Meta-Analysis Finds No Increased Risk of Psychiatric Disorders With Lupus Treatment

Belimumab therapy does not significantly increase the risk of psychiatric events or all-cause mortality compared with placebo in patients with systemic lupus erythematosus (SLE), according to a meta-analysis published online in Lupus Science & Medicine.

“Very recently, the published data of BASE [Belimumab Assessment of Safety in SLE] study showed patients with SLE with belimumab exposure had increased risks of psychiatric disorders,” explained researchers in the study introduction, “including serious depression, treatment-emergent suicidality, and sponsor-adjudicated serious suicide or self-injury events.”

To further evaluate psychiatric and mortality risk associated with belimumab exposure, researchers conducted a meta-analysis of 11 randomized controlled trials involving a total 8824 patients treated with belimumab (5160 patients) or placebo (3664 patients). Most of the trials were international, multicenter studies with observation periods that ranged from 15 weeks to 104 weeks; the median observation period was 52 weeks. All studies except one focused on adult patients.

Overall, the meta-analysis identified no increased risk with belimumab compared with placebo for all psychiatric disorders (0.89 odds ratio) or all-cause mortality (1.10 odds ratio). Similarly, subgroup analysis of psychiatric disorders showed no statistically elevated risks in serious psychiatric disorders (1.15 odds ratio), nonserious psychiatric disorders (0.83 odds ratio), suicidal ideation or behavior (0.87 odds ratio), or depression (1.29 odds ratio).

“Based on the best available datasets, this work reveals that belimumab is not associated with increased risk of psychiatric events and mortality. But in consideration of the results of BASE study, further attention is needed to confirm the psychiatric safety,” researchers wrote. “Due to the limited observational period in clinical trials and low frequency of serious psychiatric events, long-term observation in real-life setting is necessary to precisely measure such risks associated with belimumab therapy.”

Reference:
Xie W, Huang H, Zhan S, Zhang Z. Risk of psychiatric disorders and all-cause mortality with belimumab therapy in patients with systemic lupus erythematosus: a meta-analysis of randomised controlled trials. Lupus Sci Med. 2021;8(1):e000534. doi:10.1136/lupus-2021-000534