Abstract | STUDY DESIGN: An open-label study was conducted. OBJECTIVE: SUMMARY OF BACKGROUND DATA: Evidence from animal studies indicates that TNFalpha plays a role in the pathophysiology of sciatica. Anti- TNFalpha therapy has not been previously evaluated in sciatic patients. METHODS: In this study, 10 patients with disc herniation-induced severe sciatica received infliximab ( Remicade 3 mg/kg) intravenously over 2 hours. The outcome was assessed at 1 hour, 1 week, 2 weeks, 1 month, and 3 months after the infusion and compared to historical control subjects consisting of 62 patients who received saline in a trial of periradicular infiltration for sciatica. Leg pain was the primary outcome, with more than a 75% decrease from the baseline score constituting a painless state. Fisher's exact test and repeated measures analysis of variance were used for statistical analysis. RESULTS: At 1 hour after the infusion, leg pain had decreased by 50%. At 2 weeks, 60% of the patients in the infliximab group were painless, as compared with 16% of the control patients (P = 0.006). The difference was sustained at 3 months (90% vs 46%; P = 0.014). Infliximab was superior over the whole follow-up period in terms of leg pain (P = 0.003) and back-related disability (P = 0.004). At 1 month, every patient in the infliximab group had returned to work, whereas 38% of the control subjects still were on sick leave (P = 0.02). None of the patients treated with infliximab underwent surgery during the follow-up period. No immediate or delayed adverse drug reactions and no adverse effects related to medication were observed. CONCLUSIONS: Anti- TNFalpha therapy is a promising treatment option for sciatica. There is an urgent need for a randomized controlled trial to evaluate whether thesepromising early results can be confirmed.
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Authors | Jaro Karppinen, Timo Korhonen, Antti Malmivaara, Leena Paimela, Eero Kyllönen, Karl-August Lindgren, Pekka Rantanen, Osmo Tervonen, Jaakko Niinimäki, Seppo Seitsalo, Heikki Hurri |
Journal | Spine
(Spine (Phila Pa 1976))
Vol. 28
Issue 8
Pg. 750-3; discussion 753-4
(Apr 15 2003)
ISSN: 1528-1159 [Electronic] United States |
PMID | 12698115
(Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antirheumatic Agents
- Tumor Necrosis Factor-alpha
- Infliximab
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Topics |
- Adult
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Antirheumatic Agents
(adverse effects, therapeutic use)
- Female
- Follow-Up Studies
- Humans
- Infliximab
- Infusions, Intravenous
- Intervertebral Disc Displacement
(complications)
- Male
- Middle Aged
- Sciatica
(drug therapy, etiology, immunology)
- Treatment Outcome
- Tumor Necrosis Factor-alpha
(antagonists & inhibitors, immunology)
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