Abrilumab effective for ulcerative colitis
The monoclonal antibody abrilumab is effective for treating moderate-to-severe ulcerative colitis, promoting remission, clinical response and mucosal healing, a recent study has found.
Researchers randomly assigned 354 ulcerative colitis patients with inadequate responses to conventional therapies to receive abrilumab 7 mg every 4 weeks (n=21), 21 mg every 4 weeks (n=40), 70 mg every 4 weeks (n=98) or 210 mg at day 1 (n=79); or placebo (n=116). Study endpoints included remission, response and mucosal healing.
The unadjusted remission rates at 8 weeks were 4.3 percent, 0.0 percent, 2.5 percent, 13.3 percent and 12.7 percent for the placebo, 7-mg, 21-mg, 70-mg and 210-mg groups, respectively. Patients who received the two highest abrilumab doses were significantly likely to achieve remission than those who were given placebo (70 mg: odds ratio [OR], 3.35; 95 percent CI, 1.41–7.95; p=0.021; 210 mg: OR, 3.33; 1.34–8.26; p=0.030).
Unadjusted response rates at 8 weeks for the placebo, 7-mg, 21-mg, 70-mg and 210-mg groups were 25.9 percent, 14.3 percent, 50.0 percent, 49.0 percent and 46.8 percent, respectively.
Similarly, those given the highest two abrilumab doses were significantly more likely to achieve response at 8 weeks (70 mg: OR, 2.78; 1.71–4.52; p<0.001; 210 mg: OR, 2.57; 1.53–4.51; p=0.003).
The same was true for mucosal healing (70 mg: OR, 2.34; 1.35–4.07; p=0.011; 210 mg: OR, 2.10; 1.15–3.82; p=0.041). The corresponding unadjusted mucosal healing rates at 8 weeks were 21.6 percent, 14.3 percent, 15.0 percent, 32.7 percent and 29.1 percent for the placebo, 7-mg, 21-mg, 70-mg and 210-mg groups.