Table 3

Piecewise HRs (95% CI) for malignancies excluding NMSC based on a piecewise exponential hazard model at fixed change-points of 18 and 24 months and treatment-by-period interaction 2-sided p values

HR (95% CI)
Change-pointMonth 18 (day 540)Month 24 (day 720)
PeriodBaseline to Month 18Month 18 onwardsTreatment-by-period interaction 2-sided p valueBaseline to Month 24Month 24 onwardsTreatment-by-period interaction 2-sided p value
Combined tofacitinib doses* vs NFi0.93 (0.53 to 1.62)1.93 (1.22 to 3.06)0.04691.25 (0.75 to 2.07)1.70 (1.05 to 2.77)0.3864
Tofacitinib 5 mg two times per day vs TNFi0.99 (0.53 to 1.88)1.87 (1.13 to 3.10)0.12801.14 (0.63 to 2.04)1.81 (1.06 to 3.09)0.2466
Tofacitinib 10 mg two times per day vs TNFi0.86 (0.44 to 1.67)1.99 (1.20 to 3.30)0.04771.36 (0.77 to 2.40)1.59 (0.92 to 2.75)0.7055
  • In this piecewise exponential hazard model analysis, one change-point is used to divide the timelines into two periods. Log-hazards for the two periods for each treatment were estimated separately by treatment group (combined tofacitinib, tofacitinib 5 mg two times per day, tofacitinib 10 mg two times per day, and TNFi). The HR between tofacitinib versus TNFi was calculated by exponentiation of the log-hazard difference. The 95% CI was estimated assuming large sample approximation. The treatment-by-period interaction 2-sided p-value is based on the difference of the two log-hazard differences (tofacitinib dose group vs TNFi) between the two periods (period 1 vs period 2), using large sample approximation.

  • For patients randomised to the tofacitinib 10 mg two times per day group who had their dose of tofacitinib reduced to 5 mg two times per day, the data collected after patients were switched to tofacitinib 5 mg two times per day were counted in the tofacitinib 10 mg two times per day group.

  • For malignancies excluding NMSC, the risk period was total time, defined as time from first dose of trial drug until last contact date.

  • *Includes patients who received tofacitinib 5 or 10 mg two times per day in ORAL Surveillance.

  • NMSC, non-melanoma skin cancer; TNFi, tumour necrosis factor inhibitors.