Efficacy and Safety of Adalimumab in Pediatric Ulcerative Colitis: A Real-life Experience from the SIGENP-IBD Registry

ABSTRACTObjectives: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 (CS) free remission at week 52. Secondary outcomes were: the rate of sustained clinical remission, primary non-response and loss of response at weeks 12, 30, and 52 and rate of mucosal healing (MH) and side effects at week 52.Results:Thirty-two children received ADA (median age 10 ± 4years). Median disease duration before ADA therapy was 27 months. All patients received previous IFX [43% intolerant, 50% non-responders (37.5% primary, 42.5% secondary non-responders), 6.7% positive anti-IFX antibodies]. Fifty-two weeks after ADA initiation, 13 patients (41%) were in CS-free remission. MH occurred in 9 patients (28%) at 52 weeks. The cumulative probability of 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%) 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 (CS) free remission at week 52. Secondary outcomes were: the rate of sustained clinical remission, primary non-response and loss of response at weeks 12, 30, and 52 and rate of mucosal healing (MH) and side effects at week 52. Results: Thirty-two children received ADA (median age 10 ± 4years). Median disease duration before ADA therapy was 27 months. All patients received previous IFX [43% intolerant, 50% non-responders (37.5% primary, 42.5% secondary non-responders), 6.7% positive anti-IFX antibodies]. Fifty-two weeks after ADA initiation, 13 patients (41%) were in CS-free remission. MH occurred in 9 patients (28%) at 52 weeks. The cumulative probability of 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%) 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. Address correspondence and reprint requests to Marina Aloi, MD, PhD, Department of Pediatrics, Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Viale Regina Elena 324, 00161 Roma – Italy (e-mail: marina.aloi@uniroma1.it). Received 7 November, 2017 Accepted 18 December, 2017 Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org). All the authors declare no financial relationships with a commercial entity producing health-related products and or services related to this article or COI. The other authors report no conflicts of interest. © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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