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The Effect of Infliximab, a Monoclonal Antibody Against TNF-α, on Disc Herniation Resorption: A Randomized Controlled Study

Autio, Reijo A., MD*†; Karppinen, Jaro, MD, DMSc‡§¶; Niinimäki, Jaakko, MD*; Ojala, Risto, MD, DMSc*; Veeger, Nic, MSc; Korhonen, Timo, MD**; Hurri, Heikki, MD, DMSc; Tervonen, Osmo, MD, DMSc*

doi: 10.1097/01.brs.0000244616.64962.9e
Randomized Trial
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Study Design. Randomized, controlled study.

Objective. To evaluate the effect of infliximab on herniated nucleus pulposus (HNP) resorption.

Summary of Background Data. Although the effects of tumor necrosis factor alpha (TNF-α) on HNP resorption are not fully understood, TNF-α appears to be an essential mediator in HNP resorption.

Methods. As part of a substudy of the FIRST II study, magnetic resonance images (MRIs) were obtained from 21 patients who were candidates for discectomy at weeks 0, 2, 12, and 26 after receiving a single infusion of either 5 mg/kg infliximab (11 patients) or placebo (10 patients). The volume (mm3) of HNP, thickness (mm) and extent (%) of rim enhancement, and presence of nerve root edema were assessed.

Results. HNP volume decreased significantly from baseline to 6 months in both treatment groups (P < 0.01), with no difference noted between the infliximab and placebo groups. By week 2, rim enhancement thickness increased significantly in the infliximab group compared with the placebo group (P = 0.003). Two patients in each group required back surgery before the 6-month assessment.

Conclusions. Infliximab did not appear to interfere with disc herniation resorption over a 6-month period.

The effect of a single infusion of infliximab 5 mg/kg, a monoclonal antibody against tumor necrosis factor alpha (TNF-α), on disc herniation resorption was evaluated in a randomized controlled trial. Infliximab did not appear to interfere with disc herniation resorption.

From the *Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland; †Department of Radiology, Pietarsaari Hospital, Pietarsaari, Finland; ‡Department of Occupational Medicine, Finnish Institute of Occupational Health, Helsinki, Finland; §Department of Physical Medicine and Rehabilitation, Oulu University Hospital, Oulu, Finland; ¶ORTON Orthopaedic Hospital, Helsinki, Finland; ∥Trial Coordination Center, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; and **Oulu Deaconess Institute, Oulu, Finland.

Acknowledgment date: December 7, 2005. First revision date: January 12, 2006. Acceptance date: January 19, 2006.

Supported by Centocor Inc. (Malvern, PA).

The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA-approved for this indication and is/are not commercially available in the United States.

Corporate/Industry funds were received in support of this work. One or more of the author(s) has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies.

Address correspondence and reprint requests to Reijo A. Autio MD, Department of Radiology, Pietarsaari Hospital, Pohjanlandentie 1, 68601 Pietarsaari, Finland; E-mail: reijo.autio@mhso.fi

© 2006 Lippincott Williams & Wilkins, Inc.