First JAK Inhibitor Approved by FDA for Treatment of Crohn's

[Scipio]

Rinvoq:

First JAK Inhibitor Approved for Crohn's Disease

Upadacitinib lands indication for moderately to severely active disease in adults

www.medpagetoday.com

A new class of drugs for Crohn's and thus new treatment options. Due to increased risk of blood clots and cancer, use of Rinvoq is to restricted those Crohn's patients who have already flunked therapy with anti-TNFs such as Remicade or Humira.

 

[Crohn2357]

This seems to be the most unsafe drug ever to get an approval for the treatment of CD.

I wouldn’t consider using jak inhibitors unless I really had no other choice.

 

[sashaz]

Im newly on Rinvoq, should I ask to change it?

 

[cyberviper]

I remember getting asked to join a trial for it, thankfully i refused

 

[kiny]

I remember getting asked to join a trial for it, thankfully i refused

Good for you. I hope people realize the danger of these drugs and their lack of effectiveness in crohn's disease. There is enormous financial pressure on companies due to anti-TNF patents expiring and cheaper biosimilar replacing them.

I warned multiple times about them:

Another JAK1 inhibitor fails clinical trials for crohn's disease.

Galapagos ADRs Down 7% as Crohn's Study Misses Endpoints. Galapagos NV American depositary receipts fell 7% to $40.45 in late trading after a Phase 3 trial of filgotinib for Crohn's disease didn't meet two co-primary endpoints. Galapagos said it decided not to submit a Marketing Authorization...

crohnsforum.com

 

[NeverBeenEasier]

Good for you. I hope people realize the danger of these drugs and their lack of effectiveness in crohn's disease. There is enormous financial pressure on companies due to anti-TNF patents expiring and cheaper biosimilar replacing them.

I warned multiple times about them:

Another JAK1 inhibitor fails clinical trials for crohn's disease.

Galapagos ADRs Down 7% as Crohn's Study Misses Endpoints. Galapagos NV American depositary receipts fell 7% to $40.45 in late trading after a Phase 3 trial of filgotinib for Crohn's disease didn't meet two co-primary endpoints. Galapagos said it decided not to submit a Marketing Authorization...

crohnsforum.com

Are you able to provide a study that makes you so confidently say they lack effectiveness in Crohn's disease?

Also, Rinvoq is a second-generation JAK inhibitor that targets specifically JAK1 versus first-generation JAKi that tend to inhibit JAKs rather unspecifically.

 

[kiny]

139 patients
Moderate to severe crohn's disease.
No difference from placebo.
1129×1168
346,3 kB



280 subjects.
Moderate to severe crohn's disease.
Efficacy not significantly different from placebo.


78 patients.
Moderate to severe crohn's disease.
No difference from placebo.

 

[Andersen007]

Completely unrelated topic, but the other day I was wondering about how on Earth is it possible that even for really good drugs like anti TNF-s, the difference between “no treatment whatsoever” and “placebo” is often just as big, or even bigger than “placebo” and the “effective drug”. E.g. in many studies I see 0-5% remission rate with no treatment, 25-30% with placebo, 45-50% with an “effective drug”. This tends to be true for many serious organic diseases and their medication. It made me wonder whether if I would be less sceptical, would I have a shitload of treatment options with 25-30% to get into remission with each convincing placebo, like acupuncture, random herbal tablets, etc?

 

[Entchen]

Completely unrelated topic, but the other day I was wondering about how on Earth is it possible that even for really good drugs like anti TNF-s, the difference between “no treatment whatsoever” and “placebo” is often just as big, or even bigger than “placebo” and the “effective drug”. E.g. in many studies I see 0-5% remission rate with no treatment, 25-30% with placebo, 45-50% with an “effective drug”. This tends to be true for many serious organic diseases and their medication. It made me wonder whether if I would be less sceptical, would I have a shitload of treatment options with 25-30% to get into remission with each convincing placebo, like acupuncture, random herbal tablets, etc?

That’s a fair question. The answer from the literature (I’m away from my laptop but I think I have the references somewhere) is that what gets labelled a placebo effect is more likely just one small part genuine placebo effect (belief) and one huge part regression to the mean (passage of time). After a while, most flare ups of any disease will improve at least somewhat. Most Crohn’s flare ups will resolve on their own, given time (um, notwithstanding all the damage it might leave behind!). And so if a trial runs, say, 6 months or 12 months, many participants will see their active disease kind of run its natural course—both in the placebo and in the treatment arms. For those in the treatment arm, this improvement is credited to the drug. For those in the placebo arm, this improvement is attributed to the placebo effect. But it’s not the belief that singly leads to the improvement, it is also the “treatment” of time.

In a formula, Outcome = Treatment X + Time, but what happens in drug trials is this can get a bit lazily labelled as Outcome = Treatment X OR Outcome = Placebo.

 

[asadmom]

Completely unrelated topic, but the other day I was wondering about how on Earth is it possible that even for really good drugs like anti TNF-s, the difference between “no treatment whatsoever” and “placebo” is often just as big, or even bigger than “placebo” and the “effective drug”. E.g. in many studies I see 0-5% remission rate with no treatment, 25-30% with placebo, 45-50% with an “effective drug”. This tends to be true for many serious organic diseases and their medication. It made me wonder whether if I would be less sceptical, would I have a shitload of treatment options with 25-30% to get into remission with each convincing placebo, like acupuncture, random herbal tablets, etc?

Patients in clinical trials go through much more thorough testing and receive dedicated and personalized support. Patients are seen way more often and get to talk about anything and everything that's happened to them since all symptoms (including psychological) need to be logged. They get exceptional care and attention and the placebo effect happens when they feel they are better cared for and with this new found hope (although they are in the placebo arm) and way more testing and the specialists they have access to, many just feel better.

 

[Waldo]

The placebo effect tells us there is a psychological component to inflammatory bowel diseases. It seems that traumatic events can lead to physical illness, and that being cared for (by others or oneself) can dampen symptoms.
The field is called psychoneuroimmunilogy (PNI) and is worth following in my opinion.