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The Role of Patients in the Development of the
Alopecia Areata Investigator Global Assessment (AA-
IGA™), a Clinician-Repo...
Introduction and Objective
• To evaluate new alopecia areata (AA) treatments, AA outcome measures
must incorporate input f...
Methods and Samples
Methods
• 10 US dermatologists expert in the treatment of AA
– Interviews investigated treatment benef...
• Expert clinicians (n=10) judged overall AA treatment success by whether scalp hair had regrown
• Most considered 80% (n=...
Results: Initial AA-IGA Development
Iterative development of the AA-IGA
None Limited Moderate Severe Complete
Please rate ...
Results: Additional Iteration in the AA-IGA Development
Iterative development of the AA-IGA
None Limited Moderate Severe C...
Results: Small Panel Review
• Two expert clinicians reviewed the clinician data on the gradations and associated
percentag...
Results: Group 1 Input on Treatment Success and AA-IGA™
Figure 7. What amount of scalp hair -- short of 100% -- would
you ...
• The AA-IGA™ is a robust ordinal measure
- Each category represents a distinct and clinically meaningful gradation of the...
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The Role of Patients in the Development of the Alopecia Areata Investigator Global Assessment (AA-IGA™), a Clinician-Reported Measure Evaluating Clinically Meaningful Success in Clinical Trials

Through in-depth interviews of key informant groups, Lilly developed a five-grade investigator global assessment (IGA) scale to measure clinically meaningful treatment response to alopecia areata treatment for patients with ≥ 50% scalp hair loss. Patient input was essential to the development of this content valid measure.

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The Role of Patients in the Development of the Alopecia Areata Investigator Global Assessment (AA-IGA™), a Clinician-Reported Measure Evaluating Clinically Meaningful Success in Clinical Trials

