Although the use of infliximab showed no antidepressant efficacy in patients with bipolar depression in general, it was related to a reduction in depression in patients with a childhood history of physical abuse, according to study results published in JAMA Psychiatry.
Researchers conducted a double-blind placebo-controlled randomized study of 60 patients with bipolar depression (I or II) and a comorbid inflammatory condition. Study participants were randomly assigned to receive 3 infusions of infliximab (n=29) at baseline, 2 weeks, and 6 weeks, or placebo (n=31) for a total of 12 weeks. The primary outcome measured was the change in depressive symptom score from start of therapy to 12 weeks. In addition, changes in symptom score were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). A history of childhood maltreatment was used for exploratory analyses as one of several secondary outcomes, and measured using the Childhood Trauma Questionnaire.
After analysis, the researchers found no statistically significant difference between patients given infliximab vs placebo (relative risk, 1.09; 95% CI, 0.80-1.50; P =.60). With respect to safety, infliximab was overall well tolerated. However, significant and sustained response was observed in the subset of participants with a history of childhood physical abuse, exhibiting greater reductions in MADRS total score (χ2 = 12.20; P =.02) and higher response rates (≥50% reduction in MADRS total score, χ2 = 4.05; P =.04).
One key limitation of the study was the homogeneity of the patient sample compared with other clinical trials.
“Infliximab did not significantly reduce depressive symptoms compared with placebo in adults with bipolar depression,” the researchers wrote.
“Our post hoc analyses in persons reporting a history of childhood maltreatment should inform future studies that aim to stratify and enrich for persons more likely to benefit from an inflammatory intervention,” they added.
McIntyre RS, Subramaniapillai M, Lee Y, et al. Efficacy of adjunctive infliximab vs placebo in the treatment of adults with bipolar i/ii depression: a randomized clinical trial [published online May 8, 2019]. JAMA Psychiatry. doi:10.1001/jamapsychiatry.2019.0779