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Xeljanz Monotherapy Tied to Better Outcomes in Early RA

August 10, 2016

Patients with early rheumatoid arthritis (RA) treated with Xeljanz (tofacitinib; Pfizer) monotherapy demonstrated significantly greater improvements versus those with established RA, according to recent research.

According to the study, previous research concluded tofaitinib monotherapy inhibited structural damage, reduced clinical signs and symptoms of RA, and improved physical function over 24 months in methotrexate (MTX)-naïve adult patients with RA. In the recent post hoc analysis, researchers compared efficacy and safety of tofacitinib in patients with early RA (disease duration <1 year) versus established RA (≥1 year.


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The 24-month, phase III trial included MTX-naïve patients aged 18 years or older with active RA. Study participants received either tofacitinib monotherapy (5 or 10 mg, twice daily), or MTX monotherapy. The researchers administered 5 mg of tofacitinib to 373 patients, 10 mg to 397 patients, and MTX monotherapy to 186 patients.

Of the 956 enrolled patients, 54% had defined, early RA. Both treatment groups experienced similar baseline disease activity and functional disability; however, radiographic damage was greater in patients with established RA.

Patients who received 5 mg of tofacitinib experienced significantly greater clinical response rates with early RA versus established RA at 4 months. At the year and 2-year follow-up, patients in both tofacitinib dose groups had greater effects on clinical, functional and radiographic improvements compared with the MTX group. Researchers did not observe new safety data.

Irrespective of disease situation, tofacitinib demonstrated greater efficacy than MTX, and no differences in safety profiles were observed between patients with early or established RA.

This study was funded by Pfizer. -Julie Gould 



Fleischmann RM, Huuizinga TW, Kavanaugh AF, et al. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis [published online July 26, 2016]. RMD Open. doi:10.1136/rmdopen-2016-000262


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