Pegasys and Pericarditis?

[MPNBlog]

I’d like to ask if anyone else taking Pegasys has had issues with pericarditis/myocarditis? I have now had 5 Emergency Department admissions since 2019. Underlying cardiac problems have been ruled out. It is unclear what is causing the problem, but as a precaution It's been suggested to stop Pegasys. I can’t take HU (platelets cycle wildly). So if I stop PEG I have the challenge of finding other cytoreduction options. Anagrelide and Busulfan don’t look attractive! PV dx2017, over 70 yrs so high risk. Any insights would be valuable. Thanks!

[Fizzydog]

Hi during the first year on Pegasys it affected my liver counts so they reduced the dosage from weekly to monthly and it levelled out ok. I’ve been fine ever since and this was three years ago. So I can’t really help answer your question sorry. I hope you get it sorted out ok, thinking of you

[MPNBlog in reply to Fizzydog]

Hi Fizzydog, Thanks for your reply and wishes. My Peg injections have been reduced to monthly (45ug) too, and while the counts are all good, the recurrent pericarditis has still occurred. Other tests have been done to find an answer - full cardiac testing, autoimmune tests, infectious diseases panel - but all come back negative (which is good). I'd like to keep taking PEG when it's the only disease modifying drug, but stopping it is about the only other next step. Do hope someone else has a suggestion, but it does seem rare. Thanks again.

[hunter5582]

While arrhythmias are a more common adverse effect of Pegasys, apparently there can be a rare case of pericarditis. ncbi.nlm.nih.gov/pmc/articl...

Suggest this needs a collaborative review with a MPN Specialist and a cardiologist. Another option not on your list is Jakafi. There is also a new drug in clinical trials - Bomedemstat.

Very good idea to review all of your options with a MPN Specialist.

[MPNBlog in reply to hunter5582]

Hi Hunter. Thanks for your reply and the information. This site is so helpful. My haematologist and cardiologist are prepared to collaborate, so that's good. Thanks for the link to the article - it's very interesting. I will take it to the next appointments. I have gone through many of the tests mentioned, and as they report, they are all negative. (I also have had a consistent cough while on Peg). I will look into Jakafi - I think it's very expensive where I live and it's not on the government benefit list for PV, only for post-PV MF, which may be why it hasn't been suggested. I will check out Bomedemstat too. My haem looked up possible trials and couldn't find one. On 12 May 2022 the maker has applied to FDA for a Phase 3 trial in ET, but not PV, but they do have a Phase 2 trial for use in PV. I will keep an eye on it. Your advice is much appreciated. Best wishes.

[hunter5582 in reply to MPNBlog]

I believe you are in Australia. My understanding is that Jakavi and Besremi have not yet been approved for PV there. You are correct that both are quite expensive ($165,000 - $180,000 USD / year). I hope you will have access at some point. The other PV med in clinical trials is rusfertide, which is very promising. Unfortunately, I do not think the trials are available in Australia.

Hope you get it all sorted soon.

[MPNBlog in reply to hunter5582]

Hi Hunter. Yes, I'm in Australia. And you are right that Besremi and Jakavi aren't approved for PV here. With a much smaller population than the US we aren't a good location for drug companies to conduct clinical trials, or to put in submissions to our equivalent of FDA which is very conservative. Hence we miss out on a lot of opportunities, or they are quite delayed. Very strong cases need to be mounted by the drug companies to have drugs added to the benefits list, especially if there are other cheaper drugs available. With a small population, there isn't the financial benefit to them to make it worthwhile. Haem thinks we will eventually have access to Jakavi but it will take years; and we may not get access to Besremi because of its cost (though if PEG is causing me toxicity, it's likely that Besremi as an alpha interferon will have the same problem for me.) I will check out Rusfertide. I really need some options. I tolerate venesections well to control rising Hct, but the haem is worried about the platelets rising which will be inevitable after a few months . Your suggestions are appreciated. Many thanks.

[hunter5582 in reply to MPNBlog]

Access to meds can be a struggle in many places, particularly when they are so expensive. There is some thought that Besremi may be easier to tolerate due to its mono-pegylated formulation. I expect that ay be true for some but not all.

While the venesections will help control the erythrocytosis, the resulting iron deficiency can cause its own problems. this includes reactive thrombocytosis. I experienced an increase of 200K due to the venesections/iron deficiency. Other issues too (decreased energy/concentration, alopecia).

Hope you find some solutions soon.

[MPNBlog in reply to hunter5582]

I discussed Besremi with Haem. I had read the monopegylated version was causing less side effects and I thought about trying to advocate for it in AUS or to get on an AUS trial. However, haem thought that if PEG is causing the pericarditis, Besremi may cause the same - apparently the alpha interferons tend to have similar profiles (even regardless of dosage). When discussing clinical trials, haem thought 'failure' on PEG would be a contraindication for being approved to participate in any other alpha interferon trials too. So I'm getting a few dead ends at the moment.

[hunter5582 in reply to MPNBlog]

I do understand that reasoning and tend to agree. My reactions to Pegasys and Besremi have been the same. If you can't get Jakavi approved on compassionate grounds then you may have to try a combination of anagrelide and venesections. If that works - great. If not,then all the more grounds to seek Jakavi.

[MPNBlog in reply to hunter5582]

Hi Hunter. Have you ever used anagrelide? I don't like the sound of it, and even the haem doesn't like it, which is why we didn't go down that route last pericarditis episode.

[hunter5582 in reply to MPNBlog]

I have not used anagrelide. It is a second-line treatment option for a reason. However, when you compare it the the potential adverse effects of hydroxyurea, the list for anagrelide is actually shorter. Frequency may be the issue. There are others on the forum who responded poorly to hydroxyurea but did well on anagrelide. There are those who cannot tolerate anagrelide. We are all different in how we respond.

