Efficacy
OPAL Broaden & Beyond- 
PsA Efficacy Results
XELJANZ delivers rapid and sustained improvements in joint symptoms vs placebo as measured by ACR201,2
Adapted from Mease P et al. 2017.2
In 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.
§ The 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.1
Adapted from Gladman D et al. 2017.4
In addition, a significant ACR50 response was achieved at Month 3 with XELJANZ**3​​​​​​​
An ACR50 response was achieved in 29.8% of patients on XELJANZ 5 mg vs 14.5% of patients on placebo (p=0.0025)3,4
*  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

‡ 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.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

†† Statistically significant vs placebo at a p≤0.05 as per the prespecified step-down procedure for global type I error control.3
Adapted from Mease P et al. 2017 (supplementary appendix).2​​​​​​​
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 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.
​​​​​​​
‡‡ 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.
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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; mTSS=modified Total Sharp Score; PsA=psoriatic arthritis; Q2W=once every two weeks; SC=subcutaneous; TNFi=tumour necrosis factor inhibitor.
References
  1.  
  2. Mease P et al. N Engl J Med 2017; 377: 1537–1550
  3. Mease P et al. N Engl J Med 2017; 377: 1537–1550 (supplementary appendix)
  4. Gladman D et al. N Engl J Med 2017; 377: 1525–1536
  5. ​​​​​​​Gladman D et al. N Engl J Med 2017; 377: 1525–1536 (supplementary appendix)
  6.  
PP-XEL-GBR-3251. October 2021
XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.

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