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The OPAL Broaden study was not designed to provide head-to-head comparative efficacy data vs Humira® and should not be interpreted as evidence of superiority or noninferiority.2
A 12-month, randomized, multicenter, double-blind trial in which 422 patients with PsA who had an inadequate response to at least one csDMARD and were TNFi-naïve received either XELJANZ 5 mg BID, XELJANZ 10 mg BID, Humira® 40 mg SC q 2 wk, or placebo. At month 3, all patients randomized to placebo treatment were advanced in a blinded fashion to either XELJANZ 5 mg BID or XELJANZ 10 mg BID. Primary endpoints were ACR20 response and the change in HAQ-DI at month 3.2
Humira® is a registered trademark of AbbVie Inc.
ACR=American College of Rheumatology; BID=twice a day; csDMARD=conventional synthetic disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire–Disability Index; IR=inadequate responder; PASI=psoriasis area and severity index; PsA=psoriatic arthritis; q 2 wk=every 2 weeks; SC=subcutaneous; TNFi=tumor necrosis factor inhibitor.
See the XELJANZ safety data for PsA
Learn about dosing with XELJANZ, the first oral JAKi approved for PsA
Find out more about the JAKi with the longest market experience in RA, PsA, and UC
▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
XELJANZ should only be used if no suitable treatment alternatives are available in patients:
See PI for details, Section 4.4 Special Warnings and Precautions for Use: Mortality; Major Adverse Cardiovascular Events (including Myocardial Infarction); Thrombosis; Malignancy and Lymphoproliferative Disorder (excluding Nonmelanoma Skin Cancer [NMSC]); Skin Cancer and Use in the Elderly.
Before prescribing, please review full Product Information available here.
PBS Information: Authority required for the treatment of adults with severe active rheumatoid arthritis and for adults with severe psoriatic arthritis and for adults with moderate-to-severe ulcerative colitis. Refer to the PBS Schedule for full authority information. This product is not listed on the PBS for juvenile idiopathic arthritis, juvenile psoriatic arthritis, or ankylosing spondylitis.
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