Published online May 7, 2007
PEDIATRICS Vol. 119 No. 6 June 2007, pp. e1239-e1247 (doi:10.1542/10.1542/peds.2006-2962)
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ARTICLE

Oral Versus High-Dose Pulse Corticosteroids for Problematic Infantile Hemangiomas: A Randomized, Controlled Trial

Elena Pope, MD, MSca, Bernice R. Krafchik, MB, ChBa, Colin Macarthur, MD, PhDb, Diana Stempak, PhDc, Derek Stephens, MScd, Miriam Weinstein, MDa, Nhung Ho, MDa and Sylvain Baruchel, MDc

a Section of Dermatology
c New Agents and Innovative Therapy Program
d Research Institute, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
b Bloorview Research Institute, Bloorview Sick Kids Rehabilitation, Toronto, Ontario, Canada

OBJECTIVES. Oral systemic corticosteroids are the mainstay of treatment for problematic hemangiomas; however, current information is based on anecdotal experience and retrospective studies. We aimed to determine whether systemic steroids are efficacious in proliferating hemangioma and to compare the efficacy and safety of 2 corticosteroid treatment modalities.

PATIENTS AND METHODS. Twenty patients with problematic hemangiomas of infancy were randomly assigned to either daily oral prednisolone or monthly intravenous pulses of methylprednisolone. Their clinical outcomes (improvement using a visual analog score) and adverse events were compared at 3 months from baseline and 1 year of age. Data on possible surrogate markers of angiogenesis were available for the first 3 months.

RESULTS. At 3 months, orally treated patients had a median visual analog score of 70 compared with 12 in the intravenous group. This response pattern was similar at the patients' first birthday: 50.0 vs –1.5. Additional treatment beyond 3 months was needed for 65% of the patients (7 in the intravenous and 6 in the oral group). Six of 8 patients with impaired vision at enrollment had an improved function at 1 year (4 patients in the intravenous group and 3 patients in the oral group). Of the 4 surrogate markers of angiogenesis measured (plasma basic fibroblast growth factor, vascular endothelial growth factor, vascular cellular adhesion molecule 1, endoglin, and urine basic fibroblast growth factor), the only 2 that decreased over time were vascular cellular adhesion molecule 1 and endoglin. Patients in the oral group had a higher rate of adverse effects, such as hypertension (18.6% vs 13.1%), abnormal cortisol (78% vs 60%), and growth retardation.

CONCLUSIONS. Systemic corticosteroids are efficacious in stopping the proliferation of hemangiomas. The oral corticosteroids offered more clinical and biological benefit than the pulse steroids with higher risk of adverse effects.

Key Words: infantile hemangioma • corticosteroids • angiogenesis markers

Abbreviations: VEGF—vascular endothelial growth factor • VCAM-1—vascular cellular adhesion molecule 1 • bFGF—basic fibroblast growth factor • IH—infantile hemangioma • PI—principal investigator • VAS—visual analog scale • CBC—complete blood cell • BP—blood pressure • IQR—interquartile range

Accepted Nov 28, 2006.


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