Tofacitinib, an oral Janus kinase inhibitor, may become a new option to reduce disease activity among patients with active psoriatic arthritis (PsA) who have previously had an inadequate response to 1 or more tumor necrosis factor (TNF) inhibitors, according to a phase 3 study published in the New England Journal of Medicine.

Researchers randomly assigned 395 patients with active PsA that had failed to respond to treatment with a TNF inhibitor to receive tofacitinib 5 mg twice daily (n=132), tofacitinib 10 mg twice daily (n=132), or placebo with a switch at 3 months to either tofacitinib 5 mg twice daily (n=66) or tofacitinib 10 mg twice daily (n=65). 

At the 3-month analysis, 50% of patients taking tofacitinib 5 mg and 47% taking tofacitinib 10 mg demonstrated at least 20% improvement according to the criteria of the American College of Rheumatology (ACR20), compared with 24% of patients taking placebo (P <.001 for both comparisons). In addition, the mean change from baseline scores on the Health Assessment Questionnaire-Disability Index (HAQ-DI) were -0.39 and -0.35 for the 5-mg and 10-mg tofacitinib groups, respectively, compared with -0.14 for the placebo group (P <.001 for both comparisons). Adverse events were reported more frequently in patients receiving tofacitinib compared with those receiving placebo, as were elevations in aspartate and alanine aminotransferase concentrations.

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The authors concluded that “among patients with active psoriatic arthritis who had had an inadequate response to TNF inhibitors, the twice-daily doses of 5 mg and 10 mg of tofacitinib were superior to placebo over 3 months in reducing the number of inflamed joints, lowering HAQ-DI scores, and improving physical function.”


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Reference

Gladman D, Rigby W, Azevedo VF, et al. Tofacitinib for psoriatic arthritis in patients with an inadequate response to TNF inhibitors. N Engl J Med. 2017;377:1525-1536.