. Friday 8th May 2021.

Prof Adrian Newland commented for the Science Media Centre on the JCVI announcement on using an alternate vaccine to O/AZ in the under 40's.

Friday 8th May 2021.

 

Prof Adrian Newland, Professor of Haematology, Queen Mary University of London, said:

“The vaccination programme against Covid-19 has been enormously successful in the UK, with a marked reduction in infection and transmission, saving many lives.  There has, however, been the worry caused by reports of thrombosis affecting the cerebral venous sinus (CVST) associated with reduced platelet levels in some in the post-vaccination period.  These were particularly noticed in the younger population and in women, although in the latter this may reflect the populations initially targeted as the gap has become less marked as increasing numbers are vaccinated.

“The numbers remain small and it is clear that the risks of CVST are much greater following infection with Covid-19 and remain similar to those reported in the normal population.  However, the proximity to the vaccination with the AZ vaccine remains a worry and as the overall number of infections fall the potential risks and benefits of using the vaccine in the younger population is less clear.  It is therefore pragmatic advice from the JCVI to suggest looking at an alternate in the less than 40 population.  While CVST has been reported following the other vaccines, the numbers are much less and it is unclear whether the mechanisms are the same, or just reflect what would be expected in the normal population.  The mortality rate from CVST has been reported at approximately 20% and this is likely to fall with the increasing awareness of its possibility, and the availability of effective treatment.

“The AZ vaccine remains the ‘workhorse’ of the vaccination campaign, because of its less stringent storage requirements, and in the older population, where the risks from infection are so much greater it can be used freely.  Alternate products can be offered to those under 40 and supplies are such that the targets for vaccination campaign will not be missed.

“The risks from the AZ vaccine appear to follow only the first dose and so those that have received this can have the second without worry.

“If an alternate is not available then serious consideration does need to be given to receiving the AZ vaccine as, although the risks remain very low from the vaccine, there is an increasing awareness of the development of the condition known as long-Covid, that may impact on 30% of those infected, and is not only very debilitating but, as the name suggests, can cause prolonged suffering.  It may also occur in a third of those in whom the infection was symptomless. It is important, therefore, to continue with the universal vaccination programme without delay.”

Risk of rare blood clotting higher for COVID-19 than for vaccines - University of Oxford

UNIVERSITY OF OXFORD PRESS RELEASE | FOR IMMEDIATE RELEASE

Risk of rare blood clotting higher for COVID-19 than for vaccines

  • Cerebral venous thrombosis (CVT)is much more common after COVID-19
  • COVID-19 leads to several times higher risk of CVT than current COVID-19 vaccines
  • A similar pattern was seen for another serious clotting disorder, portal vein thrombosis.

Researchers at the University of Oxford have today reported that the risk of the rare blood clotting known as cerebral venous thrombosis (CVT) following COVID-19 infection is around 100 times greater than normal, several times higher than it is post-vaccination or following influenza.

The study authors, led by Professor Paul Harrison and Dr Maxime Taquet from Oxford University’s Department of Psychiatry and the NIHR Oxford Health Biomedical Research Centre, counted the number of CVT cases diagnosed in the two weeks following diagnosis of COVID-19, or after the first dose of a vaccine. The then compared these to calculated incidences of CVT following influenza, and the background level in the general population.

They report that CVT is more common after COVID-19 than in any of the comparison groups, with 30% of these cases occurring in the under 30s. Compared to the current COVID-19 vaccines, this risk is between 8-10 times higher, and compared to the baseline, approximately 100 times higher.

The breakdown comparison for reported cases of CVT in COVID-19 patients in comparison to CVT cases in those who received a COVID-19 vaccine is:

  • In this study of over 500,000 COVID-19 patients, CVT occurred in 39 in a million patients.
  • In over 480,000 people receiving a COVID-19 mRNA vaccine (Pfizer or Moderna), CVT occurred in 4 in a million.
  • CVT has been reported to occur in about 5 in a million people after first dose of the AZ-Oxford COVID-19 vaccine.
  • Compared to the mRNA vaccines, the risk of a CVT from COVID-19 is about 10 times greater.
  • Compared to the AZ-Oxford vaccine, the risk of a CVT from COVID-19 is about 8 times greater.

However, all comparisons must be interpreted cautiously since data are still accruing. 

Paul Harrison, Professor of Psychiatry and Head of the Translational Neurobiology Group at the University of Oxford, said: ‘There are concerns about possible associations between vaccines, and CVT, causing governments and regulators to restrict the use of certain vaccines. Yet, one key question remained unknown: ‘What is the risk of CVT following a diagnosis of COVID-19?’.

‘We’ve reached two important conclusions. Firstly, COVID-19 markedly increases the risk of CVT, adding to the list of blood clotting problems this infection causes. Secondly, the COVID-19 risk is higher than see with the current vaccines, even for those under 30; something that should be taken into account when considering the balances between risks and benefits for vaccination.’

Dr Maxime Taquet, also from the Translational Neurobiology Group, said: ‘It’s important to note that this data should be interpreted cautiously, especially since the data on the Oxford-AstraZeneca vaccine come from UK MHRA monitoring, whereas the other data uses the TriNetX electronic health records network. However, the signals that COVID-19 is linked to CVT, as well as portal vein thrombosis – a clotting disorder of the liver – is clear, and one we should take note of.’

An important factor that requires further research is whether COVID-19 and vaccines lead to CVT by the same or different mechanisms. There may also be under-reporting or mis-coding of CVT in medical records, and therefore uncertainty as to the precision of the results.

Full data are available from https://osf.io/a9jdq/.

Oxford study graph 15042021

Comment from Prof Adrian Newland on the Oxford report.

While there has been much interest and speculation regarding the incidence and relationship of Cerebral Sinus Vein thrombosis (CSVT) and portal vein thrombosis following the Covid-19 vaccinations there has been less emphasis on the numbers seen following Covid-19 infection.  The association between Covid-19 infection and thrombotic problems has been long recognised and this review from Oxford also confirms the high rate of CSVT in over 500,000 patients reported in the States, occurring in 39 per million and particularly affecting those under 30.    They reviewed at the same time nearly 500,000 receiving the mRNA vaccines (Pfizer and Moderna) and found a significantly lower incidence of 4 per million.  As the AZ-Oxford vaccine was not used in the States they reviewed the reports to the EMEA in Europe where the rate was 5 per million.  So the overall rates following infection were 8-10 times greater than following vaccination.  

