Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low-Back Pain With Modic Type 1 Changes: A Randomized
Elisabeth Gjefsen1, Lars C Bråten2, Erica Ponzi2
1Oslo University Hospital and University of Oslo, Oslo, Norway.
Arthritis & Rheumatology (Hoboken, N.J.)
|December 3, 2024
Summary
Infliximab did not significantly improve chronic low-back pain with Modic type 1 changes compared to placebo. The study found no superiority in reducing pain-related disability at five months.
Area of Science:
- Rheumatology
- Pain Management
- Clinical Trials
Background:
- Chronic low-back pain with Modic changes is a significant clinical challenge.
- The efficacy of tumor necrosis factor inhibitors, like infliximab, for this condition remains uncertain.
Purpose of the Study:
- To investigate the superiority of infliximab over placebo in patients with moderate to severe chronic low-back pain and Modic type 1 changes.
- To evaluate the impact of infliximab on pain intensity, disability, and quality of life.
Main Methods:
- A multicenter, randomized, triple-blind, placebo-controlled trial involving 128 patients.
- Participants received four intravenous infusions of infliximab (5 mg/kg) or placebo.
- The primary outcome was the change in Oswestry Disability Index (ODI) score at five months.
Main Results:
- No significant difference in ODI score change between the infliximab and placebo groups (1.3 ODI points, P=0.45).
- Infliximab showed no significant effect on secondary outcomes, including pain intensity and quality of life.
- Adverse event rates were comparable between the treatment groups.
Conclusions:
- Infliximab did not demonstrate superiority over placebo for treating chronic low-back pain with Modic type 1 changes.
- Further research may be needed to explore alternative treatments for this patient population.
