Efficacy and safety of tofacitinib for treatment of rheumatoid arthritis

Table 2 Results summary for primary outcomes of phase 3 published trials

Primary outcomes	ORAL solo			ORAL step			ORAL standard			ORAL sync			ORAL scan
	Placebo(n = 122)	Tofacitinib 5 mg bid(n = 243)	Tofacitinib 10 mg bid(n = 245)	Placebo(n = 132)	Tofacitinib 5 mg bid(n = 133)	Tofacitinib 10 mg bid(n = 134)	Placebo(n = 108)	Tofacitinib 5 mg bid(n = 204)	Tofacitinib 10 mg bid(n = 201)	Placebo(n = 159)	Tofacitinib5 mgbid(n = 315)	Tofacitinib 10 mgbid(n = 318)	Placebo(n = 160)	Tofacitinib5 mgbid(n = 321)	Tofacitinib 10 mgbid(n = 316)
ACR20 response (%)	26.7	59.8d	65.7d	24.4	41.7b	48.1d	28.3	51.5d	52.6d	30.8	52.1d	56.6d	25.3	51.5d	61.8d
Change from baselineHAQ-DI (LSM change)	-0.19	-0.50d	-0.57d	-0.18	-0.43d	-0.46d	-0.24	-0.55a	-0.61a	-0.16	-0.44d	-0.53d	-0.15	0.402	-0.54d
DAS-28-4(ESR) less than2.6 (%)	4.4	5.61	8.71	1.7	6.7a	8.8a	1.1	6.2a	12.5a	2.6	8.5b	12.5d	1.6	7.22	16.0d

^bP < 0.01;

^aP < 0.05;

^dP < 0.001 vs placebo trials.

¹Not significant;

²Significance not declared for this co-primary endpoint. ORAL: Oral rheumatoid arthritis triaLs; HAQ-DI: Health assessment questionnaire disability index; DAS: Disease activity score.