Modic Change Edema in Chronic Low Back Pain Treated With Infliximab or Placebo

Spine 2025;50:1091–1101

This randomized, double-blind clinical trial evaluated whether infliximab reduces Modic type 1 (MC1) edema on STIR MRI and whether baseline edema or ADC values modify its effect on disability and low back pain (LBP). Patients with chronic LBP and MC1 received four infliximab or placebo infusions; MRI and clinical outcomes (ODI, pain) were assessed at five and six months.

Results showed no clinically relevant edema reduction by infliximab in the primary per-protocol analysis, and baseline STIR edema or MC-related ADC did not modify treatment effects or prognosticate ODI or LBP. Sensitivity analyses yielded a modest edema signal in the full analysis set, but overall findings do not support infliximab for chronic LBP with MC1.

• Infliximab: Did not have a clinically relevant effect in reducing Modic change (MC) edema at six months in patients with chronic low back pain and MC type 1 (MC1) compared to placebo.

• Disability and Pain: Infliximab did not improve disability (Oswestry Disability Index) or low back pain intensity at five or nine months follow-up versus placebo.

• Edema as Modifier: Baseline MC edema and apparent diffusion coefficient (ADC) values did not modify the effect of infliximab on disability or low back pain.

• Prognostic Value: Baseline MC edema and ADC values did not predict disability or low back pain outcomes, regardless of treatment group.

• Statistical Findings: The odds ratio for reduced MC edema at six months with infliximab versus placebo was not statistically significant in the per protocol analysis (OR 2.2, 95% CI: 0.8–5.8; P = 0.12), but reached statistical significance in the full analysis set (OR 2.1, 95% CI: 1.02–4.5; P = 0.04), though the clinical benefit was limited.

• Clinical Relevance: Any observed difference in clinical improvement between patients with and without reduced edema was near or below the threshold for clinical relevance (10 ODI points, 1.5–2.0 pain points).

• Reliability: MRI assessment methods for MC and edema (using STIR imaging and ADC) showed good to very good inter-rater reliability.

• Recommendation: These results do not support the use of infliximab as a treatment for chronic low back pain with MC1.