Anaïs Havet, Epidemiologist, Reshape U1290
Clara Bouvard, Biostatistician, Reshape U1290
Oral isotretinoin treatment initiations in France between 2014 and 2021: evolution and compliance with guidelines and pregnancy prevention program.
Acne is a chronic inflammatory disease that commonly affects adolescents and young adults of both sexes. It is the eighth most common skin disease worldwide, affecting 640 million people, 85% of whom are adolescents. Isotretinoin was granted marketing authorization (AMM) in France in 1984 for the treatment of severe acne. Recommendations for the treatment of acne were updated by the French Society of Dermatology (SFD) in June 2015. 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). In addition, since the introduction of the Pregnancy Prevention Programme (PPG) in 1997 due to the teratogenic risk associated with the use of isotretinoin, several pharmacovigilance and pharmacoepidemiological studies have shown a non-negligible number of pregnancies exposed to isotretinoin, and insufficient compliance with recommendations, particularly regarding the performance of pregnancy tests. 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 the ANSM to healthcare professionals, and additional risk reduction measures (MARR) and related documents were updated.
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.