FDA Highlights: Adalimumab reduces inflammation in refractory pediatric uveitis

Investigators reported on Oct. 22 in the Journal of the American Association for Pediatric Ophthalmology and Strabismus (AAPOS)  that treatment with adalimumab may be effective for patients with steroid-resistant refractory pediatric uveitis.

They reported that, in a study of 15 children, 85.7% showed initial improvement of anterior/posterior chamber inflammation after about three months of treatment.

As background, the authors noted that corticosteroids are the first line of treatment, but children can become treatment-resistant and develop significant side effects, or resist periocular administration.

Prior research has shown that about one third of pediatric uveitis patients develop complications. Children with juvenile rheumatoid arthritis (JIA) associated uveitis are prone to develop cataracts, band keratopathy, glaucoma, and phthisis. Complications that threaten vision necessitate surgery.

The investigators enrolled 15 subjects (12 female, average age 12 years) with either JIA-associated, idiopathic, or familial juvenile systemic granulomatosis (Blau syndrome) in the study. All subjects had already been treated with systemic steroids and methotrexate. Several had failed to respond to  cyclosporine and azathioprine, as well as etanercept and infliximab.

After subcutaneous injection with adalimumab (dosage varied by bodyweight) every two weeks for an average of 32 months, 85.7% of the subjects showed improvement of anterior/posterior chamber inflammatory activity, usually after six weeks of treatment.

The researchers reported that adalimumab therapy was “effective” according to Standardization of Uveitis Nomenclature (SUN) Working Group grading criteria in 60% of patients. Four subjects failed to respond.  Only minor injection-site reactions were reported.

“The results of the present study suggest that adalimumab is a reasonable first biological agent in cases of refractory noninfectious uveitis in children with good results and a reasonable side effect profile,” said lead investigator Luciano Bravo Ljubetic, MD, of the Ophthalmology Service of the Instituto de Investigacion Hospital Universitario La Paz (Spain).

Journal of AAPOS Senior Associate Editor William V. Good, MD, commented, “Over 294,000 children are afflicted with juvenile idiopathic arthritis. For decades, uveitis associated with JIA has been treated with topical eye steroid treatment. While local therapy remains an important component of treatment, the study by Bravo-Ljubetic and colleagues demonstrates that new systemic therapies help control both joint disease and eye disease. The expectation is that as systemic therapies improve, the rate of blindness and eye-related complications will decline.”