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001-es BibID:BIBFORM119513
Első szerző:Charles-Schoeman, Christina
Cím:Risk of Venous Thromboembolism with Tofacitinib Versus Tumor Necrosis Factor Inhibitors in Cardiovascular Risk-enriched Rheumatoid Arthritis Patients / Christina Charles-Schoeman, Roy Fleischmann, Eduardo Mysler, Maria Greenwald, Steven R. Ytterberg, Gary G. Koch, Deepak L. Bhatt, Cunshan Wang, Ted R. Mikuls, All-shine Chen, Carol A. Connell, John C. Woolcott, Sujatha Menon, Yan Chen, Kristen Lee, Zoltán Szekanecz
Dátum:2024
ISSN:2326-5191 2326-5205
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Arthritis & Rheumatology. - [Epub ahead of print] (2024). -
További szerzők:Fleischmann, Roy Mysler, Eduardo Greenwald, Maria Ytterberg, Steven R. Koch, Gary G. Bhatt, Deepak L. Wang, Cunshan Mikuls, Ted R. Chen, All-shine Connell, Carol A. Woolcott, John C. Menon, Sujatha Chen, Yan Lee, Kristen Szekanecz Zoltán (1964-) (reumatológus, belgyógyász, immunológus)
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2.

001-es BibID:BIBFORM103789
035-os BibID:(WOS)000859802100001 (Scopus)85139865478
Első szerző:Charles-Schoeman, Christina
Cím: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 / Christina Charles-Schoeman, Maya H. Buch, Maxime Dougados, Deepak L. Bhatt, Jon T. Giles, Steven R. Ytterberg, Gary G. Koch, Ivana Vranic, Joseph Wu, Cunshan Wang, Kenneth Kwok, Sujatha Menon, Jose L. Rivas, Arne Yndestad, Carol A. Connell, Zoltan Szekanecz
Dátum:2022
ISSN:0003-4967
Megjegyzések:Objectives Evaluate risk of major adverse cardiovascular events (MACE) with tofacitinib versus tumour necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA) with or without a history of atherosclerotic cardiovascular disease (ASCVD) in ORAL Surveillance. Methods Patients with RA aged >= 50 years with >= 1 additional CV risk factor received tofacitinib 5 mg or 10 mg two times per day or TNFi. Hazard rations (HRs) were evaluated for the overall population and by history of ASCVD (exploratory analysis). Results Risk of MACE, myocardial infarction and sudden cardiac death were increased with tofacitinib versus TNFi in ORAL Surveillance. In patients with history of ASCVD (14.7%; 640/4362), MACE incidence was higher with tofacitinib 5 mg two times per day (8.3%; 17/204) and 10 mg two times per day (7.7%; 17/222) versus TNFi (4.2%; 9/214). HR (combined tofacitinib doses vs TNFi) was 1.98 (95% confidence interval (CI) 0.95 to 4.14; interaction p values: 0.196 (for HR)/0.059 (for incidence rate difference)). In patients without history of ASCVD, MACE HRs for tofacitinib 5 mg two times per day (2.4%; 30/1251) and 10 mg two times per day (2.8%; 34/1234) versus TNFi (2.3%; 28/1237) were, respectively, 1.03 (0.62 to 1.73) and 1.25 (0.76 to 2.07). Conclusions This post hoc analysis observed higher MACE risk with tofacitinib versus TNFi in patients with RA and history of ASCVD. Among patients without history of ASCVD, all with prevalent CV risk factors, MACE risk did not appear different with tofacitinib 5 mg two times per day versus TNFi. Due to the exploratory nature of this analysis and low statistical power, we cannot exclude differential MACE risk for tofacitinib 5 mg two times per day versus TNFi among patients without history of ASCVD, but any absolute risk excess is likely low.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Antirheumatic Agents
Arthritis
Rheumatoid
Cardiovascular Diseases
Therapeutics
Megjelenés:Annals Of The Rheumatic Diseases. - 82 : 1 (2022), p. 119-129. -
További szerzők:Buch, Maya H. Dougados, Maxime Bhatt, Deepak L. Giles, Jon T. Ytterberg, Steven R. Koch, Gary G. Vranic, Ivana Wu, Joseph Wang, Cunshan Kwok, Kenneth Menon, Sujatha Rivas, Jose L. Yndestad, Arne Connell, Carol A. Szekanecz Zoltán (1964-) (reumatológus, belgyógyász, immunológus)
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3.

001-es BibID:BIBFORM108307
035-os BibID:(Scopus)85148667393 (WoS)000926215100001
Első szerző:Dougados, Maxime
Cím:Impact of cardiovascular risk enrichment on incidence of major adverse cardiovascular events in the tofacitinib rheumatoid arthritis clinical programme / Maxime Dougados, Christina Charles-Schoeman, Zoltán Szekanecz, Jon T. Giles, Steven R. Ytterberg, Deepak L. Bhatt, Gary G. Koch, Ivana Vranic, Joseph Wu, Cunshan Wang, Kenneth Kwok, Sujatha Menon, Carol A. Connell, Arne Yndestad, Jose L. Rivas, Maya H. Buch
Dátum:2023
ISSN:0003-4967
Tárgyszavak:Orvostudományok Klinikai orvostudományok levél
folyóiratcikk
Megjelenés:Annals Of The Rheumatic Diseases. - 82 : 4 (2023), p. 575-577. -
További szerzők:Charles-Schoeman, Christina Szekanecz Zoltán (1964-) (reumatológus, belgyógyász, immunológus) Giles, Jon T. Ytterberg, Steven R. Bhatt, Deepak L. Koch, Gary G. Vranic, Ivana Wu, Joseph Wang, Cunshan Kwok, Kenneth Menon, Sujatha Connell, Carol A. Yndestad, Arne Rivas, Jose L. Buch, Maya H.
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4.

