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