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SAT0144 Tumor necrosis factor-alpha inhibitors and psychiatric side effects: results from the french pharmacovigilance database
  1. CM Yelnik1,
  2. L Gaboriau2,
  3. N Petitpain3,
  4. H Théophile4,
  5. C Scalbert5,
  6. E Delaporte5,
  7. S Gautier2,
  8. M Lambert1
  1. 1Internal Medicine Department, University of Lille, UFR Medicine, Universitary Hospital Center of Lille
  2. 2Regional Pharmacovigilance center of Hauts-de-France, Lille
  3. 3Regional Pharmacovigilance center of Lorraine, Nancy
  4. 4Universitary Hospital Center of Bordeaux, Regional pharmacovigilance center of Bordeaux, Bordeaux
  5. 5Dermatology department, University of Lille, UFR Medicine, Universitary Hospital Center of Lille, Lille, France


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 TNF-α inhibitors were withdrawn in 42 (61%) cases.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.

Table 1.

Description of psychiatric symptoms registered in the database for TNF-α inhibitors

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

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