Evidence map›Paper›PMID 23387374›Full record

Trial reportThe British journal of dermatology2013

A randomized phase 2a efficacy and safety trial of the topical Janus kinase inhibitor tofacitinib in the treatment of chronic plaque psoriasis.

W C Ports, S Khan, S Lan, M Lamba, C Bolduc, R Bissonnette, K Papp

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The British journal of dermatology, 2013. 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 70 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 7 pooled it
11.5field-weighted citation impact, top 1% 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.

NCT01246583 phase2completednot on this map

A phase 2a, multi-site, randomized, double-blind, placebo-controlled, parallel-group study of the pilot efficacy, safety, and pharmacokinetics of 2 ointment formulations of cp-690,550 in subjects with mild to moderate chronic plaque psoriasis

TypeinterventionalSponsorPfizerRan2011 to 2011Enrolled71ConditionsPsoriasisArmsCP-690,550 Ointment 1, Vehicle 1, CP-690,550 Ointment 2, Vehicle 2
NCT03185312 unknown statusnot on this mapstarted 2018, after this paper: background citation

Cutaneous JAK Expression in Vitiligo and Acne Vulgaris.

TypeobservationalSponsorAssiut UniversityRan2018 to 2019Enrolled60ConditionsVitiligo and Acne VulgarisArmsskin biopsy
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 7 syntheses or guidelines pooled it, 200 citations in OpenAlex.

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10 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

W C PortsPfizer Inc, Groton, CT 06340, USA. william.c.ports@pfizer.com
S Khan
S Lan
M Lamba
C Bolduc
R Bissonnette
K Papp
Pfizer (United States) · USInnovaderm (Canada) · CAProbity Medical Research · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTofacitinib (CP-690,550) is a novel Janus kinase inhibitor in development as an oral formulation for the treatment of several inflammatory diseases including psoriasis.

objectivesThis phase 2a study aimed to assess the efficacy, systemic safety, local tolerability and systemic pharmacokinetics of topical tofacitinib in mild-to-moderate plaque psoriasis.

methodsTwo tofacitinib ointment formulations were evaluated in this multicentre, double-blind, vehicle-controlled trial (NCT01246583). Seventy-one patients were randomized 2 : 1 : 2 : 1 to 2% tofacitinib ointment 1, vehicle 1, 2% tofacitinib ointment 2 and vehicle 2, each administered twice daily for 4 weeks to a single fixed 300 cm(2) treatment area containing a target plaque with or without one or more nontarget plaques and normal skin.

resultsThe primary endpoint of percentage change from baseline in the Target Plaque Severity Score at week 4 demonstrated statistically significant improvement for ointment 1 [least squares mean (LSM) -54.4%] vs. vehicle 1 (LSM -41.5%), but not ointment 2 (LSM -24.2%) vs. vehicle 2 (LSM -17.2%). Secondary endpoints (target plaque area and Itch Severity Item) improved similarly for tofacitinib ointment vs. corresponding vehicle. Adverse event (AE) occurrence was similar across treatment groups. All AEs were mild or moderate and none were serious or led to subject discontinuation. One application-site AE (erythema) was reported. Tofacitinib mean systemic exposure was minimal and was greater for ointment 1 than for ointment 2.

conclusionsTofacitinib ointment 1 was well tolerated and efficacious compared with vehicle for the treatment of plaque psoriasis. Further study of topical tofacitinib for psoriasis treatment is warranted.

Indexed as

Administration, CutaneousAdultAgedChronic DiseaseDermatologic AgentsDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMiddle AgedOintmentsPiperidinesProtein Kinase InhibitorsPsoriasisPyrimidinesDermatologic AgentsOintmentsPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinib

Identifiers

PMID23387374
PMCPMC3761190
OpenAlexW2054717635

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.