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Efficacy and SafetyClinical Efficacy RAORAL StrategyReal-World EvidenceORAL Surveillance and Integrated Safety SummaryClinical Efficacy PsAOPAL Clinical ProgrammeClinical Efficacy UCOCTAVE Study DesignOCTAVE Clinical ProgrammeSub GroupsPost-hoc AnalysesSafety and TolerabilitySafety Profile SummarySpecial Warnings & Precautions for UseAboutXELJANZ Mechanism of ActionDosing and AdministrationDosing in RA & PsADosingDosing in UCDosingSupport & ResourcesSupport & ResourcesMaterialsPrescribing InformationPrescribing Information
OPAL Clinical ProgrammeXELJANZ improves joint symptoms and other relevant clinical domains of PsA 1-5Significant at prespecified Week 2 endpoint.Sustained efficacy up to 12 months in csDMARD-IR patients and 6 months in TNF-IR patients.The OPAL Broaden study was designed to show the superiority of XELJANZ over placebo. Adalimumab was used as an active control. The trial was not designed and was not powered to evaluate the non-inferiority or superiority of XELJANZ as compared with adalimumab.XELJANZ delivers rapid and sustained improvements in joint symptoms vs placebo as measured by ACR20 1,2In addition, significant ACR50 and ACR70 responses were achieved at Month 31

ACR50: 28% vs 10% in the XELJANZ and placebo group, respectively (p<0.001)1
ACR70: 17% vs 5% in the XELJANZ and placebo group, respectively (p<0.004)1

Statistical testing was performed comparing placebo with XELJANZ up to three months.

Co-primary endpoints were the proportion of patients who had an ACR20 response at month 3 and the change from baseline in HAQ-DI score at Month 3.The OPAL Broaden study was designed to test for superiority of XELJANZ over placebo. Adalimumab was used as an active control. The trial was not designed and was not powered to evaluate the non-inferiority or superiority of XELJANZ as compared with adalimumab. Statistically significant vs placebo at a p≤0.05 as per the prespecified step-down procedure for type I error control within the ACR20 time course.1The result was significant at a p≤0.05 according to the prespecified step-down testing procedure for type I error control within the family of ACR responses.1XELJANZ delivered significant improvements in joint symptoms, measured by ACR20 response, as early as Week 2, which was a prespecified endpoint of the study.≤0.05 vs placebop<0.01 vs placebop<0.001 vs placebo.3Statistically significant vs placebo at a p≤0.05 as per the prespecified step-down procedure for type I error control within the ACRO20 time course1Statistically significant vs placebo at a p≤0.05 as per the prespecified step-down procedure for global type I error control.3In addition, a significant ACR50 response was achieved at Month 3 with XELJANZ#3# The result was significant at a p value of ≤0.05 according to the prespecified step-down testing procedure for type I error control within the family of ACR responses.3
  • Radiographic non-progression was observed in the majority of patients across all trial groups at 12 months (96% for XELJANZ, 98% for adalimumab and 96% for placebo to XELJANZ, respectively)1,2
  • The OPAL Broaden study was designed to show the superiority of XELJANZ over placebo. Adalimumab was used as an active control. The trial was not designed and was not powered to evaluate the non inferiority or superiority of XELJANZ as compared with adalimumab.
Radiographs of the hands and feet were obtained at baseline and at Month 12 and were scored independently by two central assessors who were unaware of the trial-group assignments.

XELJANZ in combination with methotrexate (MTX) is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.5

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Please refer to the XELJANZ Summary of Product Characteristics for full prescribing information

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; mTSS=modified Total Sharp Score; PsA=psoriatic arthritis; Q2W=once every two weeks; SC=subcutaneous; TNFi=tumour necrosis factor inhibitor.

References:Mease P et al. N Engl J Med 2017; 377: 1537–1550.Mease P et al. N Engl J Med 2017; 377: 1537–1550 (supplementary appendix).Gladman D et al. N Engl J Med 2017; 377: 1525–1536.Gladman D et al. N Engl J Med 2017; 377: 1525–1536 (supplementary index).XELJANZ Summary of Product Characteristics.
SAFETY

Learn more about the XELJANZ safety profile in PsA

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