Rux vs Vaccine

[EPguy]

I'm planning to start Besremi soon and may consider combo therapy with Rux as my Dr recommends Rux. If so I would want Rux for its anti inflammatory benefits and I would want it to be a very low dose based on this study and others:

onlinelibrary.wiley.com/doi...

<<Binding antibody...was significantly lower in ruxo-patients compared to healthy controls and the no-ruxo group. The latter conversely did not differ significantly from controls, suggesting that the potentiality to mount adequate immune response is maintained in most MPN patients who were not receiving ruxolitinib.>>

The image above shows R (Rux), N-R (No Rux), H (Healthy without MPN) antibody effects. Rux is quite detrimental to the vax response in this study.

This study was for only a 1st vax dose, but it notes another study shows a similar trend for the 2nd.

My take is is new factor has arrived in the trade off for Rux, with Covid and its vaxes likely to be around for a long time we need to think about it.

--

In another study on considering the 3rd dose for Mf patients (old news now that everyone gets one) , Rux also was detrimental. A separate item I've been seeing is that if you get bad Covid while taking Rux (which can lower cytokines which cause much of the bad Covid reactions) you should not stop taking it during that time since a cytokine rush can follow.

<<However, the drug cannot be stopped all at once in these patients once they develop COVID-19 because of the rebound spike in cytokines, which can precipitate severe systemic inflammation and death.>>

news-medical.net/news/20210...

[andrew_huang]

besremi (Ropeginterferon) (P1101) is also a clinical trial program for the treatment or prevention of COVID-19. It was awarded the US Food and Drug Administration (FDA) Pre-IND number: 150922The third phase of the experiment is currently being carried out. Hope this helps you.

[EPguy in reply to andrew_huang]

That's good info. Do you have the link for that trial?

So it will be phase 3 trial, correct? So it's possible taking it for MPN could protect from Covid, look fwd to the results.

I see this link discussing early plans for it.

archyde.com/huayao-provides...

[andrew_huang in reply to EPguy]

sciencedirect.com/science/a...

[andrew_huang in reply to andrew_huang]

hq.pharmaessentia.com/tw/ne...

[andrew_huang in reply to andrew_huang]

Early treatment with PEG IFN- α2b induced early viral clearance and improved the clinical status of patients with moderate COVID- 19. It also decreased the duration of supplemental oxygen. Treat- ment with PEG IFN- α2b provides a viable treatment option dur- ing the current pandemic situation. It can also limit the spread of SARS-CoV-2 in the community

[EPguy in reply to andrew_huang]

Thanks for the link. I see

<<80.36% vs 68.18% (P=0.037) on Day 8>>

So clearly some benefit by day 8.

Is there more Covid info in the Pharmaessentia link?

Maybe by being on INF for MPN there is some inherent covid protection. Probably we won't see clear answers to that one since there are too few MPN patients to find out.

[andrew_huang in reply to EPguy]

pubmed.ncbi.nlm.nih.gov/349...

[andrew_huang in reply to andrew_huang]

Clinical Experience with Ropeginterferon Alfa-2b in the Off-Label Use for the Treatment of COVID-19 Patients in Taiwan

[andrew_huang in reply to andrew_huang]

Ropeginterferon alfa-2b showed the potential for the treatment of moderate COVID-19 patients. A randomized, controlled Phase III study is planned to further assess the effectiveness of ropeginterferon alfa-2b in COVID-19 patients.

[EPguy in reply to andrew_huang]

Thanks for the link. I saw some talk of this on the Taiwan stock market pages. (Crown Pneumonia) My Taiwanese friend also told me the recent FDA approval was prominent in the Taiwan news.

The plot here is from the link you provided. Looks at least as good as the current IV Remdesivir. But n is small. It would be hard to find many covid patients in Taiwan. Look fwd to the Ph 3.

But this leans favorably to me when considering whether to start Besremi.

RopegCovid

[andrew_huang in reply to EPguy]

It has a therapeutic effect on patients with mild and moderate illness. I think if you take Besremi on a regular basis, can it prevent covid.This is very helpful for patients with weakened immunity, but the research is not very complete.

Hope this information is helpful to you, you can refer to it.

[EPguy in reply to andrew_huang]

Interesting note: if Ropeg is approved for Covid, its price should go way down since the market will be large while it should have competition from the new Pfizer pill.

[DJK12]

You make a very good point about ruxolitinib not being stopped abruptly. I'd read the original study which I think was Italian from the summer of 2020. When I was in hospital this year with pneumonia, unfortunately not in the haematology ward because of covid protocols, rux was stopped. Luckily I wasn't so ill that I didn't notice and I'd read the article. For some reason they didn't seem prepared to phone haematology that night and I don't know what went on outside my room but the charge nurse eventually appeared with the box and said 'you better have these as you seem to know more about it'!

I brought it up with the consultant at the morning ward round, haematology was phoned and the junior doctor had the grace to come back and say I was right.

I already kept a printout from MPN VOICE about MF in my overnight bag and I now keep information about not stopping rux and have told my family to bring it up if I were to be very ill. I've had a cytokine storm in the past, ( pre covid and pre rux), and to put it mildly it was very unpleasant and obviously dangerous.

[EPguy in reply to DJK12]

A good example of what we learn from each other on this forum.

[Aldebaran25]

In reading this (I admit to not checking the study), I wonder what is known about T cell activation and also what is known about the min. level of antibodies necessary for a decent immune response (i.e. is the level achieved by Rux patients after multiple doses sufficient and how long does it last vs no-Rux and H?) . Of course, all this goes up in the air somewhat with the new Omicron variant until more is known.

[EPguy in reply to Aldebaran25]

Your points are right on t cell and "neutralization level for protection " are big unknowns. While there is progress, this remains uncertain for all vaxes and variants. It has been determined that anitbody level does relate to protection, even that was uncertain till recently.

My thinking is whatever a good level is, more antibody response is better than less, esp with variants and their reduced responses. And Rux does at least some what reduce that protection level, my Haem agreed. The study here was for one dose, other studies I saw suggest the 2nd dose helps, and that Rux patients may catch up but slowly. But a better response on 2nd dose is broadly true for most non Ruxers who have not had the actual infection already.

I think the fix will be the new antibody treatments coming that protect for at least 6 months. AZ has one. There is another in trials, I've not been able to find again, that should be insensitive to virus mutations. It may last a year. These are not IV, but regular shots.

When these are avail, I think the risk with Rux will be less. My opinion is everyone could benefit from these antibody shots, esp if the shots are variant resistant; maybe as combo to the vaxes. But that will be up to the experts.