Hi all, good morning and wish you all a wonderful holiday.
I had a conversation with a friend about the difference in efficacy between old and new interferons. He claimed that the efficacy of older IFNs is only about half of Besremi, based on what the manufacturer Pharmaessential claimed in this slide, which seems to that less than 50% of patients using other IFNs achieve CHR, but Besremi is close to 80%. I have to say I am very skeptical about this information. First of all, from the slide it is clear that Besremi's close to 80% CHR is a result of 6-7 years of continued use. I doubt any of the other trials of other IFNs has the same duration. Second, I wonder if the result would be different if Pegasys is further isolated from other IFNs. Considering that my uncle is using Pegasys now (for ET), and that this Pharmaessential company has a history of what in my opinion irresponsible advertisement with misinformation, I'd like to seek second opinion, that is, to check with all of you if you've seen similar data or what your experience if you have ever switched between Pegasys/besremi. Thank you!
Sam
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SamHathaway1800
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I chose to switch from Pegasys to Besremi when it received the FDA indication for PV. Theoretically, Besremi could be easier to tolerate in higher doses due to its monopegylated formulation. I have not found it to be any different in terms of tolerability nor efficacy. I would note that I have no doubt that the pegylated interferons are a better choice than the older non-pegylated interferons.
Thanks for sharing. You have been very kind and helpful to other members. It is reassuring to hear that both Pegasys and Besremi works well for you. Wish you a great new year.
This is a timely topic of conversation with my MPN expert right now given the global shortage of Peg. I will likely be switching to Besremi (temporarily) until they can get the Peg supply situaiton sorted. My MPN specialist does not expect any difference in efficacy and (hopefully) in ability to tolerate/side effects between the two. My personal results on Peg have been amazing (CHR within two years and very limited side effects) and I hope they will continue on Besremi (until I move back to Peg).
Thank you for sharing. Glad that Peg works for you. Hope Besremi will works well for you too, should you ever need to switch to it. Wish you a great new year.
While Bes is an excellent product I agree with essence of your statement "Pharmaessentia company has a history of what in my opinion irresponsible advertisement with misinformation" But I'm not aware of misinformation, rather "selective" information.
See end for one reason I feel that way.
On "I doubt any of the other trials of other IFNs has the same duration." there actually is one that is familiar to regulars here. See the modified Ropeg plot here with results from Silver MD Myeloproliferative Neoplasm (MPN) Center's long term study (~30 years):
I added the green line and MFS, EFS notes. The original plot from the Silver study, Fig 1C in link above, looks less favorable because its timeline is ~30 years. I took the 7 year portion to match the Ropeg promotion. Note the "old" IFN actually looks better with a 1.0 value thru this period. This study included not just PEG, but even earlier IFN's likely including non-pegged since it dates to pre-peg era and they call it "rIFNa" ( recombinant interferon-alpha) a common term for non-pegged. These tended to be more toxic than pegged types.
Caveat: Ropeg reported EFS (event free), while Silver reported MSF (MF free). So Silver leaves out thromobotic events and the like which would favor their results. The control, HU, is a bit higher in Silver, ~0.87 vs 0.83 for Ropeg which may reflect this effect. Either way it's clear the "old" IFN does at least as well for a top concern of most MPN pts, progression.
Members here on PEG are in general doing fine. For me Ropeg was very toxic with a one-of-a-kind event, it is still IFN with the same known uncommon to rare risks.
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For reference the plot you found is from the company investor promo here:
An issue I have with P-Essentia is their communication by omission on the allele plot. They have a plenty good product and should be honest with every detail. In their studies and promos they consistently leave out the 6 and 7 year result even as they say right here they have results past 7 years. See my next reply for the plot.
This is the 5 year mutation (VAF) result from the current promo linked above. They substantially changed the prior plot design so this would have been a good opportunity to update it. But a 6 year update changed the type of info reported, omitting new median VAF data. Buried in some reports is an indication the VAF started to rise similar to the orange line. PEG shares this effect on the median as I've posted, and nothing wrong with it. But P-E should be more open as a way to maximize trust.
I knew I came to the right place to ask my questions! Your response is so thorough and includes many details I hadn’t considered before. For instance, I didn’t know that Dr. Silver has a 30-year follow-up study—this is incredibly helpful. I also realized that my original phrasing wasn’t very precise. I should have said that Pegasys doesn’t seem to have long-term follow-up data post-RCTs like Ropeg does—or at least I couldn’t find any. So, comparing Ropeg’s 7-year data following a clinical trail to other data without disclosing the average treatment duration (or even the treatment setting) might not be a very fair statement?
Your detailed analysis of how VAF is presented is also impressive. I hadn’t noticed those issues before. Thank you for pointing them out.
As for misinformation, my concern mainly stems from reading a previous post by another member who mentioned that the P-E company claimed Pegasys and Ruxolitinib had far higher side effects and even mortality rates compared to Besremi. This made me very anxious at the time. Let me see if I can find it...
Regardless, I deeply appreciate your helpful insights and have learned so much from you. It’s unfortunate that Besremi hasn’t been effective for you, but I hope other treatments can improve your condition. Wishing you a Happy New Year!
I came across this actual P-E report yesterday. I should have saved it, I 'l look. But seeing the very high Rux fatalities, and conversely very low Rux skin incidents (HR ~0. 5 I recall) , both contravene known Rux properties for PV, so this report has low credibiity.
