Background: Moderate-to-severe active ulcerative colitis (UC) may be treated with anti-TNFα. Since the Adalimumab (ADA) distribution in Italy by National Health System (April 2014), its use in UC patients follows rigid entry criteria and a standard schedule of evaluation of clinical outcomes. Aim of this study was to assess the efficacy and safety of Adalimumab in inducing remission or clinical response in outpatients UC patients treated in Italian primary Inflammatory Bowel Diseases centres.
Methods: Fifty-seven consecutive UC patients with at least 12-week follow-up were enrolled. The primary endpoint was clinical remission reaching, defined as Mayo score or partial Mayo score ≤2 after 12 weeks.
The secondary endpoints included: (1) clinical response to treatment, defined as partial Mayo score reduction of at least 2 points; (2) safety of the drug, defined as occurrence of adverse events during treatment.
Results: Demographic characteristics of the enrolled population are reported in table 1. At 8-week follow-up, clinical response was obtained in 36/57 (63.2%) patients and clinical remission was achieved in 22/57 (38.6%) patients. At 12-week follow-up, clinical response was obtained in 35/55 (63.6%) patients and clinical remission was achieved in 21/55 (38.2%) patients. Significantly, no adverse events neither colectomy were recorded during the 12-week trial.
Conclusions: Real-life effectiveness of adalimumab in inducing UC remission is promising, also in patients had already been exposed to infliximab beforehand. Larger groups of patients, with longer follow-up, are warranted to confirm such results.