Adalimumab in active ulcerative colitis: A "real-life" observational study

Alessandro Armuzzi, Livia Biancone, Marco Daperno, Alessandra Coli, Daniela Pugliese, Vito Annese, Annalisa Aratari, Sandro Ardizzone, Paola Balestrieri, Fabrizio Bossa, Maria Cappello, Fabiana Castiglione, Michele Cicala, Silvio Danese, Renata D'Incà, Pietro Dulbecco, Giuseppe Feliciangeli, Walter Fries, Stefania Genise, Paolo GionchettiStefano Gozzi, Anna Kohn, Roberto Lorenzetti, Monica Milla, Sara Onali, Ambrogio Orlando, Luigi Giovanni Papparella, Sara Renna, Chiara Ricci, Fernando Rizzello, Raffaello Sostegni, Luisa Guidi, Claudio Papi

Research output: Contribution to journalArticlepeer-review


Background and aims: The effectiveness of adalimumab in the treatment of ulcerative colitis is under debate. Although controlled trials have shown that adalimumab is significantly better than placebo, the absolute clinical benefit is modest. We report data on the effectiveness of adalimumab in a cohort of ulcerative 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 sustained clinical 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 predicted clinical 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 week 54 (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 otherwise medically refractory ulcerative colitis. Patients achieving early remission can expect a better long-term outcome.

Original languageEnglish
Pages (from-to)738-743
Number of pages6
JournalDigestive and Liver Disease
Issue number9
Publication statusPublished - Sep 2013


  • "Real-life" study
  • Adalimumab
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology


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