Brahim Azzouz1,2, Aurore Morel3, Lukshe Kanagaratnam4,5, Emmanuelle Herlem3, Thierry Trenque3,4. 1. Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Reims University Hospital, Avenue du General Koenig, Reims, France. bazzouz@chu-reims.fr. 2. EA 3797, Faculty of Medicine, University of Reims Champagne-Ardenne, 51 Rue Cognacq-Jay, Reims, France. bazzouz@chu-reims.fr. 3. Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Reims University Hospital, Avenue du General Koenig, Reims, France. 4. EA 3797, Faculty of Medicine, University of Reims Champagne-Ardenne, 51 Rue Cognacq-Jay, Reims, France. 5. Department of Research and Public Health, Reims University Hospital, Avenue du General Koenig, Reims, France.
Abstract
INTRODUCTION: Angiotensin-converting enzyme inhibitors (ACEIs) can induce or aggravate psoriasis. This risk is not specified in the Summary of Product Characteristics (SmPC) of some drugs of this class, such as captopril or enalapril. We aimed to investigate the association between psoriasis and ACEI exposure. METHODS: We analyzed spontaneous reports recorded in the French national Pharmacovigilance Database (FPVD) from 1985 to 31 December 2018. The association between psoriasis and ACEI exposure was assessed using the case/non-case method. We also reviewed literature reports. RESULTS: One hundred reports of psoriasis after ACEI exposure were registered in the FPVD. The reporting odds ratio (ROR) was 2.40 (95% CI 1.96-2.95). Time to onset was < 1 year in 67% of reports. Outcome was favorable in 73% of reports after ACEI discontinuation. Almost all ACEIs were concerned. In the literature, we found 21 published reports of psoriasis with ACEIs. Time to onset ranged from 1 week to 4 months. Outcome was also favorable after ACEI discontinuation in over half of the literature reports. CONCLUSIONS: We found a statistically significant association between psoriasis and ACEI, which constitutes a potential safety signal. The risk of psoriasis is a class effect, time to onset is less than 1 year, and outcome is favorable after ACEI discontinuation. Psoriasis should be mentioned in the SmPCs of all ACEIs, and healthcare professionals should be informed about this risk.
INTRODUCTION:Angiotensin-converting enzyme inhibitors (ACEIs) can induce or aggravate psoriasis. This risk is not specified in the Summary of Product Characteristics (SmPC) of some drugs of this class, such as captopril or enalapril. We aimed to investigate the association between psoriasis and ACEI exposure. METHODS: We analyzed spontaneous reports recorded in the French national Pharmacovigilance Database (FPVD) from 1985 to 31 December 2018. The association between psoriasis and ACEI exposure was assessed using the case/non-case method. We also reviewed literature reports. RESULTS: One hundred reports of psoriasis after ACEI exposure were registered in the FPVD. The reporting odds ratio (ROR) was 2.40 (95% CI 1.96-2.95). Time to onset was < 1 year in 67% of reports. Outcome was favorable in 73% of reports after ACEI discontinuation. Almost all ACEIs were concerned. In the literature, we found 21 published reports of psoriasis with ACEIs. Time to onset ranged from 1 week to 4 months. Outcome was also favorable after ACEI discontinuation in over half of the literature reports. CONCLUSIONS: We found a statistically significant association between psoriasis and ACEI, which constitutes a potential safety signal. The risk of psoriasis is a class effect, time to onset is less than 1 year, and outcome is favorable after ACEI discontinuation. Psoriasis should be mentioned in the SmPCs of all ACEIs, and healthcare professionals should be informed about this risk.
Authors: Giuseppe Mancia; Robert Fagard; Krzysztof Narkiewicz; Josep Redon; Alberto Zanchetti; Michael Böhm; Thierry Christiaens; Renata Cifkova; Guy De Backer; Anna Dominiczak; Maurizio Galderisi; Diederick E Grobbee; Tiny Jaarsma; Paulus Kirchhof; Sverre E Kjeldsen; Stéphane Laurent; Athanasios J Manolis; Peter M Nilsson; Luis Miguel Ruilope; Roland E Schmieder; Per Anton Sirnes; Peter Sleight; Margus Viigimaa; Bernard Waeber; Faiez Zannad; Josep Redon; Anna Dominiczak; Krzysztof Narkiewicz; Peter M Nilsson; Michel Burnier; Margus Viigimaa; Ettore Ambrosioni; Mark Caufield; Antonio Coca; Michael Hecht Olsen; Roland E Schmieder; Costas Tsioufis; Philippe van de Borne; Jose Luis Zamorano; Stephan Achenbach; Helmut Baumgartner; Jeroen J Bax; Héctor Bueno; Veronica Dean; Christi Deaton; Cetin Erol; Robert Fagard; Roberto Ferrari; David Hasdai; Arno W Hoes; Paulus Kirchhof; Juhani Knuuti; Philippe Kolh; Patrizio Lancellotti; Ales Linhart; Petros Nihoyannopoulos; Massimo F Piepoli; Piotr Ponikowski; Per Anton Sirnes; Juan Luis Tamargo; Michal Tendera; Adam Torbicki; William Wijns; Stephan Windecker; Denis L Clement; Antonio Coca; Thierry C Gillebert; Michal Tendera; Enrico Agabiti Rosei; Ettore Ambrosioni; Stefan D Anker; Johann Bauersachs; Jana Brguljan Hitij; Mark Caulfield; Marc De Buyzere; Sabina De Geest; Geneviève Anne Derumeaux; Serap Erdine; Csaba Farsang; Christian Funck-Brentano; Vjekoslav Gerc; Giuseppe Germano; Stephan Gielen; Herman Haller; Arno W Hoes; Jens Jordan; Thomas Kahan; Michel Komajda; Dragan Lovic; Heiko Mahrholdt; Michael Hecht Olsen; Jan Ostergren; Gianfranco Parati; Joep Perk; Jorge Polonia; Bogdan A Popescu; Zeljko Reiner; Lars Rydén; Yuriy Sirenko; Alice Stanton; Harry Struijker-Boudier; Costas Tsioufis; Philippe van de Borne; Charalambos Vlachopoulos; Massimo Volpe; David A Wood Journal: Eur Heart J Date: 2013-06-14 Impact factor: 29.983