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Objective: To evaluate the efficacy of Infliximab, a monoclonal antibody against tumor necrosis factor alpha (TNF ), in patients with acute/subacute sciatica secondary to herniated disc at L3/4 or L4/5. Design: A randomized controlled trial. Background: The results from our randomized trial demonstrated no efficacy for Infliximab but the subgroup results suggested that Infliximab may be effective for sciatica induced by herniations at L3/4 or L4/5. Methods: Inclusion criteria were unilateral moderate-to-severe sciatic pain with an MRI-confirmed disc herniation at L3/4 or L4/5 and candidacy for discectomy. Patients were randomized to receive either a single infusion of Infliximab 5 mg/kg or placebo. Outcomes included intensity of leg and back pain, Oswestry disability, quality-of-life (RAND-36) and straight leg raising (SLR) restriction at week 26. Data between baseline and the six-month follow-up were analyzed using Mann- Whitney U test. Results: Due to slow recruitment the trial ended prematurely after 15 patients in total were allocated to receive Infliximab (n=7) or placebo (n=8). At week 26, leg pain intensity had decreased by 73% in the Infliximab group compared to 65% in the control group (p=0.52). For all measured variables at 6 months, Infliximab treatment was associated with greater improvements compared to placebo, especially at early time points. Two patients in the Infliximab group and three in the placebo group had a discectomy or caudal injection (p=1.00). Conclusions: Our results warrant continuation of research on TNF antagonists in sciatica induced by disc herniations at L3/4 or L4/5.

The Efficacy of Infliximab in Sciatica Induced by Disc Herniations Located at L3/4 or L4/5: A Small-Scale Randomized Controlled Trial