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Subcutaneous golimumab beneficial for active UC patients
Use of subcutaneous golimumab in patients with moderate to severe active ulcerative colitis can result in clinical response, remission and mucosal healing compared with placebo, according to study results.
The therapy was effective in improving patients’ quality of life, the researchers said, and “there was a positive association between clinical response and serum golimumab concentration.”
The double blind, multicenter, randomized, placebo-controlled trial integrated a phase 2 dose-finding study and a phase 3 dose-confirmation study. The phase 2 portion included 169 tumor necrosis factor-alpha antagonist-naive adults with ulcerative colitis (Mayo score 6-12 and endoscopic subscore ≥2), while phase 3 included 774 patients.
In phase 2, patients were randomly assigned placebo or one of three golimumab (Janssen Biotech) injections subcutaneously. The injections, at weeks 0 and 2, were 100 mg followed by 50 mg; 200 mg followed by 100 mg; or 400 mg followed by 200 mg.
Median Mayo score changes from baseline were –1 for placebo and –3, –2 and –3, respectively, for golimumab, and researchers chose to study the 200 mg/100 mg and 400 mg/200 mg doses for phase 3. Patients were randomly assigned placebo or either dose regimen at weeks 0 and 2. Primary endpoint was week 6 clinical response, while secondary endpoints were clinical remission, mucosal healing and Inflammatory Bowel Disease Questionnaire (IBDQ) score change at week 6.
Clinical response rate was 51% among patients in the 200 mg /100 mg group, 54.9% among 400 mg/200 mg patients and 30.3% in the placebo group (P≤.0001 for both).
Similarly, clinical remission rate, mucosal healing and mean change in IBDQ scores also were greater among the active arms than the placebo arm (P≤.0014 for all cases).
Rates of serious adverse events were about twice as likely among golimumab patients compared with placebo (6.1% to 3%), and rates of serious infection were more than triple (1.8% to 0.5%). One patient in the 400 mg/200 mg arm died after surgical complications of an ischiorectal abscess.
Disclosure: See the study for a full list of relevant financial disclosures.