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|Treatment emergent adverse events at 3 months, pooled (occurring in ≥2% of patients in any treatment group)2,a|
|XELJANZ® 5 mg BID
|Upper respiratory tract infection||5.0%||4.7%|
|Urinary tract infection||1.3%||2.1%|
|Characteristics||PsA | All XELJANZ® Dosesb,c
|Mean age, years||48.7|
|≥65 at baseline, n (%)||72 (9.2)|
|Female, n (%)||428 (54.7)|
|BMI (kg/m2), mean||29.6|
|Disease duration (years), mean (range)||7.7 (0.2-43.4)|
|CRP (mg/L). median (Q1-Q3)||4.8 (1.7-12.6)|
|Current/ past smokers, n (%)||298 (38.1)|
|Prior therapy. n (%)|
|Non-TNFi bDMARD||46 (5.9)|
|Concomitant corticosteroids, n (%)||171 (21.8)|
|Incidence rates, patients with events/100 pt-yrs (95% CI) for safety events of interest3,4,b|
|PsA | All XELJANZ® Dosesc,d
(N=783) 2038 pt-yrs
|Serious infections||1.2 (0.7, 1.7)|
|HZ (nonserious and serious)||1.8 (1.2, 2.4)|
|TBe||0.0 (0.0, 0.2)|
|Opportunistic infections (excluding TB)e||0.3 (0.1, 07)|
|Malignancies (excluding NMSC)e||0.7 (04, 1.2)|
|NMSCe||0.8 (0.4, 1.3)|
|Lymphoma/lymphoproliferative disorderse||0.1 (0.0, 0.3)|
|MACEe,f||0.3 (0.1, 0.6)|
|VTE||0.10 (0.01, 0.34)|
|DVT||0.1 (0.0, 0.3)|
|PE||0.1 (0.0, 0.3)|
|ATE||0.34 (0.13, 0.69)|
|Gastrointestinal perforatione||0.1 (0.0, 0.3)|
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▼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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