Randomized, controlled study.
To evaluate the effect of infliximab on herniated nucleus pulposus (HNP) resorption.
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.
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.
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.
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: firstname.lastname@example.org