Intravenous golimumab shows long-term benefit for juvenile idiopathic arthritis
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Key takeaways:
- Intravenous golimumab for JIA maintained an acceptable risk-benefit profile in a long-term extension study.
- The drug’s pharmacokinetics and immunogenicity were consistent up to 244 weeks.
Intravenous golimumab yielded a durable clinical response through 116 weeks, with a stable safety profile, in polyarticular-course juvenile idiopathic arthritis, according to data published in The Journal of Rheumatology.
The long-term extension study also found “adequate” pharmacokinetic exposure and consistent immunogenicity through 244 weeks, the researchers wrote.
“Inadequately controlled active JIA and synovial inflammation can cause joint damage, which can impair physical function and negatively affect quality of life,” Hermine I. Brunner, MD, MSc, MBA, director of the division of rheumatology at Cincinnati Children’s Hospital, and colleagues wrote. “Thus, escalation of therapy is recommended for patients with continued active disease despite first-line therapies. The availability of biologic DMARDs and targeted synthetic DMARDs increases the diversity of effective treatment options available for patients with JIA.”
In a previous phase 3, open-label, single-arm, multicenter study, Brunner and colleagues wrote that golimumab (Simponi/Simponi Aria, Janssen) “generally reduced” active polyarticular-course JIA symptoms, and was well-tolerated, with adequate pharmacokinetic exposure. Following that trial, 112 patients with polyarticular-course JIA opted to enter a long-term extension study, with 69 completing all 252 weeks.
In the current study — which assessed the pharmacokinetics, immunogenicity, clinical effect, and safety of intravenous golimumab in patients who entered the long-term extension — measures of clinical response included JIA-ACR30/50/70/90 criteria score and the clinical Juvenile Arthritis Disease Activity Score in 10 joints (cJADAS10). Pharmacokinetic exposures were assessed through median steady-state trough concentrations, while anti-golimumab antibodies were measured through periodic serum samples.
At week 116, the 52-week JIA-ACR 30/50/70/90 response rates were “generally maintained,” reaching 75.6%, 74%, 65.4% and 48.8%, respectively, according to the researchers. By that point, cJADAS10 scores in the group were “generally within” the range of minimal disease activity, with a median score of 2.4 (IQR, 0.3-7.4), they added.
Median steady-state trough concentrations remained overall consistent from week 52 through week 224, ranging from 0.3 (IQR, 0.1-0.5) g/mL to 0.6 g/mL (IQR, 0.2-1). Anti-golimumab antibody rates were also consistent, being detected in 39.2% of participants with appropriate samples at week 52, and in 44.8% at week 244.
“Future studies could assess the proportion of patients who achieve JIA-ACR inactive disease and/or JIA-ACR100,” Brunner and colleagues wrote. “In addition, given that 29.9% to 37.8% of participants had a pain score > 35 mm through week 244, evaluation of the correlation of pain score with clinical response may be warranted.
“Among participants with active [polyarticular course] JIA treated with IV golimumab 80 mg/m2 Q8W, PK exposure through week 244 was consistent with that observed through week 52,” they added. “Additionally, although data were limited, the stable rates of clinically important therapeutic outcomes from week 52 through week 116 suggest a therapeutic benefit with continued IV golimumab treatment beyond 1 year and, in the context of the long-term safety data reported here, an acceptable risk-benefit profile.”
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