NEW YORK (Reuters Health) – The monoclonal antibody ustekinumab (Stelara, Janssen) appears to be at least as effective against ulcerative colitis (UC) in real-world practice as it was in the clinical trials that led to its approval, according to new research.
Several biologic and small-molecule therapies are available for the treatment of moderately to severely active UC, Dr. David T. Rubin of The University of Chicago Medicine Inflammatory Bowel Disease Center and colleagues note in Crohn’s and Colitis 360. These agents have limited efficacy, however, and many patients will lose response over time, the researchers add.
Ustekinumab demonstrated significant efficacy and safety in its pivotal trial, with clinical remission rates of 15% at week 8 and 40% at week 44, both of which were significantly higher than placebo. However, such results may not reflect those in actual clinical practice, the authors note.
To investigate, they conducted a retrospective study of 66 patients with moderately to severely active UC who received ustekinumab. The study period was 2016 to 2020, and the analysis was limited to patients who had exhausted other treatment options and included those in whom use was considered “off-label” prior to approval by the U.S. Food and Drug Administration in 2019.
Overall, most (92%) had previous exposure to biologics or tofacitinib. Many also had been using anti-TNF agents or vedolizumab, and had received other medications. More than a third were receiving steroids at the time of ustekinumab induction at which point they had had UC for a median of six years. The majority had extensive colitis or left-sided colitis.
At three months, 43% of the 47 patients for whom data were available achieved the primary endpoint of clinical remission. At 12 months, this was true of 45% of the 20 patients with available data at that time.
Of the 12 patients with colonoscopies available at 12 months, six were in endoscopic remission and four had mucosal healing.
Although four patients experienced serious adverse events leading to hospitalization, according to the investigators the overall safety profile was favorable, and no malignancies or deaths were reported during follow-up.
In this cohort of mostly biologic-refractory UC patients, the researchers conclude, “treatment with ustekinumab achieved remission in nearly half of them at 12 months.” The results, they add, “are modestly better than the pivotal trials.”
Dr. Rubin, who has served as a consultant to Janssen Pharmaceuticals, did not respond to requests for comments. A number of other authors have relationships with the company.
SOURCE: https://bit.ly/3bjx80x Crohn’s and Colitis 360, online February 6, 2021.
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