Introduction
Originally described by Mulliken and Glowacki1, infantile haemangioma (IH) is the most common benign tumour in children2,3. IH belongs to the group of vascular tumours in the ISSVA (international society for the study of vascular anomalies) classification4. Usually, IH will appear at birth or within the first few weeks after birth, and up to 3 months of age for subcutaneous haemangioma5. IH is characterized by its natural course divided into three phases, a proliferative phase characterized by a rapid growth of the tumour (up to 6 to 12 months of life), a stabilization phase (from 12 to 36 months of life), and an involution phase marked by the regression of the lesion6. This regression is complete in 90% of cases by the age of 4, but without treatment we can observe up to 70% residual lesions, such as fibrofatty tissue, telangiectasia, skin laxity and scars7. The proliferative phase may be marked by severe complications, such as necrosis, ulceration, bleeding or infection. Obstruction and functional impairment such as amblyopia, upper respiratory obstruction, obstruction of the nostrils or auditory channel, sphincter dysfunction, or feeding disorders can be caused by periorificial locations of IH (e.g. perioral and periorbital skin). Moreover, the aesthetic impact is not trivial, especially when IHs located in the centrofacial area are a source of disfigurement8,9. Large segmental facial IHs may be part of the PHACES syndrome (posterior fossa anomalies, haemangioma, arterial lesions, cardiac abnormalities, eye anomalies, sternal defects)10,11 and segmental IHs of the lower body may be part of the LUMBAR syndrome (lower body haemangioma, urogenital, myelopathy, bony, anorectal and arterial, renal anomalies)12. Finally, liver haemangioma and haemangiomatosis are high-risk complicated IHs as they may lead to cardiac failure13.
Initially, medical treatment of severe IH was based on systemic corticosteroid therapy14,15. In 2008, Leaute-Labreze et al. fortuitously discovered the anti-proliferative effect of propranolol, when using this non-selective beta-blocker for a hypertrophic obstructive cardiomyopathy, in a child with a nasal IH treated by corticosteroids16. The efficacy of oral propranolol in IH was demonstrated by two randomized controlled trials17,18. In 2014 Pierre Fabre dermo-cosmetics laboratory (Paris, France) obtained EMA (European Medicines Agency) and FDA (Food and Drug Administration) marketing authorization for Hemangiol®, the first and only drug currently approved for the treatment of proliferating IH. Hemangiol® is indicated to treat IH in children aged 5 weeks to 5 months, in case of life or functional risk, painful ulcerated lesions, or risk of permanent scarring or facial damage.
In this paediatric post-marketing surveillance drug study, we aimed to report the use of Hemangiol® in our institution from 2014 to 2018.