Since adalimumab had been previously been shown to be an effective treatment for children aged 2-17 years with polyarticular JIA, the aim of the current study was to see if it could also be of benefit in patients with ERA.
The M11-328 study was a 12-week, multicenter, double-blind trial that enrolled 46 children aged 6-18 years. They were randomized 2:1 to receive adalimumab or placebo, with continued open-label treatment for up to 3 years.
The primary endpoint, the percent change in the number of active joints with arthritis from baseline to week 12, showed a clear benefit of treatment with the biologic. Indeed, adalimumab reduced the active joint count by 62.6% vs. a reduction of 11.6% with placebo (P = .039). The treatment response was maintained with continued adalimumab treatment for 1 year. Other signs and symptoms of ERA, such as pain and enthesitis, were also reduced by the active treatment.
Dr. Sainsbury said, "The safety profile in this patient population is consistent with what we see in all other patient populations," including children aged 2 years or older with polyarticular JIA.
CHERISH 2-year data show sustained tocilizumab benefits
Dr. Eileen Baildam of Alder Hey Children’s Hospital in Liverpool, England, reported 2-year follow-up data from the CHERISH phase III trial. This trial was conducted in 58 centers in 15 countries and consisted of three phases: an open-label, lead-in phase that involved 188 children who were treated with tocilizumab for 16 weeks; a double-blind phase in which 166 children were randomized to receive tocilizumab or placebo for 24 weeks; and an open-label extension involving 60 children who were treated with tocilizumab for a further 64 weeks, bringing the total duration of therapy to 104 weeks.
Data from the second phase of the trial, at 40 weeks’ follow-up have been previously reported and "showed a very significant improvement in the flare rate in those treated vs. those on placebo," Dr. Baildam said.
A total of 82% of the 188 children enrolled in the study completed 2 years’ treatment and exhibited improvements in JIA American College of Rheumatology (ACR) 50, 70, and 90 criteria. The percentage of children who were ACR70 responders at 40 weeks and at 104 weeks were 79.3% and 86.6%, respectively, and the percentage who were ACR90 responders were a respective 50% and 70.7%.
Dr. Baildam reported a continued benefit of the anti–interleukin-6 receptor therapy, with 73.5% of children showing minimal disease activity at 40 weeks and 58.5% showing minimal disease activity at 2 years. Benefit was also seen in children who had received prior biologics.
"Overall the safety profiles remained unchanged from those at week 40, there were no deaths, and no new or unexpected safety concerns," she concluded.
The Etanercept Cohort Study is supported by Pfizer; Ms. Kearsley-Fleet had no disclosures. The CHERISH trial was supported by Pfizer; Dr. Baildam has received speaker or advisory board fees from Roche and Pfizer. The adalimumab trial was supported by AbbVie; Dr. Sainsbury is an employee of AbbVie.