Efficacy and Safety of Upadacitinib in Rheumatoid Arthritis: Real-Life Experience from a Prospective Longitudinal Multicentric Study
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Published:2024-01-11
Issue:2
Volume:13
Page:401
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ISSN:2077-0383
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Container-title:Journal of Clinical Medicine
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language:en
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Short-container-title:JCM
Author:
Baldi Caterina1ORCID, Parisi Simone2ORCID, Falsetti Paolo1ORCID, Sota Jurgen1, Ditto Maria Chiara2ORCID, Capassoni Marco3, D’alessandro Miriana4ORCID, Conticini Edoardo1ORCID, Nacci Francesca3, Peroni Clara Lisa2, Cometi Laura3ORCID, Fusaro Enrico2ORCID, Frediani Bruno1, Guiducci Serena3
Affiliation:
1. Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy 2. Rheumatology Unit, Azienda Ospedaliera Universitaria Città Della Salute e Della Scienza di Torino, 10126 Torino, Italy 3. Rheumatology Unit, Department of Experimental and Clinical Medicine, University of Florence, 50121 Firenze, Italy 4. Respiratory Disease and Lung Transplantation Unit, University of Siena, 53100 Siena, Italy
Abstract
Background: We provide the first prospective longitudinal multicenter experience on Upadacitinib efficacy and safety profile in Rheumatoid Arthritis (RA) in a real-life context, focusing on clinimetric and ultrasonographic (US) data. Methods: RA patients referred to three Italian tertiary Centers who started Upadacitinib were enrolled as per ACR/EULAR classification criteria and prospectively reviewed. The primary aim of this study was to assess changes in clinimetric and ultrasonographic scores through time (at baseline, after 1 month, 3 months, and 6 months from the beginning of the therapy). Secondary aims were to: (i) estimate the impact of biologic lines of treatment and concomitant therapies on response to therapy; (ii) explore changes in laboratory parameters; and (iii) find potential predictive factors associated with response to therapy. Results: Seventy-one patients (49 Females and 22 Males) were included. Clinimetric scores, including the Disease Activity Score (DAS28-CRP) and Simplified Clinical Disease Activity Index (SDAI), and US findings (synovial hypertrophy and power Doppler) significantly improved (p = 0.029, p = 0.001, p = 0.001, p = 0.001, respectively). Regression analysis revealed a significant association between the concomitant csDMARDs therapy at baseline and the lack of improvement in synovial hypertrophy [OR −4.824, p = 0.010] as well as with DAS28-CRP [OR −0.690, p = 0.045], whereas the presence of increased ESR or CRP at baseline was able to predict a significant improvement in SDAI [OR 8.481, p = 0.003]. No adverse events, such as deep venous thrombosis, pulmonary embolism, or herpes zoster virus infection, were reported during this study observation. Conclusion: Our real-life experience confirms the efficacy of Upadacitinib in terms of clinical and ultrasonographic improvement, as well as displaying a good safety profile.
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