Monday, 24 Feb 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

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.

QD Clinic - Hepatitis B and Biologics

QD Clinic - Lessons from the clinic Active HBV infection (HGsAg+) on anti-viral therapy but needs a biologic - what should you use?

Biosimilars for Rheum Disease: Failure to Launch

The availability of biologic biosimilars has thus far had negligible impact on prescribing practices in the United States, in stark contrast to what has been observed in some European countries, researchers reported.

Best of 2019 - Is Methotrexate Necessary with Tofacitinib?

Rheumatoid arthritis patients taking tofacitinib (Xeljanz) plus methotrexate who achieved low disease activity (LDA) may be able to withdraw from the latter agent without significant worsening of disease activity, a researcher reported at EULAR 2019 in Madrid.

Best of 2019 - Ups and Downs with Abatacept

Two recent studies have examined the effect of starting abatacept upon the risk of serious hospitalized infections or cancer, showing divergent results from claims data analyses.