Evidence map›Paper›PMID 36601090›Full record

ArticleTherapeutic advances in musculoskeletal disease2022

Fracture in clinical studies of tofacitinib in rheumatoid arthritis.

Karen E Hansen, Mahta Mortezavi, Edward Nagy, Cunshan Wang, Carol A Connell, Zaher Radi, Heather J Litman, Giovanni Adami, Maurizio Rossini

24 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in musculoskeletal disease, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 24 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.2field-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.

NCT00147498 phase2completednot on this map

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2005 to 2006Enrolled264ConditionsRheumatoid ArthritisArmsCP-690,550, Placebo
NCT00413660 phase2completednot on this map

A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone

TypeinterventionalSponsorPfizerRan2007 to 2008Enrolled509ConditionsArthritis, RheumatoidArmsCP-690,550, placebo
NCT00413699 phase3completednot on this map

A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2007 to 2017Enrolled4,488ConditionsArthritis, RheumatoidArmsCP-690,550
NCT00550446 phase2completednot on this map

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2007 to 2009Enrolled386ConditionsArthritis, RheumatoidArmsAdalimumab, CP-690-550, CP-690,550, Placebo
NCT00603512 phase2completednot on this map

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone

TypeinterventionalSponsorPfizerRan2008 to 2008Enrolled140ConditionsArthritis, RheumatoidArmsPlacebo, CP-690,550
NCT00661661 phase3completednot on this map

A Long-term, Open-label Study Of Cp-690,550 to Confirm The Safety Following Long Term Administration Of Cp-690,550 In The Treatment Of Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2008 to 2013Enrolled487ConditionsRheumatoid ArthritisArmsCP-690,550
NCT00687193 phase2completednot on this map

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD

TypeinterventionalSponsorPfizerRan2009 to 2010Enrolled318ConditionsArthritis, RheumatoidArmsPlacebo, CP-690,550
NCT00814307 phase3completednot on this map

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2009 to 2010Enrolled611ConditionsArthritis, RheumatoidArmsCP-690,550, Placebo
NCT00847613 phase3completednot on this map

Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

TypeinterventionalSponsorPfizerRan2009 to 2012Enrolled800ConditionsArthritis, RheumatoidArmsCP-690,550, Placebo
NCT00853385 phase3completednot on this map

Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

TypeinterventionalSponsorPfizerRan2009 to 2011Enrolled717ConditionsRheumatoid ArthritisArmsCP 690,550, CP-690,550, Placebo, Biologic TNFi
NCT00856544 phase3completednot on this map

Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS

TypeinterventionalSponsorPfizerRan2009 to 2011Enrolled795ConditionsArthritis, RheumatoidArmsCP-690,550, Placebo
NCT00960440 phase3completednot on this map

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors

TypeinterventionalSponsorPfizerRan2009 to 2011Enrolled399ConditionsArthritis, RheumatoidArmsCP-690,550, Placebo
NCT00976599 phase2completednot on this map

An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2009 to 2011Enrolled29ConditionsRheumatoid ArthritisArmsCP-690,550 + methotrexate, Placebo + Methotrexate
NCT01039688 phase3completednot on this map

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled956ConditionsArthritis, RheumatoidArmsCP-690,550, Disease-modifying antirheumatic drug
NCT01059864 phase2completednot on this map

Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2010 to 2010Enrolled111ConditionsRheumatoid ArthritisArmsCP-690,550, Atorvastatin, Atorvastatin Placebo
NCT01164579 phase2completednot on this map

An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2010 to 2013Enrolled109ConditionsRheumatoid ArthritisArmsTasocitinib plus Methotrexate, Tofacitinib plus placebo methotrexate, Placebo tofacitinib plus Methotrexate
NCT01262118 phase1completednot on this map

An Exploratory Phase 1, Fixed Sequence, Open-Label Study To Assess The Effects Of CP-690,550 On The Kinetics Of Cholesterol Flux Through The High Density Lipoprotein/Reverse Cholesterol Transport Pathway In Patients With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2011 to 2012Enrolled69ConditionsRheumatoid ArthritisArmsCP-690,550 (tasocitinib)
NCT01359150 phase2completednot on this map

