Adalimumab in severe and acute sciatica: a multicenter, randomized, double-blind, placebo-controlled trial.

Details

Serval ID
serval:BIB_0D5D5B947B9E
Type
Article: article from journal or magazin.
Collection
Publications
Title
Adalimumab in severe and acute sciatica: a multicenter, randomized, double-blind, placebo-controlled trial.
Journal
Arthritis and Rheumatism
Author(s)
Genevay S., Viatte S., Finckh A., Zufferey P., Balagué F., Gabay C.
ISSN
1529-0131 (Electronic)
ISSN-L
0004-3591
Publication state
Published
Issued date
2010
Volume
62
Number
8
Pages
2339-2346
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
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 alpha 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.
Keywords
Adult, Aged, Anti-Inflammatory Agents/therapeutic use, Antibodies, Monoclonal/therapeutic use, Antibodies, Monoclonal, Humanized, Diskectomy, Double-Blind Method, Female, Humans, Intervertebral Disc Displacement/complications, Male, Middle Aged, Pain Measurement, Patient Selection, Sciatica/etiology, Sciatica/therapy, Treatment Outcome
Pubmed
Open Access
Yes
Create date
05/09/2012 11:16
Last modification date
08/05/2019 14:22
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