Efficacy and safety of tofacitinib modified-release 11 mg once daily plus methotrexate in adult patients with rheumatoid arthritis: 24-week open-label phase results from a phase 3b/4 methotrexate withdrawal non-inferiority study (ORAL Shift).
Stanley B CohenJanet E PopeBoulos HaraouiEduardo MyslerAnnette DiehlTatjana LukicShixue LiuLori StockertRebecca GerminoSujatha MenonHarry ShiEdward C KeystonePublished in: RMD open (2021)
Tofacitinib modified-release 11 mg once daily plus methotrexate conferred improvements in disease activity measures, functional outcomes and PROs, with most (84.5%) patients achieving CDAI-defined LDA after 24 weeks of open-label treatment; the safety profile was generally consistent with the historic safety profile of tofacitinib.Funded by Pfizer Inc; NCT02831855.
Keyphrases
- rheumatoid arthritis
- disease activity
- open label
- high dose
- systemic lupus erythematosus
- clinical trial
- rheumatoid arthritis patients
- ankylosing spondylitis
- ulcerative colitis
- physical activity
- ejection fraction
- newly diagnosed
- juvenile idiopathic arthritis
- phase iii
- prognostic factors
- study protocol
- low dose
- patient reported outcomes