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      Treatment patterns of individualized real-life tapering approaches based on shared decision-making in rheumatoid arthritis Translated title: Behandlungsschemata individualisierter realer Ansätze zum Ausschleichen von Medikamenten auf der Basis gemeinsamer Entscheidungsfindung bei rheumatoider Arthritis

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          Abstract

          Objective

          To provide real-world evidence on patient-individual tapering patterns of disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients in daily clinical practice.

          Methods

          Data obtained through a controlled prospective cohort study in Germany conducted from July 2018 to March 2021 were analyzed. Participants consist of RA patients in sustained remission who were eligible for DMARD tapering at enrolment. Data from RA patients who experienced tapering of DMARDs at least once during the observational period ( n = 200) were used. Descriptive analyses of medical outcomes at baseline and at time of first tapering, time to first tapering, tapering patterns by substance group, and tapering intensity were documented.

          Results

          We did not observe meaningful differences in either disease activity or quality of life measures between substance groups at enrolment, time of first tapering, and at 6 or 12 months after tapering. Median time until first tapering varied between substance groups (csDMARDs: 108 days; bDMARDs: 189 days; combination: 119 days). Most patients received one iteration of tapering only (147/200 patients, 73.5%). Dose reduction was applied for patients treated with csDMARDs (79/86 patients, 91.8%), spacing of interval was the most frequent strategy for patients treated with bDMARDs only (43/48 patients, 89.5%). Necessity for increased DMARD dosage was observed in only 10% of patients (20/200). Tapering intensity by substance was overall heterogenous, indicating high individualization.

          Conclusion

          We identify highly heterogeneous tapering patterns between substance groups and within substances. Identification and recognition of patient-individual approaches of tapering will help to further improve the management of RA for both patients and rheumatologists.

          Supplementary Information

          The online version of this article (10.1007/s00393-023-01380-z) contains supplementary material, which is available to authorized users.

          Translated abstract

          Ziel

          Ziel war es, reale Daten zu patientenbezogenen Ausschleichschemata für krankheitsmodifizierende Antirheumatika (DMARD) bei Patienten mit rheumatoider Arthritis (RA) aus dem klinischen Alltag vorzustellen.

          Methoden

          Dazu wurden Daten aus einer kontrollierten prospektiven Kohortenstudie in Deutschland untersucht, die von Juli 2018 bis März 2021 durchgeführt wurde. Die Teilnehmer waren RA-Patienten in anhaltender Remission, die sich bei Aufnahme in die Studie als geeignet für ein Ausschleichen der DMARD-Therapie erwiesen. Verwendet wurden die Daten von RA-Patienten, bei denen mindestens einmal während der Beobachtungsphase ein Ausschleichen der DMARD erfolgte ( n = 200). Deskriptive Analysen der medizinischen Ergebnisse zu Studienbeginn und zum Zeitpunkt des ersten Ausschleichens, die Dauer bis zum ersten Ausschleichen, Ausschleichschemata nach Präparategruppe und Intensität des Ausschleichens wurden dokumentiert.

          Ergebnisse

          Weder bei der Krankheitsaktivität noch bei den Werten für die Lebensqualität waren bedeutende Unterschiede bei Aufnahme in die Studie, zum Zeitpunkt des ersten Ausschleichens oder 6 bzw. 12 Monate nach dem Ausschleichen zwischen den Präparategruppen festzustellen. Die mittlere Dauer bis zum ersten Ausschleichen variierte zwischen den Präparategruppen: konventionelle synthetische DMARD (csDMARD) 108 Tage, biologische DMARD (bDMARD) 189 Tage, in Kombination 119 Tage. Bei den meisten Patienten erfolgte nur eine einmalige Wiederholung des Ausschleichens (147/200 Patienten, 73,5 %). Während eine Dosisreduktion das Vorgehen bei Patienten unter Therapie mit csDMARD war (79/86 Patienten, 91,8 %), stellte eine Verlängerung des Intervalls die am häufigsten eingesetzte Strategie für Patienten mit alleiniger bDMARD-Therapie dar (43/48 Patienten, 89,5 %). Die Notwendigkeit einer erhöhten DMARD-Dosierung wurde nur bei 10 % der Patienten (20/200) festgestellt. Die Intensität des Ausschleichens nach Präparat war insgesamt heterogen, was ein Zeichen einer hohen Individualisierung ist.

          Schlussfolgerung

          Im Vergleich zwischen den Präparategruppen und innerhalb der Präparate wurden sehr heterogene Ausschleichschemata beobachtet. Die Identifizierung und das Verständnis patientenindividueller Ansätze beim Ausschleichen von Medikamenten werden dazu beitragen, die Behandlung der RA sowohl für die Patienten als auch für die Rheumatologen weiter zu verbessern.

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          Most cited references25

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          2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis

          To develop updated guidelines for the pharmacologic management of rheumatoid arthritis.
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            Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis.

