Evidence map›Paper›PMID 26875540›Full record

Trial reportThe Journal of dermatology2016

Oral tofacitinib efficacy, safety and tolerability in Japanese patients with moderate to severe plaque psoriasis and psoriatic arthritis: A randomized, double-blind, phase 3 study.

Akihiko Asahina, Takafumi Etoh, Atsuyuki Igarashi, Shinichi Imafuku, Hidehisa Saeki, Yoshiyuki Shibasaki, Yukiko Tomochika, Shigeyuki Toyoizumi, Makoto Nagaoka, Mamitaro Ohtsuki and 1 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of dermatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 10 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. La Tunisie medicale · 2025
    Guideline
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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.

Akihiko AsahinaDepartment of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
Takafumi EtohDepartment of Dermatology, Tokyo Teishin Hospital, Tokyo, Japan.
Atsuyuki IgarashiDepartment of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
Shinichi ImafukuDepartment of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Hidehisa SaekiDepartment of Dermatology, Nippon Medical School, Tokyo, Japan.
Yoshiyuki ShibasakiPfizer Japan Inc., Tokyo, Japan.
Yukiko TomochikaPfizer Japan Inc., Tokyo, Japan.
Shigeyuki ToyoizumiPfizer Japan Inc., Tokyo, Japan.
Makoto NagaokaPfizer Japan Inc., Tokyo, Japan.
Mamitaro OhtsukiDepartment of Dermatology, Jichi Medical University, Tochigi, Japan.
study investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tofacitinib is an oral Janus kinase inhibitor that is being investigated for psoriasis and psoriatic arthritis. Japanese patients aged 20 years or more with moderate to severe plaque psoriasis and/or psoriatic arthritis were double-blindly randomized 1:1 to tofacitinib 5 or 10 mg b.i.d. for 16 weeks, open-label 10 mg b.i.d. for 4 weeks, then variable 5 or 10 mg b.i.d. to Week 52. Primary end-points at Week 16 were the proportion of patients achieving at least a 75% reduction in Psoriasis Area and Severity Index (PASI75) and Physician's Global Assessment of "clear" or "almost clear" (PGA response) for psoriasis, and 20% or more improvement in American College of Rheumatology criteria (ACR20) for patients with psoriatic arthritis. Safety was assessed throughout. Eighty-seven patients met eligibility criteria for moderate to severe plaque psoriasis (5 mg b.i.d., n = 43; 10 mg b.i.d., n = 44), 12 met eligibility criteria for psoriatic arthritis (5 mg b.i.d., n = 4; 10 mg b.i.d., n = 8) including five who met both criteria (10 mg b.i.d.). At Week 16, 62.8% and 72.7% of patients achieved PASI75 with tofacitinib 5 and 10 mg b.i.d., respectively; 67.4% and 68.2% achieved PGA responses; all patients with psoriatic arthritis achieved ACR20. Responses were maintained through Week 52. Adverse events occurred in 83% of patients through Week 52, including four (4.3%) serious adverse events and three (3.2%) serious infections (all herpes zoster). No malignancies, cardiovascular events or deaths occurred. Tofacitinib (both doses) demonstrated efficacy in patients with moderate to severe plaque psoriasis and/or psoriatic arthritis through 52 weeks; safety findings were generally consistent with prior studies.

Indexed as

Arthritis, PsoriaticPiperidinesProtein Kinase InhibitorsPsoriasisPyrimidinesPyrrolesAdministration, OralAdultAgedDouble-Blind MethodFemaleHerpes ZosterHumansJapanMaleMiddle AgedPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinibJapankinase inhibitorplaque psoriasispsoriatic arthritistofacitinib

Identifiers

PMID26875540
PMCPMC5067558

What OpenQuestion holds

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Registered trials

None linked

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.