Interferon alfa-n1 (Wellferon)® in juvenile onset recurrent respiratory papillomatosis: Results of a randomized study in twelve collaborative institutions

Sixty-six patients with clinically severe juvenile-onset recurrent respiratory papillomatosis (KRP) were entered into a 12-month randomized crossover study to evaluate interferon alpha-nl WeUferon® (WFN) as an adjuvant to CO2 laser surgical excision. Eligibility required disease onset to he before age 16, and an endoscopic excision requirement of at least three operations in the 6 months immediately prior to entry. Patients were randomized to Observation versus WFN at a dose of 5 MU/m² daily for 28 days and three times weekly for 5 months. The patient groups were comparable in extent of disease at entry. Total extent of disease was determined by a composite score derived from the number of diseased anatomic sites and extent of surface area and lumen encroachment present at each site. Standard endoscopic excisions were performed every 2 months and clinical courses compared on a basis of composite scores determined at each endoscopy. Statistically significant improvement occurred in the patient group which received WFN. We conclude that interferon alpha n-1 is an effective adjuvant to surgery in RRP management.