Evidence map›Paper›PMID 38934147›Full record

Trial reportDermatology (Basel, Switzerland)2024

Patient-Reported Satisfaction with Hair Regrowth in a Study of Ritlecitinib in Alopecia Areata: Results from ALLEGRO-2b/3.

Rodney Sinclair, Ernest H Law, Xingqi Zhang, Fan Zhang, Lynne Napatalung, Samuel H Zwillich, Brett King, Natasha Mesinkovska

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Dermatology (Basel, Switzerland), 2024. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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

8 authors.

Rodney SinclairSinclair Dermatology, Melbourne, Victoria, Australia.
Ernest H LawPfizer Inc., New York, New York, USA.
Xingqi ZhangThe First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Fan ZhangPfizer Inc., Groton, Connecticut, USA.
Lynne NapatalungPfizer Inc., New York, New York, USA.
Samuel H ZwillichPfizer Inc., Groton, Connecticut, USA.
Brett KingDepartment of Dermatology, Yale School of Medicine, New Haven, Connecticut, USA.
Natasha MesinkovskaDepartment of Dermatology, University of California Irvine, Irvine, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with alopecia areata (AA) report high levels of dissatisfaction with commonly used treatments. Patient-reported outcomes are essential to understanding patients' experiences with AA treatments. The objective of this study was to evaluate patient-reported satisfaction with hair growth among patients with AA receiving ritlecitinib or placebo and the correlation between clinician-assessed efficacy and patient-reported satisfaction.

methodsIn the ALLEGRO-2b/3 (NCT03732807) trial, patients with AA and ≥50% scalp hair loss were randomized to daily ritlecitinib or placebo for 24 weeks, with a 24-week extension of continued ritlecitinib or switch from placebo to ritlecitinib. The Patient Satisfaction with Hair Growth (P-Sat) measure evaluated patients' satisfaction with hair growth in 3 domains: amount, quality, and overall satisfaction with hair growth. The prespecified analysis evaluated the proportion of patients who were slightly, moderately, or very satisfied with hair growth. Several post hoc analyses assessed the proportion of patients who were moderately/very satisfied and moderately/very dissatisfied and calculated polyserial correlations between change from baseline (CFB) in Severity of Alopecia Tool (SALT) and P-Sat scores at weeks 24 and 48.

resultsAt week 24, the proportion of patients (N = 718) reporting satisfaction (slightly, moderately, or very satisfied) overall with their hair growth ranged from 36.4% in the ritlecitinib 10-mg group (evaluated for dose ranging only) to 67.5% in the 200/50-mg group versus 22.6% in the placebo groups. In patients randomized to ritlecitinib, the proportion who were satisfied increased or was maintained at week 48. A substantially greater proportion of placebo patients who switched to ritlecitinib reported satisfaction at week 48 than at week 24. Similar results were observed for patient satisfaction with the amount and quality of hair growth. In the post hoc analyses defining satisfaction as moderately/very satisfied and dissatisfaction as moderately/very dissatisfied, the benefit of ritlecitinib was also observed. All P-Sat domain scores strongly correlated with CFB-SALT scores at weeks 24 (range 0.73-0.76; p < 0.05) and 48 (0.74-0.77; p < 0.05).

conclusionsPatients receiving active ritlecitinib doses reported favorable results versus placebo in satisfaction with hair growth up to week 48. High concordance was observed between improvement in scalp hair growth evaluated by clinicians and patient-reported satisfaction.

Indexed as

Alopecia AreataHairPatient SatisfactionAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresAlopecia areataPatient-reported outcomesRitlecitinibSatisfaction

Identifiers

PMID38934147
PMCPMC11651339

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.