Eficacia de adalimumab en el tratamiento de la colitis ulcerosa dependiente de corticoides

Introduction

Steroid dependency develops frequently (more than 30%) with regards to ulcerative colitis (UC) patients. Our aim was to evaluate the clinical efficacy of ADA in steroid-dependent UC patients.

Methods

Open-label, retrospective, consecutive, and multicentre study. Inclusion criteria were patients over 18 years old with UC and ECCO criteria of steroid-dependency. All patients received ADA treatment for induction (160/80 mg) at weeks 0 and 2 and 40 mg every 2 weeks thereafter. The main endpoint was clinical remission without steroids. Clinical response, mucosal healing and levels of C-reactive protein and calprotectine were also evaluated. Results are shown in percentages; associations were analyzed by multiple regression whenever appropriate.

Results

Thirty-seven steroid-dependent UC patients treated with ADA: 65% E3. Twelve patients (32%) naive to anti-TNF and 25 (68%) had previously received infliximab. Forty-three percent needed ADA intensification. After induction 35% of patients were in remission and after 12 months 40% of patients were in remission without steroids. The mean partial Mayo score was 6.89 basal, 3.13 at month 6 and 2.33 at month 12 (P < .01). Mucosal healing was achieved in 48% of patients. Only 3 patients (8%) needed a colectomy. We did not observe any association between clinical characteristics and response to ADA, but after multivariate analysis patients with loss of response to ADA had a lower remission rates (HR = 12.8; CI 95% 2.24-73.54; P = 0.004).

Conclusions

Adalimumab can be effective for clinical remission without steroids and mucosal healing in steroid-dependent UC. Loss of response to ADA is a predictive factor of poorer efficacy.