The safety, pharmacokinetics (PK), and efficacy of subcutaneous golimumab in the treatment of active polyarticular-course juvenile idiopathic arthritis (JIA) were evaluated in a 3-part, randomized, double-blind, placebo-controlled withdrawal trial, reported in Annals of the Rheumatic Diseases.1
A total of 173 patients between 2 and 17 years of age were enrolled in the study. In Part 1 (open label, lead-in phase; Weeks 0-16), all patients received subcutaneous golimumab
(30 mg/m2 of body surface area; maximum dose: 50 mg) every 4 weeks, along with weekly methotrexate. Patients could enter Part 2 of the study (double-blind, withdrawal period; Weeks 16-48) if they had achieved at least 30% improvement in American College of Rheumatology (ACR30) Criteria for in JIA. Patients enrolled in Part 2 continued treatment with golimumab or received placebo. In Part 3 (scheduled to continue through Week 248; discontinued early because primary and secondary end points were not met at Week 48), golimumab was continued or could be restarted per Part 1.
The primary end point of the study was JIA flares in Part 2; secondary end points included
JIA ACR50/70/90 (50%, 70%, and 90%) responses, clinical remission, PK, and safety.
In Part 1 of the study, 89.0% (154 of 173) of patients demonstrated a JIA ACR30 response, whereas 79.2%, 65.9%, and 36.4% experienced a JIA ACR50, ACR70, and ACR90 response, respectively. The primary end point was not met at Week 48, as JIA flare rates were similar in the treatment groups (41% [32/78] with golimumab vs 47% [36/76] with placebo; P =.41). Clinical remission rates were comparable in the groups (12.8% [10/78] with golimumab vs 11.8% [9/76] with placebo).
The investigators concluded that although the primary outcome of the study was not met, golimumab use in children with active polyarticular-course JIA resulted in rapid, clinically meaningful improvements. The agent was well tolerated, and no unanticipated safety events were reported.
Brunner HI, Ruperto N, Tzaribachev N, et al. Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicenter, double-blind, randomized-withdrawal trial [published online May 15, 2017]. Ann Rheumatol.