Upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis: preliminary data of a real-life multicenter study
Abstract Background Upadacitinib (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 co...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | Arthritis Research & Therapy |
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| Online Access: | https://doi.org/10.1186/s13075-023-03182-9 |
| _version_ | 1797557426844598272 |
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| author | Michele Maria Luchetti Gentiloni Valentino Paci Antonio Carletto Alen Zabotti Roberta Ramonda Maria Sole Chimenti Lorenzo Dagna Nicoletta Luciano Anna Piccinelli Ivan Giovannini Giovanni Striani Nicola Boffini Gilda Sandri Niccolò Possemato Ilenia Pantano Devis Benfaremo Carlo Salvarani Francesco Ciccia Carlo Selmi Gianluca Moroncini |
| author_facet | Michele Maria Luchetti Gentiloni Valentino Paci Antonio Carletto Alen Zabotti Roberta Ramonda Maria Sole Chimenti Lorenzo Dagna Nicoletta Luciano Anna Piccinelli Ivan Giovannini Giovanni Striani Nicola Boffini Gilda Sandri Niccolò Possemato Ilenia Pantano Devis Benfaremo Carlo Salvarani Francesco Ciccia Carlo Selmi Gianluca Moroncini |
| author_sort | Michele Maria Luchetti Gentiloni |
| collection | DOAJ |
| description | Abstract Background Upadacitinib (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. Methods One 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. Results At 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. Conclusions This 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. |
| first_indexed | 2024-03-10T17:16:53Z |
| format | Article |
| id | doaj.art-108d482682b9424eb9e04468ca9fdd9d |
| institution | Directory Open Access Journal |
| issn | 1478-6362 |
| language | English |
| last_indexed | 2024-03-10T17:16:53Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Arthritis Research & Therapy |
| spelling | doaj.art-108d482682b9424eb9e04468ca9fdd9d2023-11-20T10:27:16ZengBMCArthritis Research & Therapy1478-63622023-10-0125111110.1186/s13075-023-03182-9Upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis: preliminary data of a real-life multicenter studyMichele Maria Luchetti Gentiloni0Valentino Paci1Antonio Carletto2Alen Zabotti3Roberta Ramonda4Maria Sole Chimenti5Lorenzo Dagna6Nicoletta Luciano7Anna Piccinelli8Ivan Giovannini9Giovanni Striani10Nicola Boffini11Gilda Sandri12Niccolò Possemato13Ilenia Pantano14Devis Benfaremo15Carlo Salvarani16Francesco Ciccia17Carlo Selmi18Gianluca Moroncini19CLINICA MEDICA, Department of Molecular and Biological Sciences, Marche Polytechnic University, and Department of Internal Medicine, Azienda Ospedaliero Universitaria delle MarcheCLINICA MEDICA, Department of Molecular and Biological Sciences, Marche Polytechnic University, and Department of Internal Medicine, Azienda Ospedaliero Universitaria delle MarcheDepartment of Medicine, Rheumatology Operative Unit, AOUI VeronaDepartment of Medicine, Rheumatology Institute, University of Udine, Azienda Sanitaria Universitaria Friuli CentraleDepartment of Medicine-DIMED, Rheumatology Unit, University of PadovaRheumatology, Allergology and Clinical Immunology, University of Rome “Tor Vergata”Unit of Immunology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific InstituteDivision of Rheumatology and Clinical Immunology, IRCCS Humanitas Research HospitalDepartment of Medicine, Rheumatology Operative Unit, AOUI VeronaDepartment of Medicine, Rheumatology Institute, University of Udine, Azienda Sanitaria Universitaria Friuli CentraleDepartment of Medicine-DIMED, Rheumatology Unit, University of PadovaUnit of Immunology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Scientific InstituteDepartment of Maternal, Infantile and Adult Medical and Surgical Sciences, University of Modena and Reggio EmiliaRheumatology Unit, Azienda USL-IRCCS Di Reggio EmiliaDepartment of Precision Medicine, Rheumatology Unit, University Della Campania L. VanvitelliCLINICA MEDICA, Department of Molecular and Biological Sciences, Marche Polytechnic University, and Department of Internal Medicine, Azienda Ospedaliero Universitaria delle MarcheDepartment of Maternal, Infantile and Adult Medical and Surgical Sciences, University of Modena and Reggio EmiliaDepartment of Precision Medicine, Rheumatology Unit, University Della Campania L. VanvitelliDepartment of Rheumatology and Clinical Immunology, IRCCS Humanitas Research Hospital, Rozzano, and Department of Biomedical Sciences, Humanitas UniversityCLINICA MEDICA, Department of Molecular and Biological Sciences, Marche Polytechnic University, and Department of Internal Medicine, Azienda Ospedaliero Universitaria delle MarcheAbstract Background Upadacitinib (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. Methods One 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. Results At 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. Conclusions This 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.https://doi.org/10.1186/s13075-023-03182-9Psoriatic arthritisUpadacitinibClinical efficacyReal lifePsoriasisPeripheral arthritis |
| spellingShingle | Michele Maria Luchetti Gentiloni Valentino Paci Antonio Carletto Alen Zabotti Roberta Ramonda Maria Sole Chimenti Lorenzo Dagna Nicoletta Luciano Anna Piccinelli Ivan Giovannini Giovanni Striani Nicola Boffini Gilda Sandri Niccolò Possemato Ilenia Pantano Devis Benfaremo Carlo Salvarani Francesco Ciccia Carlo Selmi Gianluca Moroncini 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 Psoriatic arthritis Upadacitinib Clinical efficacy Real life Psoriasis Peripheral arthritis |
| title | Upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis: preliminary data of a real-life multicenter study |
| title_full | Upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis: preliminary data of a real-life multicenter study |
| title_fullStr | Upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis: preliminary data of a real-life multicenter study |
| title_full_unstemmed | Upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis: preliminary data of a real-life multicenter study |
| title_short | Upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis: preliminary data of a real-life multicenter study |
| title_sort | upadacitinib effectiveness and factors associated with minimal disease activity achievement in patients with psoriatic arthritis preliminary data of a real life multicenter study |
| topic | Psoriatic arthritis Upadacitinib Clinical efficacy Real life Psoriasis Peripheral arthritis |
| url | https://doi.org/10.1186/s13075-023-03182-9 |
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