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.
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.”
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.