Table 1: Summary of published studies on Tofacitinib.

StudyPhase DurationParticipants InterventionPrimary Outcome

Burmester et al. [15]36 monthsModerate to severe RA Patients with inadequate response to TNFα inhibitors ( )Tofacitinib 5 mg bd;
Tofacitinib 10 mg bd;
placebo all with methotrexate
ACR 20 response at month 3;
DAS 28-4 ESR < 2.6 at month 3;
HAQ-DI at month 3 (change from baseline)

Fleischmann et al. [16]36 monthsActive RA patients receiving stable doses of antimalarial agents
Prior inadequate response to at least one DMARD (biologic or nonbiologic) ( )
Tofacitinib 5 mg bd;
Tofacitinib 10 mg bd;
placebo for 3 months followed by Tofacitinib 5 mg bd;
placebo for 3 months followed by Tofacitinib 10 mg bd
ACR 20 response at month 3;
DAS 28-4 ESR < 2.6 at month 3;
HAQ-DI at month 3 (change from baseline)

Kremer et al. [17]312 monthsActive RA Patients with inadequate response to ≥1 DMARD ( )Tofacitinib 5 mg bd;
Tofacitinib 10 mg bd;
placebo
ACR 20 response at month 6;
DAS 28-4 ESR < 2.6 at month 6;
HAQ-DI at month 3 (change from baseline)

van der Heijde et al. [18]324 monthsActive RA patients receiving background methotrexate ( )Tofacitinib 5 mg bd;
Tofacitinib 10 mg bd;
placebo followed by Tofacitinib 5 mg bd;
placebo followed by Tofacitinib 10 mg bd
ACR 20 response at month 6;
DAS 28-4 ESR < 2.6 at month 6;
HAQ-DI at month 3 (change from baseline)

van Vollenhoven et al. [19]312 monthsActive RA patients receiving stable doses of methotrexate ( )Tofacitinib 5 mg bd;
Tofacitinib 10 mg bd;
adalimumab 40 mg every 2 weeks;
placebo
ACR 20 response at month 6;
DAS 28-4 ESR < 2.6 at month 6;
HAQ-DI at month 3 (change from baseline)

Fleischmann et al. [20]2b24 weeksActive RA Patients with inadequate response to DMARD ( )Tofacitinib 1 mg, 3 mg, 5 mg, 10 mg, or 15 mg bd;
adalimumab 40 mg every 2 weeks for 6 injections followed by Tofacitinib 5 mg bd;
placebo
ACR 20 response at week 12

Kremer et al. [21]2b24 weeksActive RA patients receiving stable doses of methotrexate with inadequate response to methotrexate alone ( )Tofacitinib 20 mg daily;
Tofacitinib 1 mg, 3 mg, 5 mg, 10 mg, or 15 mg bd;
placebo
ACR 20 response at week 12

Tanaka et al. [22]212 weeksActive RA patients receiving stable doses of methotrexate with inadequate response to methotrexate alone ( )Tofacitinib 1 mg, 3 mg, 5 mg, and 10 mg bd;
placebo
ACR 20 response at week 12

Kremer et al. [23] 2a6 weeksActive RA Patients with inadequate or toxic response to methotrexate, etanercept, infliximab, or adalimumab ( ) Tofacitinib 5 mg, 15 mg, and 30 mg bd;
placebo
ACR 20 response at week 6

Coombs et al. [24]26 weeksModerate to severe active RA Patients with inadequate response to methotrexate or a TNFα inhibitor ( )Tofacitinib 5 mg, 15 mg, and 30 mg bd;
placebo
Visual analogue scale scores at week 6;
HAQ-DI (change from baseline) and short form-36 (SF-36) at week 6