This article is more than 5 years old. Information may no longer be current.
Abrilumab Induces Remission, Healing in Moderate to Severe UC
Click Here to Manage Email Alerts
Abrilumab, an anti-alpha-4 beta-7 antibody, helped induce remission, clinical response and mucosal healing in patients with moderate to severe ulcerative colitis, according to research published in Gastroenterology.
William J. Sandborn, MD, director of the University of California San Diego Inflammatory Bowel Disease Center, and colleagues wrote that many patients with UC fail to achieve remission on conventional therapy and eventually require colectomy. Abrilumab could fill a significant unmet need for these patients.
“Selective targeting of gut lymphocyte trafficking by inhibiting the [alpha-4 beta-7] pathway was achieved in patients with UC and Crohn’s disease with intravenously administered vedolizumab (Entyvio, Takeda), approved by the United States Food and Drug Administration for induction and maintenance therapy in both indications,” they wrote. “Therefore, targeting gut selective lymphocyte trafficking is a promising therapeutic strategy in IBD.”
Sandborn
Sandborn and colleagues conducted a phase 2 randomized controlled trial to test the efficacy and safety of abrilumab in patients with moderate to severe UC. The patients all had a total Mayo score of 6 to 12 and a rectosigmoidoscopy score of at least 2, as well as an inadequate response or intolerance to conventional therapies.
Researchers randomly assigned patients to abrilumab 7 mg (n = 21), 21 mg (n = 40) or 70 mg (n = 98) on day 1, weeks 2 and 4, and every 4 weeks, abrilumab 210 mg (n = 79) on day 1, or placebo (n = 116). The primary endpoint of the study was remission, defined as total Mayo score of no more than 2 points with no individual subscore greater than 1.
After 8 weeks, nonadjusted remission rates were 13.3% in the 70-mg group and 12.7% in the 210-mg group compared with 4.3% in the placebo group (P < .05). Patients in the 70-mg group (OR = 3.35; 90% CI, 1.41-7.95) and the 210-mg group (OR = 3.33; 90% CI, 1.34-8.26) both had greater odds of achieving remission than patients in the placebo group. Patients who received these dosages also had better response and mucosal healing rates compared with placebo.
“The results from this phase 2 study provide preliminary evidence that abrilumab administered as multiple doses of 70 mg or a single dose of 210 mg may induce remission, clinical response and mucosal healing in patients with moderate to severe UC,” Sandborn and colleagues wrote. “Our data further support the mechanism of targeting the [alpha-4 beta-7] pathway as a therapeutic option for the management of moderate to severe UC and the use of [alpha-4 beta-7] levels as a potential prognostic indicator in UC.” – by Alex Young
Disclosures: Sandborn reports he has received research grants, served as a consultant for and/or is a stockholder of AbbVie, Allergan, Amgen, Atlantic Healthcare Limited, Boehringer Ingelheim, Celgene/Receptos, Contaus, Cosmo, Escalier Biosciences, Ferring, Genentech, Gilead Sciences, Janssen, Lilly, Miraca Life Sciences, Nivalis Therapeutics, Novartis, Nutrition Science Partners, Opplian Pharma, Otsuka, Paul Hastings, Pfizer, Precision IBD, Progenity, Prometheus Laboratories, Ritter Pharmaceuticals, Robarts Clinical Trials, Salix, Shire, Seres Therapeutics, Sigmoid Biotechnologies, Takeda, Tigenix, Tillots Pharma, UCB Pharma, and Vivelix. Please see the study for all other authors’ relevant financial disclosures.
Click Here to Manage Email Alerts