In patients with moderate to severe alopecia areata (who participated in the phase 2a ALLEGRO trial), self-reported and doctor-assessed evaluations showed significant improvements, according to study findings published in the Journal of the European Academy of Dermatology and Venereology.
Alopecia areata (AA) is often associated with poorer health-related quality of life (HRQoL), including anxiety and depression. Research findings from (ClinicalTrials.gov Identifier: NCT02974868) the phase 2a ALLEGRO trial investigating the safety and efficacy of ritlecitinib and brepocitinib in adults with alopecia areata, did not evaluate correlations between self-reported outcomes and doctor-assessed outcomes. Researchers sought to examine Alopecia Areata Symptom Impact Scale (AASIS) scores (a patient-reported outcome tool) and clinician-assessed Severity of Alopecia Tool (SALT) scores and evaluate possible correlations.
To accomplish this, they conducted a post hoc retrospective evaluation of AASIS scores and compared those results with the previously evaluated SALT scores from the randomized, double-blind, placebo-controlled, multicenter ALLEGRO trial which had been conducted in the USA, Canada, and Australia; this included 142 adult patients up to 75 years of age with AA hair loss that involved 50% or more of their scalp for 7 years or less who did not experience spontaneous regrowth in the preceding few months.
Demographic information was balanced between the 2 treatment cohorts (ritlecitinib [n = 48] and brepocitinib [n = 47]) and the placebo cohort (n= 47) for age (mean range, 34-38 years of age), sex (female, range 62%-77%), and White (77%-96%) but deviated from protocol with 3 of 47 patients in the placebo group having a current hair loss episode up to 29.5 years (inclusion of such outlier results might skew statistical analysis), and 1 patient in the ritlecitinib cohort with a current episode of 7.5 years.
“Least squares mean differences vs. placebo at week 24 were calculated for the AASIS global score, 4 subscale scores, and 13 individual item scores in the active treatment groups using a mixed-effects model with repeated measures.” Pearson’s correlation coefficients (r values) were used to assess relationships between AASIS and SALT scores.
AASIS and SALT scores at baseline were similar for the treatment cohorts, it was noted. Week 24 AASIS scores improved significantly for the treatment cohorts (least-squares mean differences vs. placebo for ritlecitinib, -0.8 to -2.3; brepocitinib, -0.9 to -3.7; P <.05 for all). Mean SALT scores [standard deviation] improved at week 24 compared with baseline (ritlecitinib, 54.4 [40.3] vs 89.4 [15.8]; brepocitinib, 31.9 [35.7] vs 86.4[18.1]). “The correlation coefficients between AASIS global and subscale scores and SALT scores at week 24 ranged from 0.34 to 0.58; P <.05 for all,” researchers said. (Correlation coefficients between 0.5 and 0.7 indicate moderate correlation. Correlation coefficients between 0.3 and 0.5 indicate low correlation.)
Study limitations included AASIS response selection bias, AASIS question ambiguity bias, inability to interpret AASIS scores, inability to assess AA improvement with AASIS questions not related to hair loss, and the small sample size of patients who were predominantly White and female urge caution in generalizing results.
Researchers reported that their analysis “showed that patients with AA who were randomized to the JAK3/TEC inhibitor ritlecitinib or the TYK2/JAK1 inhibitor brepocitinib in the phase 2a ALLEGRO trial reported statistically significant mean improvements in AASIS global and subscale scores and SALT scores after 24 weeks of treatment when compared with patients randomized to placebo.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Trial or study (research) supported by industry: Pfizer.
Winnette R, Banerjee A, Sikirica V, Peeva E, Wyrwich K. Characterizing the relationships between patient-reported outcomes and clinician assessments of alopecia areata in a phase 2a randomized trial of ritlecitinib and brepocitinib. J Eur Acad Dermatol Venereol. Published online January 9, 2022[RS1] . doi:10.1111/jdv.17909