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      Real-world evidence of biologic treatments in psoriatic arthritis in Italy: results of the CHRONOS (EffeCtiveness of biologic treatments for psoriatic artHRitis in Italy: an ObservatioNal lOngitudinal Study of real-life clinical practice) observational longitudinal study

      research-article
      Author(s): 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 23 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 22 , 1 , 1 , 1 , , and the CHRONOS Study Group 1
      Publication date (Electronic):
      Journal: BMC Rheumatology
      Publisher: BioMed Central
      Keywords: Psoriatic arthritis, Biologics, Real world evidence, ACR, DAS28, Secukinumab, TNF-inhibitors

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          Abstract

          Background

          Biologics have demonstrated efficacy in PsA in randomized clinical trials. More evidence is needed on their effectiveness under real clinical practice conditions. The aim of the present work is to provide real-world evidence of the effectiveness of biologics for PsA in the daily clinical practice.

          Methods

          CHRONOS was a multicenter, non-interventional, cohort study conducted in 20 Italian hospital rheumatology clinics.

          Results

          399 patients were eligible (56.9% females, mean (SD) age: 52.4 (11.6) years). The mean (SD) duration of PsA and psoriasis was 7.2 (6.9) and 15.3 (12.2) years, respectively. The mean (SD) duration of the biologic treatment under analysis was 18.6 (6.5) months. The most frequently prescribed biologic was secukinumab (40.4%), followed by adalimumab (17.8%) and etanercept (16.5%). The proportion of overall responders according to EULAR DAS28 criteria was 71.8% (95% CI: 66.7–76.8%) out of 308 patients at 6 months and 68.0% (95% CI: 62.7–73.3%) out of 297 patients at 1 year. Overall, ACR20/50/70 responses at 6 months were 41.2% (80/194), 29.4% (57/194), 17.1% (34/199) and at 1-year were 34.9% (66/189), 26.7% (51/191), 18.4% (36/196), respectively. Secondary outcome measures improved rapidly already at 6 months: mean (SD) PASI, available for 87 patients, decreased from 3.2 (5.1) to 0.6 (1.3), the proportion of patients with dactylitis from 23.6% (35/148) to 3.5% (5/142) and those with enthesitis from 33.3% (49/147) to 9.0% (12/133).

          Conclusions

          The CHRONOS study provides real-world evidence of the effectiveness of biologics in PsA in the Italian rheumatological practice, confirming the efficacy reported in RCTs across various outcome measures.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s41927-022-00284-w.

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          Most cited references49

          • Record: found
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          Modified disease activity scores that include twenty-eight-joint counts development and validation in a prospective longitudinal study of patients with rheumatoid arthritis

          M. Prevoo, M A Van't Hof, H. Kuper … (1995)
          Article 0 comments Cited 404 times – based on 0 reviews     Review now
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            Psoriatic Arthritis

            Dan L Longo, Christopher Ritchlin, Robert Colbert … (2017)
            Article 0 comments Cited 372 times – based on 0 reviews     Review now
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              • Record: found
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              Measurement of patient outcome in arthritis

              James F. Fries, Patricia Spitz, R. Kraines … (1980)
              A structure for representation of patient outcome is presented, together with a method for outcome measurement and validation of the technique in rheumatoid arthritis. The paradigm represents outcome by five separate dimensions: death, discomfort, disability, drug (therapeutic) toxicity, and dollar cost. Each dimension represents an outcome directly related to patient welfare. Quantitation of these outcome dimensions may be performed at interview or by patient questionnaire. With standardized, validated questions, similar scores are achieved by both methods. The questionnaire technique is preferred since it is inexpensive and does not require interobserver validation. These techniques appear extremely useful for evaluation of long term outcome of patients with rheumatic diseases.
              Article 0 comments Cited 242 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Emanuela Zagni: CHRONOSpaper@medineos.com
                Journal
                Journal ID (nlm-ta): BMC Rheumatol
                Journal ID (iso-abbrev): BMC Rheumatol
                Title: BMC Rheumatology
                Publisher: BioMed Central (London )
                ISSN (Electronic): 2520-1026
                Publication date (Electronic): 12 September 2022
                Publication date PMC-release: 12 September 2022
                Publication date Collection: 2022
                Volume: 6
                Electronic Location Identifier: 57
                Affiliations
                [1 ]GRID grid.15585.3c, Novartis Farma S.p.A, ; Largo Umberto Boccioni, 1, 21040 Origgio, Varese Italy
                [2 ]GRID grid.412725.7, ASST Spedali Civili, ; Brescia, Italy
                [3 ]Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria, Italy
                [4 ]GRID grid.432329.d, ISNI 0000 0004 1789 4477, AOU Città della Salute e della Scienza di Torino, ; Turin, Italy
                [5 ]A.O. Mauriziano, Turin, Italy
                [6 ]Ospedale Civile, Civitanova Marche, Italy
                [7 ]A.O.U. Policlinico Consorziale, Bari, Italy
                [8 ]GRID grid.412844.f, ISNI 0000 0004 1766 6239, A.O.U. Policlinico -Vittorio Emanuele, ; Catania, Italy
                [9 ]GRID grid.460094.f, ISNI 0000 0004 1757 8431, ASST Papa Giovanni XXIII, ; Bergamo, Italy
                [10 ]Department of Rheumatology, ASST Gaetano Pini-CTO, Milan, Italy
                [11 ]Ospedale Centrale di Bolzano, Bolzano, Italy
                [12 ]GRID grid.411475.2, ISNI 0000 0004 1756 948X, AOUI Verona Borgo Rome, ; Verona, Italy
                [13 ]Policlinico A. Murri, Jesi, Italy
                [14 ]A.O.U. Mater Domini, Catanzaro, Italy
                [15 ]A.O.U. Policlinico Giaccone, Palermo, Italy
                [16 ]GRID grid.414962.c, ISNI 0000 0004 1760 0715, Ospedale Civile Di Legnano, ; Legnano, Italy
                [17 ]GRID grid.415044.0, ISNI 0000 0004 1760 7116, Ospedale San Giovanni Bosco, ; Naples, Italy
                [18 ]GRID grid.413009.f, Policlinico Tor Vergata, ; Rome, Italy
                [19 ]ASST FBF Sacco, Milan, Italy
                [20 ]ASUIUD, Udine, Italy
                [21 ]GRID grid.417007.5, Azienda Policlinico Umberto I, ; Rome, Italy
                [22 ]MediNeos Observational Research, Modena, Italy
                [23 ]Rheumatology, Humanitas San Pio X, Milan, Italy
                Article
                Publisher ID: 284
                DOI: 10.1186/s41927-022-00284-w
                PMC ID: 9464489
                SO-VID: 077da8b1-882a-4502-a9c5-0a05dab231b0
                Copyright © © The Author(s) 2022
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                Date received : 8 March 2022
                Date accepted : 10 June 2022
                Funding
                Funded by: Novartis Farma S.p.A. Origgio (VA), Italy
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © The Author(s) 2022

                Keywords: psoriatic arthritis,biologics,real world evidence,acr,das28,secukinumab,tnf-inhibitors
                Data availability:
                Keywords: psoriatic arthritis, biologics, real world evidence, acr, das28, secukinumab, tnf-inhibitors

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