Evidence map›Paper›PMID 39962358›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2025

Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme.

B King, P Mirmirani, K Lo Sicco, Y Ramot, R Sinclair, L Asfour, K Ezzedine, C Paul, M Ohyama, R A Edwards and 6 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
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
NCT04006457 phase3completednot on this map

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

TypeinterventionalSponsorPfizerRan2019 to 2026Enrolled1,057ConditionsAlopecia AreataArmsPF-06651600, Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine, Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

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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

16 authors.

B KingDermatology Physicians of Connecticut, Fairfield, Connecticut, USA.ORCID https://orcid.org/0000-0002-4576-4616
P MirmiraniThe Permanente Medical Group, Vallejo, California, USA.
K Lo SiccoThe Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York, USA.ORCID https://orcid.org/0000-0002-5219-9803
Y RamotDepartment of Dermatology, Hadassah Medical Center, Jerusalem, Israel.
R SinclairSinclair Dermatology, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0001-6751-1428
L AsfourThe Dermatology Centre, Salford Royal Hospital, Salford, UK.
K EzzedineDepartment of Dermatology, Henri Mondor University Hospital and EpiDermE, Paris, France.ORCID https://orcid.org/0000-0002-5468-4589
C PaulDepartment of Dermatology, Toulouse University and CHU, Toulouse, France.
M OhyamaThe Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo, Japan.
R A EdwardsHealth Services Consulting Corporation, Boxborough, Massachusetts, USA.
G BonfantiEngineering Ingegneria Informatica, Milan, Italy.
U KerkmannPfizer Pharma GmbH, Berlin, Germany.
D WajsbrotPfizer, Inc, New York, New York, USA.
R Ishowo-AdejumoPfizer, Inc, Collegeville, Pennsylvania, USA.
S H ZwillichPfizer, Inc, Groton, Connecticut, USA.
A LejeunePfizer, Inc, Paris, France.

Funding

Pfizer
6 · The paper itself

Abstract

backgroundRitlecitinib, an oral JAK3/TEC family kinase inhibitor, demonstrated efficacy over 48 weeks in patients with alopecia areata (AA) in the ALLEGRO phase 2b/3 study.

objectivesThis post hoc analysis evaluated individual Severity of Alopecia Tool (SALT) score trajectories in patients who received ritlecitinib 50 mg and rolled over from Phase 2b/3 into the ongoing, open-label, Phase 3 ALLEGRO-LT study to describe long-term response patterns and associated baseline disease characteristics.

methodsPatients aged ≥12 years with ≥50% scalp hair loss received ritlecitinib 50 mg once daily in both studies. SALT score trajectories from baseline to Month 24 were used to categorise patients as early (SALT score ≤20 at Week 24 and Months 12 and 24), middle (≤20 at Months 12 and 24) or late responders (≤20 by Month 24) or as partial responders (maintained 30% improvement), relapsers (achieved but did not maintain 30% improvement) or non-responders (did not achieve 30% improvement). The proportions of patients achieving sustained response (achieved and maintained SALT score ≤20 at all subsequent available time points through Month 24) and complete response (SALT score 0 at ≥1 time point through Month 24) were evaluated. Multivariable logistic regression assessed variables associated with response.

resultsOf 191 patients treated with ritlecitinib 50 mg, 87 (45.5%) were responders (SALT score ≤20), 24 (12.6%) were partial responders, 24 (12.6%) were relapsers and 56 (29.3%) were non-responders. Of 87 patients categorised as responders, 81 (93.1%) sustained their clinical response and 47 (46.0%) achieved complete response. Factors associated with treatment response included female sex and less extensive and shorter duration of hair loss.

conclusionsApproximately 45% of patients were SALT score responders, with up to 11% requiring >1 year of ritlecitinib treatment to achieve response, highlighting the importance of extended treatment duration. CLINICALTRIALS: GOV REGISTRATION: ALLEGRO phase 2b/3 study (NCT03732807); ALLEGRO-LT study (NCT04006457).

Indexed as

Alopecia AreataProtein Kinase InhibitorsAdolescentAdultFemaleHumansMaleMiddle AgedPyrimidinesPyrrolesTreatment OutcomeYoung AdultPF-06651600Protein Kinase InhibitorsPyrimidinesPyrroles

Identifiers

PMID39962358
PMCPMC12105426

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.