Results from a study published in the Annals of the Rheumatic Diseases support the use of adalimumab in patients with early-onset idiopathic or juvenile idiopathic arthritis (JIA)-associated chronic uveitis who have not responded to topical steroids and methotrexate.
Patients were recruited from 9 tertiary care pediatric rheumatology centers in France for enrollment into the ADJUVITE trial (Effect of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis; ClinicalTrials.gov identifier: NCT01385826). Thirty-one patients (aged 4 years or older) with ocular inflammation measured by laser flare photometry ≥30 photon units/ms were randomly assigned to receive either placebo or adalimumab delivered subcutaneously at 24 mg/m2 in patients aged <13 years, and at 40 mg/m2 in older patients, every other week for 2 months. After the 2-month double-blind period of receiving either adalimumab or placebo, all study participants received adalimumab in the open-label phase of the trial for an additional 10 months.
The study’s primary outcome measure was response to treatment at month 2, defined by a 30% reduction in inflammation on laser flare photometry in the accessible eye, with more severe inflammation at baseline and no worsening on slit lamp examination.
At month 2, there were 9 of 16 responders receiving adalimumab and 3 of 15 receiving placebo (P =.038, χ2 test; relative risk, 2.81 [95% CI, 0.94-8.45]; risk difference, 36.3% [95% CI, 2.1%-60.6%]). There was no significant difference using the Standardized Uveitis Nomenclature classification criteria of improvement.
Thirty patients continued the trial and received adalimumab after month 2, and 29 of them reached month 12. There were 7 serious adverse events, none of which was related to the study treatment.
“Over 12 months, all patients but two continued adalimumab, which was well tolerated and associated with persistent uveitis improvement in most cases,” the researchers noted.
The researchers also noted that laser flare photometry, which detects inflammation in patients who have low-grade inflammation and sometimes no cells on slit lamp examination, enables earlier detection of improvement on adalimumab therapy. “This could help to decide after a few months (2 months in the patients with high [laser flare photometry] values at treatment onset, possibly more in the other patients), if adalimumab therapy should be continued or other treatments discussed,” they wrote.
This study had a small number of participants, and the primary end point results should therefore be interpreted with caution.
The researchers concluded that this trial indicates that adalimumab may be effective in patients with early-onset, chronic anterior uveitis who do not respond to topical therapy and methotrexate. These trial results also indicate that laser flare photometry could be a valuable tool in evaluating early treatment efficacy.
Quartier P, Baptiste A, Despert V, et al. ADJUVITE: a double-blind, randomised, placebocontrolled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis [published online December 23, 2017]. Ann Rheum Dis. doi: 10.1136/annrheumdis-2017-212089