Propranolol for infantile hemangioma (PINCH): an open-label trial to assess the efficacy of propranolol for treating infantile hemangiomas and for determining the decline in heart rate to predict response to propranolol.

BACKGROUND

Propranolol has emerged as front-line therapy for infantile hemangiomas (IHs). However, a well-defined protocol for administering and predicting response to propranolol is unavailable.

METHODS

In this open-label trial, 31 children with IH (median age=5 mo; range,1 mo to 9 y) were administered propranolol (2 mg/kg/d) for a median duration of 28 weeks (12 to 50 wk). They were compared with 14 historical controls with IH who did not receive any treatment. An image-based scoring system was used to assess involution.

RESULTS

Propranolol (28/31, 90.3%) produced better and faster response compared with control treatment (4/14, 28.6%). With propranolol, 65% to 80% involution was obtained in the first 8 weeks, with an additional 2% to 10% involution until 20 weeks. After 20 weeks, the changes in IH were insignificant. Response was more pronounced among infants ≤6 months of age who attained a peak involution score of 1.86, suggesting >80% involution of IH. The similar score in the cohort aged 6 to 36 months was 3.31. The heart rate (HR) decline after propranolol treatment was significantly higher among patients whose hemangioma responded to propranolol than in those who did not respond (P=0.0006). Decline in HR by >20%, 2 weeks after propranolol administration, was predictive of IH involution (relative risk=0.11; 95% confidence interval, 0.02-0.51; P=0.036).

CONCLUSIONS

Propranolol is efficacious in patients with IH. The most pronounced response is seen in the first 8 weeks and in infants aged 6 months or younger. A decline in HR >20% is an early marker of response to propranolol.