The recommended dose of XELJANZ in RA is 5 mg administed BID, or 11 mg administed OD, which should not be exceeded.²
a MACE defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. 
b Patients who were treated with tofacitinib 10 mg BID were switched to tofacitinib 5 mg BID.
c Patients randomised to TNFi in North America, including United States, Puerto Rico, and Canada received adalimumab 40 mg q2w; in the rest of the world, those randomized to TNFi received etanercept 50 mg qw.
d Based on Cox proportional hazard model.
e NNH over a period of 5 years was the number of patients who would need to be treated for that duration with tofacitinib rather than a TNFi to result in one additional adverse event; calculations were performed post hoc.

For adjudicated MACE and adjudicated malignancies (excluding NMSC), the prespecified noninferiority criterion was not met for the primary comparison of the combined tofacitinib doses to TNFi^a

Adjudicated MACE
•    The primary analyses included 135 patients with MACE
•    The most frequently reported MACE for tofacitinib was non-fatal myocardial infarction
•    A 60-day on-treatment time analysis was used to assess the MACE coprimary endpoint

Adjudicated malignancies (excluding NMSC)
•    The primary analyses included 164 patients with malignancies (excluding NMSC)
•    The most frequently reported malignancy with tofacitinib was lung cancer
•    A total time analysis was used to assess the malignancy coprimary endpoint

The recommended dose of XELJANZ in RA is 5 mg administed BID, or 11 mg administed OD, which should not be exceeded.² Pfizer continues to work with the EMA and other regulatory agencies to update XELJANZ labeling in their respective markets based on their ongoing review of the complete ORAL Surveillance results. 
a The noninferiority criterion was not met for the primary comparison of the combined tofacitinib doses to TNFi since the upper limit of the 95% CI exceeded the pre-specified noninferiority criterion of 1.8. (ie, for MACE: 1.94>1.8, for malignancy: 2.09>1.8).
b Defined as the time from the first dose of a trial drug until the end of the risk period (ie, last contact date or last trial dose plus 60 days, whichever was earliest). 
c Defined as the time from the first dose of a trial drug until the last contact date. The last contact date was the latest of the following: the start date of an AE, the end date of an AE, the date of the last trial visit, the withdrawal date, the telephone contact date, or the date of death. 
d Based on Cox proportional hazard model.
e NNH over a period of 5 years was the number of patients who would need to be treated for that duration with tofacitinib rather than a TNFi to result in one additional adverse event; calculations were performed post hoc. 

A 28-day-on-treament period analysis was used to assess AEs^a

The recommended dose of XELJANZ in RA is 5 mg administed BID, or 11 mg administed OD, which should not be exceeded.² Pfizer continues to work with the EMA and other regulatory agencies to update XELJANZ labeling in their respective markets based on their ongoing review of the complete ORAL Surveillance results. 
a Defined as the minimum of the date of last contact or the date of the last dose of a trial treatment plus 28 days.
b Based on Cox proportional hazard model.
c Also included are opportunistic herpes zoster and tuberculosis events.
d Included are herpes zoster adjudicated as an opportunistic infection and nonadjudicated herpes zoster events.

a Average dosing was based on average daily dose; some patients recieved 10 mg BID during the LTE.
b Patients with a DVT event, a PE event, or both DVT and PE events. A total of 5 patients experienced a DVT and PE event (may not have occurred at the same time).¹

​​​​​XELJANZ 5 mg BID and 11 mg prolonged-release QD are the only approved dosages for the treatment of RA, which should not be exceeded. 10 mg BID is not licensed for RA².​​​​​​

References