Efficacy and Safety of the Oral Janus Kinase 3/Tyrosine Kinase Inhibitor Ritlecitinib Over 24 Months: Integrated Analysis of the ALLEGRO Phase IIb/III and Long-Term Phase III Clinical Studies in Alopecia Areata

October 2024 in “ British Journal of Dermatology ”

Melissa Piliang, Jennifer Soung, Brett King, Jerry Shapiro, Lidia Rudnicka, Paul Farrant, Nina Magnolo, Bianca Maria Piraccini, Xin Luo, Robert Wołk, Deborah Woodworth, Gregor Schaefer, Alexandre Lejeune

ritlecitinib Janus kinase 3 tyrosine kinase alopecia areata ALLEGRO phase IIb/III long-term phase III clinical studies AA

Studysummary In this study, ritlecitinib showed sustained effectiveness and a favorable safety profile in treating alopecia areata in patients aged 12 and older over 24 months, with improvements observed in hair and eyebrow regrowth and patient satisfaction. Our plain-language summary of this paper — not a Tressless recommendation.

The study assessed the efficacy and safety of ritlecitinib, an oral medication for alopecia areata, over 24 months in 385 participants aged 12 and older. Results showed significant hair regrowth, with 61% of participants experiencing scalp hair regrowth after 2 years. Eyebrow and eyelash regrowth also improved, and 80% of participants were satisfied with their hair growth. The study highlighted the challenges in treating severe forms of alopecia areata, such as alopecia totalis/universalis, where discontinuation rates were higher due to lack of efficacy. Ritlecitinib demonstrated a favorable safety profile, with common adverse events including headache and nasopharyngitis. The study supports ritlecitinib as a promising long-term treatment option for alopecia areata.

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13 / 13 results

Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program

research Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program

January 2024 in “American journal of clinical dermatology”

This study reports that ritlecitinib, when used for up to 24 months in patients aged 12 and older with alopecia areata, has an acceptable safety profile, with a similar proportion of adverse events in both ritlecitinib and placebo groups in the placebo-controlled cohort.

research Inhibition of T-Cell Activity in Alopecia Areata: Recent Developments and New Directions

4 citations , November 2023 in “Frontiers in immunology”

In this narrative review, researchers outlined the role of T cells in the autoimmune pathogenesis of alopecia areata and highlighted ongoing research into therapeutic pathways, beyond current JAK inhibitors, aimed at developing new treatments for the disease.

research Treatments for Moderate-to-Severe Alopecia Areata: A Systematic Narrative Review

1 citations , October 2023 in “Dermatology and therapy”

This review concluded that baricitinib and other oral JAK inhibitors have the most robust evidence supporting their use in treating severe alopecia areata in adults, compared to other less-evaluated treatments.

Expecting Scalp Hair Regrowth During Severe Alopecia Areata Treatment with Baricitinib: Insights from Patient Trajectories in Phase III Trials

research Expecting Scalp Hair Regrowth During Severe Alopecia Areata Treatment with Baricitinib: Insights from Patient Trajectories in Phase III Trials

September 2023 in “British Journal of Dermatology”

In this study, researchers identified subgroups of patients with severe alopecia areata treated with baricitinib who experienced early, gradual, or late hair regrowth, finding that response was influenced by baseline disease severity and duration of hair loss.

research Alopecia Areata: The Clinician and Patient Voice

1 citations , September 2023 in “Journal of drugs in dermatology”

This article discusses the perspectives of clinicians and patients on alopecia areata, an autoimmune disorder with significant psychosocial impacts, highlighting the unpredictability and limited effectiveness of current treatments as well as the key unmet needs and gaps in care.

research Efficacy and Safety of Ritlecitinib in Adults and Adolescents With Alopecia Areata: A Randomised, Double-Blind, Multicentre, Phase 2b–3 Trial

227 citations , April 2023 in “The Lancet”

Ritlecitinib effectively treats alopecia areata and is well-tolerated.

research Trends in Prevalence and Incidence of Alopecia Areata, Alopecia Totalis, and Alopecia Universalis Among Adults and Children in a US Employer-Sponsored Insured Population

75 citations , March 2023 in “JAMA Dermatology”

This study reported that the prevalence of alopecia areata in the US slightly increased from 0.199% to 0.222% between 2016 and 2019, with higher rates observed in women and adults.

research Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata Over 52 Weeks in Phase III Trials

20 citations , February 2023 in “American Journal of Clinical Dermatology”

In this study, 40.9% of patients taking 4 mg baricitinib and 21.2% taking 2 mg achieved significant hair regrowth over 52 weeks, indicating potential long-term benefits for adults with severe alopecia areata without introducing new safety concerns.

research Treatment Patterns and Treatment Satisfaction Among Adults With Alopecia Areata in the United States

7 citations , October 2022 in “Advances in Therapy”

This review of real-world treatment options for AA indicates that current therapies are insufficient, with high dissatisfaction rates, highlighting a need for improved solutions.

research Ritlecitinib And Brepocitinib Demonstrate Significant Improvement In Scalp Alopecia Areata Biomarkers

36 citations , December 2021 in “The journal of allergy and clinical immunology/Journal of allergy and clinical immunology/The journal of allergy and clinical immunology”

This study observed that both ritlecitinib and brepocitinib improved scalp biomarkers in patients with alopecia areata, with associations to hair regrowth seen in this phase 2a trial.

research The Alopecia Areata Investigator Global Assessment Scale: A Measure for Evaluating Clinically Meaningful Success in Clinical Trials

86 citations , January 2020 in “British Journal of Dermatology”

This study developed the Alopecia Areata Investigator Global Assessment (AA-IGA) to measure scalp-hair loss in alopecia areata patients, incorporating perspectives of both patients and clinicians to define treatment success.

research Treatment of Alopecia Areata: An Australian Expert Consensus Statement

95 citations , November 2018 in “Australasian journal of dermatology”

This consensus statement outlines a treatment algorithm for alopecia areata, discussing when to consider systemic treatment and how to assess outcomes, without providing new clinical results.

research The Autoimmune Basis of Alopecia Areata: A Comprehensive Review

162 citations , October 2014 in “Autoimmunity reviews”

This review discusses alopecia areata, highlighting its autoimmune aspects, environmental triggers, and current treatment options, but reports no new clinical results; recent studies suggest JAK pathway intervention may offer therapeutic potential.