FAQ JANUS
What is JANUS?
JANUS is a subgroup data visualization tool designed to provide tofacitinib (Xeljanz®) efficacy and safety outcomes from clinical trials (Rheumatoid Arthritis) by user selected * clinical trial patient subgroup(s) and displayed in real-time. This is not intended to be used for the management of any individual patient in a clinical setting. JANUS is also not to be used as research tool. JANUS is a post-hoc subgroup data visualization tool for educational purposes only.
Which data are used for JANUS?
JANUS contains Pfizer-sponsored clinical trial data* including 10,875 tofacitinib-treated patients from the Pfizer-sponsored Xeljanz rheumatoid arthritis clinical development program.
*Phase 1, Phase 2, Phase 3, Phase 3b/4 and long-term extension studies; A3921019, A3921024, A3921025, A3921032, A3921035, A3921039, A3921040, A3921041, A3921044, A3921045, A3921046, A3921064, A3921068, A3921069, A3921073, A3921109, A3921129, A3921130, A3921133, A3921152, A3921187, A3921192, A3921215, A3921237.
How were input and output parameters selected?
Clinical characteristics (input) and efficacy and safety outcomes (output) are pre-defined based on clinical trial information captured in the tofacitinib clinical development program. To ensure objectivity, the input and output are consistent with a standard representation of the corresponding clinical trial data (i.e., baseline characteristics and demographics, and efficacy and safety outcomes) in their peer-reviewed scientific publications.
Is JANUS intended to support diagnosis or treatment of RA?
No.
JANUS is a subgroup data visualization tool for informational and educational purposes only, for HCPs who want to learn more about efficacy and safety outcomes by patient subgroup as observed in the tofacitinib RA clinical development program.
Is JANUS intended as a research tool?
No.
JANUS is not intended to be used as research tool. Pfizer has existing data access request procedures for investigators interested in accessing Pfizer product clinical trial data for approved research projects. Please visit Pfizer’s data request portal for more information: Pfizer – Vivli
Is Real World Evidence included?
No.
JANUS does not contain any data from real world data sources. All data in JANUS is originating from Phase 1, 2, 3, 3b/4 studies of tofacitinib in RA.
How are small subgroups and underpowered analysis handled?
The selected subgroup may have limited data, which could lead to uncertain results. Display of efficacy and safety data is contingent upon the subgroup meeting sufficient predefined criteria based on patient count and exposure duration.
Can I communicate the results from JANUS?
No. JANUS is a subgroup data visualization tool designed to provide tofacitinib efficacy and safety outcomes by patient subgroup as selected by the user and displayed in real-time. It is not intended to be used for the management of any individual patient in a clinical setting. JANUS is also not to be used as research tool.
Where can I find the product label text of XELJANZ
Please read the full US FDA prescribing information here
Please choose the category that best describes you.
The data displayed is not necessarily consistent with the XELJANZ product label
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