Evidence map›Paper›PMID 36777695›Full record

ArticleTherapeutic advances in musculoskeletal disease2023

Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib.

Lars E Kristensen, Bruce Strober, Denis Poddubnyy, Ying-Ying Leung, Hyejin Jo, Kenneth Kwok, Ivana Vranic, Dona L Fleishaker, Lara Fallon, Arne Yndestad and 1 more

10 registry-linked trialsAbstract read
In one paragraph

Article in Therapeutic advances in musculoskeletal disease, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 10 registered trials, which are not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

NCT00678210 phase2completednot on this map

A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorPfizerRan2008 to 2009Enrolled197ConditionsPsoriasisArmsCP-690,550, Placebo
NCT01163253 phase3terminatednot on this map

A Phase 3, Multi-Site, Open-Label Study Of The Long Term Safety And Tolerability Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorPfizerRan2010 to 2016Enrolled2,867ConditionsPsoriasisArmsCP-690,550
NCT01186744 phase3completednot on this map

A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled666ConditionsPsoriasisArmsCP-690,550
NCT01241591 phase3completednot on this map

A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled1,101ConditionsPsoriasisArmsCP 690,550 5 mg, CP 690,550 10 mg, Etanercept 50 mg, Placebo
NCT01276639 phase3completednot on this map

Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorPfizerRan2011 to 2013Enrolled901ConditionsPsoriasisArmsCP-690,550, Placebo/CP-690,550
NCT01309737 phase3completednot on this map

A Phase 3, Multi-Site, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorPfizerRan2011 to 2013Enrolled960ConditionsPsoriasisArmsCP-690,550, Placebo/CP-690,550
NCT01710046 phase2completednot on this map

An Exploratory Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study To Assess Mechanism Of Action (Moa) Of Cp-690,550 In The Skin When Administered Orally At 10 Mg Twice Daily (Bid) For 12 Weeks In Subjects With Moderate To Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorPfizerRan2013 to 2013Enrolled12ConditionsPlaque PsoriasisArms(CP-6890,550) Tofacitinib, Placebo, (CP-690,550) Tofacitinib
NCT01877668 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorPfizerRan2014 to 2015Enrolled422ConditionsPsoriatic ArthritisArmsTofacitinib 5 mg BID, Tofacitinib 10 mg BID, Adalimumab, Placebo
NCT01882439 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor

TypeinterventionalSponsorPfizerRan2013 to 2016Enrolled395ConditionsPsoriatic ArthritisArmsTofacitinib, Placebo
NCT01976364 phase3completednot on this map

A long-term, open-label extension study of tofacitinib (cp-690,550) for the treatment of psoriatic arthritis

TypeinterventionalSponsorPfizerRan2014 to 2019Enrolled686ConditionsArthritis, PsoriaticArmsTofacitinib, Methotrexate, Placebo Methotrexate
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. 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

11 authors.

Lars E KristensenThe Parker Institute, Bispebjerg and Frederiksberg, Copenhagen, and Copenhagen University, Copenhagen, Denmark.
Bruce StroberCentral Connecticut Dermatology Research, Cromwell, CT, USA.ORCID https://orcid.org/0000-0002-8394-2057
Denis PoddubnyyDepartment of Rheumatology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID https://orcid.org/0000-0002-4537-6015
Ying-Ying LeungDepartment of Rheumatology and Immunology, Singapore General Hospital, Singapore.ORCID https://orcid.org/0000-0001-8492-6342
Hyejin JoPfizer Inc, Groton, CT, USA.
Kenneth KwokPfizer Inc, New York, NY, USA.ORCID https://orcid.org/0000-0002-7475-3369
Ivana VranicPfizer Inc, Tadworth Surrey, UK.
Dona L FleishakerPfizer Inc, Groton, CT, USA.
Lara FallonPfizer Inc, Montreal, QC, Canada.
Arne YndestadPfizer Inc, Drammensveien 288, 0283 Oslo, Norway.
Dafna D GladmanSchroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada.ORCID https://orcid.org/0000-0002-9074-0592

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Tofacitinib is a Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA) and has been investigated for psoriasis (PsO). Objectives: This Design: Included three phase III/long-term extension (LTE) PsA trials and seven phase II/phase III/LTE PsO trials of patients receiving ⩾ 1 dose of tofacitinib. Methods: Incidence rates (IRs: patients with events/100 patient-years) for MACE and malignancies (excluding non-melanoma skin cancer) were determined in subgroups according to history of atherosclerotic CV disease (ASCVD), baseline 10-year risk of ASCVD (in patients without history of ASCVD), and baseline metabolic syndrome (MetS). Results: For patients with PsA ( Conclusion: In tofacitinib-treated patients with PsA/PsO, increased ASCVD risk and baseline MetS were associated with higher IRs for MACE and malignancies. Our results support assessing CV risk in patients with PsA/PsO and suggest enhanced cancer monitoring in those with increased ASCVD risk. Registration ClinicalTrialsgov: NCT01877668/NCT01882439/NCT01976364/NCT00678210/NCT01710046/NCT01241591/NCT01186744/NCT01276639/NCT01309737/NCT01163253. Plain Language Summary:

Indexed as

cardiovascular riskMACEmalignanciespsoriasispsoriatic arthritistofacitinib

Identifiers

PMID36777695
PMCPMC9909057

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

and 4 more above

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.