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FRI0496 Comparing tofacitinib safety profile in patients with psoriatic arthritis in clinical studies with real-world data
  1. JR Curtis1,
  2. H Yun1,
  3. O FitzGerald2,
  4. K Winthrop3,
  5. VF Azevedo4,
  6. G Burmester5,
  7. WFC Rigby6,
  8. KS Kanik7,
  9. R Rojo7,
  10. S Menon7,
  11. C Wang7,
  12. P Biswas8,
  13. T Hendrikx9,
  14. N Palmetto8
  1. 1University of Alabama at Birmingham, Birmingham, AL, United States
  2. 2Department of Rheumatology, St Vincent's University Hospital, Dublin, Ireland
  3. 3Oregon Health and Science University, Portland, OR, United States
  4. 4Universidade Federal do Paraná, Curitiba, Brazil
  5. 5Charité - University Medicine Berlin, Berlin, Germany
  6. 6Geisel School of Medicine at Dartmouth, Lebanon, NH
  7. 7Pfizer Inc, Groton, CT
  8. 8Pfizer Inc, New York, NY
  9. 9Pfizer Inc, Collegeville, PA, United States

Abstract

Background Tofacitinib is an oral Janus kinase inhibitor under investigation for the treatment of psoriatic arthritis (PsA). Two Phase 3 studies have been completed (NCT01877668; NCT01882439) and a long-term extension (LTE) study is ongoing (database not locked; NCT01976364).

Objectives To compare incidence rates (IR) for adverse events (AEs) of special interest in a tofacitinib cohort from the Phase 3 PsA trials with real-world experience in a comparison cohort from the US Truven MarketScan database.

Methods The tofacitinib cohort included adult patients (pts) from 2 Phase 3 studies with ≥6 months PsA diagnosis who met ClASsification of Psoriatic ARthritis (CASPAR) criteria, had active plaque psoriasis, and active arthritis (≥3 swollen and ≥3 tender/painful joints) and who were treated with tofacitinib. Pts were grouped by those who received tofacitinib 5 (N=238) or 10 mg (N=236) twice daily (BID) in the 2 Phase 3 studies, and all pts who received ≥1 dose of tofacitinib in the 2 Phase 3 studies or the LTE (tofacitinib all doses, N=783). The comparison cohort (N=5799) comprised pts with moderate to severe PsA, defined by ≥1 inpatient or ≥2 outpatient 696.0 diagnosis codes on 2 unique calendar days (≥1 by a rheumatologist) between Oct 2010 and Sep 2015, initiating therapy with a systemic agent for PsA. Key Phase 3 study exclusion criteria were applied to the comparison cohort. IRs for serious infection events (SIEs), herpes zoster (HZ), malignancies (excluding non-melanoma skin cancer [NMSC]), NMSC and major adverse cardiovascular events (MACE) were compared.

Results Mean age, gender and diabetes history were generally similar between the tofacitinib and comparison cohorts (48.7–49.5 years, 42.4–49.2% male, 12.2–15.7% with diabetes history). Overall more pts treated with tofacitinib had prior experience with corticosteroids (15.7–28.2%), conventional synthetic disease-modifying antirheumatic drugs (100%) and tumour necrosis factor inhibitors (48.1–55.9%) vs the comparison cohort (11.9%, 46.6% and 36.6%, respectively). IRs for SIEs were lower for the tofacitinib vs the comparison cohort (Table 1). The tofacitinib cohort had a higher rate of HZ vs the comparison cohort (Table 1). IRs for malignancies and MACE were similar between cohorts (Table 1).

Conclusions IRs of AEs of special interest reported in tofacitinib PsA Phase 3 studies were generally comparable to those in a general PsA population comprising pts receiving a range of biologic agents, except HZ, which was higher for pts treated with tofacitinb but similar to the incidence observed with tofacitinib treatment in other indications.

Acknowledgements This study was sponsored by Pfizer Inc. Editorial support was provided by A Pedder of CMC and was funded by Pfizer Inc.

Disclosure of Interest J. Curtis Grant/research support from: Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, H. Yun Grant/research support from: Pfizer Inc, O. FitzGerald Grant/research support from: AbbVie, Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Speakers bureau: Celgene, Janssen, Novartis, K. Winthrop Grant/research support from: Bristol-Myers Squibb, Pfizer Inc, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Galapagos, Pfizer Inc, UCB, V. Azevedo Grant/research support from: Bristol-Myers Squibb, GSK, Pfizer Inc, UCB, Consultant for: AbbVie, Bristol-Myers Squibb, Janssen, Merck Serono, Novartis, Pfizer Inc, G. Burmester Grant/research support from: UCB, Consultant for: AbbVie, Bristol-Myers Squibb, Eli Lilly, Hexal, Janssen, MSD, Medimmune, Novartis, Pfizer Inc, Sanofi, Roche, Speakers bureau: AbbVie, Bristol-Myers Squibb, Hexal, MSD, Novartis, Pfizer Inc, Roche, W. F. Rigby Grant/research support from: Amgen, Pfizer Inc, Roche, Consultant for: Bristol-Myers Squibb, Eli Lilly, Pfizer Inc, Roche, K. Kanik Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, R. Rojo Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, S. Menon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, C. Wang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, P. Biswas Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, T. Hendrikx Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, N. Palmetto Shareholder of: Pfizer Inc, Employee of: Pfizer Inc

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