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  1. L. E. Kristensen1,
  2. B. Strober2,3,
  3. D. Poddubnyy4,5,
  4. Y. Y. Leung6,7,
  5. H. Jo8,
  6. K. Kwok9,
  7. I. Vranic10,
  8. D. Fleishaker8,
  9. L. Fallon11,
  10. A. Yndestad12,
  11. D. D. Gladman13,14
  1. 1Copenhagen University Hospital, Bispebjerg and Frederiksberg, Department of Rheumatology, The Parker Institute, Copenhagen, Denmark
  2. 2Central Connecticut Dermatology Research, Cromwell, CT, United States of America
  3. 3Yale University, Department of Dermatology, New Haven, CT, United States of America
  4. 4Charité Universitätsmedizin, Department of Rheumatology, Infectious Diseases and Rheumatology, Berlin, Germany
  5. 5German Rheumatism Research Center Berlin, Epidemiology, Berlin, Germany
  6. 6Singapore General Hospital, Department of Rheumatology and Immunology, Singapore, Singapore
  7. 7Duke-NUS Medical School, Clinical Sciences Department, Singapore, Singapore
  8. 8Pfizer Inc, Inflammation and Immunology, Groton, CT, United States of America
  9. 9Pfizer Inc, Inflammation and Immunology, New York, NY, United States of America
  10. 10Pfizer Ltd, Inflammation and Immunology, Tadworth, United Kingdom
  11. 11Pfizer Inc, Inflammation and Immunology, Montreal, QC, Canada
  12. 12Pfizer Inc, Inflammation and Immunology, Oslo, Norway
  13. 13University of Toronto, Department of Medicine, Toronto, ON, Canada
  14. 14Toronto Western Hospital, Schroeder Arthritis Institute, Krembil Research Institute, Toronto, ON, Canada


Background Common comorbidities of psoriatic arthritis (PsA) and psoriasis (PsO) are cardiovascular (CV) disease and metabolic syndrome (MetS).1,2 Risk of CV disease may be associated with increased risk of future malignancies.3 Tofacitinib is a JAK inhibitor for treatment of PsA and has been investigated for treatment of PsO.

Objectives To examine baseline (BL) CV risk and its association with incidence rates (IRs) of major adverse CV events (MACE) and malignancies in tofacitinib-treated patients (pts) with PsA and PsO.

Methods Analysis included data from 3 (Phase [P]3/long-term extension [LTE]) trials of pts with PsA and 7 (P2/3/LTE) trials of pts with PsO receiving ≥1 dose of tofacitinib (5 or 10 mg twice daily). IRs (pts with events/100 pt-yrs) for MACE and malignancies (excluding non-melanoma skin cancer) were stratified by: history of coronary artery disease (HxCAD [≥1 of myocardial infarction, coronary heart disease, coronary artery procedure or stable angina pectoris]); BL 10-yr atherosclerotic CV disease (ASCVD) risk (ASCVD-pooled cohort equations calculator [only in pts without HxCAD]); and BL MetS (≥3 of hypertension, raised triglycerides, reduced high-density lipoprotein cholesterol, high waist circumference or high fasting glucose levels).

Results Of 783 and 3663 pts with PsA and PsO, total tofacitinib exposure was 2038 and 8950 pt-yrs, and median duration of exposure was 3.0 and 2.4 yrs, respectively. In pts with PsA and PsO, 5.0% and 2.5% had HxCAD, respectively; in those without HxCAD, >20% had intermediate/high BL 10-yr ASCVD risk (Figure 1). At BL, 40.9% and 32.7% of pts with PsA and PsO had MetS, respectively. IRs of MACE were greatest in pts with PsA and PsO who had HxCAD/high BL 10-yr ASCVD risk (Table 1). In the PsA cohort, 5/6 pts with MACE had BL MetS. IRs of malignancies in pts with PsA were greatest in those with intermediate/high BL 10-yr ASCVD risk; 8/9 pts with malignancies in these risk categories had BL MetS (Table 1). In the PsO cohort, IR of malignancies was notably greater in those with high vs low/intermediate BL 10-yr ASCVD risk (Table 1).

Table 1.

IRs of MACE and malignancies in pts with PsA and PsO receiving tofacitinib, stratified by HxCAD, BL 10-yr ASCVD risk and BL MetS

Conclusion In tofacitinib-treated pts with PsA and PsO, raised CV risk and MetS at BL were potentially associated with higher IRs of MACE and malignancies. Our findings support assessing CV risk in pts with PsA and PsO and enhanced monitoring for malignancies in those with raised CV risk.

References [1]Karmacharya et al. Ther Adv Musculoskel Dis 2021; 13: 1-15.

[2]Garshick et al. J Am Coll Cardiol 2021; 77: 1670-1680.

[3]Lau et al. JACC CardioOncol 2021; 3: 48-58.

Acknowledgements Study sponsored by Pfizer Inc. Medical writing support was provided by Emma Mitchell, CMC Connect, and funded by Pfizer Inc.

Disclosure of Interests Lars Erik Kristensen Speakers bureau: AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Eli Lilly, Janssen, MSD, Novartis, Pfizer Inc and UCB, Grant/research support from: Biogen, Janssen, Novartis and UCB, Bruce Strober Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen and Ortho Dermatologics, Consultant of: AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Boehringer Ingelheim, Bristol-Myers Squibb, Cara, Celgene, Dermavant, Dermira, Eli Lilly, GlaxoSmithKline, Janssen, Leo, Meiji Seika Pharma, Novartis, Ortho Dermatologics, Pfizer Inc, Regeneron, Sanofi-Genzyme, Sun Pharma and UCB, Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer Inc and UCB, Consultant of: AbbVie, BIOCAD, Gilead Sciences, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer Inc, Samsung Bioepis and UCB, Grant/research support from: AbbVie, MSD, Novartis and Pfizer, Ying Ying Leung Consultant of: AbbVie, Eli Lilly, Janssen and Novartis, Hyejin Jo Consultant of: Pfizer Inc, Employee of: Syneos Health, Kenneth Kwok Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Ivana Vranic Shareholder of: Pfizer Inc, Employee of: Pfizer Ltd, Dona Fleishaker Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Lara Fallon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Arne Yndestad Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Dafna D Gladman Consultant of: AbbVie, Amgen, Celgene, Eli Lilly, Galapagos, Gilead Sciences, Janssen, Novartis, Pfizer Inc and UCB.

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