Patient-Reported Hair Loss and Its Impacts as Measured by the Alopecia Areata Patient Priority Outcomes Instrument in Patients Treated with Ritlecitinib: The ALLEGRO Phase 2b/3 Randomized Clinical Trial

Abstract

Background: The ALLEGRO phase 2b/3 study investigated the efficacy and safety of ritlecitinib in patients with alopecia areata (AA).

Objective: To describe the impact of ritlecitinib on patient-reported hair loss using the Alopecia Areata Patient Priority Outcomes (AAPPO) instrument and evaluate the relationship between clinically meaningful hair regrowth and improvements in patient-reported impacts.

Methods: In ALLEGRO-2b/3, patients aged ≥ 12 years with AA and ≥ 50% scalp hair loss received once-daily ritlecitinib 50 or 30 mg (± 4-week 200-mg daily loading dose), 10 mg, or placebo for 24 weeks and then continued ritlecitinib or switched from placebo to ritlecitinib 200/50 or 50 mg for 24 weeks. The AAPPO instrument evaluated improvement in hair loss, emotional symptoms (ES), and activity limitations (AL) from weeks 4 to 48 (secondary endpoint). Mean changes in ES and AL domain scores and individual items at weeks 24 and 48 were calculated for Severity of Alopecia Tool (SALT) score ≤ 20 responders and nonresponders (exploratory endpoint).

Results: Overall, 718 patients were randomized. At week 24, 5-36% of patients receiving ritlecitinib 10-200/50 mg reported improvement in scalp hair loss versus 9% receiving placebo. The results for eyebrow, eyelash, and body hair loss were similar. Mean change from baseline in ES and AL scores at weeks 24 and 48 was small and similar between groups. Mean change was larger for individual hair loss and ES items at weeks 24 and 48 in SALT score ≤ 20 responders versus nonresponders.

Conclusions: The AAPPO instrument demonstrated the beneficial impact of ritlecitinib on patient-reported hair growth, which was consistent with improvements in clinician-reported outcomes.

Clinical trial registration: NCT03732807. INFOGRAPHIC.

Fig. 1

AAPPO v2.0. US English Pfizer Inc. 2021, All rights reserved. AAPPO Alopecia Areata Patient Priority Outcomes

Fig. 2

Improvement from baseline in AAPPO hair loss scores at weeks 24 and 48^a with ritlecitinib QD. AAPPO Alopecia Areata Patient Priority Outcomes, QD once daily. *P ≤ 0.05 versus placebo (combined) without adjustment for multiplicity. ^a Among patients with hair loss scores of ≥ 2 at baseline in the full analysis set. Baseline is defined as the latest nonmissing value from the pretreatment period. Improvement in AAPPO hair loss items (scalp, eyebrow, eyelash, and body hair) from baseline was measured as the proportion of patients with a baseline score of 2–4 (moderate to complete hair loss) who achieved a score of 0–1 (none or little hair loss)

Fig. 3

Change from baseline in AAPPO emotional symptoms and activity limitations scores up to week 48. ^a n, number of patients in the full analysis set, AAPPO Alopecia Areata Patient Priority Outcomes, CI confidence interval, LS least squares, QD once daily. ^a Mixed-effects model for repeated measures included fixed effects for treatment group, baseline value, visit, and treatment by visit interaction. Unstructured covariance matrix was used for model errors. The baseline is defined as latest nonmissing value from the pretreatment period

Fig. 4

ALLEGRO-2b/3: AAPPO item score changes by SALT score ≤ 20 response at a week 24 and b week 48. AAPPO Alopecia Areata Patient Priority Outcomes, SALT Severity of Alopecia Tool