دورية أكاديمية
Favourable effect of a 'second hit' after 13 weeks in early RA non-responders: the Amsterdam COBRA treat-to-target randomized trial.
| العنوان: | Favourable effect of a 'second hit' after 13 weeks in early RA non-responders: the Amsterdam COBRA treat-to-target randomized trial. |
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| المؤلفون: | Hartman L; Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.; Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands., Rasch LA; Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands., Turk SA; Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, The Netherlands., Ter Wee MM; Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands., Kerstens PJSM; Department of Rheumatology, Dijklander Ziekenhuis, Hoorn, The Netherlands., van der Laken CJ; Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands., Nurmohamed MT; Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.; Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, The Netherlands., van Schaardenburg D; Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, The Netherlands.; Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Universiteit van Amsterdam, Amsterdam, The Netherlands., van Tuyl LHD; Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.; Netherlands Institute for Health Services Research, Utrecht, The Netherlands., Voskuyl AE; Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands., Boers M; Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands., Lems WF; Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands. |
| المصدر: | Rheumatology (Oxford, England) [Rheumatology (Oxford)] 2023 Jun 01; Vol. 62 (6), pp. 2098-2105. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 100883501 Publication Model: Print Cited Medium: Internet ISSN: 1462-0332 (Electronic) Linking ISSN: 14620324 NLM ISO Abbreviation: Rheumatology (Oxford) Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Oxford, UK : Avenel, N.J. : Oxford University Press ; Distributed by Mercury International, c1999- |
| مواضيع طبية MeSH: | Antirheumatic Agents*/adverse effects , Arthritis, Rheumatoid*/drug therapy , Arthritis, Rheumatoid*/chemically induced, Humans ; Sulfasalazine/therapeutic use ; Methotrexate ; Prednisolone/therapeutic use ; Treatment Outcome ; Drug Therapy, Combination |
| مستخلص: | Objective: The aim of this study was to investigate the effect of treat-to-target combination therapy with intensification at 13 weeks in early RA. Methods: Early RA patients were classified as being at high or low risk of worsening RA based on disease activity and prognostic factors. High-risk patients received COBRA-light (prednisolone 30 mg/day tapered to 7.5 mg/day, MTX increasing to 25 mg/week), and low-risk patients received MTX monotherapy increasing to 25 mg/week. The primary outcome (target) was DAS44 < 1.6 or EULAR good response at 26 weeks. At 13 weeks, non-responders were randomized to (open-label) intensification [high-risk patients: prednisolone 60 mg/day tapered to 7.5 mg/day, addition of SSZ (2 g/day) and HCQ (400 mg/day); low-risk patients: prednisolone 30 mg/day tapered to 7.5 mg/day] or continuation. Results: In the high-risk group (n = 150), 110 patients (73%) reached the target at 13 weeks, and 9 dropped out. Non-responders were randomized to intensification (n = 15) or continuation (n = 16), and after 26 weeks, 12 (80%) vs 7 (44%) of these, respectively, reached the target [difference: 36%, (95% CI 2%, 71%); P = 0.04]. In the low-risk group (n = 40), 17 (43%) reached the target. Non-responders were randomized to intensification (n = 8) or continuation (n = 7); 4 vs 3, respectively, reached the target.Adverse event rates were higher in the high-risk group, and higher in the intensification subgroup of that group. Serious adverse events were rare. Protocol violations were frequent and mostly led to mitigation of actual treatment intensification. Conclusion: Initial combination therapy was very successful in high-risk RA, and early intensification was beneficial in patients not reaching the strict target. The low-risk group was too small for drawing conclusions. In routine practice, adherence to early intensification based on strict targets is difficult. Trial Registration: Netherlands Trial Register (NTR), NL4393, https://www.trialregister.nl/. (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.) |
| التعليقات: | Comment in: Rheumatology (Oxford). 2023 Jun 1;62(6):2025-2026. (PMID: 36413064) |
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| فهرسة مساهمة: | Keywords: DMARDs; RA; epidemiology; immunosuppressants; study design |
| سلسلة جزيئية: | NTR NL4393 |
| المشرفين على المادة: | 0 (Antirheumatic Agents) 3XC8GUZ6CB (Sulfasalazine) YL5FZ2Y5U1 (Methotrexate) 9PHQ9Y1OLM (Prednisolone) |
| تواريخ الأحداث: | Date Created: 20221007 Date Completed: 20230605 Latest Revision: 20230606 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC10234185 |
| DOI: | 10.1093/rheumatology/keac582 |
| PMID: | 36205538 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1462-0332 |
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| DOI: | 10.1093/rheumatology/keac582 |