This article is more than 5 years old. Information may no longer be current.
FDA Approves Xeljanz for Moderate-to-Severe UC
Click Here to Manage Email Alerts
The FDA has expanded the approval of Xeljanz to include use by adults with moderately to severely active ulcerative colitis.
Xeljanz (tofacitinib, Pfizer) is the first oral medication approved for chronic use to treat UC, the agency said in a press release.
“New treatments are needed for patients with moderately to severely active ulcerative colitis,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Today’s approval provides an alternative therapy for a debilitating disease with limited treatment options.”
The approval was backed by three controlled clinical trials, including two eight-week placebo control trials that showed 10 mg of Xeljanz taken twice daily induces remission in 17% to 18% of patients by week eight. In a placebo-controlled trial of patients who achieved remission by week eight, the results demonstrated that a 5 mg or 10 mg dose given twice daily effectively induced remission by week 52 in 34% and 41% of patients respectively, according to the FDA.
The FDA previously approved Xeljanz for the treatment of rheumatoid arthritis in 2012 and for the treatment of psoriatic arthritis in 2017.
Disclosures: Beitz is employed by the FDA.
Perspective
Back to Top
Peter D.R. Higgins, MD, PhD
Tofacitnib is the first new oral medication for ulcerative colitis in a long time, which is very convenient for patients. It's also a small molecule drug, which means patients are not going to form antibodies against it, so if it does work for a patient there's no reason it can't work for 20, 30, 40 years – which is a big deal in the age of biologics.
It's a systemic drug, so for patients who have enteropathic arthritis – which is the most common extraintestinal manifestation of UC – it works well. Further, it has good efficacy for UC, and it's fast, with symptom changes occurring as early as day three (there's an abstract on that being presented at the upcoming DDW meeting). In fact, it's so fast it could in theory compete with or even possibly replace prednisone, although for price reasons it probably won't, but it's in that category of a fast-acting tablet medication that patients are not going to develop antibodies against.
The downside is, of course, the risk for infections. It's a lot safer than prednisone but there are clearly some issues in terms of infection rates per year, which is well established in the rheumatoid arthritis population, the biggest one of course being herpes zoster. The convenient thing is there's a new zoster vaccine, so that may be a first step for a lot of people thinking about this drug.
Perspective
Back to Top
Edward V. Loftus Jr., MD
Tofacitinib is a drug with interesting attributes. It is an oral small molecule that many patients (and providers) will find appealing. The efficacy is impressive — the maintenance data in particular. So, this will be a welcome addition to our armamentarium of treatments for ulcerative colitis — it’s the first IBD drug approved with this mechanism of action. It already has a black boxed warning for serious infection and malignancy. In the UC trials there was a signal for herpes zoster at the higher maintenance dose. I suspect it will be initially used as “salvage therapy” in patients who have had inadequate response to or did not tolerate a biologic (or multiple biologics), but depending on the cost/access by third party payers and as we get more familiar with the drug it may be used earlier in the treatment pathway.
Click Here to Manage Email Alerts