WASHINGTON — Tocilizumab, an interleukin-6 inhibitor, was highly effective in the treatment of polyarticular juvenile idiopathic arthritis (JIA), leading to a significant reductions in flares, in the phase 3 CHERISH trial presented here at the ACR 2012.
"The CHERISH trial met its primary end point. Tocilizumab is highly effective and results in meaningful improvement in polyarticular JIA," said lead author Hermine Brunner, MD, MBA, from division of rheumatology at the Cincinnati Children's Hospital in Ohio.
CHERISH is a 2-year 3-part trial conducted at 58 centers in 15 countries. Dr. Brunner reported results from the second part of the trial. Part 1 was a 16-week open-label trial in which 188 patients received tocilizumab. The 166 patients who achieved at least a 30% improvement in signs and symptoms of JIA (an ACR30 response) went on to part 2, which was a 24-week study in which patients were randomized to continue on the same dose of tocilizumab or to receive placebo. Part 3 is an ongoing open-label study.
Patients 2 and 17 years of age were included in the study if they had polyarticular JIA affecting at least 5 joints. All patients had had JIA for at least 6 months and had failed methotrexate. Mean affected joint count was 20. Dosing of tocilizumab was based on weight, and patients were also taking background medications, such as methotrexate and nonsteroidal anti-inflammatory drugs. Heavier patients were older with a longer disease duration; otherwise, the demographic and disease characteristics of the 2 groups were comparable.
For the primary end point of ACR30 flare, fewer patients in the tocilizumab group than in the placebo group experienced a flare by week 40 (28% vs 48%).
"Patients on tocilizumab rapidly improved in signs and symptoms of polyarticular JIA. Response was maintained in a large proportion of patients at week 40," Dr. Brunner reported.
Overall, adverse events were comparable in the 2 groups. No deaths were reported. Infections were the main serious adverse events; at the time of the safety data cutoff, the rate of infections was 164 per 100 patient-years. No grade 4 laboratory abnormalities were reported, and there were few grade 3 laboratory abnormalities. A marked elevation in cholesterol levels was reported in 11.4% of patients who received tocilizumab.
Outside Expert Calls for Head-to-Head Studies
"I am excited to see [that] we apparently have yet another highly effective biologic agent for polyarticular JIA. I am eager to learn more about the best use of tocilizumab, compared with other FDA-approved biologic agents," said Timothy Beukelman, MD, pediatric rheumatologist at the University of Alabama at Birmingham.
The way to learn more would be head-to-head studies. "We need to begin to conduct rigorous comparative-effectiveness studies to inform us about the relevant differences in the effectiveness of biologic agents in JIA [and other rheumatologic conditions]," Dr. Beukelman said.
Dr. Brunner has disclosed no relevant financial relationships. Some of her coauthors report relationships with Pfizer, Novartis, Genentech, Abbott, Amgen, Wyeth, Regeneron Hoffmann-La Roche, AstraZeneca, BMS, Centocor, Chugai, Roche Pharmaceuticals, Janssen, NovImmune, Xoma, SOBI, UBS, Centocor, Forest Research, the Arthritis and Rheumatism journal, and the National Institutes of Health. Dr. Beukelman reports receiving consultant fees from Novartis and Genentech, and receiving a research grant from Pfizer.
ACR 2012: Abstract 1597. Presented November 12, 2012.
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Cite this: Tocilizumab Shows Promise for Juvenile Idiopathic Arthritis - Medscape - Nov 14, 2012.