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About JAKi Experience  JAKi Market Experience XELJANZ Mechanism of Action Efficacy and Safety Clinical Efficacy RA Rapid Data (ACR20) Head-to-Head Noninferiority Data (ACR50) Clinical Efficacy PsA ACR20 Data PASI75 Data Enthesitis and Dactylitis Data Clinical Efficacy UC 8-Week Efficacy Onset of Action Data 52-Week Efficacy OCTAVE Study Design Safety and Tolerability Safety in RA Safety in PsA Safety in UC Dosing and Administration Dosing in RA Dosing Practical Considerations Dosing in PsA Dosing Practical Considerations Dosing in UC Dosing Practical Considerations Resources and Support Resources and Support eXel ProgramEventsMaterials Videos
Safety in PsASafety profile from the PsA clinical trial programs​​​​​​​
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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
(n=238)  		 Placebo
(n=236) 
Nasopharyngitis 5.9% 2.5%
Upper respiratory tract infection 5.0% 4.7%
Headache 3.8% 4.7%
Diarrhea 3.4% 0.4%
Nausea 2.5% 3.0%
Bronchitis 2.5% 0.0%
Dizziness 2.5% 1.3%
Urinary tract infection 1.3% 2.1%
Dyspepsia 2.1% 0.8%
Limitations of pooled and long-term extension (LTE) data2
  • Pooled, post hoc analysis of studies from the RA clinical trial program are subject to certain limitations. First, unlike ORAL Surveillance, the patient population is not limited to a high-risk population but includes all enrolled patients. Second, endpoints of interest (such as MACE and malignancy for ORAL Surveillance) were not all specifically defined or adjudicated. Additionally, ORAL Surveillance was a long-term safety study (vs RCT phase 3 which are short term and designed to test efficacy). Resultant incidence rates in ORAL Surveillance differed from rates seen from pooled study data, suggesting the pooled data may be obscuring information about predictors of events given adverse rates may differ from one patient population to another and may change over time
  • ​​​​​​​LTE studies may provide useful data, however, conduct of open-label LTE studies where both treatment and dose are known to both investigator and patient is subject to certain biases and limitations. Most participants were known to have responded to, and tolerated, XELJANZ® (all had completed a qualifying study), hence our findings might not be generalizable to patients new to XELJANZ
  • ​​​​​​​Biases include, but are not limited to, patient selection (patient willingness or ineligibility to enroll, which may be due to a prior serious AE), prior treatment, volunteer, observer, initial dose or study drug, investigator/patient expectation and study duration. Limitations include, but are not limited to, AE frequencies and incidence rates subject to change over time due to patient entry/exit, dose changes influenced by both investigator and patient, dose restrictions in certain countries, the number of patients and exposure for a specific safety event possibly differing depending on the timing of censored events, and the number of observed patients with longer exposure times becoming lower
Integrated safety summary (ISS): baseline characteristics and demographics3
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Characteristics PsA | All XELJANZ® Dosesb,c
(N=783)
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 (%)  
    Methotrexate 725 (92.6)
    Non-bDMARD(non-methotrexate) 372 (47.5)
    TNFi 377 (48.1)
    Non-TNFi bDMARD 46 (5.9)
Concomitant corticosteroids, n (%) 171 (21.8)
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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)
  • The ISS and analysis of adverse events of special interest includes pooled data from patients exposed to ≥1 dose of XELJANZ in phase 3 clinical trials and LTE studies in PsA3
  • In LTE studies, dose adjustments for XELJANZ or concomitant medications were allowed at the investigator’s discretion for efficacy or safety reasons3
Occurring in ≥2% of patients on XELJANZ 5 mg BID + csDMARD.5Final data for the PsA cohorts are from July 31, 2019.3XELJANZ 5 mg BID is the only approved dosage for the treatment of RA and PsA, which should not be exceeded.1All doses in PsA included XELJANZ 5 mg and 10 mg BID.6 (Note: 10 mg BID is not licensed for RA or PsA).Adjudicated events3Composite MACE defined as any myocardial infarction, stroke, or cardiovascular death3Explore more Learn about the oral administration of XELJANZ See recommended dosing ACR=American College of Rheumatology; ATE=arterial thromboembolism; BID=twice a day; csDMARD=conventional synthetic disease-modifying antirheumatic drug; DVT=deep vein thrombosis; HZ=herpes zoster; JAKi=Janus kinase inhibitor; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; PE=pulmonary embolism; PsA=psoriatic arthritis; pt-yr=patient year; QD=once daily; RA=rheumatoid arthritis;  TB=tuberculosis; UC=ulcerative colitis; VTE=venous thromboembolism. Safety and Tolerability
EFFICACY

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EXPERIENCE

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References:XELJANZ Approved Product InformationData on file, Pfizer Inc, New York, NYBurmester GR, Nash P, Sands BE, et al. Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure. RMD Open. 2021;7:e001595. doi:10.1136/rmdopen-2021-001595Mease P, Charles-Schoeman C, Cohen S, et al. Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data. Ann Rheum Dis. 2020;79(11):1400-1413.Nash P, Coates LC, Kivitz AJ, et al. Safety and efficacy of tofacitinib in patients with active psoriatic arthritis: interim analysis of OPAL Balance, an open-label, long-term extension study. Rheumatol Ther. 2020;7(3):553-580.Burmester GR, Nash P, Sands BE, et al. Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and psoriasis with 37 066 patient-years of tofacitinib exposure. [supplementary appendix]. RMD Open. 2021;7(2):1-36.

▼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.

WARNINGS 
XELJANZ should only be used if no suitable treatment alternatives are available in patients: 
  • with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past, long-time smokers) 
  • with malignancy risk factors (e.g. current malignancy or history of malignancy) 
  • who are 65 years of age and older. 

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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