The Open Spine Journal
2009, 1 : 9-13Published online 2009 October 2. DOI: 10.2174/1876532700901010009
Publisher ID: TOSPINEJ-1-9
The Efficacy of Infliximab in Sciatica Induced by Disc Herniations Located at L3/4 or L4/5: A Small-Scale Randomized Controlled Trial
ABSTRACT
Objective:
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.
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 MannWhitney 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 TNFα antagonists in sciatica induced by disc herniations at L3/4 or L4/5.