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Background Rational healthcare decision-making based on clinical and economic evidence is essential to provide the best possible care for patients with atopic dermatitis (AD). Objective To evaluate treatment outcomes, resource use and cost associated with twice-weekly tacrolimus 0.03% ointment treatment vs. standard flare-only therapy in children with moderate-to-severe AD. Methods In a pan-European, Phase III multicentre randomized clinical trial, children with mild-to-severe AD were randomized to 0.03% tacrolimus ointment or vehicle twice weekly for 12 months. Disease flares were treated using open-label tacrolimus 0.03% ointment twice daily. Clinical efficacy data were evaluated in a subgroup of 153 children with moderate-to-severe AD, with resource use data – collected prospectively using caregiver questionnaires – available from 146 children. Pooled costs of resource use were determined using German unit cost data. Direct and indirect costs were considered from third-party payer, patient and caregiver, and societal perspectives. Results Twice-weekly tacrolimus ointment reduced the number of flares compared with standard therapy ( P < 0.001) and prolonged time to first flare (146 vs. 17 days, P < 0.001). Mean ± SD annual costs per patient for standard and twice-weekly therapy respectively were €2002 ± 2315 vs. €1571 ± 1122 for severe AD and €1136 ± 1494 vs. €1233 ± 1507 for moderate AD. Conclusions In children with AD, twice-weekly treatment with tacrolimus 0.03% ointment reduces the number of flares and prolongs time spent free from flares with no additional cost in children with moderate AD, and may be cost-saving in those with severe AD. [ABSTRACT FROM AUTHOR]

Unlabelled: The aim of this study was to collect representative data on the incidence and clinical characteristics of community-acquired acute gastroenteritis (AGE) due to rotavirus (RV) in German children up to 4 y of age. In 20 paediatric practices in 5 German regions every child aged 0-4 y presenting with symptoms of AGE from May 1997 to April 1998 was eligible for inclusion into the study. Stool samples were tested for RV antigen by enzyme-linked immunosorbent assay and polymerase chain reaction was performed for serotyping. The course of the disease, additional diagnoses and treatment regimen were recorded. Incidences adjusted for month and region of observation were calculated by Poisson regression. Of 15,451 children under observation 3980 (26%) presented with AGE. Of 3156 stool samples available 748 (24%) proved RV positive. The incidence of AGE and RV-positive AGE was 25.2 and 4.0 per 100 children per year, respectively, with a maximum in February/March 1998. RV-positive cases were more severe than RV-negative cases (28% vs 12% severe cases, hospitalization rate 6.2% vs 2.0%, p < 0.001). The predominant genotype of RV isolated was G1/P[8] (77%), followed by G4/P[8] (17%).Conclusion: Rotavirus accounts for a substantial part of severe cases of AGE in children up to 4 y of age. Efficient prevention, including immunization against the circulating serotypes, could save at least 122,000 children in Germany from falling ill with RV-AGE each year. [ABSTRACT FROM AUTHOR]