Humira efficacious, safe for moderate to severe UC in children
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Humira was efficacious and safe for treating children with moderate to severe ulcerative colitis, according to a presentation at UEG Week.
“Adalimumab was generally well tolerated and no new safety signals were observed,” Nicholas M. Croft, MD, Center for Immunology, Blizard Institute, Barts and London School of Medicine, Queen Mary University of London and the Royal London Children’s Hospital, said during his presentation. “We conclude that this is an efficacious and well-tolerated treatment option for children with moderate to severe UC.”
Croft and colleagues enrolled 93 children with moderate to severe UC into either the intention-to-treat or safety population. For an 8-week induction period, they randomly assigned 77 patients to double-blind Humira (adalimumab, AbbVie) 2.4 mg/kg at week 0. At 1 week patients received again adalimumab 2.4 mg/kg (high dose) or matching placebo (standard dose). At 2 weeks, they received 1.2 mg/kg and 0.6 mg/kg at 4 weeks and 6 weeks. Researchers then analyzed for primary 8-week efficacy endpoint (ITT-E). In addition, 16 patients received open-label high-dose adalimumab after protocol change in the intention-to-treat efficacy population.
In the intention-to-treat population, investigators randomly assigned 62 of the 8-week responders per the Partial Mayo Score (PMS) to high dose adalimumab (0.6 mg/kg weekly) or standard dose (0.6 mg every other week) and analyzed for primary 52-week endpoints (mITT-E). Twelve patients assigned to placebo were not included in the 52-week primary analyses per protocol change to remove the placebo arm.
The proportion of patients who achieved PMS remission at 8 weeks and Full Mayo Score (FMS) remission at 52 weeks among 8-week responders served as the co-primary endpoints. Other endpoints included percentage of patients who achieved FMS clinical response among 8-week responders, mucosal healing, FMS remission among 8-week PMS remitters and corticosteroid-free FMS remission among 8-week responders.
Investigators reported systemic corticosteroid use among 47% of the ITT population, immunosuppressant use among 59% and 84% were tumor necrosis factor inhibitor naive at baseline.
Results showed 53% of patients in the ITT-E population achieved PMS remission after 8-week induction of adalimumab (60% with high-dose and 43% with standard-dose). Among the 62 mITT-E patients, a significantly higher percentage of patients achieved all 52-week co-primary and secondary endpoints in the pooled and high-dose adalimumab during the maintenance period vs. placebo.
According to Croft, 56% of patients in the safety population reported one or more adverse events and 11% reported serious adverse events during the induction period.
“There were clinically meaningful rates of remission and response, including steroid-free remission, and mucosal healing, achieved by children in moderate to severe UC receiving adalimumab,” he said.
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Croft NM, et al. OP1140. Presented at: UEG Week; Oct. 11-13, 2020.
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