A Randomized, Double Blind, Placebo Controlled Phase 2 Study To Assess The Immune Response Following Administration Of Influenza And Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving Cp-690,550 Or Placebo Cp-690,550 With And Without Background Methotrexate

TypeinterventionalSponsorPfizerRan2011 to 2012Enrolled223ConditionsRheumatoid ArthritisArmsCP-690,550, placebo
NCT01484561 phase1completednot on this map

A Phase 1, Randomized, Placebo-Controlled, Two-Period, Fixed Sequence Study To Evaluate The Effect Of CP-690,550 On Measured Glomerular Filtration Rate In Patients With Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2012 to 2013Enrolled148ConditionsArthritis, RheumatoidArmsCP-690,550 or Placebo, Placebo
NCT02092467 phase4completednot on this map

Phase 3b/4 randomized safety endpoint study of 2 doses of tofacitinib in comparison to a tumor necrosis factor (tnf) inhibitor in subjects with rheumatoid arthritis

TypeinterventionalSponsorPfizerRan2014 to 2020Enrolled4,372ConditionsArthritis, RheumatoidArmstofacitinib, adalimumab, etanercept
NCT02147587 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, Phase 2 Study To Assess The Immune Response Following Administration Of Zoster Vaccine To Subjects With Rheumatoid Arthritis Receiving Tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment

TypeinterventionalSponsorPfizerRan2014 to 2015Enrolled112ConditionsRheumatoid ArthritisArmsTofacitinib, Placebo
NCT02187055 phase4completednot on this map

A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis

TypeinterventionalSponsorPfizerRan2014 to 2016Enrolled1,152ConditionsRhematoid ArthritisArmsTofacitinib with methotrexate, Tofacitinib without methotrexate, Adalimumab with methotrexate
NCT02281552 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With Rheumatoid Arthritis On Background Methotrexate

TypeinterventionalSponsorPfizerRan2014 to 2017Enrolled209ConditionsRheumatoid ArthritisArmsTofacitinib
NCT02831855 phase4completednot on this map

A phase 3b/4 randomized double blind placebo controlled study of methotrexate (mtx) withdrawal in subjects with rheumatoid arthritis (ra) treated with tofacitinib 11mg modified release (mr) formulation

TypeinterventionalSponsorPfizerRan2016 to 2018Enrolled694ConditionsRheumatoid ArthritisArmsCP-690,550, Methotrexate, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 15 citations in OpenAlex.

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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

9 authors at 5 institutions in 3 countries.

Karen E HansenDivision of Rheumatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Mahta MortezaviPfizer Inc., 235 E 42nd St., New York, NY 10017, USA.
Edward NagyPfizer Ltd, Tadworth, UK.
Cunshan WangPfizer Inc., Groton, CT, USA.
Carol A ConnellPfizer Inc., Groton, CT, USA.
Zaher RadiPfizer Inc., Cambridge, MA, USA.
Heather J LitmanCorEvitas, LLC, Waltham, MA, USA.
Giovanni AdamiRheumatology Unit, Department of Medicine, University of Verona, Verona, Italy.
Maurizio RossiniRheumatology Unit, Department of Medicine, University of Verona, Verona, Italy.ORCID https://orcid.org/0000-0001-9692-2293
Pfizer (United States) · USUniversity of Verona · ITNavitas Systems (United States) · USPfizer (United Kingdom) · GBUniversity of Wisconsin–Madison · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Preclinical data suggest that tofacitinib would protect bone health in patients with rheumatoid arthritis (RA). Objective: To assess fracture risk in tofacitinib RA clinical trials. Design: Post hoc analysis. Methods: We analyzed pooled data of phase I/II/III and long-term extension studies (' Results: In the Conclusion: This post hoc analysis showed numerically lower fracture risk with tofacitinib Clinical trial registration: NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT01039688, NCT02187055, NCT02831855, NCT00413699, NCT00147498, NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT00661661, NCT01164579, NCT00976599, NCT01059864, NCT01359150, NCT01262118, NCT01484561, NCT02281552, NCT02147587, NCT02092467.

Indexed as

fractureJAK inhibitorosteoporosisrheumatoid arthritistofacitinib

Identifiers

PMID36601090
PMCPMC9806361
OpenAlexW4312738049

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 18 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.