Treatment with tofacitinib in refractory psoriatic arthritis. National multicenter study of the first 87 patients of clinical practice.

OBJECTIVE Tofacitinib (TOFA) is the first Janus kinase (JAK) inhibitor approved for Psoriatic Arthritis (PsA). It has shown efficacy in patients refractory to anti-TNFα in Randomized Clinical Trials (RCT). Our aim was to assess efficacy and safety of TOFA in clinical practice. METHODS Observational, open-label multicenter study of PsA patients treated with TOFA due to inefficacy or adverse events of previous therapies. Outcome variables were efficacy, sparing corticosteroid-dose effect, retention rate and safety. Comparative study of clinical features between our cohort of patients and those from the OPAL BEYOND trial was performed. RESULTS 87 patients (28 women/59 men), mean age of 52.8±11.4 years. All patients were refractory to b-DMARDs and/or to cs-DMARDs plus Apremilast. TOFA was started at 5mg twice daily after a mean follow-up of 12.3±9.3 years from PsA diagnosis. At first month, DAS28ESR decreased from 4.8 [4.1-5.4] to 3.7 [2.8-4.7] (p <0.01), DAPSA from 28 [18.4-34.1] to 15.5 [10.1-25.7] (p < 0.01) and C-reactive protein from 1.9 [0.3-5.0] to 0.5 [0.1-2.2] mg/dL (p < 0.01). Also, TOFA led to a significant reduction of prednisone dose. Mild adverse effects were reported in 21 patients (24.13%), mainly gastrointestinal symptoms. TOFA retention rate at month 6 was 77% (CI 95%; 65.2-86.3 %). Patients of clinical practice were older with longer disease duration and received biologic agents more commonly than those in the OPAL BEYOND trial. CONCLUSION Data from clinical practice confirm that TOFA seems to be effective, rapid and relatively safe in refractory PsA despite clinical differences with patients in RCT.