Abstract | STUDY DESIGN: An open-label trial. OBJECTIVES: 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.
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Authors | Timo Korhonen, Jaro Karppinen, Antti Malmivaara, Reijo Autio, Jaakko Niinimäki, Leena Paimela, Eero Kyllönen, Karl-August Lindgren, Osmo Tervonen, Seppo Seitsalo, Heikki Hurri |
Journal | Spine
(Spine (Phila Pa 1976))
Vol. 29
Issue 19
Pg. 2115-9
(Oct 01 2004)
ISSN: 1528-1159 [Electronic] United States |
PMID | 15454701
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Tumor Necrosis Factor-alpha
- Infliximab
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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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