Infliximab does not help with chronic low back pain-related disability

In the treatment of patients with moderate-to-severe chronic low back pain, the use of infliximab does not yield meaningful reductions in pain-related disability when compared with placebo, as shown in a study.

For the study, researchers enrolled 128 patients (mean age 43 years, 65.6 percent women) with moderate-to-severe chronic low back pain and Modic type 1 changes from five Norwegian public hospitals. These patients were randomly assigned to receive four intravenous infusions of infliximab at 5 mg/kg (n=64) or placebo (n=64).

The change in the Oswestry Disability Index (ODI) score from baseline to 5 months was the primary outcome. Changes in low-back pain intensity, disability, and health-related quality of life were also evaluated as secondary outcomes.

The mean ODI score at baseline was 33.5. At 5 months, the mean ODI score decreased by 7.0 in the infliximab group vs 6.4 in the placebo group. The corresponding difference of 1.3 ODI points (95 percent confidence interval, −2.1 to 4.6) did not reach significance (p=0.45).

The same was true for secondary outcomes, with no significant differences seen between the infliximab and placebo groups.

A similar number of adverse events (AEs) was reported in the two treatment groups, but moderate AEs occurred more frequently with infliximab vs placebo (21.9 percent vs 12.5 percent). Serious AEs were documented in five patients in the infliximab group and in two patients in the placebo group, with the events deemed related to the study drug in one and two patients in the respective groups.