Citation

Gupta MA, Sheridan AD, Gupta AK. J. Eur. Acad. Dermatol. Venereol. 2020; ePub(ePub): ePub.

Affiliation

Department of Medicine, University of Toronto, Faculty of Medicine, Toronto, Ontario, Canada.

Copyright

(Copyright © 2020, John Wiley and Sons)

DOI

10.1111/jdv.16224

PMID

31981260

Abstract

BACKGROUND: 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 behaviors (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.

OBJECTIVES: To determine presence or absence of a safety signal for SB when HS is treated with TNF-α antagonists.

METHODS: We calculated the Reporting Odds Ratios (ROR) with 95%CI of SB associated with treatment for HS with TNF-α antagonists versus the reference group of all other treatments for HS in the US Food and Drug Administration pharmacovigilance database from January 1, 2004 -March 31, 2019. A second analysis excluded isotretinoin (which has been used to treat HS and has also been associated with SB) from the reference group.

RESULTS: 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] versus all other HS treatments; the ROR did not change significantly after isotretinoin was excluded from the reference group.

CONCLUSIONS: Treatment of HS with TNF-α antagonists is associated with a decreased risk of SB.

© 2020 European Academy of Dermatology and Venereology.

Language: en

Keywords

TNF-alpha antagonist; acne inversa; adalimumab; adverse effect; drug safety; epidemiology; hidradentis suppurativa; isotretinoin; psychiatric; self-injury; suicide; tumor necrosis factor alpha antagonist