Safety and Efficacy of Ritlecitinib for the Treatment of Patients with Alopecia Areata: A Systematic Review and Meta-Analysis of Controlled Trials

March 2025 in “ Journal of Clinical Medicine ”

Samah Omar Ali Alfahl, Abdullateef A. Alzolibani

Ritlecitinib alopecia areata SALT scores

Studysummary This study found that Ritlecitinib significantly reduced hair loss in patients with alopecia areata by lowering SALT scores at weeks 12 and 24 compared to placebo, with acceptable safety but increased minor side effects like headaches and acne.

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This systematic review and meta-analysis assessed the safety and efficacy of Ritlecitinib for alopecia areata by analyzing 13 randomized controlled trials with participant numbers ranging from 46 to 718. Ritlecitinib significantly reduced the Severity of Alopecia Tool (SALT) score at weeks 12 and 24, indicating improved hair regrowth compared to placebo. Patients also reported significant improvements in the Patient Global Impression of Change (PGIC) scores. Although Ritlecitinib was associated with a higher frequency of headaches, acne, and nasopharyngitis, serious adverse events were more common in the placebo group, though not statistically significant. The findings suggest Ritlecitinib is a promising treatment for alopecia areata with an acceptable safety profile, warranting further investigation in larger and long-term studies.

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Research cited in this study

18 / 18 results

research A Phase 2a Study Investigating the Effects of Ritlecitinib on Brainstem Auditory Evoked Potentials and Intraepidermal Nerve Fiber Histology in Adults with Alopecia Areata

4 citations , July 2024 in “Pharmacology Research & Perspectives”

In this phase 2a study of adults with alopecia areata, researchers observed that ritlecitinib treatment did not result in significant differences in brainstem auditory evoked potential changes or axonal swelling compared to placebo, suggesting the dog toxicity findings may not be clinically relevant in humans.

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 Hair Loss Profiles and Ritlecitinib Efficacy in Patients with Alopecia Areata: Post Hoc Analysis of the Allegro Phase 2b/3 Study

September 2023 in “Dermatology and therapy”

In this phase 2b/3 trial, ritlecitinib showed effectiveness in treating alopecia areata patients with varying hair loss profiles, significantly improving patient-reported outcomes for hair regrowth and satisfaction compared to placebo, regardless of the hair loss type and extent at baseline.

research Sustained Scalp, Eyebrow, and Eyelash Hair Regrowth With Ritlecitinib Through Week 48 in Patients With Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study

1 citations , September 2023 in “Journal of the American Academy of Dermatology”

This study reported that most patients with alopecia areata who responded to ritlecitinib treatment by achieving a SALT score ≤20, SALT score ≤10, or improvements in eyebrow and eyelash assessments at Week 24 maintained their responses through Week 48.

research Scalp, Eyebrow, and Eyelash Hair Regrowth with Continued Ritlecitinib Treatment Among Patients with Alopecia Areata Without Target Efficacy Response at Week 24: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study

1 citations , September 2023 in “Journal of the American Academy of Dermatology”

In this study, patients with alopecia areata who didn't initially respond to ritlecitinib at Week 24 showed improved response rates by Week 48, with up to 34% achieving better hair regrowth outcomes.

research Efficacy and Safety of Ritlecitinib in Adolescents with Alopecia Areata: Results from the ALLEGRO Phase 2b/3 Randomized, Double-Blind, Placebo-Controlled Trial

48 citations , July 2023 in “Pediatric Dermatology”

This study found that among adolescents with alopecia areata and significant hair loss, treatment with ritlecitinib resulted in greater hair regrowth and self-reported improvement compared to placebo over 48 weeks, with common side effects including headache, acne, and nasopharyngitis.

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 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 Epidemiological Trends in Alopecia Areata at the Global, Regional, and National Levels

11 citations , July 2022 in “Frontiers in immunology”

This study reports that the global age-standardized incidence and disability-adjusted life-year rates of alopecia areata decreased from 1990 to 2019, with the highest increases in incidence seen in some low SDI regions and countries like Kuwait and South Sudan.

research Evaluating the Therapeutic Potential of Ritlecitinib for the Treatment of Alopecia Areata

49 citations , February 2022 in “Drug Design Development and Therapy”

This study found that treatment with ritlecitinib improved hair regrowth in alopecia areata patients, with many achieving significant results after 24 weeks compared to placebo.

research Alopecia Areata: Current Understanding and Management

11 citations , January 2022 in “Journal der Deutschen Dermatologischen Gesellschaft”

This review discusses current and emerging therapies for alopecia areata, highlights the challenges in managing this chronic disease, and emphasizes the importance of addressing its psychosocial impacts; it reports no new clinical results.

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 A Phase 2a Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of the Oral Janus Kinase Inhibitors Ritlecitinib and Brepocitinib in Alopecia Areata: 24-Week Results

138 citations , March 2021 in “Journal of the American Academy of Dermatology”

This study found that treatment with ritlecitinib or brepocitinib was effective in improving scalp hair loss for patients with alopecia areata over 24 weeks compared to placebo.

research Treatments for Alopecia Areata: A Systematic Review and Network Meta-Analysis

23 citations , February 2021 in “Dermatologic therapy”

This study found that pentoxifylline plus topical corticosteroids had the highest treatment success rate for alopecia areata compared to no treatment, but the best overall treatment remains uncertain due to varying data.

research Novel Therapies for Alopecia Areata: The Era of Rational Drug Development

9 citations , December 2017 in “The Journal of Allergy and Clinical Immunology”

This review discusses the evolution of alopecia areata treatments towards more targeted therapies and reports no new clinical results, emphasizing cooperation between clinicians and scientists in understanding the disease's pathophysiology.

research Epidemiology and Burden of Alopecia Areata: A Systematic Review

144 citations , July 2015 in “Clinical, Cosmetic and Investigational Dermatology”

This review reports that alopecia areata affects about 2% of people globally and is linked with psychiatric and medical comorbidities, highlighting its significant disease burden.

research Alopecia Areata: An Update

67 citations , January 2013 in “Indian Journal of Dermatology, Venereology and Leprology”

This review discusses the causes, associated conditions, and treatment options for alopecia areata, such as corticosteroids and wigs, but reports no new clinical findings.

research Alopecia Areata: A New Treatment Plan

67 citations , July 2011 in “Clinical, cosmetic and investigational dermatology”

This review discusses various therapeutic agents for alopecia areata, categorized by efficacy and safety, and highlights the lack of curative treatments and long-term outcome studies.