Tofacitinib or adalimumab versus placebo: patient-reported outcomes from a phase 3 study of active rheumatoid arthritis
RA not only affects the physical aspects of a patient’s health but also has an impact on the psychological well-being causing a significant disease burden. This paper reports on the patient-reported outcomes (PROs) from the ORAL Standard study.
This study investigated tofacitinib 5mg BID, 10mg BID, adalimumab vs. placebo over 12 months with a primary endpoint at month 3. All treatment groups showed significant improvements over placebo in HAQ-DI, PtGA and Pain with LSM changes in baseline sustained through month 12. It is also noted that greater proportions of patients in the tofacitinib and adalimumab reported ≥MCID in HAQ-DI, PtGA and Pain, with the greatest differences being reported in the tofacitinib groups (HAQ-DI in 5mg and PtGA and Pain in 10mg).
Both the tofacitinib and adalimumab treatment arms reported clinically meaningful improvements across a wider range of PROs. While improvements were achieved with both tofacitinib 5mg BID and adalimumab, the greatest improvements were observed with tofacitinib 10mg BID.