While such studies are always difficult to do and to report as the various groups cannot be matched and data collection, the completeness of the records and the diagnostic approach is uncertain the numbers are such that the trends give considerable strength to the conclusions and suggest that the emphasis given to the risks following vaccination, which run at a rate not dissimilar to that seen in the normal population for CSVT,  may have been overemphasised.  We do not know whether the causes of clotting in the various groups is similar, and we do know that Covid-19 infection is in general associated with increased numbers of thrombotic episodes, but the figures do support the importance of pushing on with the vaccination initiative as the risks from infection far outweigh the reported risks of vaccination.

Professor Adrian Newland  15/04/2021

Covid-19 vaccines and blood clotting. Prof Adrian Newland 02/04/2021

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Covid-19 vaccines and blood clotting. Prof Adrian Newland 02/04/2021

There has been much discussion in the media recently regarding the potential development of thrombosis (clots) post-vaccination and a lot of the debate has centred on the Oxford/Astra Zeneca vaccine, although studies world-wide show that thromboses occur with all 4 currently available vaccines (Pfizer, Moderna and Johnson and Johnson) and the rate is no greater than that expected in the normal population.  A published review within the last week from Denmark looking at whole population figures has confirmed this statement. Nevertheless use has been restricted in a number of European countries to certain age groups. Canada has also recently restricted use; although their use of the Oxford/AZ vaccine is restricted and they have reported no cases of thrombosis they are following the European restrictions.

The particular worries have been caused by the recent reports of a specific type of clotting known as cerebral sinus vein thrombosis (CSVT) which is often associated with a lower platelet count.  Internationally it has been reported in about 5 cases per million following vaccination, which is equal to the rate described in the normal population.  It has attracted attention because it has predominantly occurred in younger women and occurs about 7-14 days post vaccination.  In normal populations the use of oral contraceptives enhances the clotting risk and whether there is a hormonal element in these events is not yet clear.  Deaths occur in just under half affected, although there is effective treatment if diagnosed early enough.  These reports in Europe have been predominantly in those receiving the Oxford/AZ vaccine, although there are rare cases in the other vaccines. A very recent review in the UK has reported 18 cases in the 30 million vaccinated.  The populations treated in the different countries are not always comparable and reporting may not be complete but there is no doubt that the use of all the covid-19 vaccines have been subject to closer scrutiny than any other vaccines and adverse events are recognised in all vaccines. 

Covid-19 itself causes a very similar syndrome and I am aware of at least one case who was diagnosed with Covid-19 post-mortem, so they had the infection at the time of the vaccination.  It is worth noting that Covid-19 itself causes death at the rate of about 200 per million.  It has been estimated by Professor Sir David Spiegelhalter, an eminent expert on risk from the University of Cambridge, that there are 2-3 deaths per million in people in their 50s for every week that the vaccine programme is delayed (and of course it is greater in older, more susceptible, age groups).  That is of course just one week and for the unvaccinated population that risk is present for every subsequent week that they remain unvaccinated.

It must also be pointed out that thrombotic events occur in 21% of hospitalised patients with Covid-19 and this doubles the mortality (23% against 13%).  

It is not clear yet whether the vaccines cause this CSVT syndrome, they may. The evidence is patchy and varies between countries. It may be a batch effect, related to an underlying Covid-19 infection or related to other health factors or medication and this will doubtless become clearer.  I can understand the worry but it is a case of balancing risks and benefits.  As we can see from the UK and Israel the vaccines prevent infections and rapidly reduce deaths, not to mention the million or so reported today with symptoms of long-Covid-19 problems.  The current differences between the UK and the majority of the rest of Europe reflect the impact of the success of our vaccination programme and although we cannot be complacent we can be cautiously optimistic as we slowly come out of lockdown.  The various vaccines have now been given to over 250,000,000 people world-wide.  With these numbers occasional adverse events may arise but equally with these numbers other, independent health issues will arise as well.  What we can say is, that despite many peoples’ worries about the speed of the development of the vaccines, their use has been associated with a major effect on the incidence and impact of Covid-19 infection and spread, were it has been given in sufficient quantities.  No major downsides have yet come to light.

We know from previous health scares that public confidence is fragile, as we have seen with MMR, and it is incumbent on the press and the politicians to provide the data and advice in a dispassionate way.

Professor Adrian Newland  02/04/2021

Covid-19 vaccines and Blood Clots - By Prof. Adrian Newland

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Over the last 36 hours a number of countries in Europe have suspended use of the Oxford/Astra Zeneca Covid-19 vaccine following some reports of blood clots in the period following vaccination.  These fall into the category of Deep Vein Thrombosis (DVT) and pulmonary Embolus (PE). They have continued to use the Pfizer vaccine.

From an initial analysis, through the system of recording side-effects (the Yellow Card system in the UK)  there have been 28 reports from the first 10 million Oxford/AZ vaccine and 25 from the first 11 million of the Pfizer vaccine.  from this it is hard to see why the two products have been differentiated.

The two main regulatory bodies, the EMEA (European Medicines Agency) and the MHRA (the Medicines and Healthcare Products Regulatory Agency in the UK) have both confirmed their approval of the vaccines and have not identified blood clots as a problem. The WHO (the World Health Organisation) have said there is no reason to stop using the Oxford/AZ product.

To put blood clots (or thrombosis) into perspective there are about 2,500 recorded in the under 40s each year., which would be around 600 in the last three months.  This incidence ranges from 1 in 10,000 of the under 40 population to as high as 1 in a 100 in the over 80s and, of course, it is in the older age ranges that the vaccines have been concentrated. The averages is about 1 in a 1,000 in the population as a whole.  So far it is in the older age groups that the vaccines have been concentrated and there are additional risk factors that change the risk. These include, in addition to age, obesity, Diabetes, Pregnancy and hormonal treatments such as HRT and the oral contraceptive. 

These figures suggest that we are seeing actually fewer episodes of thrombosis post vaccination than we would expect normally.  This is not to suggest that the vaccination in anyway protects from blood clots but puts the actual problem in perspective.  On the figures so far it is difficult to see why the politicians have made the decision they have, going against expert advice.  This can only delay the rate of vaccination within Europe and has the additional downside of public distrust in the vaccination programme, with its potential consequences.

