Reduction In Enthesitis And Dactylitis Symptoms in Patients with PsA

Patients with PsA experienced improvements in symptoms of enthesitis and dactylitis¹

Patients receiving XELJANZ^® (tofacitinib citrate) had a numerically greater mean change from baseline in the LEI score versus those receiving placebo at Month 3.^1,*

The OPAL Broaden study was not designed to provide head-to-head comparative efficacy data versus Adalimumab and should not be interpreted as evidence of superiority or noninferiority.¹

^{Adapted from Mease P, et al. 2017.}

*Patients with a baseline LEI score of 0 were excluded from the analyses.

• In csDMARD-IR patients with enthesitis, 33.3% (25/75) had complete resolution (LEI=0) at Month 3 with XELJANZ^® (tofacitinib citrate) versus 21.5% (14/65) with placebo. At Month 3, 47.4% (36/76) of patients receiving Adalimumab 40 mg SC Q2W + csDMARD had complete resolution of enthesitis¹
   

• Statistical significance for XELJANZ^® (tofacitinib citrate) was not achieved under the step-down procedure¹

Adapted from Gladman D, et al. 2017.

*Patients with a baseline LEI score of 0 were excluded from the analyses.

• Due to a lack of significance higher in the prespecified hierarchical testing sequence, the change from baseline in LEI at Month 3 with XELJANZ^® (tofacitinib citrate) 5 mg BID + csDMARD versus placebo + csDMARD was not tested for statistical significance controlling for type I error^2,4

Patients receiving XELJANZ^® (tofacitinib citrate) had a numerically greater mean change from baseline in DSS versus those receiving placebo at Month 3^1,*

OPAL Broaden in csDMARD-IR–treated Patients¹

The OPAL Broaden study was not designed to provide head-to-head comparative efficacy data versus Adalimumab and should not be interpreted as evidence of superiority or noninferiority.¹

Adapted from Gladman D, et al. 2017.

*Patients with a baseline DSS of 0 were excluded from the analyses.

• In csDMARD-IR patients with dactylitis, 34.4% (21/61) had complete resolution (DSS=0) at Month 3 with XELJANZ^® (tofacitinib citrate) versus 32.8% (19/58) with placebo. At Month 3, 46.6% (27/58) of patients receiving Adalimumab 40 mg SC Q2W + csDMARD had complete resolution of dactylitis¹ 
   

• Due to a lack of significance higher in the prespecified hierarchical testing sequence, the change from baseline in DSS at Month 3 with XELJANZ^® (tofacitinib citrate) 5 mg BID + csDMARD versus placebo + csDMARD was not tested for statistical significance controlling for type I error^2,4

Patients receiving XELJANZ^® (tofacitinib citrate) had a numerically greater mean change from baseline in DSS versus those receiving placebo at Month 3^1,* 

OPAL Beyond in TNFi-IR–treated Patients²

Adapted from Gladman D, et al. 2017, Data on file. Pfizer Inc.

*Patients with baseline DSS of 0 were excluded from the analyses.

• Due to a lack of significance higher in the prespecified hierarchical testing sequence, the change from baseline in DSS at Month 3 with XELJANZ^® (tofacitinib citrate) 5 mg BID + csDMARD versus placebo + csDMARD was not tested for statistical significance controlling for type I error^2,4

OPAL Broaden study design (the PsA-I study)

A 12-month, randomised, multicentre, double-blind trial in which 422 patients with PsA who had an inadequate response to at least 1 csDMARD and were TNFi-naïve received either XELJANZ^® (tofacitinib citrate) 5 mg BID, XELJANZ^® (tofacitinib citrate) 10 mg BID, Adalimumab 40 mg SC Q2W or placebo. At Month 3, all patients randomised to the placebo treatment were advanced in a blinded fashion to either XELJANZ^® (tofacitinib citrate) 5 mg BID or XELJANZ^® (tofacitinib citrate) 70 mg BID. Primary end points were ACR20 response and the change in HAQ-DI at Month 3.¹

OPAL Broaden study design (the PsA-II study)

A randomised, 6-month, double-blind trial in which 394 patients with PsA who had an inadequate response to at least 1 TNFi received either XELJANZ^® (tofacitinib citrate) 5 mg BID, XELJANZ^® (tofacitinib citrate) 10 mg BID, or placebo. At Month 3, all patients randomised to placebo were advanced in a blinded fashion to either XELJANZ^® (tofacitinib citrate) 5 mg BID or XELJANZ^® (tofacitinib citrate) 10 mg BID. The primary end points were ACR20 response rate and the change in HAQ-DI at Month 3.²

XELJANZ^® (tofacitinib citrate) 5 mg BID is the only approved dosage for the treatment of PsA, and it should not be exceeded. The dosage of 10 mg BID is not licensed for the treatment of PsA.

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ACR, American College of Rheumatology; BID, twice daily; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DSS, dactylitis severity score; HAQ-DI, Health Assessment Questionnaire-Disability Index; IR, inadequate response; LEI, life events inventory; OPAL, older persons’ assessment and liaison team; PsA, psoriatic arthritis; Q2W, every 2 weeks; SC, subcutaneously; TNFi, tumour necrosis factor inhibitor.

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