Tumor necrosis factor-[alpha] blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a double-blind, placebo randomized controlled study

• Published in: Arthritis research & therapy Vol. 17; no. 330
• Main Authors: Nguyen, Christelle, Palazzo, Clñmence, Grabar, Sophie, Feydy, Antoine, Sanchez, Katherine, Zee, Nathalie, Quinquis, Laurent, Ben Boutieb, Myriam, Revel, Michel, Lefèvre-Colau, Marie-Ma, Poiraudeau, Serge, Rannou, François
• Format: Journal Article
• Language: English
• Published: BioMed Central Ltd 19.11.2015
• Subjects: Care and treatment; Clinical trials; Dosage and administration; Infliximab; Sciatica; Tumor necrosis factor
• ISSN: 1478-6354
• DOI: 10.1186/s13075-015-0838-4

Introduction The aim of this study was to assess the efficacy and safety of tumor necrosis factor (TNF)-[alpha] inhibition with infliximab (IFX) in treating recurrent and disabling chronic sciatica pain associated with post-operative peridural lumbar fibrosis. Method A double-blind, placebo-controlled study randomized 35 patients presenting with sciatica pain associated with post-operative peridural lumbar fibrosis to two groups: IFX (n = 18), a single intravenous injection of 3 mg/kg IFX; and placebo (n = 17), a single saline serum injection. The primary outcome was a 50 % reduction in sciatica pain on a visual analog scale (VAS) at day 10. Secondary outcomes were radicular and lumbar VAS pain at day 0 and radicular and lumbar VAS pain, Quñbec disability score, drug-sparing effect and tolerance at days 10, 30, 90, and 180. Results At day 10, the placebo and IFX groups did not differ in the primary outcome (50 % reduction in sciatica pain observed in three (17.6 %) versus five (27.8 %) patients; p = 0.69). The number of patients reaching the patient acceptable symptom state for radicular pain was significantly higher in the placebo than IFX group after injection (12 (70.6 %) versus five (27.8 %) patients; p = 0.01). The two groups were comparable for all other secondary outcomes. Conclusion Treatment with a single 3 mg/kg IFX injection for post-operative peridural lumbar fibrosis-associated sciatica pain does not significantly reduce radicular symptoms at day 10 after injection. Trial registration ClinicalTrials.gov NCT00385086; registered 4 October 2006 (last updated 15 October 2015). Keywords: TNF-[alpha] blockade, Infliximab, Sciatica, Post-operative lumbar peridural fibrosis, Randomized controlled trial