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 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 50) radicular leg pain and imagingconfirmed 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.