Professor Adrian Newland  16/03/2021

Practical guidance for the management of adults with Immune Thrombocytopenia during the COVID-19 pandemic Updated January 2021

ITP Covid update Jan 2021

Practical guidance for the management of adults with Immune Thrombocytopenia during the COVID-19 pandemic

Updated January 2021

Pavord S, Thachil J, Hunt B, Murphy M, Lowe G, Laffan M, Makris M, Newland A, Provan D, Grainger J, Hill Q.

This document aims to provide practical guidance for the assessment and management of patients with Immune Thrombocytopenia (ITP) during the COVID-19 pandemic. The intention is to support clinicians and, although recommendations have been provided, it is not a formal guideline. Nor is there sufficient evidence base to conclude that alternative approaches to treatment are incorrect. Instead, it is a consensus written by clinicians with an interest in ITP or coagulation disorders and reviewed by members of the UK ITP forum.

Guidance on management of ITP during the covid pandemic updated 20210104 (PDF Version)

Covid-19 vaccination. Assessment by Prof. Adrian Newland

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We have also updated the answers to our most frequently asked questions (FAQs) regarding ITP and the Covid-19 vaccines. These can be downloaded here >>>

There has been a steady stream of positive news regarding the trials and rollout of the various Covid-19 vaccines in recent weeks, this has also resulted in questions from ITP patients.

Questions such as, I have ITP, will I be able to have one of the vaccines? or Will I be limited to one particular vaccine over another?

It is still early days and not all of the trial data is available, but Professor Adrian Newland has kindly given us his assessment of the current position, which for everyone, including those with ITP is looking more hopeful.

Covid-19 vaccination. Assessment by Prof. Adrian Newland

There looks to be some relief on the way as we now have sight of 3 potential vaccines against Covid-19.  All slightly different, which is a good thing, which means the virus will be attacked in different ways. 

The data on the Oxford/Astra Zeneca vaccine looks promising. The pharmaceutical company, Pfizer, has also developed a vaccine that has shown to be 90% effective and we have seen more data on that. Protection is apparently achieved 28 days after the initiation of the vaccination, which consists of two doses given 21 days apart. The vaccine has already been through Pfizer’s own trial and enrolled more than 40,000 people from across the world. 41 per cent of these participants are aged between 56 and 85 years old and it's really encouraging to know that the Pfizer vaccine seems to work on older people as effectively as in younger ones.

Although the full trial data has yet to be published on any of the vaccines, the companies all say that there have been no serious safety concerns.

It is natural to have questions about the safety of a vaccine produced so quickly.  However, it is important to say that the vaccines will have to meet strict safety criteria in order to satisfy the MHRA, the UK's regulator of medicines and medical devices, responsible for ensuring their safety, quality and effectiveness. The MRHA will also seek advice from the Government’s independent advisory body, the Commission on Human Medicines. The Commission will also critically assess the data on the vaccines before advising the UK Government on the safety and quality of this vaccine. It is important to understand that their development has been based on much work that was already underway.  The speed of development and size of the trials have reflected the enormous effort and funding that has gone into the whole process and corners have certainly not been cut.

The data on the vaccine will also be reviewed by the US Food and Drug Administration and the European Medicines Agency for approval, which are the counterpart regulatory bodies in the USA and Europe.

The news of this vaccine is obviously encouraging and can hopefully guide us out of this pandemic, but the full safety data of the vaccine still needs to be examined carefully by the regulatory bodies to ensure its safe for the general public and we await this news with cautious optimism. We hope that the first batches will be approved for use later in December.

We do not yet know who will be offered the vaccines in the first instance, but it is unlikely that a diagnosis of ITP alone will be sufficient.  Although the intention is that as many of the population as possible will be offered one of the vaccines eventually, the early categories will be guided by age, other susceptibilities and probably to key workers. We will have to wait government guidance on this.

There is nothing to suggest, at the moment, that one will be better than another and I suspect which vaccine is used will depend on availability.  The Oxford/Astra Zeneca vaccine will be cheaper and easier to handle as it does not need storage at very low temperatures. The third product, from a company called Moderna, is also on track but will probably concentrate its first launch in the USA as it was developed with support from the US Department of Health. It is also the most expensive.

All three vaccines will be safe for patients with ITP.  None are produced from live virus so there is no risk from that point of view and there is no need to favour one over the other.  All will be given by injection and this may pose some risk of local bleeding in patients with platelet counts below 10 but we feel that, with local pressure and precautions during the vaccination, no patient should be excluded from receiving the potential benefits.

UK ITP Forum Covid-19 update

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The UK ITP Forum have updated their information for patients with ITP regarding coronavirus (Covid-19)

Information for adult patients with immune thrombocytopenia in the setting of COVID-19 pandemic (15th July 2020) At time of writing this update, the transmission of COVID-19 in the community has gone down and the lockdown is being eased.

Information for patients with ITP regarding coronavirus (Corvid19) 15 07 2020 (PDF Format)

For more Covid-19 information - click here

Practical guidance for the management of adults with Immune Thrombocytopenia during the COVID‐19 pandemic - Published in the Brit J Haem

This advice is supported by NHS England. If you have had a Splenectomy and there are no other issues then please follow this guidance.

Practical guidance for the management of adults with Immune Thrombocytopenia during the COVID‐19 pandemic

S. Pavord, J. Thachil, B. Hunt, M. Murphy, G. Lowe, M. Laffan, M. Makris, A. Newland, D. Provan, J. Grainger, Q. Hill,

This Abstract was accepted for publication in the British Journal of Haematology, first published: 06 May 2020

Abstract

This document aims to provide practical guidance for the assessment and management of patients with thrombocytopenia, with a particular focus on Immune Thrombocytopenia (ITP) during the COVID‐19 pandemic. The intention is to support clinicians and, although recommendations have been provided, it is not a formal guideline. Nor is there sufficient evidence base to conclude that alternative approaches to treatment are incorrect. Instead, it is a consensus written by clinicians with an interest in ITP or coagulation disorders and reviewed by members of the UK ITP forum.

Management of Adults with ITP in the Covid-19 pandemic PDF Format

Practical guidance for the management of adults with Immune Thrombocytopenia during the COVID-19 pandemic Pavord S, Cooper N, Thachil J, Hunt B, Murphy M, Lowe G, Laffan M, Makris M, Newland A, Provan D, Grainger J, Hill Q. 16th April 2020

This advice is supported by NHS England. If you have had a Splenectomy and there are no other issues then please follow this guidance.

