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Golimumab effectively treats ulcerative colitis in phase 3 study
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LAS VEGAS — Patients with ulcerative colitis treated with golimumab achieved clinical response and remission more frequently and indicated better mucosal healing than patients receiving placebo in a study presented at the 2012 American College of Gastroenterology Annual Scientific Meeting.
Researchers randomly assigned 464 ulcerative colitis patients — responsive to golimumab during previous induction studies — to receive either placebo or 50 mg or 100 mg golimumab subcutaneously at baseline and then every 4 weeks through 52 weeks. Clinical response was assessed through 54 weeks, along with clinical remission and mucosal healing at 30 and 54 weeks and incidence of adverse events. Safety data were collected for 764 additional patients from induction trials who responded to placebo (n=129) or were nonresponsive to placebo or golimumab (n=635).
Investigators observed clinical response at 54 weeks in 47% of the 50-mg group and 51% of the 100-mg group, compared with 31% of those who received placebo (P=.01 for 50 mg and P<.001 for 100 mg). Remission at 30 and 54 weeks occurred in 24% of the 50-mg group (P=.091) and 29% of the 100-mg group (P=.003), compared with 15% of the placebo group. Among participants who already had been in remission following induction studies, 37% receiving 50 mg, 40% receiving 100 mg and 24% receiving placebo maintained remission through week 54. Mucosal healing also was more common in the treated groups (42% of those receiving 50 mg and 44% receiving 100 mg, compared with 27% receiving placebo, P=.001 for both comparisons).
At least one adverse event occurred in 66% of the placebo group and 73% in each treated group. Serious adverse events occurred in 14% of patients receiving 100 mg and in 8% of the placebo and 50-mg groups. Researchers noted that the safety profile of golimumab is similar to that of other anti-TNF agents used to treat IBD.
William J. Sandborn
“Subcutaneous golimumab … is effective for induction of response, remission and mucosal healing in patients with moderately to severely active ulcerative colitis,” researcher William J. Sandborn, MD, chief of the gastroenterology division and director of the IBD Center at University of California, San Diego, told Healio.com. “Among patients who respond to induction therapy with golimumab, maintenance therapy [of] 100 mg and 50 mg every 4 weeks is effective for maintenance of response, remission and mucosal healing.”
Disclosure: The researchers serve as either investigators for or employees of Janssen R&D.
For more information:
Sandborn W. #43: A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Subcutaneous Golimumab Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis: PURSUIT–Maintenance. Presented at: the 2012 American College of Gastroenterology Annual Scientific Meeting; Oct. 19-24, Las Vegas.