Quick Take: Efficacy of Adjunctive Infliximab vs Placebo in the Treatment of Adults With Bipolar I/II Depression

Depressive symptoms are an important part of bipolar disorder types I/II and contribute to significant morbidity and mortality. Establishing treatments for bipolar disorder has been difficult; in fact, no existing treatments approved by the FDA have been developed using an a priori disease model, and multiple failed clinical trials have suggested multiple biotypes within the heterogeneous population of bipolar disorders. In a previous clinical trial, infliximab, a tumor necrosis factor antagonist, was not found to have a significant effect over placebo in adults with major depressive disorder and bipolar disorder. Post-hoc analysis, however, suggested that infliximab could have an effect in patients with immune-inflammatory activation. In this randomized controlled study, investigators randomized 60 patients with bipolar disorder who met 1 biochemical or phenotypic inflammatory criteria at baseline to receive infliximab or placebo in order to study the effect of infliximab on patients with bipolar disorder and some evidence immuno-inflammatory activation. Participants were required to meet 1 of the following biochemical or phenotypic inflammatory criteria at baseline: CRP of 5 mg/L or more; obesity, and increased triglyceride levels, decreased high-density lipoprotein cholesterol level, or elevated blood pressure; type 1 or 2 diabetes; inflammatory bowel disorder; rheumatologic disorder; daily cigarette smoking; or migraine headaches. Investigators found that at 12 weeks, there were no between-group differences in treatment response (χ²=0.07, p=0.79). There were also no differences in remission rates (χ²=0.004, p=0.95). In a subgroup analysis, investigators also analyzed patients who had experienced physical abuse in childhood, and found that higher levels of physical abuse were associated with higher response rates amongst infliximab-treated patients at week 12 (RR 0.88, 95% CI 0.81 to 0.96, p=0.003). Overall, the results from this study do not support the use of infliximab as a treatment for bipolar disorder when given to patients based on inflammatory criteria. It should be noted, however, that the criteria for inflammation was broad due to a need for recruitment. Infliximab may have a role in treating patients with a history of childhood physical abuse, however, this finding requires further research due to the small sample size evaluated in this study.

Click to read the study in JAMA Psychiatry

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