 

Practical guidance for the management of adults with Immune Thrombocytopenia during the COVID-19 pandemic

Pavord S, Cooper N, Thachil J, Hunt B, Murphy M, Lowe G, Laffan M, Makris M, Newland A, Provan D, Grainger J, Hill Q.

16th April 2020

This document aims to provide practical guidance for the assessment and management of patients with thrombocytopenia, with a particular focus on Immune Thrombocytopenia (ITP) during the COVID-19 pandemic. The intention is to support clinicians and, although recommendations have been provided, it is not a formal guideline. Nor is there sufficient evidence base to conclude that alternative approaches to treatment are incorrect. Instead, it is a consensus written by clinicians with an interest in ITP or coagulation disorders and reviewed by members of the UK ITP forum. It is a live document and will be updated as new information arises.

Background

The current COVID-19 pandemic, caused by a novel coronavirus (SARS-CoV-2), poses a number of dilemmas for the investigation of thrombocytopenia and the management of patients with ITP.

This includes consideration of the advantages and disadvantages of the standard therapeutic options for new or relapsed acute ITP, and the recognition of the challenge posed to the management of ITP patients because of both bleeding and thrombotic risks seen in patients hospitalised with COVID-19 infection. Furthermore, patients are often unclear about the extent of required self-isolation procedures.

Thrombocytopenia and COVID-19

Thrombocytopenia was described in 36% of patients hospitalised with COVID-19 in one of the early papers (Guan et al., 2020), although subsequent studies have not confirmed this high frequency. The hyper-inflammatory state and cytokine storm induced by the viral infection results in a prothrombotic state and likely endothelial and platelet activation occurs. The use of antibiotics, antivirals, heparin and other commonly used agents contributes to thrombocytopenia, as well as haemodialysis and extracorporeal membrane oxygenation (ECMO). Platelet production may be affected by direct viral insult to the bone marrow and potentially impaired fragmentation of megakaryocytes due to COVID-19 induced damage to the lung and pulmonary capillary bed (as this may be a site of platelet production). In end stage COVID-19 infection multi organ failure may exacerbate thrombocytopenia and pooled results of nine studies revealed that the platelet count was lower in patients with very severe COVID-19 (p<0.001) and that thrombocytopenia was associated with a three-fold enhanced risk of worsening disease (Lippi et al 2020). This is perhaps not unexpected as other studies of critically ill patents show thrombocytopenia to be a marker of poor clinical outcome (Nijsten et al., 2000).  Huang et al found 20% of COVID-19 patients who died had a platelet count <100 x 10 9/l, compared with 1% of survivors (p<0.0001) (Huang et al., 2020).

Despite the numerous potential causes of thrombocytopenia in COVID-19 positive patients, a count below 100 x 10 9/l is unusual, only occurring in around 5% of hospitalised patients and 8% of those on ITU (Huang et al., 2020). Postulated mechanisms for the relative preservation of platelet count is increased thrombopoietin production from liver stimulation and megakaryocytes in the lung producing large amounts of platelets. Very low platelet counts of <20 x 10 9/l, or a sudden fall in the platelet count >50% over 24-48 hours is likely to indicate an immune aetiology, although this can also occur in the pre-terminal stages of COVID-19. Other causes such as thrombotic thrombocytopenia purpura and atypical haemolytic uraemia syndrome should be considered if there is associated microangiopathic haemolytic anaemia (MAHA) and, in the former, an ADAMTS13 level <10%. Experience of testing in COVID-19 without TTP, has found ADAMTS13 levels of 20-40%, typical of other inflammatory states. Drug induced thrombocytopenia develops at a median of 14 days after the onset of a new drug or sooner if there has been previous exposure. Heparin induced thrombocytopenia (HIT) occurs between 5 and 10 days after the first exposure, or within 24 hours of recurrent exposure. Autoimmune thrombocytopenia is a diagnosis of exclusion, there being no confirmative test.

Recommendation

Thrombocytopenia in COVID-19 positive patients is likely to be multifactorial.

Very low platelet counts of <20 x 10 9/l, or a sudden fall in the platelet count >50% over 24-48 hours may indicate an immune aetiology.

Other causes of immune thrombocytopenia, such as HIT, MAHA and drugs, should be considered before a diagnosis of ITP is made.

Thrombotic risk associated with ITP

ITP is associated with a mild elevation in thrombotic risk, with a cumulative incidence of 3.2% for arterial

(95% CI, 2.0–5.0) and 1.4% (95% CI, 0.8–2.5) for venous thrombosis at 5 years (Ruggeri et al., 2014). It is unknown how this combines with the many other risk factors for thrombosis in patients hospitalised with COVID-19 and whether the increment is negligible or synergistic. Risk of thrombosis in ITP patients may be slightly heightened by treatment-related factors such as splenectomy and TPO RAs and is higher where there are associated antiphospholipid antibodies.

Recommendation

One should be mindful of a potential further increased thrombotic risk in patients with COVID-19 from ITP or its treatment, although currently this is unknown.

Management of new/relapsed ITP

Like all viral infections, COVID-19 may trigger a new presentation of ITP, as illustrated in a recently published case report (Zulfiqar, 2020), or it may cause relapse in an existing patient. The need to actively treat ITP is unchanged from current consensus guidelines (Provan D et al., 2019) however, the additional potential burden of treatment in the context of the COVID-19 pandemic (for example greater hospital contact and immunosuppression and/or thrombotic risk) need to be carefully balanced against the risks of bleeding from ITP. Treatment decisions may differ depending whether the patient is COVID-19 negative or positive.

First line therapy

Standard first line therapy for the management of new or relapsed acute ITP is prednisolone, given at a dose of 1mg/kg (max 80mg) for 2 weeks and thereafter tapered off, slowly if there is a good response, or rapidly if treatment is ineffective (Provan D et al., 2019).

There are few data to inform whether or not steroids pose a higher risk of the development of COVID-19 infection or worsening symptoms once infected. However, current guidance from the WHO is to avoid steroids if there are alternative treatment options (WHO 2020). In patients who are negative for COVID-19 infection, using thrombopoietin receptor agonists (TPO-RAs) as first line therapy may be the preferred option. This use is off-label and local funding may need to be sought through the COVID-19 Interim Measures scheme. One should be mindful that TPO-RAs can take 10-14 days before an effect is seen and if urgent platelet elevation is needed, intravenous immunoglobulin may be required.

