PASI75 Response Rate

PsA patients experienced visible improvements in skin symptoms observed as early as Month 1, and sustained through Year 1^1-3

XELJANZ^® (tofacitinib citrate) is not indicated for the treatment of patients with plaque psoriasis⁴

PASI75 was achieved as early as Month 1 and sustained through Year 1^1-3,*

OPAL broaden in csDMARD-IR–treated patients²

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.²

Adapted from Mease P, et al. 2017.

*Number of patients with >3% of body surface area affected and PASI >0 at baseline were: 82 (XELJANZ^® [tofacitinib citrate] 5 mg BID), 82 (placebo), 77 (Adalimumab 40 mg SC Q2W).^2
†P≤0.05 versus placebo.^1,3
‡P<0.001 versus placebo.^1,3
§Statistically significant versus placebo at P≤0.05 as per the prespecified step-down procedure for type I error control within the ACR20 time course.² PASI75 was defined as a ≥75% improvement from baseline in the PASI score. Patients were included in these analyses if they had >3% of body surface area affected and PASI >0 at baseline.²

• In OPAL Beyond in TNFi-IR–treated patients, there was no significant difference in the proportion of patients achieving a PASI75 response with XELJANZ^® (tofacitinib citrate) versus placebo at Month 3⁵
   

• The PASI75 response rate for XELJANZ^® (tofacitinib citrate) 5 mg BID + csDMARD at Month 3 was 21% versus 14% with placebo; P>0.05; not significant^1,5

OPAL Broaden study design

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 placebo treatment 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 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 PsA.

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ACR, American College of Rheumatology; BID, twice daily; csDMARD, conventional synthetic disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire-Disability Index; IR, inadequate responder; OPAL, older persons’ assessment and liaison team; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; Q2W, every 2 weeks; SC, subcutaneously; TNFi, tumour necrosis factor inhibitor.