- Assessment of individual therapeutic responses provides valuable information concerning treatment benefits in individual patients. We evaluated individual therapeutic responses as determined by the Disease Activity Score-28 joints critical difference for improvement (DAS28-dcrit) in rheumatoid arthritis (RA) patients treated with intravenous tocilizumab or comparator anti-tumor necrosis factor (TNF) agents. The previously published DAS28-dcrit value [DAS28 decrease (improvement) ≥ 1.8] was retrospectively applied to data from two studies of tocilizumab in RA, the 52-week ACT-iON observational study and the 24-week ADACTA randomized study. Data were compared within (not between) studies. DAS28 was calculated with erythrocyte sedimentation rate as the inflammatory marker. Stability of DAS28-dcrit responses and European League Against Rheumatism (EULAR) good responses was determined by evaluating repeated responses at subsequent timepoints. A logistic regression model was used to calculate p values for differences in response rates between active agents. Patient-reported outcomes (PROs; pain, global health, function, and fatigue) in DAS28-dcrit responder versus non-responder groups were compared with an ANCOVA model. DAS28-dcrit individual response rates were 78.2% in tocilizumab-treated patients and 58.2% in anti-TNF-treated patients at week 52 in the ACT-ion study (p = 0.0001) and 90.1% versus 59.1% at week 24 in the ADACTA study (p < 0.0001). DAS28-dcrit responses showed greater stability over time (up to 52 weeks) than EULAR good responses. For both active treatments, DAS28-dcrit responses were associated with statistically significant improvements in mean PRO values compared with non-responders. The DAS28-dcrit response criterion provides robust assessments of individual responses to RA therapy and may be useful for discriminating between active agents in clinical studies and guiding treat-to-target decisions in daily practice.
MetadatenAuthor: | Michaela KöhmORCiDGND, Matthew J. McIntosh, Michael W. Hofmann, Varghese Abraham, Cem GabayORCiD, Ernest H. ChoyORCiD, Arthur KavanaughORCiDGND, Harald BurkhardtORCiDGND, Frank BehrensORCiDGND |
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URN: | urn:nbn:de:hebis:30:3-813024 |
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DOI: | https://doi.org/10.1007/s00296-020-04514-7 |
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ISSN: | 1437-160X |
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Parent Title (English): | Rheumatology international |
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Publisher: | Springer |
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Place of publication: | Berlin ; Heidelberg [u.a.] |
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Document Type: | Article |
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Language: | English |
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Date of Publication (online): | 2020/02/10 |
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Date of first Publication: | 2020/02/10 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Release Date: | 2024/02/28 |
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Tag: | Anti-rheumatic agents; Patient outcome assessment; Rheumatoid arthritis; Tocilizumab; Treatment effectiveness |
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Volume: | 40 |
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Issue: | 5 |
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Page Number: | 9 |
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First Page: | 747 |
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Last Page: | 755 |
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Note: | Open Access funding provided by Projekt DEAL. The authors thank Sharon L. Cross, Ph.D. (CIRI, Frankfurt am Main, Germany) for medical writing support, funded by Chugai Pharma Europe Ltd., and Jinglan Pei, Ph.D. (Genentech) for critical review of the manuscript. Elements of this work were published in abstracts for the European League Against Rheumatology 2016 (https://ard.bmj.com/content/75/Suppl_2/686.1) and American College of Rheumatology 2017 (https://acrabstracts.org/abstract/comparative-analysis-of-achievement-of-individual-important-response-measured-by-das28dcrit-in-a-randomized-head-to-head-trial-of-tocilizumab-vs-adalimumab-in-active-rheumatoid-arthritis/).
This study was supported by Chugai Pharma Europe Ltd., German Branch Office. F. Hoffmann- La Roche Ltd provided funding for the original clinical studies on which this retrospective analysis is based. Chugai Pharma Europe Ltd. and Genentech Inc. are corporate partners of F. Hoffman-La Roche Ltd. |
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Note: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (https://www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
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HeBIS-PPN: | 520350308 |
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Institutes: | Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Licence (German): | Creative Commons - CC BY - Namensnennung 4.0 International |
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