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Randomized Controlled Trial
. 2025 May;77(5):615-623.
doi: 10.1002/art.43073. Epub 2025 Jan 15.

Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low-Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial

Elisabeth Gjefsen  1 , Lars C Bråten  2 , Erica Ponzi  2 , Magnhild H Dagestad  3 , Gunn H Marchand  4 , Thomas Kadar  5 , Gunnstein Bakland  6 , Anne J Haugen  7 , Fredrik Granviken  8 , Tonje W Flørenes  3 , Nils Vetti  3 , Lars Grøvle  7 , Aksel T Nilsen  6 , Astrid Lunestad  9 , Thor E Holmgard  10 , Morten Valberg  1 , Nils Bolstad  2 , Ansgar Espeland  3 , Jens I Brox  1 , Guro L Goll  11 , Kjersti Storheim  12 , John-Anker Zwart  1
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Randomized Controlled Trial

Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low-Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial

Elisabeth Gjefsen et al. Arthritis Rheumatol. 2025 May.

Abstract

Objective: The efficacy of tumor necrosis factor inhibitors for treating chronic low-back pain with Modic changes is uncertain. This study investigated the superiority of infliximab over placebo in patients with Modic type 1 changes.

Methods: In this multicenter, randomized, triple-blind, placebo-controlled trial, patients aged 18 to 65 years with moderate to severe chronic low-back pain and Modic type 1 changes were enrolled from five Norwegian public hospitals between January 2019 and October 2022. Participants were randomly assigned to four intravenous infusions of 5 mg/kg infliximab or placebo. The primary outcome was difference in change in the Oswestry Disability Index (ODI) score from baseline to five months. Secondary outcomes included changes in low-back pain intensity, disability, and health-related quality of life. A linear mixed model was used for efficacy analyses.

Results: A total of 128 patients (mean age 43 years, 65.6% women) participated (64 in each group). All patients who received at least one dose of the allocated infusion were included in the primary analyses. The average ODI score (±SD) change was -7.0 (±9.7) in the group who received infliximab and -6.4 (±10.4) in the group who received placebo. The difference in the ODI score change between the two groups was 1.3 ODI points (95% confidence interval -2.1 to 4.6, P = 0.45). Analyses showed no effect of infliximab compared to placebo on secondary outcomes. Adverse event rates were similar between groups.

Conclusion: Infliximab did not demonstrate superiority over placebo in reducing pain-related disability in patients with moderate to severe chronic low-back pain with Modic type 1 changes at five months.

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Figures

Figure 1
Figure 1
Flowchart showing group assignment. One patient was randomized and allocated to receive infliximab but did not fulfill inclusion criteria due to no MC1 on study‐specific MRI and was excluded before receiving study medication. MC1, Modic type 1 changes; MRI, magnetic resonance imaging; NRS, numeric rating scale; ODI, Oswestry Disability Index. Color figure can be viewed in the online issue, which is available at http://onlinelibrary.wiley.com/doi/10.1002/art.43073/abstract.
Figure 2
Figure 2
Estimated marginal change in ODI from baseline for treatment groups over time. Infliximab was not superior to placebo in reducing pain‐related disability at five months in patients with chronic low‐back pain and Modic changes type 1 (estimated difference of 1.3 ODI points in the average marginal change between the two groups from baseline to five months [95% confidence interval −2.1 to 4.6, P = 0.45]). ODI, Oswestry Disability Index.
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