Journal Article

AB0477 EFFICACY AND SAFETY OF UPADACITINIB IN RHEUMATHOID ARTHRITIS: REAL-LIFE EXPERIENCE FROM A MULTICENTRIC ITALIAN STUDY

Parisi, S., Cometi, L., Baldi, C., Peroni, C.L., Fusaro, E., Guiducci, S., Nacci, F., Ditto, M.C., Sota, J., Falsetti, P., D'alessandro, M., Capassoni, M., Frediani, B., Conticini, E.

2023

Overview

Upadacitinib (UPA), a JAK inhibitor engineered for a greater selectivity towards JAK1, has demonstrated a favourable benefit-to-risk profile in rheumatoid arthritis (RA) patients with an inadequate response to cDMARDs and biologic agents in randomized clinical trials. However, real-life data on its efficacy and safety are limited. We herein provide the first prospective multicentre experience on UPA efficacy and safety profile in RA in a real-life context, focusing on clinimetric and ultrasonographic (US) data. The primary aim of the study was to assess changes in clinimetric and US scores between different time point observations (baseline, 1 month, 3 months and 6 months). Secondary aims were to: (i) estimate the impact of biologic line of treatment and of concomitant therapies on response to therapy; (ii) explore changes in laboratory parameters; (iii) find potential predictive factors associated with response to therapy. Medical records of consecutive RA patients treated with UPA and referred to three Italian tertiary Centers were prospectively reviewed. Adult patients meeting ACR/EULAR classification criteria for RA were enrolled. Our real-life experience confirms the efficacy in terms of clinical and US improvement as well as displaying a good safety profile. The combination therapy with a conventional immunosuppressants predicts a significantly lower clinical and US improvement, likely reflecting a more severe and aggressive course worthy of ad-hoc and more in-depth investigation. An improvement in the SDAI and DAS28CRP was observed, already from the first month of therapy and has been maintained over time. In conclusion, these results demonstrated the short term efficacy of Upadacitinib 15 mg for up to 6 months and providing a prompt improvement of PROs. Even if further studies are needed to clarify those results, these novel findings may provide new insight for the management of UPA treatment in clinical practice. Our real-life experience confirms the efficacy in terms of clinical and US improvement as well as displaying a good safety profile. The combination therapy with a conventional immunosuppressants predicts a significantly lower clinical and US improvement, likely reflecting a more severe and aggressive course worthy of ad-hoc and more in-depth investigation. An improvement in the SDAI and DAS28CRP was observed, already from the first month of therapy and has been maintained over time. In conclusion, these results demonstrated the short term efficacy of Upadacitinib 15 mg for up to 6 months and providing a prompt improvement of PROs. Even if further studies are needed to clarify those results, these novel findings may provide new insight for the management of UPA treatment in clinical practice. NIL. NIL. None Declared. [Display omitted] Table 1Changes in clinimetric and ultrasonographic scores throughout the study period and significance levels (p values) for single comparisons between different observations in time.EndpointOverall significanceT0 vs T1T0 vs T3T0 vs T6T1 vs T3T1 vs T6T3 vs T6Synovitis grade< 0.0010.8040.090<0.001< 0.001< 0.001< 0.001PD signal grading0.0290.9140.3200.0260.0290.0090.066Tenosinovitis grading0.0120.9680.3700,0310,0180,0090,059DAS28-CRP0.0050.014< 0.001< 0.0010.2200.0150.035SDAI index< 0.0010.003< 0.001< 0.001< 0.001< 0.001< 0.001List of abbreviation: DAS28-CRP Disease Activity Score 28 – C-reactive protein, PD power Doppler, SDAI Simplified Clinical Activity Index, T0 baseline, T1 1 month evaluation, T3 3 month evaluation, T6 6 month evaluation

• Publisher: Elsevier B.V,Elsevier Limited
• Subject: Arthritis / C-reactive protein / Clinical medicine / Clinical trials / Immunosuppressive agents / Janus kinase / Medical records / Patients / Real-world evidence / Rheumatoid arthritis / Safety / Synovitis / Targeted synthetic drugs / Ultrasound