Like you, I cannot tolerate hydroxyurea. It is just too toxic. I have responded well to Pegasys/Besremi with only minimal side effects. It appears that you may not be able to tolerate Pegasys. The obvious next choice would be Jakavi. Here in the USA it is FDA approved for PV as it is in other countries too. Note that hydroxyurea is actually not FDA approved for PV. It is just cheap so the insurance companies don't care if it is used off label.

It is unfortunate that your healthcare system has not caught up in approving Jakavi for PV yet. If you are unable to get it approved though an appeal, then your options are limited. Anagrelide is the only other drug in the system left to try. I would not consider busulfan as it is a third-line option and has significant risks.

I have no knowledge of how an appeal for the use of Jakavi would work in your healthcare system. I suspect you would have an even stronger case if your try anagrelide and it does not work/cannot tolerate it. You do have the option of treating the PV with venesection-only and ignoring the platelet levels other than taking a blood thinner. Not sure whether that is an acceptable option given your profile.

If you are not already seeing one of the MPN Specialists in Australia it may be worth a consult. Perhaps that doc would have a better idea of how to pursue Jakavi if that is what you would prefer. mpnforum.com/list-hem./

All the best in your quest for a desirable treatment plan.

[MPNBlog in reply to hunter5582]

Hi Hunter. Thanks very much for your considered reply. My haem is an MPN expert, it just seems that the options here aren't as good as they could/should be. I will follow up the leads and advise this forum if I find a solution in case it helps others. Many thanks.

[Meatloaf9]

Hi, probably not applicable for you but have you had covid? It seems that long covid is being found to cause more and more long term problems. Hope you get answers soon. Best.

[MPNBlog in reply to Meatloaf9]

Hi Meatloaf. Thanks for your post. I haven't had Covid. I'm very careful and wear N95 masks if I go out, and I have had 3 primary vaccinations and a booster. I've been advised not to get another booster until the pericarditis is sorted out, so I'll need to continue to be careful. Best wishes.

[Kinsale]

Hi. I have ET and Jak2+ Live in Australia and have been on Peg for 4 years. In the first year of taking Peg (the end of 2019) whilst in the UK I got suspected pericarditis. Upon returning to Oz, I got another less stronger bout. The next bout occurred last month after I had my 4th Covid vaccine (Moderna - first time I had that vaccine). I had a shocking reaction to it however again the same symptoms occurred as the previous two times and went to the Emergency Department. The consensus was that it seemed the moderna jab had triggered a myo/pericarditis reaction. There isn’t much awareness/knowledge re these rare events. To be honest I now accept that these events may occur and I keep a watching brief re my health in case they occur again. Cheers

Mark

[MPNBlog in reply to Kinsale]

Gosh. That's sobering Mark. No-one talks about these things. From your experience, the advice to avoid the next Covid booster for now sounds like a good idea. I've had x2 AZ, x1 Pfizer and then a Moderna Booster in January. I felt like I'd been hit by a truck with the last one, (no reaction with the other ones) but no pericarditis thank goodness. The first bout of Pericarditis in 2019 was the worst I've had, partly because I didn't know what was happening and went to the hospital a bit too late. So by then troponin was quite high and there was panic that I was having a heart attack, so they did a coronary angiogram with a wire through the R arm - something I don't want to do again unnecessarily. I've gone in earlier for the other bouts because I knew what's happening. Also the cardiologist has prescribed Colchicine and says to take extra tablets of those.

I've done a bit of research and pericarditis with PEG is extremely rare. Most of the articles I can find are about cases in Hepatitis or melanoma patients. I've only found one article from 2014 of a patient with an MPN (PV) . That article notes that in a lit review they did, they only found 7 pericarditis/interferon-alpha cases (regardless of underlying disease) over the previous 2 decades. So it's quite a challenge.

I'll DM you about where you live and who is treating you if that's OK. I need some answers, so any information I can get is much appreciated. Best wishes.

[Kinsale in reply to MPNBlog]

Hi MPNBlog. In regards to Covid vaccines, I’m still a big fan as I know they have protected me during the last 2+ years. Like you I’ve had 2 AZ, 1 Pfizer and the last was the Moderna. If my haematologist said get a 5th jab I would but not Moderna based on my last experience. I’d go with another jab of Pfizer. I’m happy to provide any info that you might need. Cheers

Mark

[MPNBlog in reply to Kinsale]

Hi Mark, I also am pro vax. Haem suggested asking the cardiologist about Novavax for next booster. But I've read it also has resulted in cases of pericarditis, so I'll be interested to see what he thinks when I visit mid-June. I'm being extra careful in the meantime, given there are still 20 deaths on average per day from Covid in NSW and about 40/day nationally.

[JohnSC]

Hi,Yes, I had pericarditis and pleural effusions that were attributed to Pegasys.

I had to be admitted to cardiac critical care we’re stopping Pegasys and being prescribed strong anti-biopics resolved the infection.

I have since started on Besremi with no adverse effects.

[MPNBlog in reply to JohnSC]

Hi JohnSC, Thanks for your reply. I read your other posts and I'm amazed at what occurred. Sorry to hear about the heart damage. Pericarditis from Pegasys toxicity does seem to be a thing, though quite rare. it seems very ill-understood here in Australia at least. So thanks for the information and I will add your case details (not your name) to the information I'm compiling to try to get a conversation going here with all my specialists. Your description in particular indicates that I can no longer take the risk on PEG and need to find another solution. As above, the options are limited.

Glad to hear that Besremi is going so well for you, that's good news. Best wishes.