Xelijanz (Tofacitinib) for Crohn's?

In this FDA press release a drug called Xelijanz (tofacitinib) was approved for rheumatoid arthritis (autoimmune disease like Crohns). This trial showed that patients improved when taking the drug twice a day (at 3 mg) over a 6 month period. Here is a great article that includes tofacitinib along with other possible upcoming treatments for Crohns. Pfizer (the drug company who made this drug) has every incentive to test this drug for other autoimmune diseases. What I have noticed is that one drug can treat many different things (Remicade and Humira treat multiple autoimmune diseases).

One a drug is approved by the FDA it can be used for what is known as “off-label” use. The FDA can’t regulate the practice of medicine so in theory a doctor could prescribe tofacitinib for Crohns however he may have to have the patient consent to some things before hand. Crohns patients who are chronically ill need all the help they can get. We want as many possible tools as possible to fight something that is awful, painful, and makes us worry all the time. Allowing the FDA to get out of the way an let informed patients and doctors experiment could work wonders.

STELARA (Ustekinumab) Promising Results for Crohn's

I was thrilled to see that STELARA (ustekinumab) seems to help Crohn’s patients in this study just published by the New England Journal of Medicine. The drug was approved for psoriasis in 2009 (interesting how so many autoimmune drugs work for so many various things! STELARA in the trial was used after one TNF drug failed (Remicade, Humira, Cizmia). The results showed that 40% of patients saw a decrease in their CDAI (Crohn’s Disease Activity Index). The drug was given every 2 months via I.V. STELARA works by targeting interleukin-12 and interleukin 13 which plays a role in Crohn’s disease. The trial was pretty large with 526 patients (which means it also was very expensive to run the trial). Around 40% of patients had a clinical response by the end of 6 weeks which was greater than the 24% with the placebo). On a side note it seems risky to be injecting a placebo into patients with Crohn’s.  In addition to this 31% of patients who took usterkinumab were in remission didn’t need steroids.

Although the drug is not approved yet I personally would take it seeing its benefits and a trial from last year showed that it has benefits for Crohn’s patients. I hope the FDA will approve STELARA for Crohn’s patients seeing how it is effective and seems safe (no adverse side effects). Approval for this drug would also create more competition for treatments which would bring the costs of TNF drugs down which benefits consumers.

Breaking News: Humira Approved for Ulcerative Colitis!

Today, it was announced that Humira can be used for people with ulcerative colitis (inflammatory bowel disease). Although, I do not suffer from colitis but from Crohn’s I am happy now more patients will have access to a drug that has really helped me (no pain since June!). Perhaps the post I did back in August maybe persuaded the FDA! The panel decision of 15-2 made it pretty clear that the drug should be approved. As I said in that post the FDA really has no business telling patients with chronic diseases what drugs they should or should not use. Often these patients have more and better knowledge than bureaucrats.

 Humira is an $8 billlion drug that is already used for things like Crohn’s, psoriatic arthritis, anklosing spondylitis, plaque psoriasis, and juvenile idiopathic arthritis. I hope the drug is approved for more uses (I have a feeling Humira could help other autoimmune diseases not sure which ones though). Humira is pretty simple to use. You can go onto the forums and other blogs that describe how scary it is but it is a piece of cake (especially if you have gone through a horrible disease like Crohn’s or ulcerative colitis). The injection stings a little bit and really just feels like you banged your skin against something hard. I put band aids over where I inject it to be safe and ripping off the band-aid hurts more than the Humira injection! Today makes a day we have improved the world just a little bit more.