medwireNews: Individuals with active polyarticular juvenile idiopathic arthritis (JIA) are more likely to respond to early treatment with etanercept plus methotrexate than with methotrexate alone, trial findings indicate.
Gerd Horneff (Asklepios Clinic Sankt Augustin, Germany) and co-investigators say their results show that etanercept plus methotrexate combination therapy “is a universal treatment regimen that can be used for patients with both mild and severe disease courses to quickly reduce inflammation and articular symptoms during the first 12 weeks of treatment.”
They found that 94.3% of the 35 patients randomly assigned to receive etanercept 0.8 mg/kg per week (maximum 50 mg/week) plus methotrexate 10–15 mg/week achieved a JIA ACR30 response at week 12.
By comparison, 60.6% of the 33 participants given placebo plus methotrexate reached this target, a statistically significant difference.
At baseline, all participants were aged between 4 and 13 years, were biologic-naïve, and were not receiving DMARDs, and the researchers note that the difference in JIA ACR30 response rate was significant from week 4 onwards with a similar pattern seen for JIA ACR50, 70, 90, and 100 response rates.
Further analysis revealed that the people who responded to placebo plus methotrexate had significantly milder disease than methotrexate nonresponders and those who responded to etanercept plus methotrexate.
This suggests that methotrexate “quickly provides relief only to children with a mild course of JIA, while [etanercept plus methotrexate] can help all children, regardless of disease severity,” write Horneff and co-authors in Pediatric Rheumatology.
At 12 weeks, participants who had not achieved a JIA ACR 30 response were given open-label etanercept as rescue treatment and followed up for a further 12 weeks.
At week 24, similar proportions of patients in the initial combination therapy and monotherapy groups had inactive disease according to the Wallace criteria (31.4 vs 33.3%). Those who did not have inactive disease were also given rescue therapy with etanercept.
At the final follow-up visit, at week 48, 48.6% and 60.6% of the combination and monotherapy groups, respectively, had achieved inactive disease and 31.4% and 24.2%, respectively, had achieved remission.
The researchers report that the median time taken to achieve an inactive disease state was 24 weeks for patients initially given etanercept plus methotrexate and 32 weeks for those given placebo plus methotrexate.
Horneff et al also report that “both cohorts showed an acceptable safety profile.”
The team concludes that “earlier addition of [etancercept] to the treatment regimen shortens the time to achieve remission, which “improves patients’ quality of life.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group