Tocilizumab may reduce polyarticular juvenile idiopathic arthritis flares

The interleukin-6 receptor inhibitor tocilizumab reduced disease flares during and after administration compared with methotrexate or placebo among children with polyarticular juvenile idiopathic arthritis, according to a recent study.

The three-part, randomized, double-blind, placebo-controlled withdrawal study included patients who had active polyarticular juvenile idiopathic arthritis (PJIA) for 6 months or longer, as well as an inadequate response to methotrexate.

“Our findings suggest treatment with tocilizumab (Actemra, Genentech) in children [with PJIA] resulted in rapid clinically meaningful improvement that was maintained over time,” lead author, Hermine I. Brunner, MD, a professor for the Division of Rheumatology at Cincinnati Children’s Hospital Medical Center in Cincinnati, Ohio, told Orthopedics Today.

“This is clinically meaningful because a high proportion (89%) of patients achieved JIA-ACR30 response by week 16, 62% of patients achieved JIA-ACR70 response and 26% even achieved JIA-ACR90 response,” he said. “Inactive disease was achieved by 30 of the patients by week 40.”

Study format

Data from 188 participants aged 2 to 17 years indicated decreased flare frequency following treatment with tocilizumab: 25.6% of those receiving the drug reported flares compared to 48.1% on placebo. Concluding placebo phase, 45.1% of the tocilizumab recipients reported flares compared with 64.6% on placebo.

Disease activity was measured using JIA-ACR30/50/70/90 criteria, CHAQ, well-being and inhibited motion assessments, JADAS-27, Pain visual analog scale score, C-reactive protein levels and erythrocyte sedimentation rates. Initially, participants with a body weigh less than 30 kg receivedeither 10 mg/kg (n = 35) or 8 mg/kg (n = 34) tocilizumab, and those with a body weight of 30 kg or more received 8 mg/kg every 4 weeks for 16 weeks. Those who improved entered the 24-week, double-blind phase with a placebo cohort (81 patients) and medication cohort (82 patients). In phase three, all received tocilizumab for an additional 64 weeks.

Brunner noted the study design restricted data on late-onset response, as well as safety and efficacy comparison among placebo patients, as the drug may not have cleared the system.

Inclusion, exclusion criteria

Patients with additional rheumatic or autoimmune disease, non-ambulatory patients, those previously treated with tocilizumab or other disease-modifying anti-rheumatic drugs, and corticosteroids within 4 weeks were excluded.

Actemra received FDA approval in 2013 for the treatment of PJIA in children 2 years of age, which came on the heels of a 2011 approval for systemic juvenile idiopathic arthritis. — by Katie Pfaff

Reference: Brunner HI. Ann Rheum Dis. 2014;doi: 10.1136/annrheumdis-2014-205351

Disclosure: Hoffman-La Roche sponsored the study; co-authors, Andrew Kenwright and Peng Lu affiliated with Roche.