Table 2.

Incidence rate, crude hazard ratio, and corresponding 95% confidence intervals for the primary composite cardiovascular outcome in RWE and RCT-duplicate cohort of rheumatoid arthritis patients initiating treatment with tofacitinib or tumor necrosis factor inhibitors

Data source	Exposure group	Sample Size	Events	Total person years of follow-up	Crude Incidence Rate (95% CI)*	Crude Incidence Rate Difference (95% CI)*	Crude HR (95% CI)
RWE Cohort
Optum	TNFI	24,805	143	23,458	0.61 (0.51 to 0.72)	Ref	Ref
	Tofacitinib	3,763	24	3,273	0.73 (0.47 to 1.09)	0.12 (−0.19 to 0.43)	1.21 (0.78 to 1.86)
MarketScan	TNFI	28,776	141	27,257	0.52 (0.44 to 0.61)	Ref	Ref
	Tofacitinib	5,307	35	4,655	0.75 (0.52 to 1.05)	0.23 (−0.03 to 0.50)	1.44 (0.99 to 2.09)
Medicare	TNFI	35,830	562	30,277	1.86 (1.71 to 2.02)	Ref	Ref
	Tofacitinib	3,782	69	3,229	2.14 (1.66 to 2.70)	0.28 (−0.25 to 0.81)	1.15 (0.89 to 1.48)
Pooled	TNFI	89,411	846	80,992	1.24 (1.16 to 1.33)	Ref	Ref
	Tofacitinib	12,852	128	11,157	1.31 (1.10 to 1.56)	0.20 (0.01 to 0.39)	1.23 (1.02 to 1.48)
RCT-Duplicate Cohort
Optum	TNFI	6,077	56	5,932	0.94 (0.71 to 1.23)	Ref	Ref
	Tofacitinib	801	10	752	1.33 (0.64 to 2.45)	0.39 (−0.47 to 1.25)	1.43 (0.73 to 2.81)
MarketScan	TNFI	6,920	55	6,857	0.80 (0.60 to 1.04)	Ref	Ref
	Tofacitinib	1,151	13	1,069	1.22 (0.65 to 2.08)	0.41 (−0.28 to 1.11)	1.50 (0.82 to 2.74)
Medicare	TNFI	18,576	289	16,241	1.78 (1.58 to 2.00)	Ref	Ref
	Tofacitinib	1,545	32	1,338	2.39 (1.64 to 3.38)	0.61 (−0.24 to 1.47)	1.35 (0.93 to 1.94)
Pooled	TNFI	31,573	400	29,030	1.46 (1.32 to 1.61)	Ref	Ref
	Tofacitinib	3,497	55	3,159	1.83 (1.41 to 2.39)	0.46 (0.01 to 0.92)	1.39 (1.05 to 1.85)

-Abbreviations: CI-Confidence interval, HR-Hazard ratio, RCT-randomized controlled trial, Ref-Reference, RWE-Real world evidence, TNFI-tumor necrosis factor inhibitors

-All estimates were pooled using fixed effects models with inverse variance weighting

^*Per 100 person-years