Background. This report investigates the effect of pimecrolimus cream 1%(Elid el., Novartis pharma AG, Basel, Switzerland), a nonsteroid, cell-selective, cyt okine inhibitor on the course of atopic dermatitis (AD), as...Background. This report investigates the effect of pimecrolimus cream 1%(Elid el., Novartis pharma AG, Basel, Switzerland), a nonsteroid, cell-selective, cyt okine inhibitor on the course of atopic dermatitis (AD), as assessed by changes in body surface involvement and pattern of drug use over time. Methods. Data fro m 961 patients in two 1-year double-blind, multicenter, pediatric studies of s imilar design were analyzed:250 infants (aged 3-23 months) were randomized 4: 1 and 711 children (aged 2-17 years) were randomized 2:1 to receive pimecrolim us cream 1%or vehicle, respectively. Emollients were used by all patients to al leviate dry skin and, at the first signs or symptoms of AD, pimecrolimus or vehi cle was applied twice daily to prevent progression to flares. If flares occurred in either group, moderately potent topical corticosteroids were mandated. Resul ts. Pimecrolimus was applied for 68.4%(infants) and 53.8%(children) of study d ays, and frequency of use of pimecrolimus decreased over time, reflecting improv ement in disease control. The mean total body surface area affected decreased co ntinuously over time. Significantly more patients in the pimecrolimus than contr ol groups were maintained without corticosteroid therapy (infants:63.7%vs. 34. 8%, P <.0.001; children:57.4%vs. 31.6%, P < 0.001, respectively). Conclusion . The need for pimecrolimus therapy decreases over time as the patients’disease improves. Hence, once long-term management of AD with pimecrolimus is establis hed, the burden of disease for both the patient and the caregiver decreases sign ificantly and disease-free periods become more frequent.展开更多
文摘Background. This report investigates the effect of pimecrolimus cream 1%(Elid el., Novartis pharma AG, Basel, Switzerland), a nonsteroid, cell-selective, cyt okine inhibitor on the course of atopic dermatitis (AD), as assessed by changes in body surface involvement and pattern of drug use over time. Methods. Data fro m 961 patients in two 1-year double-blind, multicenter, pediatric studies of s imilar design were analyzed:250 infants (aged 3-23 months) were randomized 4: 1 and 711 children (aged 2-17 years) were randomized 2:1 to receive pimecrolim us cream 1%or vehicle, respectively. Emollients were used by all patients to al leviate dry skin and, at the first signs or symptoms of AD, pimecrolimus or vehi cle was applied twice daily to prevent progression to flares. If flares occurred in either group, moderately potent topical corticosteroids were mandated. Resul ts. Pimecrolimus was applied for 68.4%(infants) and 53.8%(children) of study d ays, and frequency of use of pimecrolimus decreased over time, reflecting improv ement in disease control. The mean total body surface area affected decreased co ntinuously over time. Significantly more patients in the pimecrolimus than contr ol groups were maintained without corticosteroid therapy (infants:63.7%vs. 34. 8%, P <.0.001; children:57.4%vs. 31.6%, P < 0.001, respectively). Conclusion . The need for pimecrolimus therapy decreases over time as the patients’disease improves. Hence, once long-term management of AD with pimecrolimus is establis hed, the burden of disease for both the patient and the caregiver decreases sign ificantly and disease-free periods become more frequent.
