Efficacy and safety of tofacitinib for treatment of rheumatoid arthritis

Table 1 Summary of published phase 3 tofacitinib studies

Study	Duration	Participants	Demographics	Intervention	Primary outcome
ORAL solo	6 mo	Active RA patients with inadequate response to at least one DMARD (biologic or nonbiologic) receiving stable doses of antimalarial	n = 611 Age: 49.7-52.4 yr Female: 85.2%-88.2% Duration of RA: 7.7-8.6 Baseline HAQ-DI: 1.50-1.53 Baseline DAS-28: 6.65-6.71	Tofacitinib 5 mg bid; Tofacitinib 10 mg bid; placebo for 3 mo then Tofacitinib 5 mg bid; placebo for 3 mo then Tofacitinib 10 mg bid	ACR20 response at month 3; DAS 28-4 ESR < 2.6 at month 3; HAQ-DI at month 3 (change from baseline)
ORAL step	6 mo	Moderate to severe RA patients with inadequate response to TNF alpha inhibitors	n = 399 Age: 54.4-55.4 yr Female: 80.3%-86.36% Duration of RA: 11.3-13.0 yr Baseline HAQ-DI: 1.5-1.6 Baseline DAS-28: 6.4-6.5	Tofacitinib 5 mg bid; Tofacitinib 10 mg bid; placebo for 3 mo then Tofacitinib 5 mg bid; placebo for 3 mo then Tofacitinib 10 mg bid	ACR20 response at month 3; DAS 28-4 ESR < 2.6 at month 3; HAQ-DI at month 3 (change from baseline)
ORAL standard	12 mo	Active RA patients receiving stable doses of methotrexate	n = 717 Age: 51.9-55.5 yr Female: 75.0%-85.3% Duration of RA: 6.9-9.0 yr Baseline HAQ-DI: 1.4-1.5 Baseline DAS-28: 6.3-6.6	Tofacitinib 5 mg bid; Tofacitinib 10 mg bid; adalimumab 40 mg SC every 2 wk; placebo for 6 mo then Tofacitinib 5 mg bid; placebo for 6 mo then Tofacitinib 10 mg bid	ACR20 response at month 6; DAS 28-4 ESR < 2.6 at month 6; HAQ-DI at month 3 (change from baseline)
ORAL sync	12 mo	Active RA patients with inadequate response to one or more DMARD	n = 792 Age: 50.8-53.3 yr Female: 75.0%-83.8% Duration of RA: 8.1-10.2 yr Baseline HAQ-DI: 1.24-1.45 Baseline DAS-28: 6.14-6.44	Tofacitinib 5 mg bid; Tofacitinib 10 mg bid; Placebo	ACR20 response at month 6; DAS 28-4 ESR < 2.6 at month 6; HAQ-DI at month 3 (change from baseline)
ORAL scan	24 mo	Active RA patients receiving background methotrexate	n = 797 Age: 52.0-53.7 yr Female: 80.2%-91.1% Duration of RA: 8.8-9.5 yr Baseline HAQ-DI: 1.23-1.41 Baseline DAS-28: 6.25-6.34	Tofacitinib 5 mg bid; Tofacitinib 10 mg bid; placebo for 3 mo then Tofacitinib 5 mg bid; placebo for 3 mo then Tofacitinib 10 mg bid	ACR20 response at month 6; DAS 28-4 ESR < 2.6 at month 6; HAQ-DI at month 3 (change from baseline); SHS at month 6 (change from baseline)
ORAL start	24 mo	Methotrexate naïve patients with active RA	n = 952 Baseline TSS: 16.51-20.30	Tofacitinib 5 mg bid; Tofacitinib 10 mg bid; methotrexate 10 mg per week with 5 mg increments every 4 wk to 20 mg per week	Modified Total Sharp Score at month 6; ACR70 response at month 6

DMARD: Disease-modifying antirheumatic drug; TSS: Total sharp score; TNF: Tumor necrosis factor; SHS: Sharp/van der Heijde Score; HAQ-DI: Health Assessment Questionnaire Disability Index; DAS: Disease activity score.