Tumor necrosis factor-alpha blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a two-year , double-blind , placebo randomized controlled study
Dr Christelle NGUYENa, Dr Clémence PALAZZOa, Dr Sophie GRABARb, Prof Antoine FEYDYc, Dr Katherine SANCHEZa, Dr Nathalie ZEEc, Dr Laurent QUINQUISb, Dr Myriem BEN BOUTIEBb, Prof Michel REVELa, Dr Marie-Martine LEFÈVRE-COLAUa, Prof Serge POIRAUDEAUa, Prof François RANNOUa
a Service de rééducation et de réadaptation des pathologies de l'appareil locomoteur et du rachis, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, b Unité de biostatistiques et d'épidémiologie, Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, c Service de radiologie B, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris
Objective. 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.
Methods. A double-blind, randomized, placebo controlled study randomized 35 patients presenting sciatica pain associated with post-operative peridural lumbar fibrosis to 2 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 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.
Results. At day 10, the placebo and IFX groups did not differ in the primary outcome (50% reduction in sciatica pain observed in 3 [17.6%] vs 5 [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%] vs 5 [27.8%], p=0.01). The 2 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.
Keywords : TNF-alpha blockade, infliximab, sciatica, post-operative lumbar peridural fibrosis, randomized controlled trial