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A 1-year, double-blind, triple-dummy, phase 3b/4, active comparator, head-to-head controlled trial in which 1146 patients with moderately to severely active RA who had an inadequate response to MTX received XELJANZ 5 mg BID, XELJANZ 5 mg BID + MTX, or Humira® 40 mg SC q 2 wk + MTX. The primary endpoint was ACR50 at month 6 powered to test noninferiority through independent comparisons of XELJANZ 5 mg BID to Humira® 40 mg SC q 2 wk + MTX; XELJANZ 5 mg BID + MTX to Humira® 40 mg SC q 2 wk + MTX; and XELJANZ 5 mg BID to XELJANZ 5 mg BID + MTX.1,3
Learn more about the XELJANZ safety profile
Learn about dosing with XELJANZ, the first oral JAKi approved for RA
Find out more about the JAKi with the longest market experience in RA, PsA, 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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