Impact of tofacitinib on patient-reported outcomes in patients with psoriatic arthritis. Data from the real clinical practice
Authors: Vorobyeva L. D. , Korotaeva T. V. , Loginova E. Yu. , Korsakova Yu. L. , Gubar E. E. , Nasonov E. L. 
Published: July 2022

Objective – to study the effect of tofacitinib (TOFA) on Patient-Reported Outcomes (PROs) in psoriatic arthritis (PsA) patients (pts) activity in real clinical practice.

Material and methods. Included 41 patients, predominantly men (58.9%), with a reliable diagnosis of psoriatic arthritis (PsA) according to the CASPAR criteria (2006), and signed informed consent to participate in the study. Mean age – 43.0±10.1 years, PsA duration – 18.6±10.4 years, psoriasis duration – 7.7±7.1 years, disease activity according to DAPSA (Disease Activity in Psoriatic Arthritis) – 44.2±17. At the initial visit, after 3 and 6 months, all patients underwent a standard rheumatological examination. The tender joint number (TJN) out of 68, the swollen joints number (SJN) out of 66 were evaluated, the DAPSA index was calculated, C-reactive protein (CRP, mg/dL), ESR (mm/h), patients with enthesitis and dactylitis in %. The prevalence and severity of psoriasis was determined by BSA (Body Surface Area). Among PROs, the severity of joint pain and disease activity were assessed according to the patient’s opinion of patient global assessment (PtGA) and pain using the visual analogue scale VAS (0–100 mm, respectively), HAQ, RAPID-3, DLQI, PsAID-12. All patients included in the study were prescribed TOFA 5 mg twice a day, followed by a possible increase in the dose to 10 mg twice a day. Also, after 3 and 6 months from the start of therapy, the PASS index (Patient-Acceptable Symptom State) was evaluated, i. e. symptom score below which the patient considers himself healthy, which corresponds to a total PsAID-12 score˂ 4 points and minimal clinically significant improvement (MCID, Minimal Clinical Improvement Disease – change in total PsAID-12 by 3 points).

Results. In the whole group, DAPSA was 44.2±17.1, most patients (87.8%) had high PsA activity. By month 3/6 of follow-up, DAPSA significantly decreased to 15.2±12.4/11.8±9.4 (for all p<0.0001). By month 3/6 of TOFA therapy, there was a significant positive trend in all PROs (PtGA Pain, PtGA, BASDAI, HAQ, RAPID-3, FACIT-F, DLQI). Prior to therapy, PsAID-12 was 5.18±2.14. By month 3/6, PsAID-12 significantly decreased to 2.07±1.65/1.68±1.48 (for all p><0.0001). By the 6th month of therapy, MCID was noted in 90.2% of patients. Prior to the start of therapy, PASS was observed in 25.6% of patients. By month 3/6, the number of patients achieving PASS significantly increased to 66.7/71.8%, respectively (for all p><0.0001). By month 3/6 of TOFA therapy, there was a significant positive trend in all PROs (PtGA Pain, PtGA, BASDAI, HAQ, RAPID-3, FACIT-F, DLQI). Prior to therapy, PsAID-12 was 5.18±2.14. By month 3/6, PsAID-12 significantly decreased to 2.07±1.65/1.68±1.48 (for all p<0.0001). By the 6th month of therapy, MCID was noted in 90.2% of patients. Prior to the start of therapy, PASS was observed in 25.6% of patients. By month 3/6, the number of patients achieving PASS significantly increased to 66.7/71.8%, respectively (for all p><0.0001). By the 6th month of therapy, MCID was noted in 90.2% of patients. Prior to the start of therapy, PASS was observed in 25.6% of patients. By month 3/6, the number of patients achieving PASS significantly increased to 66.7/71.8%, respectively (for all p<0.0001).

Conclusion. TOFA therapy for 6 months leads not only to a significant decrease in PsA activity, but also to an improvement in overall health according to the patient, assessed by PROs scales and questionnaires (PtGA Pain, PtGA, BASDAI, HAQ, RAPID-3, FACIT-F, DLQI). Dynamics of PsAID-12 shows the achievement of MCID in most patients. Positive dynamics is observed already by the 3rd month of treatment.