For patients who are COVID-19 positive, the treatment dilemma is even more pronounced. A concern with the use of TPO-RAs for initial treatment is the increased thrombotic potential, which might exacerbate venous thromboembolic risk in a patient with COVID-19. Steroids may be the preferred option for initial treatment. There is concern about higher risks of mortality and secondary infection which were shown in a systematic review of observational studies of corticosteroids in patients with influenza; however, most related to high steroid doses (>40mg methylprednisolone per day) and the evidence was judged as very low to low quality, owing to confounding by indication (Lansbury et al., 2019). Another study that addressed this limitation by adjusting for time-varying confounders found no effect on mortality (Delaney et al., 2016). Finally, a recent study of patients receiving corticosteroids for MERS used a similar statistical approach and found no effect of corticosteroids on mortality but delayed clearance of MERS-CoV from the lower respiratory tract (Arabi et al., 2018).

Whilst further evidence is awaited, steroids may be the better option for COVID-19 positive patients presenting with new or relapsed ITP, however the dose and duration of treatment should be kept to the minimum necessary. Starting doses of 20mg daily (whatever the patient’s weight) may be considered in non-bleeding patients, and increasing after 3-5 days if no response. Long courses of steroids should be avoided, and the usual recommendation of tapering after 2 weeks should be adhered to.

Thrombopoietin receptor agonists

Current licensed TPO-RAs used in the UK include romiplostim and eltrombopag. They are effective in stimulating platelet production, with responses seen from 7 -10 days in the majority of cases.

Concern has been raised regarding their prothrombotic potential. This was supported by a recent in vitro study of samples from 26 patients which showed that those with ITP had increased microvesicle-associated thrombin generation two weeks after initiation of TPO-RA-treatment compared with controls and pre-treatment levels (Garabet et al.,  2020).

Systematic review of trials looking at clinical thromboembolic events has found higher rates in patients on TPO RAs compared with controls (Catala-Lopez et al., 2012) and a long-term clinical study of eltrombopag showed 6% of patients developed arterial or venous thrombosis (Wong et al., 2017). There are similar findings with romiplostim but direct comparison with placebo, showed no increase in thrombotic risk (Cines et al.,  2017, Kuter et al., 2019), however, as expected, risk of thrombosis increases with age (Kuter et al., 2019).

Hepatobiliary events have been found to occur in 15% of patients on eltrombopag (Wong et al., 2017) and the drug carries a black box warning for risk for hepatotoxicity. Although clinically significant liver injury has reported to be uncommon in COVID-19 (Bangash et al., 2020), liver enzymes are usually elevated and the required monitoring of liver function tests throughout treatment with eltrombopag (Promacta®, 2018, Revolade, 2018), would be complicated. Although there are no data on the use of TPO-RAs in COVID-19 positive patients, the risk of hepatotoxicity and potential for increased thrombosis would prompt caution with their use in this setting.

Intravenous Immunoglobulin

Intravenous immunoglobulin (IvIg) may be necessary if immediate elevation of the platelet count is required to control bleeding, although this cannot be relied upon as indicated in a recent case report of ITP occurring in the context of COVID-19 infection (Zulfiqar, 2020). IvIg may also be used as second line treatment if there is failure to respond to steroids. Response usually lasts for 6 weeks or more and may be long enough to cover the worst of the pandemic period. However, administration requires hospital attendance, supply is short and whilst clinical complications are rare, they can be significant.

The role IvIg may play in the management of patients with severe COVID-19 infection is unknown. A small retrospective study from Wuhan suggested that initiation of IVIG as adjuvant treatment for COVID-19 pneumonia within 48 hours of admission to intensive care may reduce the use of mechanical ventilation and promote earlier recovery of patients (Xie et al., 2020). Larger studies are required before any recommendations can be made of the use of IvIg for COVID-19 infection.

Tranexamic acid

Tranexamic acid (TXA) inhibits fibrinolysis and while it is contraindicated in frank DIC, the COVID-19 associated coagulopathy (CAC) does not fulfil the ISTH criteria for DIC. However localised fibrin thrombi occur in the alveolar capillaries and small vessels in association with inflammation and alveolar damage (Fox et al., 2020), and endogenous fibrinolysis breaking down the disseminated thrombi could theoretically aid recovery from this. Therefore, in a bleeding patient with COVID-19 disease, judgement should be made regarding the balance of risks associated with bleeding and thrombosis. If tranexamic acid is used, the duration of treatment should be kept to the minimum necessary. For oral bleeding, tranexamic acid mouthwashes can be given to rinse and spit out.

Interestingly, a recent report in Physiological Reviews proposed that the endogenous protease plasmin acts on COVID-19 virus by cleaving a newly inserted furin site in the S protein portion of the virus resulting in increased infectivity and virulence (Ji et al., 2020). Blunting of this response with tranexamic acid has been postulated to reduce infectivity of the virus and an exploratory, randomised, placebo-controlled, double-blind Phase 2 clinical trial is being established (Ness, 2020).

Immunosuppressant drugs and rituximab

There is concern that immunosuppressant drugs and rituximab increase risk of COVID-19 infection and these should be avoided in new or relapsed patients during the COVID-19 pandemic if possible.

Platelet transfusions

Platelet transfusions are not usually necessary or helpful and should not be routinely offered to thrombocytopenic COVID-19 patients who are not bleeding. In patients with immune thrombocytopenia they are likely to be consumed too quickly to be of value. Platelet transfusions should only be given if it is considered that haemorrhage is life-threatening or in a critical site such as the eyes

Recommendation

There is little evidence to inform the optimal management of a patient presenting with new or relapsed acute ITP.

In patients who are negative for COVID-19, TPO-RAs may be preferred as first line treatment, to avoid corticosteroids which may increase risk of COVID-19 infection during the pandemic.

In patients who are positive for COVID-19, TPO-RAs may potentially increase the thrombotic complications or hepatotoxicity and should be avoided if possible. For these patients steroids may be the preferred option.

If steroids are used as first line therapy, the dose and duration should be kept to the minimum necessary.

Starting dose of 20mg daily may be considered in non-bleeding patients, with increase to 1mg/kg after 3-5 days if there has been no response.

Steroid doses should be tapered after 2 weeks – slowly if there has been good response, rapidly if there is no response.

Intravenous immunoglobulin (1g/kg) may be necessary if immediate elevation of the platelet count is required to control bleeding. It may also be used as second line treatment if there is failure to respond to steroids.

