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Dr. Genevay has received consulting fees, speaking fees, and/or honoraria from Bristol-Myers Squibb, Merck, and Pfizer (less than $10,000 each).
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Sciatica
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Adalimumab in severe and acute sciatica: A multicenter, randomized, double-blind, placebo-controlled trial†
Article first published online: 6 APR 2010
DOI: 10.1002/art.27499
Copyright © 2010 by the American College of Rheumatology
Additional Information
How to Cite
Genevay, S., Viatte, S., Finckh, A., Zufferey, P., Balagué, F. and Gabay, C. (2010), Adalimumab in severe and acute sciatica: A multicenter, randomized, double-blind, placebo-controlled trial. Arthritis & Rheumatism, 62: 2339–2346. doi: 10.1002/art.27499
- †
ClinicalTrials.gov identifier: NCT00470509.
- ‡
Dr. Genevay has received consulting fees, speaking fees, and/or honoraria from Bristol-Myers Squibb, Merck, and Pfizer (less than $10,000 each).
- §
Dr. Gabay has received consulting fees, speaking fees, and/or honoraria from Abbott, Bristol-Myers Squibb, Roche, Wyeth, and Essex (less than $10,000 each).
Publication History
- Issue published online: 3 AUG 2010
- Article first published online: 6 APR 2010
- Manuscript Accepted: 30 MAR 2010
- Manuscript Received: 17 MAY 2009
Funded by
- Abbott AG
- Abstract
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- Cited By
Abstract
Objective
Based on several experimental results and on a preliminary study, a trial was undertaken to assess the efficacy of adalimumab, a tumor necrosis factor α inhibitor, in patients with radicular pain due to lumbar disc herniation.
Methods
A multicenter, double-blind, randomized controlled trial was conducted between May 2005 and December 2007 in Switzerland. Patients with acute (duration of <12 weeks) and severe (Oswestry Disability Index score of >50) radicular leg pain and imaging-confirmed lumbar disc herniation were randomized to receive as adjuvant therapy either 2 subcutaneous injections of adalimumab (40 mg) at 7-day intervals or matching placebo. The primary outcome was the score for leg pain, based on a visual analog scale (0–100 mm), which was recorded every day for 10 days and at 6 weeks and 6 months.
Results
Of the 265 patients screened, 61 were enrolled; 31 patients were assigned to receive adalimumab, and 4 patients in the placebo group were lost to followup. Over time, the course of leg pain was more favorable in the adalimumab group than in the placebo group (P = 0.002). However, the effect size was relatively small, and at the last followup visit the difference was 13.8 (95% confidence interval −11.5, 39.0). Compared with patients in the placebo group, approximately twice as many patients in the adalimumab group fulfilled the criteria for “responders” and for “low residual disease impact” (P < 0.05), and fewer surgical discectomies were performed (6 versus 13 in the placebo group; P = 0.04).
Conclusion
The addition of a short course of adalimumab to the treatment regimen of patients experiencing acute and severe sciatica resulted in a small decrease in leg pain and in significantly fewer surgical procedures.