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Authors
Batko, Bogdan https://orcid.org/0000-0003-3999-8093
Jeka, Slawomir
Wiland, Piotr https://orcid.org/0000-0001-9999-0267
Zielińska, Agnieszka
Stopińska-Polaszewska, Maria
Stajszczyk, Marcin https://orcid.org/0000-0002-3939-7194
Kosydar-Piechna, Magdalena
Cadatal, Mary Jane
Rivas, Jose L. https://orcid.org/0009-0004-6736-3962
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Clinical Trials BETA
Clinical trials referenced in this document:
nct02092467 at ClinicalTrials.govDocuments that mention this clinical trial
Waiting for JAK inhibitor safety data
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Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data
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EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update
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RMD commentary, JAK kinase inhibitors: a preferred alternative to TNF inhibitors?
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https://doi.org/10.1136/annrheumdis-2022-eular.1016
Correspondence on ‘EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update‘
https://doi.org/10.1136/annrheumdis-2020-218573
POS0674 RISK FACTORS FOR MAJOR ADVERSE CARDIOVASCULAR EVENTS IN PATIENTS AGED ≥50 YEARS WITH RHEUMATOID ARTHRITIS AND ≥1 ADDITIONAL CARDIOVASCULAR RISK FACTOR: A POST HOC ANALYSIS OF ORAL SURVEILLANCE
https://doi.org/10.1136/annrheumdis-2022-eular.1234
Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database
https://doi.org/10.1136/annrheumdis-2021-221276
POS0824 CARDIOVASCULAR (CV) AND MALIGNANCY EVENTS IN THE FILGOTINIB (FIL) RHEUMATOID ARTHRITIS (RA) CLINICAL DEVELOPMENT PROGRAM UP TO 8.3 YEARS
https://doi.org/10.1136/annrheumdis-2023-eular.1425
POS0520 ASSOCIATION BETWEEN BASELINE STATIN TREATMENT AND MAJOR ADVERSE CARDIOVASCULAR EVENTS IN PATIENTS WITH RHEUMATOID ARTHRITIS: A POST HOC ANALYSIS OF ORAL SURVEILLANCE
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Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance (Results)
https://doi.org/10.1136/ard-2022-222259
Impact of cardiovascular risk enrichment on incidence of major adverse cardiovascular events in the tofacitinib rheumatoid arthritis clinical programme
https://doi.org/10.1136/ard-2022-223406
SAT0139 AGE-BASED (<65 VS ≥65 YEARS) INCIDENCE OF INFECTIONS AND SERIOUS INFECTIONS IN TOFACITINIB-, ADALIMUMAB- AND PLACEBO-TREATED PATIENTS WITH RHEUMATOID ARTHRITIS: A POST HOC ANALYSIS OF PHASE 2, PHASE 3 AND PHASE 3B/4 TOFACITINIB STUDIES
https://doi.org/10.1136/annrheumdis-2020-eular.1432
Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: a post hoc analysis of a phase 3b/4 randomised safety study
https://doi.org/10.1136/rmdopen-2023-003912
OP0269 BIOMARKERS TO PREDICT RISK OF VENOUS THROMBOEMBOLISM IN PATIENTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB OR TUMOUR NECROSIS FACTOR INHIBITORS
https://doi.org/10.1136/annrheumdis-2022-eular.787
Infections in patients with rheumatoid arthritis receiving tofacitinib versus tumour necrosis factor inhibitors: results from the open-label, randomised controlled ORAL Surveillance trial
https://doi.org/10.1136/ard-2022-222405
Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure
https://doi.org/10.1136/rmdopen-2021-001595
Age-based (<65 vs ≥65 years) incidence of infections and serious infections with tofacitinib versus biological DMARDs in rheumatoid arthritis clinical trials and the US Corrona RA registry
https://doi.org/10.1136/annrheumdis-2020-218992
AB0530 A PRACTICAL FRAMEWORK FOR INDIVIDUALIZED BENEFIT/RISK ASSESSMENT AND CLINICAL DECISION-MAKING ON TREATMENT WITH TOFACITINIB
https://doi.org/10.1136/annrheumdis-2024-eular.2850
Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trials
https://doi.org/10.1136/bmjopen-2023-082366
Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance
https://doi.org/10.1136/ard-2022-223715
POS0827 CLINICAL OUTCOMES OF PATIENTS WITH RHEUMATOID ARTHRITIS WHO DISCONTINUED TOFACITINIB OR TUMOUR NECROSIS FACTOR INHIBITORS: RESULTS FROM ORAL SURVEILLANCE
https://doi.org/10.1136/annrheumdis-2023-eular.2670
OP0043 IMPACT OF CARDIOVASCULAR COMORBIDITIES ON EFFICACY OF TOFACITINIB VS TNFI IN RHEUMATOID ARTHRITIS
https://doi.org/10.1136/annrheumdis-2023-eular.2688
Biomarkers to predict risk of venous thromboembolism in patients with rheumatoid arthritis receiving tofacitinib or tumour necrosis factor inhibitors
https://doi.org/10.1136/rmdopen-2022-002571
Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial
https://doi.org/10.1136/ard-2022-222543
Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study
https://doi.org/10.1136/annrheumdis-2021-221915
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Funding
Funding for this research was provided by:
Pfizer
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Article History
Received: 16 December 2023
Accepted: 14 June 2024
First Online: 26 July 2024
Declarations
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: Bogdan Batko has speaking contracts, clinical trial contracts, and/or has acted as a consultant for AbbVie, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, Medac, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sandoz, Sobi, and UCB. Slawomir Jeka has acted as a consultant for AbbVie, AstraZeneca, Celgene, Egis, Eli Lilly, Gilead, Medac, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sandoz, Sobi, and UCB. Piotr Wiland has speaking contracts, clinical trial contacts, and/or has acted as a consultant for AbbVie, AstraZeneca, Bristol Myers Squibb, Janssen, Medac, Novartis, Pfizer, and Sandoz. Agnieszka Zielińska and Maria Stopińska-Polaszewska have nothing to disclose. Marcin Stajszczyk has speaking contracts, clinical trial contracts, and/or has acted as consultant for AbbVie, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sandoz, Swedish Orphan Biovitrum, and UCB. Magdalena Kosydar-Piechna, Mary Jane Cadatal, and Jose L Rivas are employees and shareholders of Pfizer.
: ORAL Surveillance was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines of the International Council for Harmonisation, and was approved by the Institutional Review Board and/or Independent Ethics Committee at each center (Supplementary Material). Patients provided written informed consent.