I know, right? It is ridiculous to say such irresponsible thing only to promote the sales of its own product. Imagine how concerning some patients on Rux would be seeing those numbers.
This study likely generated many reports, probably some familiar that we've posted on. Worth a deeper look, there must be some good data on the mutation and blood counts. But the dates indicate it didn't get well into the post 5 year period that remains a question on VAF reductions.
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On the morals of P-E, this is them losing an important arbitration by AOP, the company who ran the pivotal Euro trial for Bes. My understanding is P-E tried to market Bes directly in Euro to the exclusion of AOP after AOP spent great resources on the trial. P-E does have direct marketing in the US and elsewhere i believe.
Bes was actually very effective for me, perfect bloods, even on 50-70mcg, and VAF reduced by half in ~11 months. No liver elevations too, all as if I had no MPN at all. But I did have bad malaise on an excess dose of 140. I've also responded well to HU and Rux. But Bes for me ended uniquely tragically, you can see my post "Last Dose". Agree on the other treatments for the other evil, there are none for now.
Thank you. I didn't know that PEG also has a phase 3 RCT. Thank you for telling me.
I searched the arbitration you referred to and found this: jusmundi.com/en/document/de... I assume it is the same one? I think that speaks quite something about P-E's integrity.
I checked your post - so sorry to hear that you have to gone through the rare side effects of besremi. I hope you are doing well now.
I didn't know about that RCT either till I looked for here. It should explain how Euro members get ready access to PEG for both ET and PV.
That is the arbitration. One random excerpt " AOP's research led to the discovery of P1101's (Bes) potential for treating polycythemia vera (PV)." If this is true then AOP is really a primary inventor. (I am one my self so I get it) In drugs, a new use can be a separate invention subject to extended claim terms.
Thanks for the wishes. Unfortunately Sjo is usually progressive and treatments are largely palliative. So it's only downhill for me, males are a further worst case. But Tx are on the way in ph 3. Autoimmunes are in the severe black box warning for both IFNs and have been reported here, so the risk is real. (thyroid effects are a separate area) But there is usually time to act, my instant irreversible crash upon a single dose is not representative.
For drugs, that is the typical effect. I'm not sure whether the previous inventor also must be named, but it's usually by the same company so in effect it's a patent extension. New uses can also be novel combinations of old drugs. An example might be the IFN/Rux combo in a specific dosing schedule. But the broad idea of this combo would not be allowed since it is well known already. Pharm is a special patent category. For gadgets (my field) no such extension benefit.
EPguy is right. There is another patent on using Ropeg to treat MPN and AOP is probably the real inventor of this therapy. The patent name Ko-Chung Lin, who is the founder of Pharmaessentia as the first inventor but also put Rudolf Widmann, who seems to be the founder of AOP, as the coinventor. patents.google.com/patent/U...
From the document Sam provided, which states that "AOP's research led to the discovery of P1101's (Bes) potential for treating polycythemia vera (PV)."and "On 8 December 2010, [REDACTED] and Rudolf Widmann executed a joint assignment of the patent for the treatment of rare blood cancers with P1101 to PEC", I'd say it was AOP's idea to use the drug in MPN treatment. Parmaeesntia was probably named as inventor for business reasons.
There is a US provisional patent ca 2009, but the USPTO (patent office) "improved" their service and last few years it's unusable. Seeing this prov patent app would answer a lot of these trivia questions.
I agree about the overly aggressive nature of Pharmaessentia's advertising. Pharmaessentia literature and sales reps will never admit there are many Pegasys users who find it more tolerable - not less tolerable - than Besremi and equally effective at 1/4th the cost.
peg interferon I am on has had excellent results & if I am moved to Besremi because of shortages I am happy with that . The actual results of people using these are testimony to true results . 👌
from what I read and hear there is little difference between the two, i saw a slide at the 2023 doc conference in New York showing higher drop out rate with Bes. And as others have mentioned some feel better on Peg. And I know of some patients who even prefer the old Interferons to Peg. I suspect they are all similar , even Dr Silver told me the old Interferons are as good as Peg. Probably best just to try the different ones to see what suits.
Thank you for sharing. Do you remember which conference was the slide presented? It might be quite helpful. Thank you so much in advance and wish you a great new year.
The advantage of PEG and Bes over the old rIFN-a is longevity and thus less frequent dosing. I recall early IFN was at least every few days or more frequent. Pegged supposedly also holds more constant levels of IFN in the body avoiding damaging peaks. But well managed non-pegged could have worked fine as they said.
I experienced a one-of-a-kind downside of the Pegged longevity, when something went wrong it took weeks/months to clear the Besremi IFN.
The less frequent is a plus for Bes or Peg but some feel better on the older infs , if I recall correctly some are injected 3 times a week. Also for some in some countries there is a cost issue with Bes or Peg
I think all of the non-pegged are off the market. There was Intron A (a powder) and later Roferon. Likely they decided these were obsolete with the advances in pegylation. There was even a "PegIntron" also off market. Maybe there is still some other non pegged version for sale. This was all for the Hepatitis C era.
If we're lucky we will follow Hep C wherein a magic pill is a cure that made IFN largely obsolete. There are posts on possible early candidates for some MPNs. But nothing coming soon.
I am about to start on Besremi after being on hydrea for 18months will let you know how I get on... switching due to side effects and my platelets beginning to creep up 3 shots per week.
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