AbbVie announced that Health Canada has approved Humira (adalimumab) for the treatment of chronic noninfectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate. Humira is now the only approved biologic treatment option for chronic noninfectious anterior uveitis in children aged 2 years and older in Canada.
“This approval marks an important milestone for pediatric uveitis patients and their caregivers who, up until this point, had no biologic treatment options available to them,” Stéphane Lassignardie, General Manager of AbbVie Canada, said in a company news release. “This label expansion for Humira further demonstrates AbbVie’s dedication to addressing the unmet medical needs for both adult and pediatric patients living with serious immune-mediated inflammatory diseases.”
“For many children, the diagnosis of uveitis carries a significant burden in terms of number of visits to the hospital, threat to the patient’s vision, and anxiety for the whole family,” Eric Fortin, MD, ophthalmologist at the University of Montreal Ophthalmology Center, said in a news release. “Having this approval for the indication of pediatric uveitis will hopefully lead to easier access to Humira for those patients who need it. That is something that is very important both to me and my patients.”
“Pediatric uveitis is a debilitating and potentially blinding condition, which poses overwhelming challenges to children and their families,” said Christina Pelizon, Medical Director, AbbVie Canada. “The SYCAMORE study showed that Humira in combination with methotrexate significantly delayed the time to treatment failure compared with methotrexate plus placebo. These results demonstrate Humira has the potential to help many children who have failed standard treatments preserve their eyesight from the ocular complications associated with chronic noninfectious anterior uveitis.”
The SYCAMORE clinical trial is a randomized controlled study of the clinical efficacy and safety of Humira combined with methotrexate versus methotrexate plus placebo for the treatment of active JIA-associated uveitis. It was sponsored by the University Hospitals Bristol NHS Foundation Trust and coordinated by the Clinical Trials Research Centre at the University of Liverpool. The Independent Data Safety and Monitoring Committee (IDSMC) recommended unmasking the trial early after 90 randomized patients with active JIA-associated uveitis because it showed that Humira combined with methotrexate controlled ocular inflammation better and was associated with a significantly lower rate of treatment failure, defined according to several criteria, including multiple components of intraocular inflammation, than placebo.