Assessment of quality of life and resource utilization in patients with atopic dermatitis: the rainbow study

Abstract

Atopic dermatitis (AD), an inflammatory skin disease, adversely affects all age groups and has been demonstrated to negatively impact patients’ quality of life (QoL). The Rainbow study is a multicentre, open-label, single arm, prospective clinical trial of a novel agent, pimecrolimus, to assess treatment of AD, in addition to impact on QoL and utilization of medical resources, for a 6 month period.Methods: Canadian pediatric and adult patients with a diagnosis of AD were enrolled. Severity of AD was characterized as clear/almost clear, mild, moderate, severe/very severe disease by the Investigator’s Global Assessment (IGA). All patients were treated with pimecrolimus by topical application to affected areas twice daily (as needed). QoL and Resource Utilization (RU) questionnaires were completed at baseline, month 2 and month 6.Results: 515 patients aged 3 months to 80 years were enrolled. 47.5% were 18 years or older and 55.7% were female. For all patients, baseline IGA was 3.7% clear/almost clear, 27.8% mild, 52.2% moderate and 16.3% severe/very severe disease. The following results focus on the QoL and RU aspects of the study. In both the intent-to-treat (ITT) and per protocol (PP) populations, for infant (3-23 months), children (2-12 years) and adult (>18 years) age groups, total QoL scores improved significantly at 6 months (ITT p < 0.001, PP < 0.0001) with remarkable change in patients with mild and moderate whole body IGA (p < 0.0001 and p < 0.0001 respectively). Severe/very severe IGA total QoL scores at 6 months were significantly improved for only the infant (PP p = 0.0321) and children (PP p = 0.0002) age groups. RU was favorably impacted with significantly fewer visits to the dermatologist for all ages and a reduction in visits to the family doctor for all but the 13-17 year age group. Outpatient medical visits were reduced for children and adult age groups. Additionally, the 2-12 year age group made fewer visits to the emergency room (PP p < 0.05). Time and productivity cost were predominantly impacted for the 2-12 year age group with a decrease in the amount of time the caregiver was prevented from attending work or leisure activities (PP p < 0.05). Conclusion: In combination with improved clinical characteristics, use of pimecrolimus for the treatment of AD reduces RU and decreases the demand on caregiver employment and leisure time. Moreover, there was significant improvement in QoL with pimecrolimus in infants, children and adults. Atopic dermatitis (AD), an inflammatory skin disease, adversely affects all age groups and has been demonstrated to negatively impact patients’ quality of life (QoL). The Rainbow study is a multicentre, open-label, single arm, prospective clinical trial of a novel agent, pimecrolimus, to assess treatment of AD, in addition to impact on QoL and utilization of medical resources, for a 6 month period. Methods: Canadian pediatric and adult patients with a diagnosis of AD were enrolled. Severity of AD was characterized as clear/almost clear, mild, moderate, severe/very severe disease by the Investigator’s Global Assessment (IGA). All patients were treated with pimecrolimus by topical application to affected areas twice daily (as needed). QoL and Resource Utilization (RU) questionnaires were completed at baseline, month 2 and month 6. Results: 515 patients aged 3 months to 80 years were enrolled. 47.5% were 18 years or older and 55.7% were female. For all patients, baseline IGA was 3.7% clear/almost clear, 27.8% mild, 52.2% moderate and 16.3% severe/very severe disease. The following results focus on the QoL and RU aspects of the study. In both the intent-to-treat (ITT) and per protocol (PP) populations, for infant (3-23 months), children (2-12 years) and adult (>18 years) age groups, total QoL scores improved significantly at 6 months (ITT p < 0.001, PP < 0.0001) with remarkable change in patients with mild and moderate whole body IGA (p < 0.0001 and p < 0.0001 respectively). Severe/very severe IGA total QoL scores at 6 months were significantly improved for only the infant (PP p = 0.0321) and children (PP p = 0.0002) age groups. RU was favorably impacted with significantly fewer visits to the dermatologist for all ages and a reduction in visits to the family doctor for all but the 13-17 year age group. Outpatient medical visits were reduced for children and adult age groups. Additionally, the 2-12 year age group made fewer visits to the emergency room (PP p < 0.05). Time and productivity cost were predominantly impacted for the 2-12 year age group with a decrease in the amount of time the caregiver was prevented from attending work or leisure activities (PP p < 0.05). Conclusion: In combination with improved clinical characteristics, use of pimecrolimus for the treatment of AD reduces RU and decreases the demand on caregiver employment and leisure time. Moreover, there was significant improvement in QoL with pimecrolimus in infants, children and adults.