Upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis: preliminary data of a real-life multicenter study

Arthritis Research & Therapy

Research

Gianluca Moroncini¹  Devis Benfaremo¹  Michele Maria Luchetti Gentiloni¹  Valentino Paci²  Gilda Sandri³  Carlo Salvarani⁴  Alen Zabotti⁵  Ivan Giovannini⁵  Anna Piccinelli⁶  Antonio Carletto⁶  Giovanni Striani⁷  Roberta Ramonda⁷  Ilenia Pantano⁸  Francesco Ciccia⁸  Carlo Selmi⁹  Nicoletta Luciano^1,10  Niccolò Possemato^1,11  Maria Sole Chimenti^1,12  Lorenzo Dagna^1,13  Nicola Boffini^1,13 

[1] CLINICA MEDICA, Department of Molecular and Biological Sciences, Marche Polytechnic University, and Department of Internal Medicine, Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy;CLINICA MEDICA, Department of Molecular and Biological Sciences, Marche Polytechnic University, and Department of Internal Medicine, Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy;Internal Medicine Residency Program, Marche Polytechnic University, Ancona, Italy;Department of Maternal, Infantile and Adult Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy;Department of Maternal, Infantile and Adult Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy;Rheumatology Unit, Azienda USL-IRCCS Di Reggio Emilia, Reggio Emilia, Italy;Department of Medicine, Rheumatology Institute, University of Udine, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy;Department of Medicine, Rheumatology Operative Unit, AOUI Verona, Verona, Italy;Department of Medicine-DIMED, Rheumatology Unit, University of Padova, Padua, Italy;Department of Precision Medicine, Rheumatology Unit, University Della Campania L. Vanvitelli, Naples, Italy;Department of Rheumatology and Clinical Immunology, IRCCS Humanitas Research Hospital, Rozzano, and Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy;Division of Rheumatology and Clinical Immunology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy;Rheumatology Unit, Azienda USL-IRCCS Di Reggio Emilia, Reggio Emilia, Italy;Rheumatology, Allergology and Clinical Immunology, University of Rome “Tor Vergata”, Rome, Italy;Unit of Immunology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, Milan, Italy;

关键词: Psoriatic arthritis;    Upadacitinib;    Clinical efficacy;    Real life;    Psoriasis;    Peripheral arthritis;    Axial inflammation;    Minimal disease activity;    Bio-refractory;    Safety;   

DOI  :  10.1186/s13075-023-03182-9

 received in 2023-08-05, accepted in 2023-09-25,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundUpadacitinib (UPA) is a selective JAK inhibitor recently approved for the treatment of psoriatic arthritis (PsA). In this post-approval study, we aimed to evaluate the effectiveness and safety of UPA over 24 weeks and identify clinical predictors of response, in a multicentric cohort of patients affected by PsA.MethodsOne hundred and twenty-six patients with PsA treated with UPA were enrolled in 10 Italian centres. UPA effectiveness outcomes, such as the proportion of patients with MDA status, DAPSA remission, and low disease activity, ASDAS-CRP inactive and low disease activity, and change from baseline in DAPSA and ASDAS-CRP scores, were evaluated every 12 weeks until week 24. The proportion of DAPSA minor, moderate, and major improvement, and ASDAS clinically important improvement (CII) and major improvement (MI) were considered as well. All treatment-related adverse events were collected during the observation period. Clinical predictors of MDA response at week 24 were evaluated through multivariate analysis.ResultsAt baseline, 124/126 (98%) and 54/126 (43%) patients showed peripheral and axial involvement, respectively; 110 (87%) patients were intolerant or resistant to biologic DMARDs. At 24 weeks, MDA status, DAPSA remission, and ASDAS-CRP inactive disease were achieved in 47%, 23%, and 48% of patients, respectively. Minor, moderate, and major DAPSA improvement was observed in 67%, 39%, and 23%, respectively; while 65% and 35% achieved ASDAS-CRP CII and MI, respectively. The mean change from baseline was 15.9 ± 13.5 (p < 0.001) for DAPSA and 1.21 ± 0.97 (p < 0.001) for ASDAS-CRP. Thirteen patients (10%) discontinued UPA due to a lack of efficacy or non-serious adverse events. No serious adverse events were observed. Male gender (OR 2.54, 95% CI 1.03–6.25 p = 0.043), being naïve to biological DMARDs (OR 4.13, 95% CI 1.34–12.71, p = 0.013) and elevated baseline CRP (OR 2.49, 95% CI 1.02–6.12, p = 0.046) were associated with MDA response at week 24.ConclusionsThis is one of the first real-life studies supporting the effectiveness of UPA and its safety profile in PsA patients. Furthermore, the study identifies predictors of MDA response to UPA treatment at 6 months.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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