Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis
<p><strong>Objectives</strong> To examine which composite measures are most sensitive to change when measuring psoriatic arthritis (PsA) disease activity, analyses compared the responsiveness of composite measures used in a 48-week randomized, controlled trial of MTX and etanercep...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Oxford University Press
2020
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| _version_ | 1826280937937174528 |
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| author | Coates, L Merola, JF Mease, PJ Ogdie, A Gladman, DD Strand, V van Mens, L J.J. Liu, L Yen, PK Collier, DH Kricorian, G Chung, JB Helliwell, PS |
| author_facet | Coates, L Merola, JF Mease, PJ Ogdie, A Gladman, DD Strand, V van Mens, L J.J. Liu, L Yen, PK Collier, DH Kricorian, G Chung, JB Helliwell, PS |
| author_sort | Coates, L |
| collection | OXFORD |
| description | <p><strong>Objectives</strong> To examine which composite measures are most sensitive to change when measuring psoriatic arthritis (PsA) disease activity, analyses compared the responsiveness of composite measures used in a 48-week randomized, controlled trial of MTX and etanercept in patients with PsA.</p>
<p><strong>Methods</strong> The trial randomised 851 patients to receive weekly: MTX (20 mg/week), etanercept (50 mg/week) or MTX plus etanercept. Dichotomous composite measures examined included ACR 20/50/70 responses, minimal disease activity (MDA) and very low disease activity (VLDA). Continuous composite measures examined included Disease Activity Score (28 joints) using CRP (DAS28-CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity for Psoriatic Arthritis (DAPSA) and Psoriatic Arthritis Disease Activity Score (PASDAS).</p>
<p><strong>Results</strong> At week 24, etanercept-treated groups were significantly more effective than MTX monotherapy to achieve ACR 20 (primary end point) and MDA (key secondary end point). When examining score changes from baseline at week 24 across the five continuous composite measures, PASDAS demonstrated relatively greater changes in the etanercept-treated groups compared with MTX monotherapy and had the largest effect size and standardized response. Joint count changes drove overall score changes at week 24 from baseline in all the continuous composite measures except for PASDAS, which was driven by the Physician and Patient Global Assessments.</p>
<p><strong>Conclusion</strong> PASDAS was the most sensitive continuous composite measure examined with results that mirrored the protocol-defined primary and key secondary outcomes. Composite measures with multiple domains, such as PASDAS, may better quantify change in PsA disease burden.</p>
<p><strong>Trail registration</strong> https://ClinicalTrials.gov, number NCT02376790.</p> |
| first_indexed | 2024-03-07T00:21:14Z |
| format | Journal article |
| id | oxford-uuid:7c9f805c-797c-46e5-9a38-6e8aafefea44 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T00:21:14Z |
| publishDate | 2020 |
| publisher | Oxford University Press |
| record_format | dspace |
| spelling | oxford-uuid:7c9f805c-797c-46e5-9a38-6e8aafefea442022-03-26T20:58:18ZPerformance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritisJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:7c9f805c-797c-46e5-9a38-6e8aafefea44EnglishSymplectic ElementsOxford University Press2020Coates, LMerola, JFMease, PJOgdie, AGladman, DDStrand, Vvan Mens, L J.J.Liu, LYen, PKCollier, DHKricorian, GChung, JBHelliwell, PS<p><strong>Objectives</strong> To examine which composite measures are most sensitive to change when measuring psoriatic arthritis (PsA) disease activity, analyses compared the responsiveness of composite measures used in a 48-week randomized, controlled trial of MTX and etanercept in patients with PsA.</p> <p><strong>Methods</strong> The trial randomised 851 patients to receive weekly: MTX (20 mg/week), etanercept (50 mg/week) or MTX plus etanercept. Dichotomous composite measures examined included ACR 20/50/70 responses, minimal disease activity (MDA) and very low disease activity (VLDA). Continuous composite measures examined included Disease Activity Score (28 joints) using CRP (DAS28-CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity for Psoriatic Arthritis (DAPSA) and Psoriatic Arthritis Disease Activity Score (PASDAS).</p> <p><strong>Results</strong> At week 24, etanercept-treated groups were significantly more effective than MTX monotherapy to achieve ACR 20 (primary end point) and MDA (key secondary end point). When examining score changes from baseline at week 24 across the five continuous composite measures, PASDAS demonstrated relatively greater changes in the etanercept-treated groups compared with MTX monotherapy and had the largest effect size and standardized response. Joint count changes drove overall score changes at week 24 from baseline in all the continuous composite measures except for PASDAS, which was driven by the Physician and Patient Global Assessments.</p> <p><strong>Conclusion</strong> PASDAS was the most sensitive continuous composite measure examined with results that mirrored the protocol-defined primary and key secondary outcomes. Composite measures with multiple domains, such as PASDAS, may better quantify change in PsA disease burden.</p> <p><strong>Trail registration</strong> https://ClinicalTrials.gov, number NCT02376790.</p> |
| spellingShingle | Coates, L Merola, JF Mease, PJ Ogdie, A Gladman, DD Strand, V van Mens, L J.J. Liu, L Yen, PK Collier, DH Kricorian, G Chung, JB Helliwell, PS Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis |
| title | Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis |
| title_full | Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis |
| title_fullStr | Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis |
| title_full_unstemmed | Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis |
| title_short | Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis |
| title_sort | performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis |
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