P401 Adalimumab as first-line anti-TNF treatment in ulcerative colitis. A "real-life" observational study
R. Lorente*1, C. Verdejo1, O. Roncero2, D. López3, P. Robledo4, A. Bouhmidi5, D. Hervías6
1Hospital General Ciudad Real, Gastroenterology, Ciudad Real, Spain, 2Hospital Mancha Centro, Gastroenterology, Alcázar San Juan, Spain, 3Hospital de Llerena, Gastroenterology, Llerena, Spain, 4Hospital San Pedro Alcántara, Gastroenterology, Cáceres, Spain, 5Hospital Santa Bárbara, Gastroenterology, Puertollano, Spain, 6Hospital Virgen Altagracia, Gastroenterology, Manzanares, Spain
Recently, randomized controlled trials have demonstrated that Adalimumab (ADA) is effective in the induction and maintenance treatment of moderate to severe ulcerative colitis (UC) that did not present sufficient response to conventional therapy, including corticosteroids and immunosuppressants. However, the absolute benefit in terms of clinical practice requires new evidence when used as the first anti-TNF treatment. Our goal is to obtain data on efficacy and safety of ADA in treating patients with active ulcerative colitis who had not previously received another anti-TNF.
Retrospective review of 17 patients older than 18 years diagnosed with UC refractory to conventional treatment, ADA-treated for 1 year, according to product label in real-life situations. Response and clinical remission at 6 months and 1 year was assessed according to partial Mayo index.
Seventeen patients (10 men) with a mean age of 49.7 years. Duration of disease 6 years. Montreal classification of UC: Extent - E2 6 patients (35.3%), E3 11 patients (64.7%). Severity - S1 2 patients (11.8%), S2 10 patients (58.8%), S3 5 patients (29.4%). Receiving concomitant immunosuppressive treatment 16 patients, 15 with azathioprine / 6MP (88.2%) and 1 with methotrexate (5.9%). All were treated with induction with ADA at doses of 160/80 mg and maintenance with ADA 40 mg every 2 weeks. Response and remission in 16 (94.1%) and 12 (70.6%) at 6 months and 15 (88.2%) and 14 (82.4%) at 12 months was observed. Eight patients (46.1%) required intensification of treatment. Colonoscopy was performed in 11 patients at 12 months; 7 (63.6%) had mucosal healing. Treatment was suspended in 4 patients (23.5%), 1 of them for loss of efficacy. In 2 patients malignancies were diagnosed, 1 of them showed recurrence of low-grade bladder urothelial carcinoma and another was diagnosed with lung cancer (ex-smoker). Four patients had mild infectious complications. One patient (5.9%) required colectomy due to sustained activity refractory to second anti-TNF treatment with infliximab.
ADA has shown efficacy in the treatment of UC as first line anti-TNF in real clinical practice, in adult patients. Response and remission real clinical data with ADA as first line anti-TNF in UC are higher than randomized controlled trials efficacy data of ADA versus placebo. It is important to monitor the development of new neoplasias, mainly if there are risk factors or history of neoplasia.