Trial reportAmerican journal of clinical dermatology2024
Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program.
Trial report in American journal of clinical dermatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 2a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety profile of pf-06651600 and pf-06700841 in subjects with moderate to severe alopecia areata with a single-blind extension period and a cross-over open label extension period
A phase 2b/3 randomized, double-blind, placebo-controlled, dose-ranging study to investigate the efficacy and safety of pf-06651600 in adult and adolescent alopecia areata (aa) subjects with 50% or greater scalp hair loss
A phase 3 open-label, multi-center, long-term study investigating the safety and efficacy of pf-06651600 in adult and adolescent participants with alopecia areata
A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.
- JAK Inhibitor Safety in Atopic Dermatitis and Alopecia Areata: A 4.5-Year Real-World Retrospective Cohort Study.Dermatology and therapy · 2026Pooled it
- Long-Term Efficacy and Safety of Ritlecitinib in Adults and Adolescents with Alopecia Areata: 3-Year Results from the ALLEGRO Phase 2b/3 and ALLEGRO-LT Phase 3 Clinical Studies.American journal of clinical dermatology · 2026Trial
- Updated Integrated Safety Analysis of Ritlecitinib up to ~ 5 Years in Patients with Alopecia Areata from the ALLEGRO Clinical Trial Program.American journal of clinical dermatology · 2026Trial
- Efficacy and Safety of Ritlecitinib in the Asian Subpopulation of the ALLEGRO-2b/3 and ALLEGRO-LT Clinical Studies for Alopecia Areata.The Journal of dermatology · 2026Trial
- Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025Trial
- Long-term safety and efficacy of ritlecitinib in adults and adolescents with alopecia areata and at least 25% scalp hair loss: Results from the ALLEGRO-LT phase 3, open-label study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025Trial
- A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata.Pharmacology research & perspectives · 2024Trial
- Epidemiology, Diagnosis and Management of Alopecia Areata: An Asia-Pacific Modified Delphi Expert Panel Recommendations.International journal of dermatology · 2026Article
- Patterns of Clinical Response in Rollover Adolescent Patients with Alopecia Areata Treated with Ritlecitinib in the Ongoing Long-Term, Open-Label, Phase 3 ALLEGRO-LT Study.Dermatology and therapy · 2026Article
- Comparative Effectiveness and Safety of Baricitinib and Ritlecitinib in Severe Alopecia Areata: A Real-World Monocentric Retrospective Study.Dermatology and therapy · 2026Article
- Real-World Ritlecitinib Treatment of Severe Alopecia Areata in the United States: Patient Characteristics and Physician Satisfaction According to a Secondary Database Analysis.Dermatology and therapy · 2026Article
- Dermatologic Toxicities Induced by JAK Inhibitors.American journal of clinical dermatology · 2026Review
- Chemotherapy-Induced Alopecia Beyond Cytotoxicity: Hair Follicle Immune Privilege Collapse and JAK-STAT Signaling.International journal of molecular sciences · 2026Review
- Ritlecitinib for Severe Alopecia Areata: A 24-Week, Multicentre, Real-World Study.American journal of clinical dermatology · 2026Observational
- SALT score distribution with ritlecitinib treatment up to 24 months in alopecia areata.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
- Therapeutic expansion of JAK inhibitors in Chinese dermatological practice: beyond atopic dermatitis to novel autoimmune frontiers.Frontiers in medicine · 2026Review
- JAK Inhibitors for Alopecia Areata: Approved Therapies, Efficacy, and Unanswered Questions.Drug design, development and therapy · 2026Review
- The role of JAK3 and TEC family kinases in vitiligo pathogenesis.Frontiers in immunology · 2026Review
- Piperidine-catalyzed synthesis of (RSC advances · 2025Article
- Alopecia areata.Nature reviews. Disease primers · 2025Review
Corrections and comments
- Erratum issued
- Erratum issued
- Erratum issued
- Erratum issued
Authors and funding
15 authors at 10 institutions in 6 countries.
Funding
Abstract
backgroundThe ALLEGRO phase 2a and 2b/3 studies demonstrated that ritlecitinib, an oral JAK3/TEC family kinase inhibitor, is efficacious at doses of ≥ 30 mg in patients aged ≥ 12 years with alopecia areata (AA).
objectiveThe objective of this study was to evaluate the safety of ritlecitinib in an integrated analysis of four studies in AA.
methodsTwo cohorts were analyzed: a placebo-controlled and an all-exposure cohort. Proportions and study size-adjusted incidence rates (IRs) of adverse events (AEs) of interest and laboratory abnormalities are reported.
resultsIn the placebo-controlled cohort (n = 881; median exposure: 169 days), the proportion of ritlecitinib-treated patients with AEs was 70.2-75.4% across doses versus 69.5% in the placebo group; serious AEs occurred in 0-3.2% versus 1.9% for the placebo. A total of 19 patients permanently discontinued due to AEs (5 while receiving the placebo). In the all-exposure cohort (n = 1294), median ritlecitinib exposure was 624 days [2091.7 total patient-years (PY)]. AEs were reported in 1094 patients (84.5%) and serious AEs in 57 (4.4%); 78 (6.0%) permanently discontinued due to AEs. The most common AEs were headache (17.7%; 11.9/100 PY), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive test (15.5%; 9.8/100 PY), and nasopharyngitis (12.4%; 8.2/100 PY). There were two deaths (breast cancer and acute respiratory failure/cardiorespiratory arrest). Proportions (IRs) were < 0.1% (0.05/100 PY) for opportunistic infections, 1.5% (0.9/100 PY) for herpes zoster, 0.5% (0.3/100 PY) for malignancies (excluding nonmelanoma skin cancer), and 0.2% (0.1/100 PY) for major adverse cardiovascular events.
conclusionsRitlecitinib is well tolerated with an acceptable safety profile up to 24 months in patients aged ≥ 12 years with AA (video abstract and graphical plain language summary available). TRIAL REGISTRIES: ClinicalTrials.gov: NCT02974868 (date of registration: 11/29/2016), NCT04517864 (08/18/2020), NCT03732807 (11/07/2018), and NCT04006457 (07/05/2019).
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.