To evaluate the efficacy of Infliximab, a monoclonal antibody against tumor necrosis factor alpha
(TNFα), in patients with acute/subacute sciatica secondary to herniated disc at L3/4 or L4/5.
A randomized controlled trial.
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.
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 MannWhitney
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).
Our results warrant continuation of research on TNFα antagonists in sciatica induced by disc herniations at
L3/4 or L4/5.