medwireNews: Treatment with the anti-tumor necrosis factor (TNF) α antibody golimumab could improve disease activity in children with polyarticular-course juvenile idiopathic arthritis (polyJIA), researchers report.
In the first part of the GO-KIDS trial, 173 participants with active JIA despite methotrexate treatment were all given open-label subcutaneous golimumab 30 mg/m2 every 4 weeks alongside weekly methotrexate for 16 weeks. A total of 154 patients who experienced at least a 30% improvement in the American College of Rheumatology Criteria for JIA (JIA ACR30) were then randomly assigned to either continue treatment with golimumab or switch to placebo from weeks 16 to 48.
“This trial design was introduced in JIA for ethical reasons to minimise placebo exposure and for sample size consideration,” explain Hermine Brunner (University of Cincinnati, Ohio, USA) and study co-authors in the Annals of the Rheumatic Diseases.
The researchers found no significant difference in the proportion of patients without JIA flares at week 48 – the primary study endpoint – with 41.0% of 78 patients receiving golimumab having no flares, compared with 47.4% of 76 patients in the placebo group.
Similarly, patients in the golimumab and placebo groups had comparable rates of clinical remission, at 12.8% and 11.8%, respectively.
The plan was for patients to continue taking golimumab or switch from placebo to golimumab if still not in clinical remission through to week 248, but Brunner and colleagues note that “the study was discontinued by the sponsor earlier because the primary and major secondary efficacy endpoints at week 48 were not met.”
They suggest that “failure in achieving the primary and all major secondary endpoints could have been influenced by the mandatory [methotrexate] background therapy that might have helped maintain disease control.”
However, the authors note that even though these endpoints were not met, “golimumab resulted in rapid, clinically meaningful, improvement in children with active polyJIA.”
Indeed, participants experienced improvements in disease activity with golimumab treatment during the first part of the study; 89.0% experienced a JIA ACR30 response at week 16, while 79.2%, 65.9%, and 36.4% experienced at least a 50%, 70%, and 90% improvement in the JIA ACR criteria, respectively. A total of 34.1% had clinically inactive disease at week 16.
Over the course of the study, 92.5% of patients reported at least one adverse event (AE), while 22.5% experienced serious adverse events (SAEs). Rates of AEs and SAEs were comparable in the golimumab and placebo groups in the randomized part of the study, at 358.5 versus 526.3 per 100 patient–years of exposure and 17.1 versus 32.5 per 100 patient–years of exposure, respectively.
In all, 16 participants experienced 21 AEs or SAEs leading to treatment discontinuation, including worsening of JIA, transient transaminitis, increased aminotransferase levels, serum sickness-like reaction, uveitis, chest pain, gall bladder edema, affective disorder, and demyelination.
“The safety profile of golimumab was consistent with that observed in adults and other TNFα agents in JIA with few patients discontinuing the study because of AEs,” conclude the authors.
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