Evidence map›Paper›PMID 30188571›Full record

ArticleThe British journal of dermatology2019

Benefit-risk profile of tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: pooled analysis across six clinical trials.

B E Strober, A B Gottlieb, P C M van de Kerkhof, L Puig, H Bachelez, E Chouela, S Imafuku, D Thaçi, H Tan, H Valdez and 4 more

Open access · hybridAbstract read
In one paragraph

Article in The British journal of dermatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 11% 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.

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

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Article
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  6. Article
  7. Article
  8. Review on Novel Oral Therapies for Psoriasis.The Journal of clinical and aesthetic dermatology · 2021
    Review
  9. [Granulomatous rosacea-like dermatitis under therapy with tofacitinib].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2021
    Article
  10. Review
  11. Review
  12. Review
  13. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 9 institutions in 8 countries.

B E StroberDepartment of Dermatology, University of Connecticut Health Center, Farmington, CT, U.S.A.ORCID 0000-0002-8394-2057
A B GottliebNew York Medical College at Metropolitan Hospital, New York, NY, U.S.A.
P C M van de KerkhofRadboud University Nijmegen Medical Centre, Nijmegen, the Netherlands.
L PuigDepartment of Dermatology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona Medical School, Barcelona, Spain.ORCID 0000-0001-6083-0952
H BachelezSorbonne Paris Cité Université Paris Diderot, Assistance Publique-Hôpitaux de Paris, Service de Dermatologie, Hôpital Saint-Louis, Paris, France.
E ChouelaUniversidad de Buenos Aires, Buenos Aires, Argentina.
S ImafukuDepartment of Dermatology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
D ThaçiComprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
H TanPfizer Inc., Groton, CT, U.S.A.
H ValdezPfizer Inc., Groton, CT, U.S.A.
P GuptaPfizer Inc., Groton, CT, U.S.A.
M KaurPfizer Inc., Collegeville, PA, U.S.A.
V FrajzyngierPfizer Inc., New York, NY, U.S.A.
R WolkPfizer Inc., Groton, CT, U.S.A.
Pfizer (United States) · USDélégation Paris 7 · FRFukuoka University · JPMetropolitan Hospital Center · USProbity Medical Research · CARadboud University Nijmegen · NLUniversidad de Buenos Aires · ARUniversitat Autònoma de Barcelona · ESUniversity Hospital Schleswig-Holstein · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough existing psoriasis treatments are effective and well tolerated in many patients, there is still a need for new effective targeted treatment options. Tofacitinib is an oral Janus kinase inhibitor that has been investigated in patients with moderate-to-severe chronic plaque psoriasis.

objectivesTo consider the benefits and risks of tofacitinib in patients with moderate-to-severe psoriasis.

methodsData were pooled from one phase II, four phase III and one long-term extension study comprising 5204 patient-years of tofacitinib treatment. Efficacy end points included patients achieving Physician's Global Assessments of 'clear' or 'almost clear', ≥ 75% and ≥ 90% reduction in Psoriasis Area and Severity Index (coprimary end points) and improvements in Dermatology Life Quality Index score, Hospital Anxiety and Depression Scale depression score and Itch Severity Item score, at weeks 16 and 52. Safety data were summarized for 3 years of tofacitinib exposure.

resultsTofacitinib 5 and 10 mg twice daily (BID) showed superiority over placebo for all efficacy end points at week 16, with response maintained for 52 weeks of continued treatment. Tofacitinib improved patients' quality of life and was well tolerated. Rates of safety events of interest (except herpes zoster) were similar to those in the published literature and healthcare databases for other systemic psoriasis therapies. Tofacitinib 10 mg BID demonstrated greater efficacy than 5 mg BID.

conclusionsTofacitinib has a benefit-risk profile in moderate-to-severe psoriasis consistent with that of other systemic treatments.

Indexed as

Administration, OralAdolescentAdultAgedAged, 80 and overChronic DiseaseDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedPiperidinesProtein Kinase InhibitorsPsoriasisPyrimidinesPyrrolesPiperidinesProtein Kinase InhibitorsPyrimidinesPyrrolestofacitinib

Identifiers

PMID30188571
PMCPMC7379291
OpenAlexW2891620699

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.