  1. 1. The Role of Patients in the Development of the Alopecia Areata Investigator Global Assessment (AA- IGA™), a Clinician-Reported Measure Evaluating Clinically Meaningful Success in Clinical Trials Kathleen W. Wyrwich1, Helen Kitchen2, Sarah Knight2, Natalie V. J. Aldhouse2, Jake Macey2, Fabio P. Nunes1, Yves Dutronc1, Natasha A. Mesinkovska3, Justin M. Ko4, Brett A. King5 1Eli Lilly and Company 2DRG Abacus 3University of California; Irvine School of Medicine 4Stanford University School of Medicine 5Yale School of Medicine
  2. 2. Introduction and Objective • To evaluate new alopecia areata (AA) treatments, AA outcome measures must incorporate input from both experienced clinicians and patients with AA to understand clinically meaningful success • Through in-depth interviews of key informant groups, we developed a five- grade investigator global assessment (IGA) scale to measure clinically meaningful treatment response to AA treatment for patients with ≥ 50% scalp hair loss • Patient input was essential to the development of this content valid measure Company Confidential ©2018 Eli Lilly and Company
  3. 3. Methods and Samples Methods • 10 US dermatologists expert in the treatment of AA – Interviews investigated treatment benefit and clinical gradations • 30 US patients with AA history of ≥ 50% scalp hair loss (Group 1) – Patients who had been successfully treated with oral Janus kinase inhibitors (JAKi) were included to understand their perception of scalp hair growth success – The patient interviews explored perspectives and expectations of AA treatment • Data from clinicians and Group 1 patients were analyzed using thematic methods – Identified key treatment outcome and the content validity of the newly developed IGA • 40 US patient interviews conducted by NAAF PRO Consortium Partnership (Group 2) – Transcripts reviewed and coded to summarize key concepts and provided insights on patients’ aspirations for an ideal AA treatment Characteristic Patients (N=30) Female, n (%) 17 (57) Age Mean [range] Adults aged ≥18, n (%) Adolescents aged 15-17, n (%) 35.3 [15-72] 25 (83) 5 (17) Successfully treated with JAKi, n (%) 18 (60) Most recent SALT score, mean [range] 57.9 (0.0-100.0) Table 2: Patient Interviews - Group 1 Characteristic Clinicians (N=10) Years experience treating patients with AA, mean [range] 23.2 [9-45] Type of practice, n (%) University hospital Specialist dermatology center 9 (90) 1 (10) Table 1: Clinician Interviews Table 3: Patient Interviews - Group 2 Characteristic Patients (N=40) Female, n (%) 27 (68) Age Adults aged ≥18, n (%) Adolescents aged 12-17, n (%) 30 (75) 10 (25) Currently receiving treatment, n (%) 17 (43) Patient-estimated percentage of scalp hair loss 25-49% 50-75% 75-100% 5 (13) 12 (30) 23 (58)
  4. 4. • Expert clinicians (n=10) judged overall AA treatment success by whether scalp hair had regrown • Most considered 80% (n=5) or 75% (n=3) scalp hair as a treatment success threshold (Figure 1) • Scalp hair loss was the most bothersome AA sign/symptom for 77% (n=23) of the sample in Group 1 • 73% of the adults and 87% of the adolescents noted some aspect of scalp hair regrowth when describing an ideal treatment/meaningful improvement in Group 2 Important signs/symptoms of AA Results: Key Concept Figure 1. Clinician Treatment Success Thresholds
  5. 5. Results: Initial AA-IGA Development Iterative development of the AA-IGA None Limited Moderate Severe Complete Please rate the patient’s scalp hair loss, as it looks today. ____% ____% ____% ____% ____% • Clinicians were shown the draft AA-IGA in Figure 2 and asked to suggest percentage ranges of scalp hair loss for each response category (Figure 3) Figure 2. Draft AA-IGA shown to clinicians : Initial clinician-proposed descriptions of the draft IGA category percent ranges*1 2 Figure 3. Draft AA-IGA category percentages suggested by clinicians
  6. 6. Results: Additional Iteration in the AA-IGA Development Iterative development of the AA-IGA None Limited Moderate Severe Complete Please rate the patient’s scalp hair loss, as it looks today. 0% 1-20% 21-49% 50-99% 100% • Clinicians were then shown proposed ranges in Figure 4 and asked their opinions (Figure 5) Figure 4. AA-IGA Category percentages suggested to clinicians Figure 5. Draft AA-IGA category percentages suggested by clinicians
  7. 7. Results: Small Panel Review • Two expert clinicians reviewed the clinician data on the gradations and associated percentages, with a focus on observed inconsistencies • They concluded that the fifth category of the IGA should be named ‘Very Severe’ and include patients with 95–100% hair loss due to these patients: – Being clinically very similar to those with 100% hair loss, with few terminal hairs on the scalp, and – Clinically differentiated from patients with 50–94% (‘Severe’) scalp hair loss Iterative development of the AA-IGA: Small Panel Review Draft full version of the AA-IGA™ for review in patient interviews1 2 None Limited Moderate Severe Very Severe Please rate the patient’s scalp hair loss, as it looks today. 0% 1-20% 21-49% 50-94% 95-100% Figure 6. Draft version of AA-IGA used in patient interviews (Group 1)
  8. 8. Results: Group 1 Input on Treatment Success and AA-IGA™ Figure 7. What amount of scalp hair -- short of 100% -- would you consider a treatment success? Most patients perceived treatment success as achieving ~70 - 90% scalp hair (median = 80%) Iterative development of the AA-IGA: Patient (Group 1) Review • All 30 patients confirmed the appropriateness of the AA-IGA and the specific gradations • All queried patients stated that reaching the ‘Limited’ AA-IGA category after treatment would be a success
  9. 9. • The AA-IGA™ is a robust ordinal measure - Each category represents a distinct and clinically meaningful gradation of the SALT 0-100% scores that reflects clinicians’ and patients’ perspectives and treatment expectations • Nearly all queried clinicians and patients confirmed that achieving 0-20% scalp affected was an appropriate treatment success threshold for patients with ≥ 50% scalp hair loss • When reviewed with patients and clinicians, the AA-IGA was supported as a meaningful clinician-reported measure of scalp hair loss Figure 8. Alopecia Areata Investigator Global Assessment (AA-IGA™) Conclusions

Through in-depth interviews of key informant groups, Lilly developed a five-grade investigator global assessment (IGA) scale to measure clinically meaningful treatment response to alopecia areata treatment for patients with ≥ 50% scalp hair loss. Patient input was essential to the development of this content valid measure.

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