A randomized, double-blind, placebo-controlled 12-Week trial of Infliximab in patients with Juvenile-Onset Spondyloarthritis or Enthesitis Related Arthritis

Objective: To assess the efficacy and safety of infliximab versus placebo in the treatment of patients with Juvenile-onset Spondyloarthritis and enthesitis-related arthritis (JoSpA/ERA). Methods: . Phase III, randomised, double-blind, placebo-controlled-trial of 12-weeks that included patients < 18-year-old with JoSpA/ERA not-responding to nonsteroidal-anti-inflammatory drugs, sulfasalazine, or methotrexate. Patients were randomly assigned 1:1 to the infusion of Infliximab 5mg/kg or placebo; completers entered then an open-label extension (OLE) period of 42 weeks. The primary endpoint was the number of active joints. Secondary outcomes included the assessment of disease activity, tender entheses, spinal mobility, serum C reactive protein (CRP), the Bath Ankylosing Spondylitis Disease Activity and Functional Index, and the Childhood Health Assessment Questionnaire (CHAQ). Results: . We randomized 12 patients to Infliximab and 14 to placebo. No significant differences were found between groups at baseline. At week 12, the mean number of active joints was 1.4 (SD 2.4) in the Infliximab group and 4.1 (SD 3.0) in the placebo group (p=0.0002). A repeated measures mixed model analysis that included all endpoints in the study demonstrated sustained favourable outcomes of Infliximab for active joints, tender joints, swollen joints and tender entheses counts, as well as for CHAQ and CRP (p<0.01). Adverse events were more frequent in the Infliximab group, including infections and infusion reactions, but none of them were serious. Conclusion: Infliximab is efficacious for patients with JoSpA/ERA with an inadequate response to conventional treatment. No serious adverse events with the use of infliximab were observed.