TY - JOUR T1 - Efficacy and Safety of Adalimumab in Pediatric Ulcerative Colitis: A Real-life Experience from the SIGENP-IBD Registry. JF - J Pediatr Gastroenterol Nutr Y1 - 2018 A1 - Aloi, Marina A1 - Bramuzzo, Matteo A1 - Arrigo, Serena A1 - Romano, Claudio A1 - D'Arcangelo, Giulia A1 - Lacorte, Doriana A1 - Gatti, Simona A1 - Illiceto, Maria T A1 - Zucconi, Francesca A1 - Dilillo, Dario A1 - Zuin, Giovanna A1 - Knafelz, Daniela A1 - Ravelli, Alberto A1 - Cucchiara, Salvatore A1 - Alvisi, Patrizia AB -

OBJECTIVES: The aim of this study was to evaluate the effectiveness and safety of adalimumab (ADA) in children with ulcerative colitis (UC) previously treated with infliximab (IFX).

METHODS: Retrospective study including children with UC from a national registry who received ADA therapy. The primary endpoint was the rate of corticosteroid-free remission at week 52. Secondary outcomes were the rate of sustained clinical remission, primary nonresponse, and loss of response at weeks 12, 30, and 52 and rate of mucosal healing and side effects at week 52.

RESULTS: Thirty-two children received ADA (median age 10 ± 4 years). Median disease duration before ADA therapy was 27 months. All patients received previous IFX (43% intolerant, 50% nonresponders [37.5% primary, 42.5% secondary nonresponders], 6.7% positive anti-IFX antibodies). Fifty-two weeks after ADA initiation, 13 patients (41%) were in corticosteroid-free remission. Mucosal healing occurred in 9 patients (28%) at 52 weeks. The cumulative probability of a clinical relapse-free course was 69%, 59%, and 53% at 12, 30, and 52 weeks, respectively. Ten patients (31%) had a primary failure and 5 (15%) a loss of response to ADA. No significant differences in efficacy were reported between not-responders and intolerant to IFX (P = 1.0). Overall, 19 patient (59%) maintained ADA during 52-week follow-up. Seven patients (22%) experienced an adverse event, no serious side effects were observed and none resulted in ADA discontinuation.

CONCLUSIONS: Based on our data, ADA seems to be effective in children with UC, allowing to recover a significant percentage of patients intolerant or not-responding to IFX. The safety profile was good.

VL - 66 IS - 6 U1 - http://www.ncbi.nlm.nih.gov/pubmed/29315163?dopt=Abstract ER -