Étude des initiations de traitement par isotrétinoïne par voie orale en France entre 2014 et 2021 : évolution et respect des indications et du programme de prévention des grossesses

Background

Acne is a chronic inflammatory disease that frequently affects teenagers and young adults of both sexes. It is the eighth most common skin disease worldwide, affecting 640 million people, 85% of whom are teenagers. Isotretinoin was granted marketing authorization (AMM) in France in 1984 for the treatment of severe acne. Recommendations for the management of acne were updated in June 2015 by the French Society of Dermatology (SFD). They recommended the use of oral isotretinoin as a first-line treatment for very severe grade 5 acne, and as a second-line treatment after oral antibiotic therapy and topical therapy for moderate and severe acne (grades 3 and 4). Also, since the introduction of the pregnancy prevention program (PPG) in 1997 due to the teratogenic risk associated with the use of isotretinoin, several pharmacovigilance and pharmaco-epidemiological studies have shown a non-negligible number of pregnancies exposed to isotretinoin, and insufficient compliance with recommendations, particularly concerning the performance of pregnancy tests. Thus, in May 2015, the French National Agency for the Safety of Medicines and Health Products (ANSM) restricted the initial prescription of isotretinoin to dermatologists, but prescription renewals could be carried out by any doctor. In December 2018 and January 2019, safety information on teratogenicity was again distributed by ANSM to healthcare professionals, and additional risk reduction measures (MARR) and associated documents were updated.

Objectifs

The aims of the present study were i) to describe the use of oral isotretinoin over the period 2014-2021 and ii) to assess the effect of the ANSM measure restricting initial prescribing to dermatologists in 2015, the updated MARRs in 2019 and the updated SFD recommendations in 2015 on compliance with recommendations for use.

Résultats clés

→ Entre 2014 et 2021 parmi l’ensemble des cures, 41% des cures ne respectaient pas le PPG à l’initiation, 29% des dispensations ne respectaient pas le PPG pendant les cures et 90% des cures ne respectaient pas le PPG en fin de cure. 

→ La mesure ANSM de restriction de la prescription initiale aux dermatologues en 2015 était associée à un meilleur respect des critères stricts du PPG à l’initiation et pendant les cures, alors qu’elle était associée à une diminution du respect strict du PPG en fin de cure parmi les cures suivantes.

→ La mise à jour des MARR par l’ANSM en 2019 n’a pas eu d’effet significatif sur le respect strict du PPG à l’initiation et en fin de cure, et était associée à une diminution du respect strict du PPG pendant les cures.