FDA Approves Adalimumab as Treatment for Children With Ulcerative Colitis


The approval makes adalimumab the only subcutaneous biologic for pediatric patients with ulcerative colitis that can be administered at home.

Officials with the FDA have approved adalimumab (Humira; AbbVie) for the treatment of moderately to severely active ulcerative colitis in pediatric patients ages 5 years and older. According to AbbVie, the approval makes adalimumab the only subcutaneous biologic for pediatric patients with ulcerative colitis that can be administered at home.

This approval is based on results from the phase 3, randomized, double-blind, multicenter ENVISION I (NCT02065557) study, which showed that adalimumab achieved the co-primary endpoints of clinical remission per Partial Mayo Score (PMS) at Week 8 and, among those who responded at Week 8, clinical remission per Full Mayo Score (FMS) at one year (52 weeks). Clinical remission was defined as a PMS or as a FMS less than or equal to 2 and no individual sub-score greater than 1.

"Ulcerative colitis is unpredictable and affects everyone, especially children, in different ways," said Marla Dubinsky, MD, chief, Division of Pediatric Gastroenterology for the Mount Sinai Health System and co-director of the Susan and Leonard Feinstein IBD Center at Mount Sinai in New York, in a prepared statement.

Ulcerative colitis is characterized by inflammation of the large intestine with symptoms ranging from mild to severe bowel urgency and bowel incontinence as well as weight loss and fatigue. It remains a lifelong condition that is not adequately controlled in many patients. According to AbbVie, significant unmet needs remain in moderate to severe pediatric ulcerative colitis, compared to adults, as pediatric patients tend to have more extensive disease often causing significant morbidity in children.

The ENVISION I study was designed to evaluate the efficacy, safety and the pharmacokinetics of adalimumab in pediatric patients (ages 4-17 years) with moderate to severe ulcerative colitis (defined as a FMS of 6 to 12 with endoscopy subscore of 2 to 3 points, confirmed by centrally read endoscopy), administered subcutaneously.

Through Week 8, patients in both dosage groups received 2.4 mg/kg (maximum of 160 mg) at Week 0, 1.2 mg/kg (maximum of 80 mg) at Week 2, and 0.6 mg/kg (maximum of 40 mg) at Weeks 4 and 6. The higher dosage group also received an additional dosage of 2.4 mg/kg (maximum of 160 mg) at Week 1. Between Week 8 and Week 52, patients received double-blind placebo, HUMIRA 0.6 mg/kg (maximum of 40 mg) every other week, or every week. The co-primary endpoints of the study were clinical remission per PMS (defined as PMS ≤ 2 and no individual subscore > 1) at Week 8, and clinical remission per the Mayo Score (defined as Mayo Score ≤ 2 and no individual subscore > 1) at Week 52 in patients who achieved clinical response per PMS at Week 8.

Study results demonstrated 60% of patients taking the higher dosage of adalimumab achieved clinical remission per PMS, at the end of the 8-week induction period and 43% of patients in the lower dosage group. At Week 52, among Week 8 PMS responders, 45% of patients receiving the higher dosage of adalimumab achieved remission per FMS and 29% of patients taking the lower dosage of adalimumab and 33% of those randomized to placebo. According to AbbVie, there are limitations to the interpretability of the placebo data due to the small sample size.

In the ENVISION I study, no new safety signals for HUMIRA were observed. Throughout any adalimumab exposure in the study, 22.6% of patients experienced a serious adverse event. The most frequently reported (5% or greater) treatment-emergent adverse events during induction and maintenance periods were headache and worsening of ulcerative colitis. No deaths, malignancies, active tuberculosis or demyelinating disease were observed in this study.


HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis [news release]. North Chicago, IL; February 24, 2021; AbbVie. Accessed February 24, 2021. https://news.abbvie.com/news/press-releases/humira-adalimumab-receives-fda-approval-to-treat-pediatric-patients-living-with-moderately-to-severely-active-ulcerative-colitis.htm?view_id=3018

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