            To update the evidence for the efficacy of biological disease-modifying antirheumatic drugs (bDMARD) in patients with rheumatoid arthritis (RA) to inform the European League Against Rheumatism(EULAR) Task Force treatment recommendations. Medline, Embase and Cochrane databases were searched for articles published between January 2009 and February 2013 on infliximab, etanercept, adalimumab, certolizumab-pegol, golimumab, anakinra, abatacept, rituximab, tocilizumab and biosimilar DMARDs (bsDMARDs) in phase 3 development. Abstracts from 2011 to 2012 American College of Rheumatology (ACR) and 2011-2013 EULAR conferences were obtained. Fifty-one full papers, and 57 abstracts were identified. The randomised controlled trials (RCT) confirmed the efficacy of bDMARD+conventional synthetic DMARDs (csDMARDs) versus csDMARDs alone (level 1B evidence). There was some additional evidence for the use of bDMARD monotherapy, however bDMARD and MTX combination therapy for all bDMARD classes was more efficacious (1B). Clinical and radiographic responses were high with treat-to-target strategies. Earlier improvement in signs and symptoms were seen with more intensive initial treatment strategies, but outcomes were similar upon addition of bDMARDs in patients with insufficient response to MTX. In general, radiographic progression was lower with bDMARD use, mainly due to initial treatment effects. Although patients may achieve bDMARD- and drug-free remission, maintenance of clinical responses was higher with bDMARD continuation (1B), but bDMARD dose reduction could be applied (1B). There was still no RCT data for bDMARD switching. The systematic literature review confirms efficacy of biological DMARDs in RA. It addresses different treatment strategies with the potential for reduction in therapy, particularly with early disease control, and highlights emerging therapies.
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              Tapering biologic and conventional DMARD therapy in rheumatoid arthritis: current evidence and future directions.

              Improvements in the control of inflammation in rheumatoid arthritis (RA) by conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARDs) have led to a substantial change in the clinical outcomes of patients during the last 30 years. Current treatment can lead to sustained remission in some patients raising questions about the optimal management strategies in this subgroup of patients. Today, tapering of DMARDs and even their discontinuation appears as an interesting concept for achieving a more tailored and dynamic treatment approach of RA, especially in patients, who achieved full disease control by DMARD treatment. In this review article, current developments of DMARD tapering are discussed. The article provides an overview of existing studies on this topic and addresses new strategies to reach drug-free remission. Furthermore, concepts for defining patients eligible for DMARD tapering are described and potential future strategies in using biomarkers in predicting the risk for disease relapse after initiation of DMARD tapering are addressed. These findings are finally considered in light of the vision to achieve cure as an ultimate goal in patients with RA achieving full control of inflammation.
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                Author and article information

                Contributors
                dr.benjamin.birkner@gmail.com
                juergen.rech@uk-erlangen.de
                Journal
                Z Rheumatol
                Z Rheumatol
                Zeitschrift Fur Rheumatologie
                Springer Medizin (Heidelberg )
                0340-1855
                1435-1250
                23 June 2023
                23 June 2023
                2024
                : 83
                : 2
                : 142-150
                Affiliations
                [1 ]Hamburg Center for Health Economics (HCHE), Universität Hamburg, ( https://ror.org/00g30e956) Esplanade 36, 20354 Hamburg, Germany
                [2 ]GRID grid.5330.5, ISNI 0000 0001 2107 3311, Medizinische Klinik 3 – Rheumatologie und Immunologie, Universitätsklinikum Erlangen, , Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), ; Ulmenweg 18, 91054 Erlangen, Germany
                [3 ]GRID grid.5330.5, ISNI 0000 0001 2107 3311, Deutsches Zentrum Immuntherapie, , Friedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, ; 91054 Erlangen, Germany
                [4 ]Berufsverband Deutscher Rheumatologen e.V, Hauptstraße 9, 13055 Berlin, Germany
                [5 ]Techniker Krankenkasse, ( https://ror.org/000466g76) Bramfelder Straße 140, 22305 Hamburg, Germany
                Author notes
                [Redaktion]

                Ulf Müller-Ladner, Bad Nauheim

                Uwe Lange, Bad Nauheim

                Article
                1380
                10.1007/s00393-023-01380-z
                10901995
                37351593
                723b8e4a-9817-4375-a2cb-22c6d4ef8253
                © The Author(s) 2023

                Open Access This 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/.

                History
                : 15 March 2023
                Funding
                Funded by: Friedrich-Alexander-Universität Erlangen-Nürnberg (1041)
                Categories
                Versorgung
                Custom metadata
                © Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2024

                Rheumatology
                rheumatoid arthritis,disease-modifying antirheumatic drugs (dmard’s),dose tapering,cohort study,real world conditions,rheumatoide arthritis,krankheitsmodifizierende antirheumatika (dmard’s),dosisreduktion,kohortenstudie,reale bedingungen

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