Tranexamic acid in COVID-19 infected patients should be used as required for the management of bleeding in ITP patients, but avoided in those with frank DIC.

Platelet transfusions should only be given if bleeding is thought to be life threatening, or at a critical site.

Management of chronic ITP

Management of patients with chronic stable ITP should not alter because of the pandemic, patients should remain on their current medication, even if this includes steroids and immunosuppressants. However attention to isolation procedures is crucial. The British Society for Rheumatology provides helpful guidance on shielding measures for patients on immunosuppressants (Figure 1).

Patients with splenectomy are probably not at increased risk of COVID-19 infection but are susceptible to bacterial infections and must be vigilant with their prophylactic antibiotics during this time and up to date with their pneumococcal, haemophilus influenza and meningitis vaccinations.

ITP patients not requiring treatment in the last 12 months, or on non-immunosuppressive agents such as thrombopoietin receptor agonists, are not considered to be at increased risk of COVID-19 infection and should comply with self-isolation measures as for all individuals in the UK.

Recommendation

Patients with chronic ITP should remain on their usual treatment.

They should be vigilant with self-isolation and shielding measures as appropriate.

Splenectomised patients should be stringent with their antibiotic prophylaxis and up to date with vaccinations.

Regular patient contact should be maintained and appointments conducted by telephone or online platforms.

Thromboprophylaxis in hospitalised COVID-19 patients

Potential risk factors for venous thrombosis in patients hospitalised with COVID-19 include infection, immobilisation, respiratory failure, mechanical ventilation, and central venous catheter use. Those with or without ITP should be considered for venous thromboprophylaxis, according to NICE guidance. This needs to be balanced against the bleeding risk which is seen in some patients with severe COVID-19 infection, even without thrombocytopenia (Wang T et al., 2020). Low molecular weight heparin is the preferred anticoagulant, with clinical trials showing it to be more efficacious than UFH. It also has anti-complement and anti-inflammatory properties. LMWH should be avoided if platelets are <30 x 10 9/l and intermittent pneumatic compression should be used. The LMWH should be recommenced once the platelet count can be raised above this threshold. Regular assessment of both bleeding and thrombotic risk is essential throughout the course of the hospital stay and upon discharge.

Recommendation

ITP patients hospitalised with COVID-19 should receive LMWH thromboprophylaxis provided platelets are >=30 x 10 9/l and there are no haemorrhagic features.

ITP patients hospitalised with COVID-19 whose platelets are <30 x 10 9/l should receive intermittent  pneumatic compression alone until their platelet count recovers.

Patient information

This is an anxious time for everyone and not least for those with autoimmune diseases. Contact with patients is important and reassurance that services will continue as normal but that outpatient appointments will be conducted by telephone or online F2F platforms wherever possible. Arrangements for blood tests and safe pick-up or delivery of medications should be made clear.

They should be provided with information regarding self-isolation procedures and shielding (Figure 1), maintaining mental well-being, and who to contact if they are feeling unwell with fever and cough or are having difficulty breathing.

They should also be made aware that COVID-19 infection, like all viral infections, may cause a relapse of their ITP and informed who to contact if they think their platelet count has dropped or if they experience bleeding or unusual bruising. 

Recommendation

Hospital attendance should be kept to the minimum necessary, with outpatient appointments conducted by telephone or online face to face platforms where possible.

Patients should be provided with information regarding self-isolation and shielding procedures and given contact arrangements for COVID-19 related symptoms or suspected ITP relapse.

Figure 1

Patients who should be shielding

The Government strongly advises people with serious underlying health conditions to follow shielding measures. Guidance from the British Society for Rheumatology suggests inclusion of the following immunosuppressant regimes 

•          Corticosteroids ≥20mg (0,5mg/kg) prednisolone, or equivalent, per day for > 4 weeks

•          Corticosteroid dose of ≥5mg prednisolone (or equivalent) per day for >4 weeks plus at least one other immunosuppressive medication (e.g. azathioprine, mycophenolate, ciclosporin) or rituximab within the last 12 months.

•          A combination of 2 immunosuppressive medications including rituximab within the last 12 months plus an additional co-morbidity (age >70, Diabetes Mellitus, any pre-existing lung disease, renal impairment, any history of Ischaemic Heart Disease or hypertension).

•          Splenectomy and ongoing immunosuppressive agents. (Authors’ added guidance)

Shielding measures include

1.                  Staying in the home and receiving deliveries of food and medicines as necessary.

2.                  Strict avoidance of contact with someone who is displaying symptoms of COVID-19.

3.                  Avoiding gatherings, including friends and families in private places

4.                  Using remote technology for contact (phone, internet, social media).

5.                  Register for the Government helpline for vulnerable people www.gov.uk/coronavirusextremely-vulnerable or call 0800 0288327

References

Arabi, Y.M., Mandourah, Y., Al-Hameed, F., et al. (2018) Corticosteroid therapy for critically ill patients with Middle East respiratory syndrome. American Journal of Respiratory and Critical Care Medicine, 197:757-767. doi: 10.1164/rccm.201706-1172OC. PMID: 29161116.

Bangash, M., Patel, J., Parekh, D. (2020) COVID-19 and the liver: little cause for concern. The Lancet Gastroenterology and Hepatology, 20 March. DOI:https://doi.org/10.1016/S2468-1253(20)30084-4.

Catala-Lopez, F., Corrales, I., Martin-Serrano, G., Tobias, A., Calvo, G. (2012) Risk of thromboembolism with thrombopoietin receptor agonists in adult patients with thrombocytopenia: systematic review and meta-analysis of randomized controlled trials. Medicina Clinica, 139: 421-429.

Cines, D.B., Wasser, J., Rodeghiero, F., et al. (2017) Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica, 102:1342-1351.

Delaney, J.W., Pinto, R., Long, J., et al. (2016) The influence of corticosteroid treatment on the outcome of influenza A(H1N1pdm09)-related critical illness. Critical Care. 20:75. Epub 2016/04/03. doi: 10.1186/s13054-016-1230-8. PubMed PMID: 27036638; PMCID: PMC4818504.

