Adalimumab In Active Ulcerative Colitis: A “Real-Life” Observational Study on behalf of the Italian Group for the study of Inflammatory Bowel Disease.

Background and aims: The effectiveness of adalimumab in the treatment of ulcerative colitis is underdebate. Although controlled trials have shown that adalimumab is significantly better than placebo, theabsolute clinical benefit is modest. We report data on the effectiveness of adalimumab in a cohort ofulcerative colitis patients treated in 22 Italian centres.Methods: All patients with active disease treated with adalimumab were retrospectively reviewed. Co-primary endpoints were clinical remission at weeks 4, 12, 24 and 54. Secondary endpoints were sustainedclinical remission, steroid discontinuation, endoscopic remission and need for colectomy.Results: Eighty-eight patients were included. Most patients had received previous infliximab treatment.Clinical remission rates were 17%, 28.4%, 36.4% and 43.2% at 4, 12, 24 and 54 weeks respectively. Twenty-two patients required colectomy. Clinical remission and low C-reactive protein at week 12 predictedclinical remission at week 54 (OR 4.17, 95% CI 2.36–19.44; OR 2.63, 95% CI 2.32–14.94, respectively).Previous immunosuppressant use was associated with a lower probability of clinical remission at week54 (OR 0.67, 95% CI 0.08–0.66) and with a higher rate of colectomy (HR 9.7, 95% CI 1.46–9.07).Conclusion: In this large “real-life” experience adalimumab appears effective in patients with otherwisemedically refractory ulcerative colitis. Patients achieving early remission can expect a better long-termoutcome.