But not for corticosteroid-free clinical remission; also, ustekinumab superior to placebo
WEDNESDAY, Sept. 25, 2019 (HealthDay News) — In moderate-to-severe ulcerative colitis, vedolizumab is superior to adalimumab for achieving clinical remission and endoscopic improvement, but not corticosteroid-free clinical remission, and ustekinumab is superior to placebo for inducing and maintaining remission, according to two studies published in the Sept. 26 issue of the New England Journal of Medicine.
Bruce E. Sands, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted a phase 3 trial comparing vedolizumab with adalimumab in 769 adults with moderately to severely active ulcerative colitis (383 and 386 patients, respectively). The researchers found that clinical remission was achieved in a higher percentage of patients in the vedolizumab group than in the adalimumab group at week 52 (31.3 versus 22.5 percent), as was endoscopic improvement (39.7 versus 27.7 percent). In the vedolizumab and adalimumab groups, 12.6 and 21.8 percent of patients, respectively, experienced corticosteroid-free clinical remission.
In a second study, Sands and colleagues assessed ustekinumab as eight-week induction and 44-week maintenance therapy in 961 patients with moderate-to-severe ulcerative colitis. Patients were randomly assigned to receive an intravenous induction dose of ustekinumab, a weight range-based dose, or placebo (320, 322, and 319 patients, respectively). Patients with a response to induction therapy were randomly assigned to receive subcutaneous maintenance injections every 12 or eight weeks or placebo (172, 176, and 175 patients, respectively). The researchers found that the percentage of patients who had clinical remission at eight weeks was significantly higher with ustekinumab (15.6 and 15.5 percent, respectively, versus 5.3 percent). For patients who had a response to induction therapy and underwent a second randomization, clinical remission was seen in 38.4, 43.8, and 24.0 percent, respectively.
These results “highlight the importance of alternative biologic treatments and regimens for ulcerative colitis in patients who are not able to receive anti-tumor necrosis factor therapies,” write the authors of an accompanying editorial.
The first study was funded by Takeda, which manufactures vedolizumab; the second study was funded by Janssen, which manufactures ustekinumab.
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