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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 randomiseda Mean DAS28-3(CRP)a Mean DAS28-4(ESR)a Mean HAQ-DIa Mean no of swollen jointsa Mean no of tender jointsa
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
      Placebob: 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 Placeboc: 5.6, 5.3 Placeboc: 6.6, 6.3 Placeboc: 1.5, 1.4 Placeboc: 16.9, 16.4 Placeboc: 26.6, 28.1
      Placeboc: 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
      Placebob: 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 Placeboc: 5.14, 5.18 Placeboc: 6.25, 6.29 Placeboc: 1.4, 1.23 Placeboc: 14.0, 14.5 Placeboc: 23.3, 22.6
      Placeboc: 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      
  1. 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.
  2. aNo. of patients in tofacitinib group are presented in ascending order of dose.
  3. 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.
  4. 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.