Objectives: To investigate the association between exposure of Captopril/ Enalapril and occurrence of psoriasis.
Methods: We performed a qualitative review and in-depth analysis to identify any substantial information available for the drug-event pairs from different sources including databases, PubMed and Embase. Also, we did an analysis of Reference Safety Information (RSI) of all the drugs of this class. 
Results: Data was retrieved from various safety databases [EudraVigilance Data Analysis System (EVDAS), FDA Adverse Event Reporting System (FAERS)] and literature searches [PubMed and Embase] to identify an association between Psoriasis and Captopril/Enalapril. From databases, a total of nine relevant cases of Captopril/ Enalapril induced psoriasiform eruptions or aggravation of psoriasis could be identified. Further, from the literature searches, 12 publications with additional relevant information for these drug-event pairs could be identified. Causality assessment was done with WHO-UMC causality assessment scale. During causality assessment of 18 case reports (9 identified from safety database and 9 from literature publications), 11 were identified with probable association and seven were identified with possible association. 
Also, in some of the publications, the authors suggested a few possible mechanisms of ACE- inhibitors induced Psoriasis, such as role of bradykinin, possible association of ACE gene polymorphism and allergic reaction to the sulfhydryl component. 
Subsequently, upon review of RSIs of all the ACE- inhibitors, we could identify that psoriasis is speciﬁed 
i)	as undesirable effects in the Summary of Product Characteristics (SmPCs) of some drugs of this class (imidapril, lisinopril, perindopril, quinapril, ramipril, trandolapril) and 
ii)	as adverse reactions in the United States Prescribing Information (USPI) of lisinopril and perindopril. 
However, psoriasis is not labelled in the RSIs of Captopril and Enalapril.
Conclusion: From this analysis, we could identify that the understated risk of psoriasis is a class effect, time to onset was less than a year and outcome was also favorable after discontinuation of Captopril/Enalapril in most of the cases. This highlights a potential safety signal for two of the ACE-inhibitors (Captopril & Enalapril) we analysed. Although a few cases and literature publications were identified from the multiple sources, considering the quality of information available, strength of association and positive de-challenge information, psoriasis should be included in the labelling of these two products and healthcare workers should also be aware of this risk.


ACE-inhibitors induced Psoriasis: A known information or a SIGNAL?

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