Abstract
Aims: To evaluate the efþcacy and safety of inßiximab, a monoclonal chimeric antibody against TNFα, for the treatment of severe sciatica. Background: Evidence from animal studies indicates that tumour necrosis factor (TNF)α plays a role in the pathophysiology of sciatica. Anti-TNFα therapy has not been previously evaluated in sciatic patients. Methods: 10 patients with disc herniation-induced severe sciatica received inßiximab (Remi-cade¨; 3mg/weight-kg) intravenously over 2 hours. The outcome was assessed at 1 hour, 1 week, 2 weeks, 1 month and 3 months after the infusion, and was compared to historical controls consisting of 62 patients who received saline in a trial of periradicular inþltration for sciatica. Leg pain was the primary outcome, with over 75% decrease from baseline score constituting a painless state. Fisherñs exact test and repeated measures analysis of variance were used for statistical analysis. Results: One hour after the infusion, leg pain had decreased by 50%. At 2 weeks, 60% of patients in the inßiximab group were painless vs. 16% of control patients (P = 0.006). The difference was sustained at 3-months (90% vs. 46%; P = 0.014). Inßiximab was superior over the whole follow-up period in leg pain (P=0.003) and back-related disability (P=0.004). At 1 month, every patient in the inßiximab group had returned to work whereas 38% of controls were still on sick leave (P=0.02). None of the patients treated with inßiximab underwent surgery during the follow-up. No immediate or delayed adverse drug reactions, or any adverse effects due to medication were observed. Conclusions: Anti-TNFα therapy is a promising treatment option for sciatica. There is an urgent need for a ran-domised controlled trial to evaluate if these promising early results can be conþrmed.
Theses abstracts were prepared by Professor Dr. Frantz Langlais. Correspondence should be addressed to him at EFORT Central Office, Freihofstrasse 22, CH-8700 Küsnacht, Switzerland.
