Unboxing the black box on topical calcineurin inhibitors and cancer risk

A partir d'une revue systématique de la littérature publiée jusqu'en juin 2022 (110 études dont 52 essais randomisés ; durée de suivi moyenne : 11 mois), cette méta-analyse évalue l'association entre une utilisation d'inhibiteurs topiques de la calcineurine et le risque de cancer chez des patients pédiatriques atteints de dermatite atopique

Résumé en anglais

The topical calcineurin inhibitors, tacrolimus and pimecrolimus, are effective immunomodulators used in the management of moderate-to-severe atopic dermatitis. Topical tacrolimus ointment (0·03% and 0·1%) was approved by the US Food and Drug Administration (FDA) in 2000, and pimecrolimus cream (1%) in 2001, as second-line agents in children aged 2 years or older. However, in 2006, the FDA announced a black-box warning stating that the long-term safety of topical calcineurin inhibitors had not been established, citing post-marketing reports of increased risks of lymphoma and skin cancers in mainly isolated case reports, organ transplant recipients, and animal studies. Consequently, considerable apprehension regarding their use among health-care providers and patients caused reduction in treatment adherence or cessation of use, resulting in suboptimal control of atopic dermatitis.