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©2014 Baishideng Publishing Group Inc.
World J Orthop. Sep 18, 2014; 5(4): 504-511
Published online Sep 18, 2014. doi: 10.5312/wjo.v5.i4.504
Published online Sep 18, 2014. doi: 10.5312/wjo.v5.i4.504
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 |
- Citation: Lundquist LM, Cole SW, Sikes ML. Efficacy and safety of tofacitinib for treatment of rheumatoid arthritis. World J Orthop 2014; 5(4): 504-511
- URL: https://www.wjgnet.com/2218-5836/full/v5/i4/504.htm
- DOI: https://dx.doi.org/10.5312/wjo.v5.i4.504