May 13, 2019
Adjunctive infliximab did not significantly reduce depressive symptoms in patients with bipolar depression, according to a study published online in JAMA Psychiatry.
“The results of this randomized, placebo-controlled clinical trial failed to show the efficacy of infliximab in the treatment of bipolar disorder,” researchers wrote. “It is unclear whether our results suggest a negative or a failed study.”
The 12-week, double-blind trial, which was conducted at 2 outpatient sites in Canada and the United States, included 60 adults with bipolar I or bipolar II depression as well as inflammatory conditions. Twenty-nine patients were randomized to receive intravenous infusions of tumor necrosis factor (TNF) antagonist infliximab at baseline, week 2, and week 6, and 31 patients were randomized to placebo. Researchers gauged efficacy by measuring change in total scores on the Montgomery-Åsberg Depression Rating Scale between baseline and week 12.
Overall, patients who received infliximab did not demonstrate a significant reduction in depression symptom severity by week 12. However, a significant reduction in depressive symptoms with infliximab, compared with placebo, was noted for one particular subgroup: participants with a childhood history of physical or sexual abuse.
“In a secondary post hoc analysis, a significant and sustained response was observed in the subset of participants with a history of childhood maltreatment, mainly physical abuse,” researchers wrote. “Although the analyses in individuals with childhood maltreatment was a secondary outcome of interest, it was noteworthy that childhood maltreatment was associated with improved antidepressant response to infliximab and reduced response to placebo.”
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. JAMA Psychiatry. 2019 May 8;[Epub ahead of print].