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Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies
Author(s) -
Fleischmann Roy,
Kremer Joel,
Tanaka Yoshiya,
Gruben David,
Kanik Keith,
Koncz Tamas,
Krishnaswami Sriram,
Wallenstein Gene,
Wilkinson Bethanie,
Zwillich Samuel H.,
Keystone Edward
Publication year - 2016
Publication title -
international journal of rheumatic diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.795
H-Index - 41
eISSN - 1756-185X
pISSN - 1756-1841
DOI - 10.1111/1756-185x.12901
Subject(s) - tofacitinib , medicine , janus kinase inhibitor , rheumatoid arthritis , safety profile , janus kinase , methotrexate , adverse effect , pharmacology , cytokine
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis ( RA ). Here, the safety and efficacy data from five Phase 2 studies of tofacitinib in patients with RA are summarized. Tofacitinib 1–30 mg twice daily was investigated, as monotherapy and in combination with methotrexate, in patients with RA . Tofacitinib 20 mg once daily was investigated in one study. Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3 studies; therefore, the efficacy and safety of tofacitinib 5 and 10 mg twice daily in Phase 2 studies are the focus of this review. Tofacitinib ≥ 5 mg twice daily was efficacious in a dose‐dependent manner, with statistically significant and clinically meaningful reductions in the signs and symptoms of RA and patient‐reported outcomes. The safety profile was consistent across studies. The efficacy and safety profile of tofacitinib in Phase 2 studies supported its further investigation and the selection of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily for evaluation in Phase 3 studies.