Tumor necrosis factor-alpha monoclonal antibody, infliximab, used to manage severe sciatica.

Abstract

STUDY DESIGN:

An open-label study was conducted.

OBJECTIVE:

To evaluate the efficacy and safety of infliximab, a monoclonal chimeric antibody, against tumor necrosis factor-alpha (TNFalpha) for the treatment of severe sciatica.

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.

• 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)

Chemical References

• Antibodies, Monoclonal
• Antirheumatic Agents
• Tumor Necrosis Factor-alpha
• Infliximab

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)