Mirikizumab: New med sounds very promising!

Fifty Percent of Patients with Ulcerative Colitis Treated with Mirikizumab Achieved Clinical Remission at One Year in Lilly's Pivotal Phase 3 Study:

https://investor.lilly.com/news-releases/news-release-details/fifty-percent-patients-ulcerative-colitis-treated-mirikizumab

" In Eli Lilly and Company's Phase 3 LUCENT-2 study, patients with ulcerative colitis (UC) who responded to mirikizumab at 12 weeks achieved and maintained statistically superior and clinically meaningful improvements at one year compared to placebo across the primary endpoint of clinical remission and all key secondary endpoints, including bowel urgency severity, using a novel, patient-reported outcome measure....If approved, mirikizumab would become the first and only anti-IL23p19 treatment for people with UC.

Mirikizumab was superior to placebo on clinical, symptomatic, endoscopic and histologic endpoints regardless of previous failure to TNF inhibitors, tofacitinib or other biologics. Among patients who had responded to 12-week induction treatment with mirikizumab, one-half of patients receiving mirikizumab maintenance treatment (49.9%, n=182/365) achieved clinical remission at one year compared to one-fourth of patients on placebo (25.1%, n=45/179, p<0.001). Nearly two-thirds of patients receiving mirikizumab who achieved clinical remission at 12 weeks maintained clinical remission at one year (63.6%, n=91/143) compared to one-third of patients on placebo (36.9%, n=24/65, p<0.001). Nearly all patients receiving mirikizumab who achieved clinical remission at one year were not taking corticosteroids for at least three months prior to the end of maintenance treatment (97.8%, n=178/182).

Patients receiving mirikizumab in the LUCENT-2 study reported a lower frequency of serious adverse events compared to placebo (mirikizumab: 3.3%, n=13/389; placebo: 7.8%, n=15/192) and were less likely to discontinue the study due to adverse events (mirikizumab: 1.5%, n=6/389; placebo: 8.3%, n=16/192)."

A decision on approval by the FDA is expected to be announced in 2023!

Hi! Oh, sorry, I did a quick look before posting and didn't see yours!

Wow, you're right, I didn't even pick up on that. They don't say in the press release. The second or third paragraph is a quote from a GI doctor saying half of everyone taking it achieved remission (the quote doesn't specify that that only meant of the initial folks who responded at 12 weeks). That's some pretty heavy public relations spin I missed. Well, that's disappointing. I'll have to look into the trials more to figure out our question.

Still, nice to have a few more options left if Xeljanz fails me someday.

The study found that 24% of patients treated with mirikizumab were in clinical remission at 12 weeks – meaning inflammation of the colon is controlled or resolved – compared to 13% of the placebo group

Source: https://pharmaphorum.com/news/lilly-unveils-mirikizumab-data-in-ulcerative-colitis-as-it-preps-filings/

Whilst that might not sound great, it's pretty standard for UC treatments. Also the success rate in real life is usually higher than in the trials (in real life patients are not constrained to improve within a given time frame).

Overall it's good news. I think any time we get a new medicine with a different mechanism of action is good. My understanding is that the safety for this medicine is great. It is like Stelara, except that it only blocks IL23 (Stelara blocks IL12/23).

Yeah, the safety profile was safer than placebo! If it's like Stelara, and Stelara did nothing for me, I also don't feel much hope about it.

No problem.

I am not a doctor, but I think similar type of medicine( anti body) traet cancer too, correct me if I am wrong

It was safer than the placebo in the trial. Not like Imuran, no. It's not been approved yet but likely will be next year.

poopydoop said...
It's nothing like imuran, it's a biologic, and by the looks of it the safety profile is pretty good.

I take a cancer drug to treat my osteoporosis, I don’t think about it much. Didn’t have much choice because I was at risk of a vertebral fracture otherwise.

Thanks, I suppose the side effects of this drug( Mirikizumab)is the possibility to having cancer more. If this the case, many doctors will hesitate to give this drug, unless it is so necessary.

I hope I am wrong

Sultan said...

Thanks, I suppose the side effects of this drug( Mirikizumab)is the possibility to having cancer more. If this the case, many doctors will hesitate to give this drug, unless it is so necessary.

I hope I am wrong

I think most drugs which change the immune system have some cancer risk but untreated UC has a much bigger cancer risk. Also from what I remember, the biologics (which this is) are significantly lower risk than imuran.

I was scared of these kind of drugs for a lomg time and delayed treatment but it got to the point where I had zero quality of life and the risks were worth it.

I haven't checked the safety profile of this drug in detail but from what Sara says it is safer than many other approved UC treatments so there should be no hesitation from doctors on that front.

29%, or whatever, of what? Just quoting a statistic in relation to a drug trial is useless and misleading. It is done here a lot. All drug trials are statistical scientific processes and will have defined 'end points' to which some or all of the statistics are related. This could be histological remission, it could be endoscopic remission or it could by symptamatic remission. It would relate to an end point after 10 weeks, 6 months or 12 months or 5 years.

I'm not doubting any of the numbers on here but when people are using stats to dish and bash each other I think we should try to be more accurate about what the statistic relates to. There are newbie members on here who could grossly be mislead by the way we flaunt through statistics and blood markers without no attempt to give the basis being reported.

Be accurate in how you dispense info. #FakeStatisticalNews

I cited my source and as well as the type of remission and the time frame 😇

Hello

Did anyone heard about “ Zeposia” ?
I read an article and it seems promising.

That's true, but 12 weeks isn't very long either. True healing can take months. That is really the limitation of clinical trials (or one of the limitations). On xeljanz I took 16 weeks to reach endoscopic remission. Histologic remission (normal biopsies) takes even longer.... in fact my doctor said 90% of patient in clinical/endoscopic remission will still show microscopic inflammation on a biopsy.