Golimumab shows potential in treatment of paediatric polyJIA patients
Golimumab appears to induce rapid, clinically meaningful improvements in children with active polyarticular-course juvenile idiopathic arthritis (polyJIA), according to the results of a trial that did not meet its primary endpoint.
The three-part randomized withdrawal trial included 173 paediatric polyJIA patients treated with open-label golimumab (30 mg/m2 of body surface area; maximum, 50 mg/dose) every 4 weeks in combination with weekly methotrexate during part 1 (weeks 0 to 16). Patients showing at least 30 percent improvement in the American College of Rheumatology Criteria for JIA (JIA ACR30) in part 1 entered the double-blinded part 2 (weeks 16 to 48) and were randomized to either continue golimumab or start placebo. In part 3, golimumab was continued or could be restarted as in part 1.
The primary outcome was JIA flares in part 2, whereas secondary outcomes included JIA ACR50/70/90 responses, clinical remission, PK and safety.
Of the patients, 89.0 percent showed a JIA ACR30 response in part 1. The corresponding percentage of patients who demonstrated JIA ACR50/70/90 responses were 79.2, 65.9 and 36.4 percent.
At week 48, the primary endpoint was not met as JIA flare rates were comparable between the two treatment groups (41 percent with golimumab vs 47 percent with placebo; p=0.41). Likewise, rates of clinical remission were similar (12.8 vs 11.8 percent).
In terms of safety, adverse event and serious adverse event rates did not significantly differ between the treatment groups during part 2. Injection site reactions occurred with <1 percent of all injections. Adequate golimumab dosing for polyJIA was confirmed in pharmacokinetic analysis.
First-line drugs used in the treatment of children with polyJIA include nonsteroidal anti-inflammatory drugs and methotrexate. Those who are intolerant to MTX or fail to achieve adequate disease control may require treatment with biological disease-modifying antirheumatic drugs (DMARDs) such as golimumab, a fully human, antitumour necrosis factor (TNF)α monoclonal antibody that can be administered by either intravenous infusion or subcutaneous injection. [J Rheumatol 2004;31:390–2; Arthritis Care Res 2011;63:465–82; Nat Rev Rheumatol 2015;11:290–300]