• Timo Korhonen, Jaro Karppinen, Leena Paimela, Antti Malmivaara, Karl-August Lindgren, Simo Järvinen, Jaakko Niinimäki, Nic Veeger, Seppo Seitsalo, and Heikki Hurri.
• Department of Physical Medicine and Rehabilitation, Oulu University Hospital, Oulu, Finland.
• Spine. 2005 Dec 15; 30 (24): 2724-8.

Study DesignA randomized controlled trial.ObjectivesTo evaluate the efficacy of infliximab, a monoclonal antibody against tumor necrosis factor (TNF)-alpha in a randomized controlled setting.Summary Of Background DataRecently, we obtained encouraging results in an open-label study of infliximab in patients with disc herniation-induced sciatica. Furthermore, the results of experimental studies support the use of infliximab in sciatica. Therefore, we initiated a randomized, controlled trial (FIRST II, Finnish Infliximab Related STudy) to confirm the efficacy of a single infusion of infliximab for sciatic pain.MethodsInclusion criteria were unilateral moderate to severe sciatic pain with an MRI-confirmed disc herniation concordant with the symptoms and signs of radicular pain. Patients had to be candidates for discectomy, as evaluated by an independent orthopedic surgeon. Forty patients were allocated to a single intravenous infusion of either infliximab 5 mg/kg or placebo. Assessments at baseline and various time points included clinical examination with measurement of straight leg raising restriction; questionnaires related to subjective symptoms (leg and back pain by 100-mm visual analog scale, Oswestry disability); sick leaves; number of discectomies; and adverse effects possibly related to treatment. The primary endpoint was a reduction in leg pain from baseline to 12 weeks, which was analyzed using a Mann-Whitney U test and repeated-measures analysis.ResultsA significant reduction in leg pain was observed in both groups, with no significant difference between treatment regimens. Similar efficacy was observed between treatment groups for secondary endpoints. Seven patients in each group required surgery. No adverse effects related to treatment were encountered.ConclusionsThe results of this randomized trial do not support the use of infliximab for lumbar radicular pain in patients with disc herniation-induced sciatica.

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