Adalimumab Gets a Thumbs Up in Juvenile Idiopathic Arthritis

Alice Goodman

June 16, 2014

PARIS — Adalimumab is safe and well tolerated in children with polyarticular juvenile idiopathic arthritis that is moderately to severely active, according to an interim analysis of 4-year safety data from a multicenter observational registry.

"Based on this interim analysis, the known safety profile of adalimumab remains unchanged," said investigator Gerd Horneff, MD, a pediatric rheumatologist at Asklepios Children's Hospital in Sankt Augustin, Germany.

The results of the analysis were presented here at the European League Against Rheumatism Congress 2014.

Four-year follow-up data were evaluated for patients with polyarticular juvenile idiopathic arthritis. Planned follow-up is 10 years.

At study enrollment, the children ranged in age from 2 to 17 years. For this interim analysis, 765 patients were evaluated — 459 were treated with adalimumab with or without methotrexate and 305 were treated with methotrexate alone.

The enrollment target of 800 patients has just been reached, Dr. Horneff reported.

The 131 patients who did not respond to methotrexate alone were switched to adalimumab with or without methotrexate. Follow-up started from the time they initiated treatment with adalimumab.

At baseline, patients treated with adalimumab were older (12.2 vs 9.6 years), heavier (47.8 vs 37.9 kg), and taller (150.3 vs 137.2 cm) than those treated with methotrexate monotherapy. In addition, mean disease duration was longer in those treated with adalimumab (3.8 vs 1.3 years). All other demographic and disease characteristics were similar in the 2 groups.

Adverse events were reported in 30.9% of the adalimumab group and 40.0% of the methotrexate monotherapy group. Severe adverse events were reported in 4.8% of the adalimumab group and 3.9% of the methotrexate monotherapy group. There were no reports of death or malignancies.

"No safety concerns were raised regarding the total number of serious adverse events, as graded by the local physician, or predefined serious adverse events, including the number and rate of infectious events," Dr. Horneff reported.

"Most serious infections occurred only once, and there have been no reports of opportunistic infections and no tuberculosis so far," he added.

Complete results will be presented later, but Dr. Horneff gave audience members a glimpse at the efficacy data. The mean Juvenile Arthritis Disease Activity Score in 71 joints (JADAS71) decreased from baseline to month 6 in both treatment groups.

Table. Change in JADAS71 Over 6 Months

Time Adalimumab Group Methotrexate Monotherapy Group
Baseline 12.1 13.1
Month 1 8.5 11.2
Month 3 5.7 6.4
Month 6 5.4 5.1

 

"The importance of these data are their demonstration that, as used in real patients, these drugs are safe," said James Jarvis, MD, a pediatric rheumatologist at the University at Buffalo, State University of New York.

"While we are still doing even longer-term follow-up to be sure of this, I think parents and patients can be assured that, after 10 years of widespread use of anti-TNF drugs, we are still not seeing serious safety issues."

Dr. Horneff reports financial relationships with AbbVie, Novartis, Pfizer, and Roche. Dr. Jarvis has disclosed no relevant financial relationships.

European League Against Rheumatism (EULAR) Congress 2014: Abstract OP0006. Presented June 11, 2014.

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