Factors associated with early relapse of infantile haemangioma in children treated for at least six months with oral propranolol: A case-control study using the 2014-2021 French Ouest DataHub

Ann Dermatol Venereol. 2023 Sep;150(3):189-194. doi: 10.1016/j.annder.2023.03.007. Epub 2023 May 22.

Abstract

Background: The factors associated with early relapse of infantile haemangioma (IH) after a first course of treatment with oral propranolol for at least six months (initiated after the marketing authorization had been granted) have not previously been investigated.

Objectives: To identify factors associated with the risk of early relapse in children with IH treated with oral propranolol according to the current prescribing guidelines.

Methods: We performed a multicentre, retrospective, case-control study, using the Ouest Data Hub database. All children treated for at least 6 months with oral propranolol for IH between 31 June 2014 and 31 December 2021, and with a follow-up visit at least three months after treatment discontinuation were included. A case was defined as relapse of IH within three months of treatment discontinuation; each case was matched for age at treatment initiation and for centre, with four (relapse-free) controls. The association between relapse and treatment or IH characteristics was expressed as an odds ratio (OR) from univariate and multivariate conditional logistic regressions.

Results: A total of 225 children were included. Of these, 36 (16%) relapsed early. In a multivariate analysis, a deep IH component was a risk factor for early relapse [OR = 8.93; 95%CI: 1.0-78.9, p = 0.05]. A propranolol dosage level of less than 3 mg/kg/day protected against early relapse [OR = 0.11; 95%CI: 0.02-0.7, p = 0.02]. Tapering before propranolol discontinuation was not associated with a lower risk of early relapse.

Conclusion: The risk factors for late and early relapse are probably different. Investigation of the risk factors for early vs. late IH relapse is now warranted.

Keywords: Early relapse; Infantile haemangioma; Oral propranolol; Post-marketing authorization.

MeSH terms

  • Administration, Oral
  • Case-Control Studies
  • Child
  • Chronic Disease
  • Hemangioma, Capillary*
  • Humans
  • Infant
  • Propranolol / therapeutic use
  • Retrospective Studies
  • Skin Neoplasms* / drug therapy
  • Treatment Outcome

Substances

  • Propranolol