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Efficacy of infliximab for disc herniation-induced sciatica: one-year follow-up.

AbstractSTUDY DESIGN:
An open-label trial.
OBJECTIVES:
To test the long-term efficacy of infliximab, a monoclonal antibody against tumor necrosis factor-alpha (TNF-alpha), in disc herniation-induced sciatica.
SUMMARY OF BACKGROUND DATA:
Our recent trial indicated that a single infusion of 3 mg/weight-kg of infliximab produced a rapid curative effect in disc herniation-induced sciatica. Here, we describe the 1-year effect of a 3 mg/kg of infliximab in these 10 patients and our experience with a lower dose of 1 mg/kg of infliximab for the same indication in 2 additional patients.
METHODS:
Patients with severe sciatica were treated with a single infusion of infliximab, 3 mg/weight-kg in 10 patients and 1 mg/kg in 2 patients, intravenously over 2 hours. The outcomes (leg and back pain on a 100-mm visual scale, Oswestry disability, clinical signs) were assessed at 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after the infusion. The outcomes with 3 mg/kg of infliximab were compared to 62 patients who received periradicular saline for sciatica in a previous trial. The resorption rate of disc herniations from baseline to 1 year was compared between infliximab and control groups.
RESULTS:
The response to 1 mg/kg of infliximab for leg pain was good only in 1 of the 2 patients treated, whereas the response to 3 mg/kg of infliximab for leg pain was sustained in most patients over the 1-year follow-up. The 1-year response significantly favored 3 mg/kg of infliximab over periradicular saline in leg pain (P = 0.005) and disability (P = 0.003). Neurologic abnormalities normalized more comprehensively in the infliximab group (P = 0.001). Reduction in disc herniation volume did not differ between the infliximab-treated patients and controls.
CONCLUSIONS:
The results showed that the beneficial effect of a single infusion of 3 mg/kg of infliximab for herniation-induced sciatica is sustained in most patients over a 1-year follow-up period. Furthermore, infliximab does not seem to interfere with the spontaneous resorption of disc herniations.
AuthorsTimo Korhonen, Jaro Karppinen, Antti Malmivaara, Reijo Autio, Jaakko Niinimäki, Leena Paimela, Eero Kyllönen, Karl-August Lindgren, Osmo Tervonen, Seppo Seitsalo, Heikki Hurri
JournalSpine (Spine (Phila Pa 1976)) Vol. 29 Issue 19 Pg. 2115-9 (Oct 01 2004) ISSN: 1528-1159 [Electronic] United States
PMID15454701 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Monoclonal
  • Tumor Necrosis Factor-alpha
  • Infliximab
Topics
  • Antibodies, Monoclonal (administration & dosage, therapeutic use)
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Infliximab
  • Infusions, Intravenous
  • Intervertebral Disc Displacement (complications)
  • Leg (pathology)
  • Male
  • Pain (drug therapy, etiology)
  • Sciatica (drug therapy, etiology)
  • Time
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha (immunology)

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