Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

• Drug: Tofacitinib 5 mg BID
  
  Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
• Drug: Tofacitinib 10 mg BID
  
  Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
• Drug: Adalimumab
  
  Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
• Drug: Placebo
  
  Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months
• Drug: Placebo
  
  Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months

• Experimental: Tofacitinib 5 mgBID x 12 months
  
  Intervention: Drug: Tofacitinib 5 mg BID
• Experimental: Tofacitinib 10 mg BID x 12 months
  
  Intervention: Drug: Tofacitinib 10 mg BID
• Active Comparator: Adalimumab 40 mg q2 weeks x 12 months
  
  Intervention: Drug: Adalimumab
• Placebo Comparator: Placebo x3 months, then tofacitinib 5 mg BIDx 9 months
  
  Intervention: Drug: Placebo
• Placebo Comparator: Placebo x 3 months, then tofacitinib 10 mg BID x 9 months
  
  Intervention: Drug: Placebo

• Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Jan 31. doi: 10.1007/s40264-020-00904-9. [Epub ahead of print]
• Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.
• van der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab. J Rheumatol. 2019 Sep;46(9):1089-1096. doi: 10.3899/jrheum.180971. Epub 2019 Mar 1.
• Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Graham D, Wang C, Cappelleri JC, Hendrikx T, Hsu MA. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2019 Jan 11;5(1):e000806. doi: 10.1136/rmdopen-2018-000806. eCollection 2019.
• Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5. Corrected and republished in: J Patient Rep Outcomes. 2019 May 20;3(1):30. Retraction in: J Patient Rep Outcomes. 2019 May 28;3(1):32.
  
  Retraction in:J Patient Rep Outcomes. 2019 May 28;3(1):32
• Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.
• Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cie?lak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975.

Inclusion Criteria:

• Males or females, aged >= 18 years at time of consent.
• Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
• Meet the Classification Criteria of PsA (CASPAR) at time of screening
• Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
• Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
• Must not have taken a biologic Tumour Necrosis Factor Inhibitor
• Must have 3 or more swollen joints AND 3 or more tender joints
• Must have active psoriasis skin lesions

Exclusion Criteria:

• Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
• Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
• New York Heart Association Class III and IV congestive heart failure
• History of hypersensitivity or infusion reaction to biologic agents
• Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection