AI Article Synopsis

  • The ALLEGRO studies show that ritlecitinib is effective and well-tolerated for treating alopecia areata in patients aged 12 and older for up to 24 months.
  • Results indicate significant improvement in hair regrowth, with a marked increase in patients achieving favorable Severity of Alopecia Tool (SALT) scores at both 12 and 24 months.
  • The safety profile of ritlecitinib remains consistent with previous studies, confirming its long-term tolerability for users.

Article Abstract

Background: The ALLEGRO phase IIa and IIb/III (NCT02974868 and NCT03732807) studies have demonstrated that ritlecitinib is effective and well tolerated in adults and adolescents with alopecia areata (AA) up to 48 weeks.

Objectives: To assess the efficacy of ritlecitinib through month 24 and safety through data cutoff in the ALLEGRO phase IIb/III study and the ongoing long-term open-label phase III ALLEGRO-LT study (NCT04006457).

Methods: Patients aged ≥ 12 years with AA and ≥ 50% scalp hair loss from ALLEGRO IIb/III who rolled over to ALLEGRO-LT after up to 48 weeks were included. Proportions of patients with responses based on clinician-reported Severity of Alopecia Tool (SALT) scores of ≤ 20 and ≤ 10, eyebrow assessment (EBA) and eyelash assessment (ELA), patient global impression of change (PGI-C) and patient satisfaction with hair growth were reported through month 24 for patients who received ritlecitinib 50 mg daily with or without a 200-mg 4-week daily loading dose. Observed and imputed data [last observation carried forward (LOCF)] were reported up to 9 December 2022. Safety was assessed throughout.

Results: At month 12, a SALT score ≤ 20 was achieved by 45.1% and 45.9% (observed) and 40.3% and 41.8% (LOCF) of the 191 and 194 patients who received ritlecitinib 50 mg and ritlecitinib 200 mg/50 mg, respectively. At month 24, these proportions increased to 60.8% and 63.1% (observed) and 46.1% and 50.8% (LOCF), respectively. Patients with abnormal EBA or ELA scores at baseline achieved responses at month 24 [EBA observed: 57.6% (50 mg), 61.0% (200/50 mg); EBA LOCF: 46.8% (50 mg), 50.9% (200/50 mg); ELA observed: 51.2% (50 mg), 62.7% (200/50 mg); ELA LOCF: 43.2% (50 mg), 51.7% (200/50 mg)]. PGI-C response was achieved by patients at month 24 [observed: 70.0% (50 mg), 76.4% (200/50 mg); LOCF: 56.6% (50 mg), 65.5% (200/50 mg)]. Safety profiles for both treatment groups were consistent with the known safety profile of ritlecitinib.

Conclusions: Ritlecitinib has clinically meaningful and sustained efficacy beyond 1 year with a favourable safety and tolerability profile, supporting its long-term use in patients aged ≥ 12 years with AA.

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Source
http://dx.doi.org/10.1093/bjd/ljae365DOI Listing

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Background: ALLEGRO-LT is an ongoing, long-term, open-label, multicentre, phase 3 study of ritlecitinib in adults and adolescents with alopecia areata (AA).

Objectives: To evaluate ritlecitinib safety and efficacy through Month 24 in patients with AA and ≥25% scalp hair loss.

Methods: ALLEGRO-LT enrolled rollover patients who previously received study intervention in either ALLEGRO phase 2a or 2b/3 studies and de novo patients who had not received treatment in either study.

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Article Synopsis
  • The ALLEGRO study assessed the effectiveness and safety of ritlecitinib, a treatment for alopecia areata (AA), focusing on patient-reported hair loss outcomes.
  • Patients aged 12 and older with significant scalp hair loss participated in a 48-week trial comparing different dosages of ritlecitinib to a placebo.
  • Results showed that 5-36% of ritlecitinib patients reported improved hair loss after 24 weeks, which correlated with positive changes in emotional symptoms and activity limitations, indicating the treatment's beneficial effects.
View Article and Find Full Text PDF
Article Synopsis
  • The ALLEGRO studies show that ritlecitinib is effective and well-tolerated for treating alopecia areata in patients aged 12 and older for up to 24 months.
  • Results indicate significant improvement in hair regrowth, with a marked increase in patients achieving favorable Severity of Alopecia Tool (SALT) scores at both 12 and 24 months.
  • The safety profile of ritlecitinib remains consistent with previous studies, confirming its long-term tolerability for users.
View Article and Find Full Text PDF
Article Synopsis
  • This study investigates the effectiveness and safety of ritlecitinib, a treatment for alopecia areata (AA), over 48 weeks in patients with varying responses by Week 24.
  • Results showed that over 85% of patients who had good responses at Week 24 maintained their improvement, while some nonresponders also began to show better results by Week 48.
  • The study had a small sample size, but it concludes that ritlecitinib can lead to sustained hair regrowth in many patients with AA.
View Article and Find Full Text PDF

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