Tumor necrosis factor-α 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 2015-11, Vol.17 (1), p.330-330, Article 330
• Main Authors: Nguyen, Christelle, Palazzo, Clémence, Grabar, Sophie, Feydy, Antoine, Sanchez, Katherine, Zee, Nathalie, Quinquis, Laurent, Ben Boutieb, Myriam, Revel, Michel, Lefèvre-Colau, Marie-Martine, Poiraudeau, Serge, Rannou, François
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antirheumatic Agents - therapeutic use; Arthritis; Chronic Disease; Cicatrix - complications; Cicatrix - etiology; Diskectomy - adverse effects; Double-Blind Method; Female; Fibrosis; Human health and pathology; Humans; Infliximab - therapeutic use; Life Sciences; Lumbar Vertebrae - pathology; Lumbosacral Region; Male; Middle Aged; Pain Measurement; Postoperative Complications - drug therapy; Sciatica - drug therapy; Sciatica - etiology; Treatment Outcome; Tumor Necrosis Factor-alpha - antagonists & inhibitors
• ISSN: 1478-6354; 1478-6362; 1478-6354
• DOI: 10.1186/s13075-015-0838-4

The aim of this study was to assess the efficacy and safety of tumor necrosis factor (TNF)-α inhibition with infliximab (IFX) in treating recurrent and disabling chronic sciatica pain associated with post-operative peridural lumbar fibrosis. 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, Québec disability score, drug-sparing effect and tolerance at days 10, 30, 90, and 180. 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. 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. ClinicalTrials.gov NCT00385086 ; registered 4 October 2006 (last updated 15 October 2015).