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

A randomized controlled trial. To evaluate the efficacy of infliximab, a monoclonal antibody against tumor necrosis factor (TNF)-alpha in a randomized controlled setting. Recently, we obtained encouraging results in an open-label study of infliximab in patients with disc herniation-induced sciatica....

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Bibliographic Details
Published in:Spine (Philadelphia, Pa. 1976) Pa. 1976), 2005-12, Vol.30 (24), p.2724-2728
Main Authors: KORHONEN, Timo, KARPPINEN, Jaro, PAIMELA, Leena, MALMIVAARA, Antti, LINDGREN, Karl-August, JÄRVINEN, Simo, NIINIMAKI, Jaakko, VEEGER, Nic, SEITSALO, Seppo, HURRI, Heikki
Format: Article
Language:English
Subjects:
Adult
Antibodies, Monoclonal - pharmacology
Antibodies, Monoclonal - therapeutic use
Biological and medical sciences
Cerebrospinal fluid. Meninges. Spinal cord
Drug toxicity and drugs side effects treatment
Female
Follow-Up Studies
Humans
Immunomodulators
Infliximab
Intervertebral Disc Displacement - complications
Intervertebral Disc Displacement - drug therapy
Intervertebral Disc Displacement - physiopathology
Male
Medical sciences
Middle Aged
Nervous system (semeiology, syndromes)
Neurology
Pain Measurement - drug effects
Pharmacology. Drug treatments
Sciatica - drug therapy
Sciatica - etiology
Sciatica - physiopathology
Toxicity: nervous system and muscle
Treatment Outcome
Tumor Necrosis Factor-alpha - antagonists & inhibitors
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Summary:A randomized controlled trial. To evaluate the efficacy of infliximab, a monoclonal antibody against tumor necrosis factor (TNF)-alpha in a randomized controlled setting. 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. 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. 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. The results of this randomized trial do not support the use of infliximab for lumbar radicular pain in patients with disc herniation-induced sciatica.
ISSN:0362-2436
1528-1159
DOI:10.1097/01.brs.0000190815.13764.64