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Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs

Strand V, Kremer J, Wallenstein G, Kanik KS, Connell C, Gruben D, Zwillich SH, Fleischmann R. - Arthritis Research & Therapy (2015) 17:307 DOI: 10.1186/s13075-015-0825-9 [Epub ahead of print]

RA presents a significant health and socioeconomic burden particularly in physical functioning, fatigue, and emotional roles. A phase III 6-month study of tofacitinib in patients with active RA, who had prior inadequate responses to cDMARDs or bDMARDs, uses patient-reported outcomes (PROs) to assess the impact on quality of life. Patients were randomized 4:4:1:1 to receive tofacitinib 5 or 10 mg BID, or placebo for 3 months followed by tofacitinib 5 or 10 mg BID.

At month 3, tofacitinib 5 and 10 mg demonstrated statistically significant improvements across multiple PROs including Patient Global Assessment of Disease Activity (PtGA). Pain, HAQ-DI, and Physical and Mental component summary scores. Significant changes versus placebo are seen at the first time point post-baseline, as early as 2 weeks. In patients continuing to month 6, improvements are greater for 10 versus 5 mg BID.

This study demonstrates that tofacitinib treatment provides relief from the burden of active RA, impacting a wide range of physical and emotional PROs.

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Upload date: December 2015

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