As said before, my brother started Besremi recently. And since then I am doing some researches about the safety of drugs for PV and other MPN. To ease my anxious, I guess, my brother sent me a slide seems from Pharmaessential (the mfg of Besremi), as above.
The title of the slide is "Besremi is far safer than Pegasys and Jakafi". It showed that Jakafi and Pegasys seem to have way more serious adverse events than Besremi? The source of data suggests it was from FAERs, which seems to be the FDA's data base but I can't verify the numbers. Maybe I am doing it wrong?
I have not seen the data presented this way before. Not sure that it can be taken as accurate. My own experience is that there is not much difference between Besremi and Pegasys. Theoretically, Besremi will be easier to tolerate than Pegasys due to its monopegylated formulation. Whether this is true remains to be seen.
I do take Besremi. I am doing fine on it. The medication is both effective and very easy to tolerate.
I am doing very well, thank you. I am very glad I opted for treatment with the interferons. My quality oflife has improved and I am achieving treatment success with minimal side effects. I think what matters most is to have an individualized treatment plan. We each respond differently to the treatment options. There is no one-size-fits-all solution.
Hmm, I’d be inclined to take the title ‘Besremi is far safer than Pegasys and Jakafi’ with a pinch of salt! It’s important to remain cautious of bias too.
From the link, and of particular significance:
‘Existence of a report does not establish causation: For any given report, there is no certainty that a suspected drug caused the event. While consumers and healthcare professionals are encouraged to report adverse events, the event may have been related to the underlying disease being treated, or caused by some other drug being taken concurrently, or occurred for other reasons. The information in these reports reflects only the reporter's observations and opinions’.
In relation to your anxiety.
There are members on the forum doing very well on Besremi, hopefully your brother will be just fine too, and remember he will be monitored well. He’s lucky to have a sibling advocating so strongly on his behalf.
Thank you so much. My brother-my older brother actually, always complains that I am becoming more and more like our mom after she left us. I feel there's some truth in it. Just like my mother, I tend to worry too much. Sometimes I envy brother for being able to just let things be.
Also thank you for bringing up FDA's own note on the data limitation. I read that part before but did not link it with the charts on the slide. Panicked in trying to figure out how to use the FDA website. Totally agree with you about the chart could cause enormous anxiety for Pegasys and Jakafi users. Even I was so shocked as I remember my brother discussed with his doctor whether he should use Pegasys or Besremi...It's not right to use data in this way and now I know it, thanks to kind people here.
Not credible IMHO. I am one of several PV patients who could NOT tolerate Besremi, but have no trouble tolerating Pegasys.
Dry eyes, rapid heartbeat, elevated blood pressure, loss of exercise stamina, bad joint and muscle pain when on Besremi, but not Pegasys. All that suffering without a corresponding improvement in blood counts.
Jakafi is also used for MF patients to decrease the size of their spleen. So comparing death rates makes no sense at all. I see no indication these were only PV patients.
Thank you for bring up this point. I should be more careful when reading manufacturer's information. Like what I replied below, I am a bit surprised to know that there were so many problems in this slide...I thought pharma companies are not allowed to do so...
OK, I sent the slide to my friend who works in the pharmaceutical industry, and here is his response. Just like mhos61 reminded, there are problems with this kind of use of data.
"Hi Lilly, FAERS is the abbreviation for FDA Adverse Event Reporting System, and it is indeed the official system of the FDA. I am not familiar with the three drugs mentioned in the slide, nor have I checked if the numbers are accurate.
However, my initial reaction is that if a pharmaceutical company uses this slide for marketing, they may get itself into trouble. Anyone familiar with the FAERS database knows that the reported events does not imply causality and the reports are often incomplete.
Compliance is another issue. The FDA does not allow any comparative claims without sufficient scientific basis, which means that pharmaceutical companies cannot advertise their drugs as safer or more effective than others without strong scientific evidence. I am pretty sure that if there is only FAERS data, the FDA will not buy it."
Thank you for letting me know your friend's response. It sounds quite logical. Should be more careful about the info provided by the manufacturer from now on. A good lesson learnt.
frankly I think this is BS at best and very misleading. In a recent presentation at the doc to doc conference in NY Dr Gisslinger showed a slide that in fact Besremi drop out due to sides was a bit higher than Peg. Some are better on Bes and vice versa and believe it or not some are better on the original non Peg Inf. from what I read and hear Bes and Peg are similar. As for Jakavi and Pegasys , saying they is more dangerous than the Bes is rubbish. I don’t know where those charts came from but I would discard them. I would like to see the full supporting data and report. As somebody mentioned one can factor in that up to now Jakavi is prescribed more for MF but there is nothing in these charts to show that. Very misleading , so if anyone is worried looking at those charts forget it, I think they are incorrect and possibly a fabrication for some reason.
Thank you for the useful input. Before, I only feel the figures to be somewhat weird. Now I know its not the best way to present the relevant data... It was not my intention to spread problematic info. To be honest I am a little bit shocked to see a pharmaceutical company does this (or it is actually quite common??). Now I learnt that I should be more careful about the data provided by the drug company, and will let my brother know as well. I hope his doctor's decision making is not influenced by this kind of practice...
I agree with what others are saying here about the accuracy/completeness of this information. But, going back to the underlying issue, which I think is whether you should worry about your brother…
All of these drugs, like many drugs, have potentially serious side effects. My spouse worked in the pharmaceutical industry for years, and she said the Besremi prescribing information included a longer list of scary side effects than she’d almost ever seen (including a black box warning).
But the pharma companies have to report all that, even if the side effects happen to a small number of people. I started Besremi because I believed the upside was worth giving it a try. My doctor monitored me for any concerns with the drug, and I kept notes on how I was feeling. I’m tolerating it well, and it’s doing its job.
All three of these drugs do good things if patients can tolerate them. Given the alternative, I think it’s worth a shot and worth tolerating the tolerable side effects. You’re a good sibling for worrying about your bro! He’s lucky to have you.
Thank you very much for your patient explanation. It is really reassuring to know other's positive experience with the drug. Funny enough, deep down in my mind I know that doctors know better than me and even my brother himself is not worrying, but part of me just don't let it go. I guess I need to stop scaring myself Thanks again.
Besremi is relatively still new, I think only 2 or 3 years and it is hard to make comparisons this early in the game. I am currently on Peg and I want to switch to Besremi, but only because it is administered every 2 weeks instead of weekly.
First, the FDA expressly warns that AE reports do not mean causality, and this slide just ignores it.
Second, I can tell you, the figures are WRONG, and VERY WRONG.
I looked into the FDA link you mentioned, and it provides that in 2022, among 4806 Jakafi AE reports, only 608 record death of the patient and 1926 recorded serious AEs (including death). It's less than 13% and 40% respectively.
And how many does the slide show? 40% death and more than 70% serious AEs among all reports! That's just so wrong.
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Thanks again. 
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