Atopic dermatitis (AD) is a chronic inflammatory skin disease that appears in early childhood. It is characterized by intense pruritus, dry skin, and skin lesions that appear in flares and have a considerable impact on patients’ lives.1,2 In recent years, the prevalence of AD has increased to between 7% and 20% in children and between 2% and 7% in adults.2,3 The etiology of AD has been linked to genetic, biological, immunological, and environmental factors.4 As a consequence of certain pathophysiological features of AD, such as the persistence of subclinical inflammation and skin barrier dysfunction, there has been a paradigm shift in the approach to treating the disease. It is now possible, after the resolution of a flare, to recommend a proactive treatment strategy aimed at preventing new flares and achieving longer flare-free intervals.5,6

AD can cause various difficulties. Numerous studies have highlighted the physical, psychological, and social impact of the disease on patients’ lives, especially during acute episodes.1,7–9 AD flares can interfere with sleep and rest, disrupt personal performance in school, at work, and in social relationships, and lead to considerable emotional distress associated with symptom severity. We believed it would be interesting to assess how patients with AD on maintenance therapy perceive their health-related quality of life (HRQOL), as there is little evidence on this group of patients in Spain. Previous studies have examined patients’ attitudes toward medical recommendations and treatment for AD flares.10,11 Nevertheless, research on patient satisfaction with maintenance strategies and on adherence to maintenance therapy is needed because these factors have important clinical implications.12–14 The primary objective of this study was to evaluate HRQOL, patient satisfaction, and treatment adherence in patients receiving maintenance therapy to control AD. The secondary objective was to confirm the basic psychometric properties of the Atopic Dermatitis Impact Scale (ADIS).

A total of 156 dermatologists throughout Spain participated in this multicenter, cross-sectional, epidemiological study. The enrollment period lasted from November 2009 to June 2010. During this period, each dermatologist consecutively interviewed 2 patients—1 adult (aged > 16 years) and 1 child (aged 2-15 years)—who had been clinically diagnosed with moderate or severe AD in accordance with the diagnostic criteria described by Hanifin and Rajka.15 Patients enrolled in the study had a disease duration of at least 16 months and had been receiving topical pharmacologic maintenance therapy for at least 4 months as a proactive strategy to prevent flares and control the disease. Topical pharmacologic maintenance therapy was defined as the prescription of topical calcineurin inhibitors, topical corticosteroids, or alternatives, with or without emollients, once the dermatologist had determined that the AD flare for which the patient had previously been treated was under control (stable or inactive AD lesions in the dermatologist's judgment). This topical therapy was prescribed according to the dermatologist's criteria, following the routine clinical practice of each hospital. All patients (or their parents, in the case of children) gave their written informed consent to participate in the study, which was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki.

Data were recorded for 309 patients with AD (155 adults and 154 children). Twenty-seven patients (14 adults and 13 children) were excluded from the study because they did not meet the inclusion criteria described in the previous section. The final sample for analysis comprised 282 patients (141 adults and 141 children). The sociodemographic and clinical characteristics of the sample are summarized in Table 1 and Fig. 1. According to the dermatologists’ clinical impression, AD severity was moderate in 85.8% of the children and 79.4% of the adults. The median time on maintenance therapy was 10 months (Table 1).

Figure 1.

Number and Duration of Atopic Dermatitis (AD) Flares per Year Before and After the Start of Maintenance Therapy.

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Improvement in the frequency and duration of flares after the start of maintenance therapy was observed in children and adults (Fig. 1) and was statistically significant in both groups (Wilcoxon test, P<.001).

As for HRQOL, the results showed that in most cases AD had a mild impact on the daily lives of patients receiving maintenance therapy (Table 2). However, patients with moderate AD had higher levels of emotional, physical, and social well-being than those with severe AD (Figs. 2 and 3). The differences were statistically significant in adults (Fig. 3).

Figure 2.

Impact of Atopic Dermatitis (AD) and Satisfaction of Pediatric Patients by Severity of Disease.

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Figure 3.

Impact of Atopic Dermatitis (AD) and Satisfaction of Adult Patients by Severity of Disease.

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Satisfaction with the maintenance therapy was high in adults and children (Table 3). Both groups were satisfied with the information they received from the dermatologists about the role of maintenance therapy in preventing flares and about how to treat flares when they occur. As for satisfaction as a function of disease severity, patients with moderate AD were more satisfied than those with severe disease but the differences were small and not significant (Figs. 2 and 3).

As for adherence to medical recommendations, responses to the Morisky Medication Adherence Scale showed that 18.4% of children and 14.9% of adults followed the treatment regimen correctly. More specifically, 49.9% of children and 64.5% of adults reported that they occasionally forgot to apply their treatment. In addition, 34.0% of children and 46.8% of adults said that they stopped using the treatment when they did not have any AD-related symptoms. If we apply less stringent criteria and consider as adherent all patients who said they never forgot apply their treatment and continued to use it when they had no symptoms, then 42.6% of children and 27% of adults adhered to treatment. There were discrepancies between the dermatologists’ perception of patients’ adherence and the patients’ self-reported adherence. The dermatologists considered that the vast majority of their patients (88.7% of children and 88.9% of adults) adhered to the maintenance therapy, but self-reported adherence rates were lower (18.4%-42.6% in children and 14.9%-27.0% in adults). Satisfaction with frequency of application was significantly associated with adherence in adults (adjusted OR, 2.12; 95% CI, 1.38-3.25; P=.001) while low HRQOL was associated with a greater likelihood of nonadherence in children (adjusted OR, 0.529; 95% CI, 0.325-0.859; P=.01).

