Evidence map›Paper›PMID 37707764›Full record

ArticleDermatology and therapy2023

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

Diamant Thaçi, Christos Tziotzios, Taisuke Ito, Justin Ko, Ayşe Serap Karadağ, Hong Fang, Roger A Edwards, Gianluca Bonfanti, Robert Wolk, Helen Tran and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03732807 (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), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.3field-weighted citation impact, top 8% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT03732807 phase2 / phase3completednot on this map

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

TypeinterventionalSponsorPfizerRan2018 to 2021Enrolled718ConditionsAlopecia AreataArmsPF-06651600 Induction Dose, PF-06651600 Maintenance Dose #1, PF-06651600 Maintenance Dose #2, PF-06651600 Maintenance Dose #3, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 7 countries.

Diamant ThaçiInstitut and Comprehensive Center for Inflammation Medicine, University of Luebeck, Luebeck, Germany.
Christos TziotziosSt. John's Institute of Dermatology, King's College London, London, UK.
Taisuke ItoDepartment of Dermatology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Justin KoDepartment of Dermatology, Stanford University School of Medicine, Stanford, CA, USA.
Ayşe Serap KaradağDepartment of Dermatology, School of Medicine, Memorial Health Group, Istanbul Arel University, Istanbul, Turkey.
Hong FangDepartment of Dermatology, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou City, China.
Roger A EdwardsHealth Services Consulting Corporation, Boxborough, MA, USA.
Gianluca BonfantiEngineering Ingegneria Informatica, SPA, Milan, Italy.
Robert WolkPfizer Inc, Groton, CT, USA.
Helen TranPfizer Inc, New York, NY, USA.
Ernest LawPfizer Inc, New York, NY, USA. ernest.law@pfizer.com.
Pfizer (United States) · USHamamatsu University School of Medicine · JPIngegneria dei Sistemi (Italy) · ITIstanbul Arel University · TRKing's College London · GBStanford University · USUniversity of Lübeck · DEZhejiang University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRitlecitinib demonstrated efficacy in patients with alopecia areata (AA) in the ALLEGRO phase 2b/3 study (NCT03732807). However, hair loss presentation may vary based on location (e.g., scalp, eyebrow/eyelash, body). Here, we sought to identify distinct hair loss profiles at baseline and evaluate whether they affected the efficacy of ritlecitinib.

methodsPatients with AA aged ≥ 12 years with ≥ 50% scalp hair loss were randomized to daily ritlecitinib 10 mg (assessed for dose ranging only), 30 or 50 mg (± 4-week, 200-mg loading dose), or placebo for 24 weeks. Latent class analysis (LCA) identified hair loss profiles based on four baseline measurements: clinician-reported extent of scalp (Severity of Alopecia Tool score), eyebrow hair loss, eyelash hair loss, and patient-reported body hair loss. Logistic regression evaluated ritlecitinib (50 and 30 mg) efficacy vs placebo using Patient Global Impression of Change (PGI-C) and Patient Satisfaction with Hair Growth (P-Sat; amount, quality, and overall satisfaction) responses at Week 24, adjusting for key covariates, including latent class membership.

resultsLCA identified five latent classes: (1) primarily non-alopecia totalis (AT; complete loss of scalp hair); (2) non-AT with moderate non-scalp involvement; (3) extensive scalp, eyebrow, and eyelash involvement; (4) AT with moderate non-scalp involvement; and (5) primarily alopecia universalis (complete scalp, face, and body hair loss). Adjusting for latent class membership, patients receiving ritlecitinib 30 or 50 mg were significantly more likely to achieve PGI-C response (30 mg: odds ratio, 8.62 [95% confidence interval, 4.42-18.08]; 50 mg: 12.29 [6.29-25.85]) and P-Sat quality of hair regrowth (30 mg: 6.71 [3.53-13.51]; 50 mg: 8.17 [4.30-16.46]) vs placebo at Week 24. Results were similar for P-Sat overall satisfaction and amount of hair regrowth.

conclusionDistinct and clinically relevant hair loss profiles were identified in ALLEGRO-2b/3 participants. Ritlecitinib was efficacious compared with placebo, independent of hair loss profile at baseline.

trial registrationClinicalTrials.gov identifier, NCT03732807.

Indexed as

Alopecia areataHair lossLatent class analysisRitlecitinib

Identifiers

PMID37707764
PMCPMC10613177
OpenAlexW4386726138

What OpenQuestion holds

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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.