SAT0144 Tumor necrosis factor-alpha inhibitors and psychiatric side effects: results from the french pharmacovigilance database. (15th June 2017)

• Record Type: Journal Article
• Authors: Yelnik, CM; Gaboriau, L; Petitpain, N; Théophile, H; Scalbert, C; Delaporte, E; Gautier, S; Lambert, M
• Is Part Of: Annals of the rheumatic diseases. Volume 76(2017)Supplement 2
• Page Start: 823
• Page End: 824
• Publication Date: 2017-06-15
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2017-eular.1610
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: Although Tumor Necosis Factor alpha (TNF-α) is a major proinflammatory cytokine in the brain, potential psychiatric side effects of TNF-α inhibitors have been little investigated. Manic and psychotic disorders are not recognized as TNF-α inhibitors' side effects even though few reports of such complications have been reported. Objectives: This study reports cases with psychiatric symptoms (in the spectrum of psychotic and manic disorders) that occur during treatment with tumor necrosis factor alpha (TNF-α) inhibitors and aims to evaluate the role of these agents as causative factors. Methods: We searched the French Pharmocovigilance Database for consecutive cases of positive psychiatric side effects reported during treatment with TNF-α inhibitors. Major psychiatric symptoms were defined, according to DSM-V, as mania and psychosis, and minor psychiatric symptoms as psychomotor agitation, euphoria, hallucinations, personality distortion, and increased libido. Each case had one major symptom or at least one minor symptom. Results: Among 7912 consecutive cases of side effects registered in the database for TNF-α inhibitors, 184 reported psychiatric symptoms, and of these, 71 met inclusion criteria, whereas 113 met an exclusion criterion. Depression was the most frequent cause for exclusion. TNF-α inhibitors were the only medication suspected in 56 cases (79%). The time between beginning TNF-α inhibitors and onset of symptoms varied from hours to months with a median time of 49 days (IQR=156); initial symptoms mostly worsened under treatment. TNF-α inhibitors were withdrawn in 42 (61%) cases. The improvement of symptoms was significantly associated with treatment withdrawal (78% versus 22%, p=0.01 ). Relapses occurred after rechallenge of TNF-α inhibitors in three of four patients. Conclusions: We report the first cohort of 71 cases with psychiatric symptoms in the spectrum of manic and psychotic disorders during treatment with TNF-α inhibitors. Our experience suggests that anti-TNFα therapy may cause manic or psychotic side effects. Disclosure of Interest: None declared