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Rheumatoid arthritis (RA) Rheumatoid arthritis (RA) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions Psoriatic arthritis (PsA) Psoriatic arthritis (PsA) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions Ulcerative colitis (UC) Ulcerative colitis (UC) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions
EfficacyOPAL Broaden Study1

The primary end points were the proportion of patients who had an ACR20a response at month 3 and the change from baseline in HAQDIb score at month 3.1

Reduction in the signs and symptoms of PsA at month 3 and month 12, as measured by ACR response1 Clinical improvement in physical function with XELJANZ® (tofacitinib) 5 mg at month 3 and month 12, as measured by HAQ-DI score1 Study design

In a 12-month, double-blind, active-controlled and placebo-controlled phase 3 trial that evaluated XELJANZ® (tofacitinib) in patients with active PsA who previously had an inadequate response to csDMARDs: 318 patients were randomised to receive one of the following regimens: XELJANZ® (tofacitinib) at a 5 mg dose taken orally twice daily (107 patients), adalimumab at a 40-mg dose administered subcutaneously once every 2 weeks (106) or placebo (105). Placebo groups were pooled for analyses up to month 3.1

OPAL Beyond Study2

The primary end points were an ACR20a response and the change from baseline score on the HAQ-DIb score at the month 3 analysis.2

Reduction in the signs and symptoms of PsA at month 3 and month 6, as measured by ACR response2 Clinical improvement in physical function with XELJANZ® (tofacitinib) 5 mg at month 3 and month 6, as measured by HAQ-DI score2 Study design

In a 6-month randomized, placebo-controlled, double-blind, phase 3 trial evaluated XELJANZ® (tofacitinib) in patients with active psoriatic arthritis who had previously had an inadequate response to TNFis: 262 patients were randomised to: 5 mg of XELJANZ® (tofacitinib) administered orally twice daily (131) or placebo (131). Data from the patients who received placebo during the first 3 months of the trial were pooled.2

  1. ACR20/50/70 response is defined as achieving a respective ≥20/50/70% reduction from baseline in tender and swollen joints and at least three of five other domains (patient’s assessment of arthritis pain, patient’s global assessment of arthritis, physician’s global assessment of arthritis, C-reactive protein, and HAQ-DI).1,2
  2. HAQ-DI response is defined as a decrease ≥0.35 among patients with baseline HAQ-DI score ≥ 0.35.1,2
Abbreviations:ACR: American College of Rheumatology; BID: twice daily; csDMARDs: conventional synthetic disease-modifying antirheumatic drugs; HAQ-DI: Health Assessment Questionnaire–Disability Index; PsA: psoriatic arthritis; SC Q2W: once every 2 weeks; SE: standard error; TNFi: tumor necrosis factor imhibitor
ReferencesMease P, Hall S, FitzGerald O, et al. Tofacitinib or adalimumab versus placebo for psoriatic arthritis. N Engl J Med 2017;377(16):1537-1550.Gladman D, Rigby W, Azevedo VF, et al. Tofacitinib for psoriatic arthritis in patients with an inadequate response to TNF inhibitors. N Engl J Med 2017;377(16):1526-1536.
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