Fox, S.E., Akmatbekov, A., Harbert, J., Li, G., Brown, Q.,  Vander Heide, R.S. (2020) Pulmonary and Cardiac Pathology in COVID-19: The First Autopsy Series from New Orleans. medRxiv 2020.04.06.20050575; DOI: https://doi.org/10.1101/2020.04.06.20050575

Garabet, L., Ghanima, W., Hellum, M., et al. (2020) Increased microvesicle-associated thrombin generation in patients with immune thrombocytopenia after initiation of thrombopoietin receptor agonists. Platelets 31: 322-328, DOI: 10.1080/09537104.2019.1639655

Guan, W., Ni, Z., Hu, Y. et al. (2020) for the China Medical Treatment Expert Group for COVID-19. Clinical Characteristics of Coronavirus Disease 2019 in China.  New England Journal of Medicine.  February 28.
DOI: 10.1056/NEJMoa2002032

Huang, C., Wang, Y., Li, X. et al. (2020) Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China, The Lancet. 395:497–506. https://doi.org/10.1016/S0140-6736(20)30183-5.

Ji, H.L., Zhao, R., Matalon, S., Matthay, M.A. (2020) Elevated Plasmin(ogen) as a Common Risk Factor for COVID-19 Susceptibility. Physiological Reviews. 100:1065-1075. DOI: 10.1152/physrev.00013.2020. Epub 2020 Mar 27.

Kuter, D,J., Newland, A., Chong, B.H., et al. (2019) Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies. British Journal of Haematology. 185:503-513.

Lansbury, L., Rodrigo, C., Leonardi-Bee, J., Nguyen-Van-Tam, J., Lim, W.S. (2019) Corticosteroids as adjunctive therapy in the treatment of influenza. Cochrane Database of Systematic Reviews, 24;2. DOI: 10.1002/14651858.CD010406.pub3.

Lippi, G., Plebani, M., Henry, B.M. (2020) Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19)infections:A meta-analysis.ClinicaChimicaActa 506:145-148. https://doi.org/10.1016/j.cca.2020.03.022

Ness, T. (2020) Tranexamic Acid (TXA) and Corona Virus 2019 (COVID19) in Inpatients (TCInpatient). ClinicalTrials.gov: NCT04338126

Nijsten, M.W., ten Duis, H-J., Zijlstra, J. et al. (2000) Blunted rise in platelet count in critically ill patients is associated with worse outcome. Critical Care Medicine 28:3843–3846.

PROMACTA® (2018) (eltrombopag) tablets, for oral use; PROMACTA® (eltrombopag) for oral suspension [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.

Provan, D., Arnold, D., Bussell, J. et al. (2019) Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Advances 3:3780–3817.

Revolade (2018). Revolade (olamine) [summary of product characteristics]. Dublin, Ireland: Novartis Europharm Limited.

Ruggeri, M., Tosetto, A., Palandri, F. et al. (2014) for the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Anemia and Thrombocytopenias Working Party. GIMEMA Study ITP0311. Thrombotic risk in patients with primary immune thrombocytopenia is only mildly increased and explained by personal and treatment‐related risk factors. Journal of Thrombosis and Haemostasis, 12: 1266– 73.

Wang, T., Chen, R., Liu, C. et al.(2020) Attention should be paid to venous thromboembolism prophylaxis in the management of COVID-19. The Lancet Haematology. April 09. DOI:https://doi.org/10.1016/S2352-3026(20)30109-5

Wong, R., Saleh, M., Khelif, A., et al.  (2017) Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood 130: 2527–2536. DOI: https://doi.org/10.1182/blood-2017-04-748707

World Health Organisation. Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. Interim guidance 13 March 2020.

Xie, Y., Cao, S., Li, Q. (2020) Effect of regular intravenous immunoglobulin therapy on prognosis of severe pneumonia. Journal of Infection, DOI: https://doi.org/10.1016/j.jinf.2020.03.044

Zhou, F., Yu, T., Du, R. et al. (2020) Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet 395:1054-1062

Zulfiqar, A-A., Lorenzo-Villalba, N. (2020) Immune thrombocytopenia in a patient with COVID-19. The New England Journal of Medicine, April 15.

 

Webinar: ITP and Covid-19 Q&A - 16th April - Full Recording

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Webinar: ITP and Covid-19 Q&A - 16th April - Full Recording

The United Kingdom ITP Support Association has a proud record spanning 25 years, providing trusted resources and advice for those living life with ITP.

We are acutely aware from the many emails, letters and telephone calls we have received from around the world during the Coronavirus emergency that patients and caregivers managing ITP have specific questions and concerns related to COVID-19 and their condition.

Please join Mervyn Morgan CEO, Prof. Adrian Newland CBE and Rhonda Anderson from the ITP Support Association as they facilitate your questions to a team of World-Renowned ITP experts, Dr. Drew Provan, Dr. Sue Pavord and Dr Quentin Hill.


 
 Full recording


 
Webinar Speakers
 
Professor Adrian Newland is Professor of Haematology at Barts and The London School of Medicine and Dentistry.  He has a long term interest in ITP studying new treatments and the understanding of the disease. With his colleague Drew Provan, he established the UK Adult ITP Registry at Barts and has published extensively on ITP. He is chair of the Trustees of the UK ITP Patient Association.
 
Dr Drew Provan is Emeritus Reader in Autoimmune Haematology at Barts and The London School of Medicine and Dentistry in London, UK. Dr Provan’s research interests include immune thrombocytopenia (ITP), neutropenia and haemolytic anaemia. Along with international colleagues, Drew has recently published the Revised International Consensus Guidelines for the diagnosis and management of ITP in children and adults in Blood Advances.
 
Dr Sue Pavord is a Consultant Haematologist at Oxford University Hospitals and Associate Senior Lecturer in Medicine. Her special areas of interest are obstetric haematology and bleeding disorders, with a particular interest in Immune Thrombocytopenia.  She is co-founder of the UK Obstetric Haematology Group and joint editor of The Obstetric Haematology Manual . Sue runs international courses on haematology in obstetrics, has over 100 publications and book chapters and has authored national and international guidelines relating to the management of haematological disorders in pregnancy.
 
Dr Quentin Hill is a Consultant Haematologist at Leeds Teaching Hospitals and an Honorary Clinical Associate Professor at the University of Leeds. His areas of specialist interest include red cell disorders and immune haematology and he has been particularly involved with studies in Immune Thrombocytopenia and Autoimmune Haemolytic Anaemia and has interests in both treatment effectiveness and quality of life. He is Chair of the UK ITP Clinical Forum and has published widely on the subject of ITP.

Mervyn Morgan is the CEO of the ITP Support Association in the United Kingdom.

