Marina Aloi1, Matteo Bramuzzo2, Serena Arrigo3, Claudio Romano4, Giulia D'Arcangelo1, Doriana Lacorte5, Simona Gatti6, Maria T Illiceto7, Francesca Zucconi1, Dario Dilillo8, Giovanna Zuin8, Daniela Knafelz9, Alberto Ravelli10, Salvatore Cucchiara1, Patrizia Alvisi5. 1. Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome. 2. Pediatric Department, Gastroenterology and Nutrition Unit, Institute for Maternal and Child Health, IRCCS "Burlo Garofolo," Trieste. 3. Pediatric Gastroenterology and Endoscopy Unit, Institute "Giannina Gaslini", Genoa. 4. Pediatric Gastroenterology Unit, Pediatric Department, Messina. 5. Pediatric Gastroenterology Unit, Maggiore Hospital, Bologna. 6. Pediatric Department, Salesi Children's Hospital, Ancona. 7. Pediatric Gastroenterology and Endoscopy Unit, Spirito Santo Hospital, Pescara. 8. Pediatric Department, Gastroenterology Unit, Buzzi Children Hospital, Milan. 9. Gastroenterology and Nutrition Unit, "Bambino Gesù" Children Hospital, Rome. 10. Pediatric Gastroenterology Unit, Spedali Civili Hospital, Brescia, Italy.
Abstract
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.
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.