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Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors

Gladman D, Rigby W, Azevedo VF, Behrens F, Blanco R, Kaszuba A, Kudlacz E, Wang C, Menon S, Hendrikx T, Kanik KS. - N Engl J Med 2017;377:1525–36.

The study data presented that tofacitinib (TOF) improves efficacy response rates in patients with severe psoriatic arthritis (PsA) who have an inadequate response to TNF inhibitors.

The Phase 3 Oral Psoriatic Arthritis Trial (OPAL) Beyond study evaluated patients with active PsA who had inadequate responses to more than one TNFi. Patients were randomised 2:2:1:1 to 5 mg TOF BID or 10 mg TOF BID for 6 months; or PBO, with a switch to 5 mg TOF BID or to 10 mg BID at 3 months.

Primary endpoints were ACR20 response rates and change in HAQ-DI score from baseline. Secondary endpoints included: PASI75 response, Dactylitis Severity Score and Leeds Enthesitis index Score.

ACR20 and HAQ-DI responses were significantly improved with both doses of TOF compared with placebo. However, patients who were initially given the placebo had lower rates of AEs than the patients who received TOF from the start of the trial.

A duration of 6 months is not long enough to assess long-term safety and efficacy; a 12-month Phase 3 trial in patients who had an inadequate response to csDMARDs has been conducted and recently reported (1).

1. Mease P, et al. N Engl J Med 2017;377:1537–50.

Keywords: JAK, Tofacitinib, Clinical, Phase 3

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Upload date: November 2017

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