001-es BibID:BIBFORM117872
035-os BibID:(WoS)001142644000003 (Scopus)85182237892
Első szerző:Szekanecz Zoltán (reumatológus, belgyógyász, immunológus)
Cím:Efficacy and safety of JAK inhibitors in rheumatoid arthritis : update for the practising clinician / Zoltán Szekanecz, Maya H. Buch, Christina Charles-Schoeman, James Galloway, George A. Karpouzas, Lars Erik Kristensen, Steven R. Ytterberg, Attila Hamar, Roy Fleischmann
Dátum:2024
ISSN:1759-4790 1759-4804
Megjegyzések:Janus kinase (JAK) inhibitors, including tofacitinib, baricitinib, upadacitinib and filgotinib, are increasingly used in the treatment of rheumatoid arthritis (RA). There has been debate about their safety, particularly following the issuance of guidance by regulatory agencies advising caution in their use in certain patients. The registrational clinical trials and registry data of JAK inhibitors did not identify a difference in the risk of major adverse cardiovascular events (MACEs), venous thromboembolism, malignancies or infections (other than herpes zoster) with a JAK inhibitor versus a biologic DMARD. In the ORAL Surveillance trial, which enrolled patients >50 years of age with ?1 cardiovascular risk factor, tofacitinib was statistically inferior to TNF inhibitors for the occurrence of MACEs and malignancy. Further post hoc analysis of the data revealed that an age of ?65 years, a high baseline cardiovascular risk, a history of smoking, sustained inflammation, disease activity and suboptimal treatment of cardiovascular comorbidities all increase the risk of these outcomes. The guidance issued by regulatory agencies should be carefully considered to ensure appropriate and safe treatment of patients with RA without undertreatment of patients who might benefit from JAK inhibitor, as well as biologic, treatment. As always, the risks associated with the use of these agents, treatment goals, costs and patient preferences should be discussed with the patient.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:Nature Reviews Rheumatology. - 20 : 2 (2024), p. 101-115. -
További szerzők:Buch, Maya H. Charles-Schoeman, Christina Galloway, James Karpouzas, George A. Kristensen, Lars Erik Ytterberg, Steven R. Hamar Attila Béla (1990-) (általános orvos) Fleischmann, Roy
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5.

001-es BibID:BIBFORM104617
035-os BibID:(cikkazonosító)e002571 (WoS)000880432900004 (Scopus)85141212385
Első szerző:Weitz, Jeffrey I.
Cím:Biomarkers to predict risk of venous thromboembolism in patients with rheumatoid arthritis receiving tofacitinib or tumour necrosis factor inhibitors / Jeffrey I. Weitz, Zoltán Szekanecz, Christina Charles-Schoeman, Ivana Vranic, Burak Sahin, Sara A. Paciga, Zhenyu Wang, Craig Hyde, David A. Martin
Dátum:2022
ISSN:2056-5933
Megjegyzések:ObjectiveIn the ORAL (Oral Rheumatoid Arthritis triaL) Surveillance study of patients with rheumatoid arthritis aged >=50 years with >=1 additional cardiovascular risk factor, incidence of pulmonary embolism was higher with tofacitinib 10 mg two times per day than with tumour necrosis factor inhibitors (TNFi). This exploratory post hoc analysis examined whether biomarkers explained the associations of tofacitinib versus TNFi with venous thromboembolism (VTE).MethodsORAL Surveillance was a prospective, open-label, event-driven, non-inferiority, postauthorisation safety study. Patients were randomised 1:1:1 to receive tofacitinib 5 mg or 10 mg two times per day or a TNFi. For this analysis, 294 soluble, proteomic, genetic and antibody biomarkers (of which 79 had a known role in inflammation, coagulation, vascular biology or Janus kinase signalling) were quantified in serum collected at baseline, month 12 and study end.ResultsOverall, 4362 patients were randomised and treated. The exploratory biomarker data set included 285 patients (57 VTE cases; 228 matched controls). D-dimer was quantified in 3732 patients (54 VTE cases; 3678 controls). No biomarker demonstrated a clear mechanistic association with the increased risk of VTE for tofacitinib versus TNFi. Month 12 D-dimer levels were positively associated with risk of a subsequent VTE within the tofacitinib 5 mg and 10 mg two times per day arms.ConclusionsOverall, this post hoc analysis did not identify biomarkers that explained the increased VTE risk for tofacitinib versus TNFi. Individual VTE risk should be considered when making decisions about initiation or maintenance of tofacitinib treatment.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:RMD Open. - 8 : 2 (2022), p. 1-10. -
További szerzők:Szekanecz Zoltán (1964-) (reumatológus, belgyógyász, immunológus) Charles-Schoeman, Christina Vranic, Ivana Sahin, Burak Paciga, Sara A. Wang, Zhenyu Hyde, Craig Martin, David A.
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