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


CONCLUSIONS
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.
Genevay
Stéphane
S
Hôpital Beau Séjour, University Hospitals of Geneva, Geneva, Switzerland. stephane.genevay@hcuge.ch
Viatte
Sebastien
S
Finckh
Axel
A
Zufferey
Pascal
P
Balagué
Federico
F
Gabay
Cem
C
D000068879:Adalimumab; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D017586:Diskectomy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D018579:Patient Selection; D012585:Sciatica / Q000209:etiology / Q000628:therapy*; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab