Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: a systematic review and meta-analysis

He, Ying; Wong, Angel YS; Chan, Esther W; Lau, Wallis CY; Man, Kenneth KC; Chui, Celine SL; Worsley, Alan J; Wong, Ian CK

doi:10.1186/1471-2474-14-298

Table 1 Characteristics of randomised controlled studies included in this meta-analysis

From: Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: a systematic review and meta-analysis

Article	Region	Study duration, weeks	Possible concomitant medication	Dose of tofacitinib	No of patients randomised^a	Mean DAS28-3(CRP)^a	Mean DAS28-4(ESR)^a	Mean HAQ-DI^a	Mean no of swollen joints^a	Mean no of tender joints^a
Fleischmann 2012a [21]	United States; Europe; Latin American; the Republic of Korea	24	NSAIDs; antimalarial agents; opioids; acetaminophen; oral glucocorticoids	1, 3, 5, 10, 15 mg bid	Total: 386	Placebo:5.6	Placebo:6.6	Placebo:1.54	Placebo:16.9	Placebo:25.9
					Placebo: 59
					tofacitinib: 54, 51, 49, 61, 57	tofacinitib: 5.5, 5.4, 5.6, 5.5, 5.5	tofacinitib: 6.5, 6.4, 6.6, 6.5, 6.5	tofacinitib: 1.57, 1.53, 1.40, 1.49, 1.62	tofacinitib: 16.7, 15.9, 17.4, 16.3, 16.9	tofacinitib: 27.0, 24.6, 27.1, 25.7, 25.9
					adalimumab 40 mg qow: 53	adalimumab 40 mg qow: 5.4	adalimumab 40 mg qow: 6.3	adalimumab 40 mg qow: 1.44	adalimumab 40 mg qow: 14.9	adalimumab 40 mg qow: 24.1
					Randomised but not treated: 2
Fleischmann 2012b [25]	United States; Europe; Latin America; Asia	24	NSAIDs; glucocorticoids;	5, 10 mg bid	Total: 611	Placebo: 5.56	Placebo: 6.65	Placebo: 1.53	Placebo: 17.3	Placebo: 28.9
					Placebo^b: 61, 61	tofacitinib: 5.68, 5.60	tofacitinib: 6.71, 6.70	tofacitinib: 1.53, 1.50	tofacitinib: 16.3, 17.0	tofacitinib: 29.4, 29.1
					tofacitinib:243, 245
					Randomised but not treated: 1
Kremer 2009 [20]	United States; Canada; Europe; Latin American	6 (treatment)?+?6 (follow-up)	NSAIDs; selective COX-2 inhibitors; opioids; acetaminophen; oral glucocorticoids	5, 15, 30 mg bid	Total: 264	Placebo: 6.0	NA	Placebo: 1.7	Placebo: 20.01	Placebo: 30.3
					Placebo: 65
					tofacitinib: 61, 69, 69	tofacitinib: 6.2, 5.7, 5.9		tofacitinib: 1.7, 1.6, 1.6	tofacitinib: 21.1, 16.2, 19.5	tofacitinib: 32.3, 26.7, 29.3
Kremer 2012 [19]	United States; Europe; Latin America	24	MTX (compulsory)	1, 3, 5, 10, 15 mg bid, 20 mg qd	Total: 509	Placebo: 5.3	Placebo: 6.1	Placebo: 1.20	Placebo: 15.7	Placebo: 21.6
					Placebo: 69	tofacitinib: 5.5, 5.3, 5.1, 5.3, 5.4	tofacitinib: 6.4, 6.1, 6.1, 6.4, 6.2	tofacitinib: 1.58, 1.36, 1.44, 1.33, 1.41	tofacitinib: 6.5, 15.7, 14.1, 14.7, 15.3	tofacitinib: 23.6, 22.8, 21.5, 24.8, 23.7
					tofacitinib: 70, 68, 71, 74, 75	20 mg qd: 5.3	20 mg qd: 6.3	20 mg qd: 1.46	20 mg qd: 15.2	0 mg qd: 23.1
					20 mg qd: 80Randomised but not treated: 2
Tanaka 2011 [18]	Japan	12	MTX supplemented with folic acid (compulsory);	1, 3, 5, 10 mg bid	Total: 140	Placebo: 4.9	Placebo: 5.9	Placebo: 1.3	Placebo: 13.8	Placebo: 16.4
					Placebo: 28
					tofacitinib: 28, 27, 27, 26	tofacitinib: 5.0, 5.1, 5.0, 4.9	tofacitinib: 6.1, 6.1, 6.0, 5.9	tofacitinib: 1.1, 1.3, 1.2, 1.2	tofacitinib: 13.2, 15.1, 15.6, 15.1	tofacitinib: 16.4, 16.2, 17.8, 15.4
			NSAIDs;selective COX-2 inhibitors; glucocorticoids		Randomised but not treated: 4
van Vollenhoven2012 [22]	North America; Latin America; Europe; etc.	52	MTX (compulsory) 5, 10 mg bid		Total: 717	Placebo^c: 5.6, 5.3	Placebo^c: 6.6, 6.3	Placebo^c: 1.5, 1.4	Placebo^c: 16.9, 16.4	Placebo^c: 26.6, 28.1
					Placebo^c: 56, 52	tofacitinib: 5.4, 5.4	tofacitinib: 6.6, 6.5	tofacitinib: 1.5, 1.5	tofacitinib: 16.7, 15.8	tofacitinib: 28.5, 26.1
					tofacitinib: 204, 201	adalimumab 40 mg qow: 5.3	adalimumab 40 mg qow: 6.4	adalimumab 40 mg qow: 1.5	adalimumab 40 mg qow:16.4	adalimumab 40 mg qow: 26.7
					adalimumab 40 mg qow: 204
Burmester 2013 [24]	North America, Europe, Latin America, etc.	24	MTX (compulsory); antimalarial therapy; No other DMARDs (non-biological or biological) were permitted NSAIDs, selective cyclooxygenase-2 inhibitors, or glucocorticoids	5, 10 mg bid	Total: 399	Placebo: 5.4	Placebo: 6.4	Placebo: 1.6	Placebo: 17.2	Placebo: 28.2
					Placebo^b: 66, 66	tofacitinib: 5.4, 5.3	tofacitinib: 6.5, 6.4	tofacitinib: 1.6, 1.5	tofacitinib: 16.2, 16.6	tofacitinib: 28.4, 27.6
					tofacitinib: 133, 134
Van der Heijde 2013 [23]	America, Europe, Asia, Australia	104	MTX (compulsory); NSAIDs; corticosteroids	5, 10 mg bid	Total: 797	Placebo^c: 5.14, 5.18	Placebo^c: 6.25, 6.29	Placebo^c: 1.4, 1.23	Placebo^c: 14.0, 14.5	Placebo^c: 23.3, 22.6
					Placebo^c: 81, 79	tofacitinib: 5.22, 5.20	tofacitinib: 6.34, 6.25	tofacitinib: 1.41, 1.39	tofacitinib: 14.1, 14.4	tofacitinib: 24.1, 23.0
					tofacitinib: 321, 316

DAS28: Disease Activity Score for 28 joint counts; CRP: C-reactive protein; ESR: erythrocyte sedimentation rate; HAQ-DI: Health Assessment Questionnaire disability index; bid, twice daily; qd, once daily; qow, once every other week; NSAIDs: non-steroidal anti-inflammatory drugs; MTX: methotrexate; COX-2: cyclooxygenase-2.
^aNo. of patients in tofacitinib group are presented in ascending order of dose.
^bPatients in placebo group were assigned to 5 or 10 mg tofacitinib after 3 months; Numbers are presented in ascending order of dose of tofacitinib after switch.
^cPatients assigned to placebo were randomly switched to either 5 or 10 mg of tofacitinib if they did not reduce the number of swollen and tender joints by 20% after 3 months. All patients in the placebo group were assigned in a blinded fashion to either 5 or 10 mg of tofacitinib after 6 months; Numbers are presented in ascending order of dose of tofacitinib after switch.

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