Prévalence des effets indésirables de l’hydroxychloroquine (Plaquenil®) dans une population dermatologique : étude rétrospective sur 102 patients

Publication date: Available online 20 May 2018
Source:Annales de Dermatologie et de Vénéréologie
Author(s): P. Tétu, A. Hamelin, B. Lebrun-Vignes, A. Soria, A. Barbaud, C. Francès, F. Chasset
ButL'objectif de cette étude était d'étudier la prévalence des effets indésirables (EI) et celle de l'arrêt de l'hydroxychloroquine (HCQ) pour EI dans une population issue d'un recrutement dermatologique.Patients et méthodesIl s'agissait d'une étude rétrospective incluant consécutivement entre janvier 2013 et juin 2014 tous les patients traités ou ayant reçu de l'HCQ. Les EI étaient déclarés à partir d'un questionnaire standardisé puis évalués par un interrogatoire et un examen clinique systématique permettant de guider les éventuelles explorations paracliniques nécessaires. L'imputabilité médicamenteuse était évaluée par la méthode française de pharmacovigilance. Le critère de jugement principal était la prévalence des EI pour lesquels l'HCQ avait un score d'imputabilité intrinsèque « I » supérieur à 2.RésultatsAu total, 102 patients ont été inclus dont 93 femmes, d'âge médian 44,5 ans (22–90). L'indication de l'HCQ était principalement le lupus cutané (n=70). Cinquante-cinq patients ont déclaré au moins un EI. Parmi les 91 EI déclarés, 59 (65 %) étaient imputables (score I>2), avec une prédominance des EI digestifs (n=30) et cutanés (n=21). Les EI étaient responsables d'un arrêt définitif de l'HCQ dans 19 cas. Parmi eux, 8 (42 %) n'étaient pas imputables à l'HCQ. Parmi les 8 diagnostics de maculopathie, 5 ont été infirmés par une équipe ophtalmologique spécialisée.ConclusionPlus de la moitié des patients ont rapporté des EI sous HCQ et ces EI ont été responsables d'un arrêt définitif de l'HCQ dans un tiers des cas. Une évaluation précise de l'imputabilité est nécessaire, en particulier pour les EI oculaires car dans deux tiers des cas ils n'étaient pas imputables à l'HCQ.AimOur aim was to assess the prevalence of adverse effects (AEs) pertaining to the use and withdrawal of hydroxychloroquine (HCQ) in dermatological outpatients.Patients and methodsWe conducted a retrospective study between January 2013 and June 2014 that included consecutive patients currently or previously receiving HCQ seen in our department. AEs were collated using a standardized questionnaire and validated by clinical and laboratory examination. Drug causality was evaluated using the updated French drug reaction causality assessment method. The main evaluation criterion was the prevalence of AEs in which HCQ had an intrinsic imputability score of I>2.ResultsWe included 102 patients (93 of whom were women, with a median age of 44.5; range: 22–90years). HCQ was given for cutaneous lupus in most cases (n=70). At least one AE was reported for 55 patients. Among the 91 reported AEs, 59 (65%) had an HCQ intrinsic imputability score I>2. AEs were responsible for permanent HCQ discontinuation in 19 cases. Of these, 8 were unrelated to HCQ based on imputability score. The most common AEs associated with HCQ were gastrointestinal and cutaneous signs. Of the 8 patients diagnosed with retinopathy, only 3 were confirmed after reevaluation.ConclusionAEs associated with HCQ were reported for over 50% of patients and were responsible for permanent HCQ discontinuation in one-third of cases. A more in-depth evaluation of imputability seems necessary, particularly regarding ophthalmological symptoms, since in two thirds of cases the reasons for discontinuation were not related to HCQ.



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