Wednesday, 01 Apr 2020

You are here

FDA Approves Ustekinumab for Ulcerative Colitis

Ustekinumab (Stelara) is now FDA-approved to treat moderately to severely active ulcerative colitis, said drugmaker Janssen on Monday, in addition to its indications for psoriasis, psoriatic arthritis, and Crohn's disease.

Approval was based primarily on results from the Johnson & Johnson unit's UNIFI trial, in which subcutaneous injections of ustekinumab led to clinical remission rates of 38%-44% after 12 months, depending on the dosing interval (12 and 8 weeks, respectively), versus 24% in a placebo group.

Janssen also boasted that ustekinumab "is the first and only approved treatment for ulcerative colitis to demonstrate improvement of the colon as measured by a novel histologic-endoscopic mucosal improvement endpoint" -- a composite of histologic examination and visual inspection during colonoscopy. The company noted, however, that it's unclear whether this biomarker is predictive of long-term clinical outcomes.

Ustekinumab targets the IL-12 and IL-23 interleukin cytokines. It was first approved 10 years ago for treating adults with moderate to severe plaque psoriasis, with a series of label expansions in the years following.

The drug comes with a number of cautions, particularly increased risk for infections, as well as a rare but life-threatening complication known as reversible posterior leukoencephalopathy syndrome that has been seen with a number of immune-modulating therapies.

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

ACR Infusion Guidance During COVID-19 Crisis

The American College of Rheumatology (ACR) has published a guidance document on infusions and office based therapies.

Infusions in the Time of Coronavirus

As they say, necessity is the mother of invention. After years of bemoaning the challenges of telemedicine, our rheumatology clinic transition entirely to a remote clinic in the space of a week. One of the few good things to come out of this crisis is that we may learn that in-person visits are not as critical as we thought, which may in turn help our specialty’s access issues.

Earlier Anakinra Initiation Warranted in Still's Disease

An Italian study examined the outcomes in adult onset Still's disease (AOSD) based on whether they received early or delayed treatment with anakinra (ANK). 

A total of 141 AOSD patients were retrospectively studied.

Overall, they found no differences in efficacy if ANK was started within 6 (or 12 mos) vs. thereafter.  

Switching Biologics in JIA

While there are numerous agents approved for use in juvenile idiopathic arthritis, little is know about actual use biological disease-modifying antirheumatic drug (DMARD) use or switching in the biologic era. A cohort comparison study has shown that after an unsuccessful trial of a first biologic, changing to a second TNFi is as effective as switching to a non-TNFi biologic.

Tofacitinib Effective in Refractory Still's Disease

Fourteen cases reported from mainland China suggest that tofacitinib (TOFA) may be effective in patients with refractory adult-onset Still’s disease (AOSD), further adding to a growing list of potential use of JAK inhibition in managing inflammatory, and now autoinflammatory, disease.