The treatment of disc herniation-induced sciatica with infliximab: results of a randomized, controlled, 3-month follow-up study.

Abstract

STUDY DESIGN:

A randomized controlled trial.

OBJECTIVES:

To evaluate the efficacy of infliximab, a monoclonal antibody against tumor necrosis factor (TNF)-alpha in a randomized controlled setting.

SUMMARY OF BACKGROUND DATA:

Recently, we obtained encouraging results in an open-label study of infliximab in patients with disc herniation-induced sciatica. Furthermore, the results of experimental studies support the use of infliximab in sciatica. Therefore, we initiated a randomized, controlled trial (FIRST II, Finnish Infliximab Related STudy) to confirm the efficacy of a single infusion of infliximab for sciatic pain.

METHODS:

Inclusion criteria were unilateral moderate to severe sciatic pain with an MRI-confirmed disc herniation concordant with the symptoms and signs of radicular pain. Patients had to be candidates for discectomy, as evaluated by an independent orthopedic surgeon. Forty patients were allocated to a single intravenous infusion of either infliximab 5 mg/kg or placebo. Assessments at baseline and various time points included clinical examination with measurement of straight leg raising restriction; questionnaires related to subjective symptoms (leg and back pain by 100-mm visual analog scale, Oswestry disability); sick leaves; number of discectomies; and adverse effects possibly related to treatment. The primary endpoint was a reduction in leg pain from baseline to 12 weeks, which was analyzed using a Mann-Whitney U test and repeated-measures analysis.

RESULTS:

A significant reduction in leg pain was observed in both groups, with no significant difference between treatment regimens. Similar efficacy was observed between treatment groups for secondary endpoints. Seven patients in each group required surgery. No adverse effects related to treatment were encountered.

CONCLUSIONS:

The results of this randomized trial do not support the use of infliximab for lumbar radicular pain in patients with disc herniation-induced sciatica.

• Authors: Timo Korhonen, Jaro Karppinen, Leena Paimela, Antti Malmivaara, Karl-August Lindgren, Simo Järvinen, Jaakko Niinimäki, Nic Veeger, Seppo Seitsalo, Heikki Hurri
• Journal: Spine (Spine (Phila Pa 1976)) Vol. 30 Issue 24 Pg. 2724-8 (Dec 15 2005) ISSN: 1528-1159 [Electronic] United States
• PMID: 16371894 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• Adult
• Antibodies, Monoclonal (pharmacology, therapeutic use)
• Female
• Follow-Up Studies
• Humans
• Infliximab
• Intervertebral Disc Displacement (complications, drug therapy, physiopathology)
• Male
• Middle Aged
• Pain Measurement (drug effects)
• Sciatica (drug therapy, etiology, physiopathology)
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors)