Exploring Factors That Influence the Measurement of Patient-Reported Impacts of Alopecia Areata
摘要
The ALLEGRO- 2b/3 (Clinicaltrials.gov Identifier: NCT03732807) study demonstrated efficacy and safety of ritlecitinib in patients with alopecia areata (AA). Despite clinically meaningful improvement in hair regrowth, differences in patient-reported emotional symptoms or activity limitations (subscales of the Alopecia Areata Patient Priority Outcomes [AAPPO]) between treatment groups were not significant. This study aimed to identify potential factors that may impact the measurement of patient-reported outcomes in AA.
MethodsThis mixed methods study conducted remote interviews with individuals with self-reported AA. Interviews were designed to understand how experiences with AA impacted study participant health-related quality of life and gain insights into how historical personal circumstances and individual characteristics might impact AAPPO responses. Qualitative data were analyzed using thematic and content analytical processes; quantitative data were analyzed descriptively.
ResultsQualitative analysis of interview transcripts of 30 adults with AA (seeking or had received AA treatment) yielded three overarching themes: mechanisms of adaptation (subthemes: behavioral and mental strategies), impact changes over disease journey (subthemes: hair loss and regrowth as an event and changes in impact over time after loss and/or regrowth), and underlying characteristics that moderate adaptation. Participants reported requiring 50–100% regrowth for 6–12 months before they would provide different AAPPO emotional and activity limitation responses.
ConclusionsHigh levels of hair regrowth over a sustained period of time would be required to change AAPPO responses. Factors identified that may affect measurement of patient-reported psychosocial outcomes in AA included length of time since hair regrowth. Understanding factors that impact adaptation can help inform clinical practice and research.