There were corresponding significant (P <.005) decreases in the proportions of patients responding that they moderately/extremely or most/all of the time: felt angry (–13.0%); worried about AV worsening (–28.1%); had thoughts about AV (–28.1%); had a certain level of worries about AV (–34.8%); altered their social media/selfie activity (–20.2%); had an impact on real-life plans due to AV (–12.6%); made efforts to hide AV (–17.8%); felt picked-on/judged due to AV (–7.5%); were concerned about their ability to reach future goals due to AV (–9.1%); or had their sleep impacted due to AV (–6.3%) (Figure 3a and 3b).
Responses to additional questions revealed that almost twice as many parents/caregivers (56.4%) vs their children (29.7%) reported being quite a bit/very much concerned about (child’s) AV at baseline. These values decreased to 20.8% and 7.9%, respectively, by week 12. Similarly, 25.8% of parents/caregivers and 7.9% of children reported being quite a bit/very much concerned about (child’s) ability to reach future goals due to AV. These values decreased to 16.5% and 1.9%, respectively, by week 12. Most pediatric patients (62.4%) and their parents/caregivers (71.3%) reported that parents understood the child’s AV-related concerns quite a bit/very much. There was little change in these values at week 12 (Table 2).
DISCUSSION
AV and its sequelae have a profound influence on patients' physical, social, and psychological well-being, significantly reducing their social/emotional functioning.28 This impaired QoL may be improved by successful treatment of AV.29 An undesirable skin appearance may result in a body image that provokes anger, anxiety, humiliation, embarrassment, bullying, and stigmatization among peers. Identifying such concerns in patients with AV is pivotal to providing comprehensive care leading to clinical and overall psychosocial improvement.30 It has been shown that AV can result in psychological disturbance,31 interference with social/leisure activities, and social avoidance.30 Careful assessment of the impact of AV on patient-reported social/emotional well-being, and overall effect on AV-related concerns may help characterize the overall disease burden, identify psychologically vulnerable patients, and support appropriate integrated treatment. It is also important for assessing the benefits of new AV therapies.32-34
Results from this real-world study employing the novel EPQ suggest that 12 weeks of oral antibiotic treatment significantly reduced the adverse effects of AV on emotional/social functioning and ADL. At the end of 12 weeks, high percentages of patients reported no/least impact of AV in each of the 3 domains assessed by the EPQ. Specifically, after 12-weeks of treatment, most patients responded that they never/rarely felt angry, altered their social media activity, felt an impact on their real-life plans due to AV, or had their sleep impacted due to AV. Treatment also positively affected patients’ attitudes toward interactions via social media. At baseline, most patients chose to alter their appearance to hide their skin lesions, considering it to be personal imperfection and unattractive. At the conclusion of this study, patients seldom thought of altering their social media activities, indicating less concern about their appearance, and suggesting increased self-confidence. By the end of the study, most patients never/rarely felt picked on/judged due to AV and were positive regarding their ability to reach future goals, suggesting improved self-esteem and social functioning. At the study’s conclusion, a minority of patients reported that they most/all of the time made efforts to hide their AV, worried about AV worsening, or had concerns about their ability to reach future goals due to AV.
Reducing psychosocial stress should be considered a guiding principle in AV management. Employment of safe and effective therapeutic options, and monitoring of both clinical responses and PRO have the potential to significantly decrease psychosocial burden associated with AV.28 If systemic antibiotics are used, proper stewardship supports the use of narrow-spectrum agents to minimize disruption of the normal microflora and limit development of resistance.22
Various validated scoring systems are being used to determine patients’ QoL and the effectiveness of clinical interventions on patients’ psychosocial well-being.32,35-37 However, most do not focus on patients’ social/emotional functioning and ADL, which remain under-explored; do not address facial AV or issues that matter most to young patients; and/or take a long time to administer.35,38 The EPQ fills the unmet need in AV-related PRO measurement. The EPQ is sensitive to therapy, as it demonstrated improvements in patients receiving an efficacious acne treatment.25 The questionnaire could be helpful in routine clinical practice to improve AV patient management and document health outcomes, including patients’ emotional/social functioning.
This study had significant limitations. Results may be subject to biases such as recall bias, reporting bias, selection bias, and other biases commonly seen in real-world and open-label studies. Approaches such as standardized study inclusion/exclusion criteria, consecutive sampling, and diverse dermatology clinics/investigators from across the US with varied prior experience with sarecycline were employed to minimize biases.
CONCLUSION
The novel EPQ appears to be a clinically relevant and responsive AV-related PRO instrument that effectively measures the impact of the disease and its treatment. Appropriate AV treatment with sarecycline was associated with a reduction in psychosocial impairment and supports the conclusion that the EPQ is a promising tool for supplementing clinical judgment in AV management.
ACKNOWLEDGMENT
Funding for this study was provided by Almirall S.A. We thank Avant Health LLC and their collaborating partner Molecular Connections Analytics Pvt. Ltd. as well as Phase to Phase Strategy, LLC for medical writing services.