Regarding the construct validity of the ADIS, a single general factor explained an adequate percentage of the variance in scores (54.04% in the children's ADIS and 48.22% in the adult version). In addition, the scales had good internal consistency (Cronbach α of 0.872 and 0.859 for the children's and adult ADIS, respectively) and all items in both versions were moderately to highly correlated with this single underlying factor (range of correlations for the children's and adult ADIS, 0.701-0.774 and 0.611-0.799, respectively). Finally, the correlation coefficients between scores on both versions of the ADIS and scores on the specific HRQOL questionnaires were moderate to high (range of correlations for children's ADIS and cDLQI, 0.327-0.521; P<.01; range of correlations for adult ADIS and DLQI, 0.553-0.767; P<.01).

In this study, we observed that maintenance therapy has positive effects on the control of AD symptoms. After maintenance therapy was started, the proportion of patients with fewer than 5 flares per year increased significantly. In addition, the number of days the flares lasted decreased significantly in adults and children. This benefit was reflected in greater physical and emotional well-being. In particular, we observed that the impact of AD on patients’ lives was smaller than that reported in previous cohort studies of patients with moderate or severe AD who did not fully adhere to pharmacologic maintenance therapy.11,21 In our study, the mean DLQI and cDLQI scores of patients with moderate or severe AD indicated a mild to slightly moderate impact on HRQOL. Specifically, the impact of AD on HRQOL was mostly mild in patients with moderate disease and moderate in patients with severe disease (Figs. 2 and 3). Despite the small number of patients with severe AD in our sample, these results show the benefit of using pharmacologic maintenance therapy to control AD in clinical practice and are consistent with evidence from more strictly controlled experimental studies.5,6,22–24

Patients were highly satisfied with both the frequency of application of the pharmacologic maintenance therapy and its success in lengthening flare-free intervals. These levels of satisfaction are comparable to, but slightly higher than, the overall levels of satisfaction with treatment for AD flares found in a 2008 study by Schmitt et al.25 in Germany. The same study found that the impression that the treating physician is professionally competent and provides useful information about controlling AD were the strongest determinants of patient satisfaction.25 In the present study, both adults and children placed the highest value on the information they received from their dermatologists about treating flares during maintenance therapy and about controlling the disease with topical pharmacologic agents.

It appears necessary for dermatologists to stress to patients that adherence to therapy and medical recommendations is essential to obtaining clinical benefits and controlling AD.12–14 In our study population, there was room for improvement in adherence to maintenance therapy. The high percentage of patients (34% of children and 47.8% of adults) who stopped using the treatment when the symptoms subsided and who occasionally forgot to use it (49.9% of children and 64.5% of adults) were especially noteworthy. These results are consistent with those of previous studies on topical therapies.12,13,26 We therefore consider that dermatologists should stress the importance of adherence to therapy and adopt patient education strategies.27–29 We believe that outcomes could be optimized by applying long-term AD management strategies of this sort. Moreover, we found that adherence in adult patients was significantly associated with satisfaction with frequency of application, and we believe that this association should be taken into account in efforts to improve adherence.

The main limitation of this study was its cross-sectional design, as this prevented us from recording and measuring the magnitude of clinical changes—related to a reduction in symptom intensity and possible treatment-related adverse effects—and from assessing their relationship with the constructs mentioned above (HRQOL, satisfaction, and adherence). Nevertheless, we achieved our primary objective—to describe HRQOL, patient satisfaction, and adherence in patients receiving maintenance therapy—by applying psychometrically valid scales. In addition, it is important to note that AD severity was assessed on the basis of the dermatologists’ diagnostic criteria within the routine clinical practice of their hospitals. It would have been preferable to complement this assessment with a specific measure of recognized validity30 such as the SCORing Atopic Dermatitis (SCORAD) index. However, we were unable to include this objective instrument in our study because it is not yet widely used in routine clinical practice in Spain.11 Another limitation was the use of indirect measures to detect nonadherence. While we recognize that more accurate results could have been obtained with electronic monitoring systems12,13 or other objective measures, the number of hospitals and patients in this study made the use of such tools unfeasible. We therefore decided instead to include dermatologists’ perception of patients’ adherence in order to incorporate at least 2 assessment methods in this variable. Furthermore, although we are aware that the Morisky Medication Adherence Scale tends to overestimate nonadherence,31 the adherence rates obtained with this test were similar to those found in earlier studies in children.12,26 We included the adherence rates found with the various items of this test in order to provide dermatologists with more information about nonadherence in our patients.

In conclusion, in this study we have confirmed that the ADIS is a short assessment instrument with adequate psychometric properties. Further, the high internal consistency and convergent validity detected between the ADIS and widely validated30 scales such as the DLQI16 and the cDLQI18 support the use of the ADIS in routine clinical practice to obtain additional information about the impact of moderate or severe AD in patients receiving topical pharmacologic maintenance therapy.

This study was funded by Astellas Pharma S.A.

Dr. Emilio Pedrosa is employed by Astellas Pharma Spain. However, given the aims and scope of this study, the other authors declare that there are no conflicts of interest.