Rhonda Anderson is the Senior Patient Mentor at the ITP Support Association and has been with the Charity for many years. Rhonda produces various articles for the Associations Quarterly Journal ‘The Platelet’.

We would like to thank our webinar sponsors and supporters for making this event possible.

Coronavirus (Covid-19) - Updated Information Statement from the ITP Forum & ITP Support Association - 23rd March 2020

Coronavirus (Covid-19) - Updated Information Statement from the ITP Forum & ITP Support Association - 23rd March 2020

Information for adult patients with immune thrombocytopenia in the setting of COVID-19 pandemic (Please note this equally applies to children)

Immune thrombocytopenia (ITP) is not considered a ‘serious’ health condition in the situation of the current COVID-19 pandemic. However, we are sure you and your families are concerned about the risk of coronavirus infection at this time and want to provide some guidance on what you should do as a person who has ITP.

The large majority of people who contract coronavirus can stay at home to recover and do not need to seek medical advice unless their symptoms worsen.

It is also worth remembering that, like any viral infection, the coronavirus infection might trigger an episode of ITP.

Some of the treatments used for ITP will affect your immune system and may reduce your ability to fight the infection. These treatments include:

Prednisolone (steroid)

Mycophenolate Mofetil (Cellsept)

Azathioprine

Cyclosporine

Vincristine

Rituximab (given in the past 12 months)

Splenectomy (patients are advised to be diligent with their antibiotic prophylaxis and be up-to-date with their vaccination schedule)

Neither Romiplostim (N-Plate) nor Eltrombopag (Revolade) will affect the immune system and risk will depend on other treatments being received at the same time or in the recent past.

Any change in ITP medication should be discussed with your ITP centre and should NOT be discontinued unless advised.  If you think your platelet count is low, please do not attend your centre without phoning first and a plan of action can be determined. This may be simply a change in treatment or you may be asked to come to the centre at a specified time, to minimise your wait.

Many ITP consultations can be done through telephone conversations and some centres may have a nursing team who can come to your house to take blood tests and review how you are. You will then not need to travel or wait in hospital. You will then be advised about dosing of medication over the phone. Your Centre will be able to advise you on the best course of action and how to access care.

As in any other circumstances, if there are any bleed-related symptoms, please contact the ITP centre.

If you do need to seek medical attention with corona virus infection, please ask the health-care professional to contact your ITP centre

Please follow the national guidance for isolation, which is being updated daily on the NHS website or on the UK government website.  

The following should also be discussed:

Delay non-essential travel

School: follow issued advice by the authorities as per other children

Work: explore options to work from home as appropriate

Advice on social distancing is given here (updated 23rd March 2020):

https://www.gov.uk/government/publications/covid-19-guidance-on-social-distancing-and-for-vulnerable-people/guidance-on-social-distancing-for-everyone-in-the-uk-and-protecting-older-people-and-vulnerable-adults

And the latest guidance on staying at home can be found here:

https://www.gov.uk/coronavirus

Additional advice has now been published on shielding and protecting people defined on medical grounds as extremely vulnerable from COVID-19 (21st March 2020).

https://www.gov.uk/government/publications/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19

This provides advice on some additional actions to reduce the risk of contracting COVID-19.

People defined as extremely vulnerable includes people on immunosuppressive therapies sufficient to significantly increase risk of infection.  Since that risk varies, the British Society of Rheumatology has published guidance on how to stratify risk.  The full guidance can be found on their website https://www.rheumatology.org.uk/News-Policy/Details/Action-needed-coronavirus-identifying-high-risk-patients but a summary of that advice as it relates to typical ITP treatment is written below.

Consider you have a significant increased risk of infection (extremely vulnerable from COVID-19) if taking:

  • Corticosteroids ≥20mg (0,5mg/kg) prednisolone (or equivalent per day for more than 4 weeks
  • Corticosteroid dose of ≥5mg prednisolone (or equivalent) per day for more than four weeks plus at least one other immunosuppressive medication (e.g. azathioprine, mycophenolate, ciclosporin) or rituximab within the last 12 months.
  • A combination of 2 immunosuppresive medications including rituximab within the last 12 months plus an additional co-morbidity (age >70, Diabetes Mellitus, any pre-existing lung disease, renal impairment, any history of Ischaemic Heart Disease or hypertension)

Most patients with controlled disease and no major co-morbidities receiving a single immunosuppressive therapy would be considered to have moderate risk and take standard advice on social distancing and staying at home.  However some individuals on a single immunosuppressive therapy may have other concerns or high-risk circumstances and following individual risk assessment be advised to follow guidelines for the extremely vulnerable.

Coronavirus (Covid-19) Latest UK and Ireland Governments, WHO, NHS guidance and other trusted sources of info.

COVID-19 is a new illness that can affect your lungs and airways. It's caused by a virus called coronavirus. Below are links to various NHS and UK Government pages that contact the latest advice on coronavirus.

Get coronavirus (COVID-19) advice

Find out what to do if:

you think you have symptoms

you might have been exposed to the virus when travelling

https://111.nhs.uk/covid-19


NHS Digital - Shielded Patient List

https://digital.nhs.uk/coronavirus/shielded-patient-list


Overview - Coronavirus (COVID-19)

https://www.nhs.uk/conditions/coronavirus-covid-19/


Coronavirus (COVID-19): latest information and advice from the UK Government

Information for the public on the outbreak of coronavirus, including the current situation in the UK and information about the virus and its symptoms.

https://www.gov.uk/coronavirus


Coronavirus (COVID-19): latest information and advice from NHS Wales

https://covid19-phwstatement.nhs.wales/


Coronavirus (COVID-19): latest information and advice from NHS Scotland

https://www.scot.nhs.uk/coronavirus-covid-19/ 


Coronavirus (COVID-19): latest information and advice from the Government of Ireland

https://www.gov.ie/en/publication/472f64-covid-19-coronavirus-guidance-and-advice/


 

The BSH aim to provide members with both general and haematology specific up-to-date COVID-19 information.  

https://b-s-h.org.uk/about-us/news/covid-19-updates/


World Health Organization Logo

The latest Covid-19 updates from the WHO.

https://www.who.int/emergencies/diseases/novel-coronavirus-2019


The latest Covid-19 information from our colleagues at the PDSA in the United States of America

https://pdsa.org/covid-19


 

COVID-19 Global Updates & Resources

https://globalitp.org/index.php/covid-19