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Anti-MAdCAM antibody induces remission in ulcerative colitis
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Adult patients with moderate-to-severe ulcerative colitis safely achieved 12-week remission with investigational anti-MAdCAM antibody PF-00547659, with the strongest benefit observed with 22.5 mg to 75 mg doses every 4 weeks, according to data presented at the 10th Congress of ECCO in Barcelona, Spain.
“This is an important study which met its primary endpoint and several secondary endpoints and hence represents a significant advance in the therapeutic pipeline of UC,” Séverine Vermeire, MD, PhD, from Leuven University Hospital in Belgium, told Healio Gastroenterology.
Séverine Vermeire
William J. Sandborn
Vermeire, William J. Sandborn, MD, from the Inflammatory Bowel Disease Center at University of California, San Diego, and colleagues performed a randomized, multicenter, double blind, placebo-controlled clinical trial (TURANDOT trial) to determine the preferred dose of PF-00547659 (PF) for induction of remission in patients with moderate-to-severe UC.
Included patients (n = 357) were adults aged 18 to 65 years who had failed at least one approved therapy. Anti-tumor necrosis factor therapy was stopped at least 6 weeks before treatment, immunosuppressants were stopped by week 12, prednisone doses greater than 20 mg per day were not allowed, and other drugs were required to be stable. Patients were assigned to placebo or 7.5 mg, 22.5 mg, 75 mg or 225 mg PF every 4 weeks for three doses, and were evaluated for 12-week remission, response and mucosal healing.
“Remission and mucosal healing were significantly greater in the 22.5 mg- and 75-mg dose groups vs. placebo, while response was significantly greater for 22.5 mg and 225 mg groups vs. placebo,” the researchers wrote.
The primary endpoint (week 12 remission) was met. The strongest benefit was observed in dose groups who received 22.5 mg to 75 mg PF every 4 weeks, and PF appears to be well tolerated and not associated with increased infection. Seven patients remain in ongoing safety follow-up. – by Adam Leitenberger
Reference:
Vermeire S, et al. Abstract OP021. Presented at: 10th Congress of ECCO; Feb. 18-21, 2015; Barcelona, Spain.
Disclosure: Sandborn and Vermeire report financial ties with Pfizer, the sponsor of this study, and numerous other relevant financial disclosures. Please see the ECCO website for all researchers’ relevant financial disclosures.