Reduced risk of suicidal behaviours associated with the treatment of hidradenitis suppurativa with tumour necrosis factor alpha antagonists: results from the US FDA Adverse Events Reporting System pharmacovigilance database.

Abstract

Hidradenitis suppurativa (HS) is a chronic, recurrent condition that presents as painful, suppurating lesions in the apocrine gland-bearing skin regions. HS has been associated with increased suicidal behaviours (SB), independent of any treatment. TNF-alpha antagonists are used to treat moderate-to-severe HS and have also been associated with SB, a factor that could confound the decision to use the TNF-α antagonists in the moderately to severely affected HS patients, who may already be experiencing increased SB risk. To determine presence or absence of a safety signal for SB when HS is treated with TNF-α antagonists. We calculated the reporting odds ratios (ROR) with 95% CI of SB associated with treatment for HS with TNF-α antagonists vs. the reference group of all other treatments for HS in the US Food and Drug Administration pharmacovigilance database from 1 January 2004 to 31 March 2019. A second analysis excluded isotretinoin (which has been used to treat HS and has also been associated with SB) from the reference group. There was a signal for decreased risk of SB with TNF-α antagonists (ROR=0.1959, 95% CI 0.1247-0.3079; z=7.071, P<0.0001] vs. all other HS treatments; the ROR did not change significantly after isotretinoin was excluded from the reference group. Treatment of HS with TNF-α antagonists is associated with a decreased risk of SB.