Positive Opinion Issued for Humira in Pediatric Patients with Crohn's Disease

The European Committee for Medicinal Products for Human Use (CHMP) granted positive opinion for adalimumab (Humira) for pediatric patients with moderate-to-severe active Crohn’s disease.

Humira was evaluated in pediatric patients who are intolerant to or have had an inadequate response to conventional therapy, including primary nutrition therapy, a corticosteroid, or an immunomodulator.

“There is no known cure for children and adolescents affected by Crohn's disease, therefore treatment options are important,” said Jeffrey S. Hyams, MD, Connecticut Children’s Medical Center. “A large-scale investigation such as the IMAgINE trial showcases the safety and efficacy profile of Humira in the moderately to severely active pediatric Crohn's disease population.”

The positive opinion was based on the results of the multi-center, randomized, open-label induction clinical study called IMAGINE. The study was followed by a double-blind maintenance trial that involved patients ages 6 to 17-years-old suffering from moderate-to-severe active Crohn’s disease.

Humira was initiated with a 4-week induction period of a 80-mg dose and 40-mg dose administered subcutaneously at weeks 0 and 2, respectively, to patients with a bodyweight of <40 kg or 160 mg and 80 mg at weeks 0 and 2, respectively, for patients with bodyweight >40 kg.

After the induction period, 188 randomized patients received either a standard dose or low dose Humira treatment.

The standard dose consisted of 20-mg every other week for patients with a body weight of <40 kg or 40-mg every other week for patients with bodyweight >40 kg.

The low dose consisted of 10-mg every other week for patients with a body weight of <40 kg or 20 mg every other week for patients with bodyweight >40 kg.

The results of the study showed that at week 26, there were 63 patients who were in clinical remission, and an even larger portion of patients in the standard dose Humira group (36/93) reached clinical remission compared to the low-dose group (27/95; P=0.075).

By week 52, more patients in the standard Humira dose group (31/93) reached clinical remission than the low dose Humira group (22/95; P=0.100).

Researchers defined clinical remission as a PCDAI score less than 10.

“The positive CHMP opinion represents a significant milestone for the pediatric gastroenterology community as we move closer to European approval of Humira in pediatric patients with moderately to severely active Crohn's disease, a chronic condition with no known cure that affects a growing number of children worldwide,” said Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie.

In the meantime, AbbVie will continue to work towards their goal of treating more pediatric patients with Crohn’s.

“AbbVie is committed to the ongoing study and innovation of Humira, and we look forward to expanding this treatment option, once approved, to help more children with this debilitating illness during a vulnerable time in their lives,” Severino said.