Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: Twelve-month data from a twenty-four–month phase III randomized radiographic study

Arthritis & Rheumatism 2013; 65(3):559-70

The ORAL Scan trial is one of six studies conducted as part of the phase 3 research programme for the oral Janus kinase (JAK) inhibitor tofacitinib. This is the 12-month interim results published for the ORAL Scan study, a 24-month, phase 3 study that compared the effects of tofacitinib and placebo on structural preservation in patients with active RA despite methotrexate therapy. Patients were randomised to 5 or 10 mg tofacitinib twice daily or placebo, which was switched to 5 or 10 mg tofacitinib at month 3 in non-responders and month 6 for the remainder. Mean changes in modified total Sharp score (mTSS) at month 12 were significantly greater with 10 mg tofacitinib than placebo (p=0.05) and numerically greater with 5 mg. Both tofacitinib doses resulted in less progression for both components of the mTSS (erosion score and joint space narrowing [JSN] score) than placebo at months 6 and 12 (statistically significant at month 12 for both tofacitinib groups for JSN (p=0.05) but not erosion). Proportions of patients with no radiographic progression at months 6 and 12 were similar for both tofacitinib doses and significantly greater compared to placebo (p=0.05). Proportions of patients with no progression in erosion score were numerically greater with both tofacitinib doses than placebo at month 6 (p>0.05) and significantly greater at month 12 (p=0.05). The study reports the first evidence of tofacitinib’s potential to inhibit progression of structural damage.

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