Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry
Abstract Introduction Anti-citrullinated protein antibodies (ACPAs) are highly specific serological biomarkers that are indicative of a poor prognosis in patients with rheumatoid arthritis (RA). The effectiveness of biologic disease-modifying antirheumatic drugs (bDMARDs) with different mechanisms o...
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2019-03-01
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| Series: | Rheumatology and Therapy |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1007/s40744-019-0149-3 |
| _version_ | 1818336418322186240 |
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| author | Leslie R. Harrold Heather J. Litman Sean E. Connolly Evo Alemao Sheila Kelly Sabrina Rebello Winnie Hua Joel M. Kremer |
| author_facet | Leslie R. Harrold Heather J. Litman Sean E. Connolly Evo Alemao Sheila Kelly Sabrina Rebello Winnie Hua Joel M. Kremer |
| author_sort | Leslie R. Harrold |
| collection | DOAJ |
| description | Abstract Introduction Anti-citrullinated protein antibodies (ACPAs) are highly specific serological biomarkers that are indicative of a poor prognosis in patients with rheumatoid arthritis (RA). The effectiveness of biologic disease-modifying antirheumatic drugs (bDMARDs) with different mechanisms of action may vary, based on patients’ serostatus. The aim of this study is to compare the effectiveness of abatacept versus tumor necrosis factor inhibitors (TNFis) in patients with RA who were anti-cyclic citrullinated peptide antibody positive (anti-CCP+). Methods Abatacept or TNFi initiators with anti-CCP+ status (≥ 20 U/ml) at or prior to treatment initiation were identified from a large observational US cohort (1 December 2005–31 August 2016). Using propensity score matching (1:1), stratified by prior TNFi use (0, 1 and ≥ 2), effectiveness at 6 months after initiation was evaluated. Primary outcome was mean change in Clinical Disease Activity Index (CDAI) score. Secondary outcomes included achievement of remission (CDAI ≤ 2.8), low disease activity/remission (CDAI ≤ 10), modified American College of Rheumatology 20/50/70 responses and mean change in modified Health Assessment Questionnaire score. Results After propensity score matching, the baseline characteristics between 330 pairs of abatacept and TNFi initiators (biologic naïve, n = 97; TNFi experienced, n = 233) were well balanced with absolute value standardized differences of ≤ 0.1. Both overall, and in the biologic-naïve cohort, there were no significant differences in mean change in CDAI score at 6 months. However, in the TNFi-experienced cohort, there was a significantly greater improvement in CDAI score at 6 months with abatacept versus TNFi initiators (p = 0.033). Secondary outcomes showed similar trends. Conclusions Improvements in clinical disease activity were seen in anti-CCP+ abatacept and TNFi initiators. TNFi-experienced anti-CCP+ patients with RA had more improvement in disease activity with abatacept versus TNFis, whereas outcomes were similar between treatments in the overall population and in biologic-naïve patients. Trial Registration ClinicalTrials.gov identifier: NCT01625650. Funding This study is sponsored by Corrona, LLC and funded by Bristol-Myers Squibb. Bristol-Myers Squibb funded the publication of this manuscript. |
| first_indexed | 2024-12-13T14:39:00Z |
| format | Article |
| id | doaj.art-812cba2a5c4548318fedf2a8c36e6960 |
| institution | Directory Open Access Journal |
| issn | 2198-6576 2198-6584 |
| language | English |
| last_indexed | 2024-12-13T14:39:00Z |
| publishDate | 2019-03-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Rheumatology and Therapy |
| spelling | doaj.art-812cba2a5c4548318fedf2a8c36e69602022-12-21T23:41:40ZengAdis, Springer HealthcareRheumatology and Therapy2198-65762198-65842019-03-016221723010.1007/s40744-019-0149-3Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona RegistryLeslie R. Harrold0Heather J. Litman1Sean E. Connolly2Evo Alemao3Sheila Kelly4Sabrina Rebello5Winnie Hua6Joel M. Kremer7Departments of Medicine and Orthopedics, University of MassachusettsCorrona, LLCBristol-Myers SquibbBristol-Myers SquibbBristol-Myers SquibbCorrona, LLCCorrona, LLCAlbany Medical College and the Center for RheumatologyAbstract Introduction Anti-citrullinated protein antibodies (ACPAs) are highly specific serological biomarkers that are indicative of a poor prognosis in patients with rheumatoid arthritis (RA). The effectiveness of biologic disease-modifying antirheumatic drugs (bDMARDs) with different mechanisms of action may vary, based on patients’ serostatus. The aim of this study is to compare the effectiveness of abatacept versus tumor necrosis factor inhibitors (TNFis) in patients with RA who were anti-cyclic citrullinated peptide antibody positive (anti-CCP+). Methods Abatacept or TNFi initiators with anti-CCP+ status (≥ 20 U/ml) at or prior to treatment initiation were identified from a large observational US cohort (1 December 2005–31 August 2016). Using propensity score matching (1:1), stratified by prior TNFi use (0, 1 and ≥ 2), effectiveness at 6 months after initiation was evaluated. Primary outcome was mean change in Clinical Disease Activity Index (CDAI) score. Secondary outcomes included achievement of remission (CDAI ≤ 2.8), low disease activity/remission (CDAI ≤ 10), modified American College of Rheumatology 20/50/70 responses and mean change in modified Health Assessment Questionnaire score. Results After propensity score matching, the baseline characteristics between 330 pairs of abatacept and TNFi initiators (biologic naïve, n = 97; TNFi experienced, n = 233) were well balanced with absolute value standardized differences of ≤ 0.1. Both overall, and in the biologic-naïve cohort, there were no significant differences in mean change in CDAI score at 6 months. However, in the TNFi-experienced cohort, there was a significantly greater improvement in CDAI score at 6 months with abatacept versus TNFi initiators (p = 0.033). Secondary outcomes showed similar trends. Conclusions Improvements in clinical disease activity were seen in anti-CCP+ abatacept and TNFi initiators. TNFi-experienced anti-CCP+ patients with RA had more improvement in disease activity with abatacept versus TNFis, whereas outcomes were similar between treatments in the overall population and in biologic-naïve patients. Trial Registration ClinicalTrials.gov identifier: NCT01625650. Funding This study is sponsored by Corrona, LLC and funded by Bristol-Myers Squibb. Bristol-Myers Squibb funded the publication of this manuscript.http://link.springer.com/article/10.1007/s40744-019-0149-3Anti-TNFDMARDs (biologic)Outcomes researchRheumatoid arthritis |
| spellingShingle | Leslie R. Harrold Heather J. Litman Sean E. Connolly Evo Alemao Sheila Kelly Sabrina Rebello Winnie Hua Joel M. Kremer Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry Rheumatology and Therapy Anti-TNF DMARDs (biologic) Outcomes research Rheumatoid arthritis |
| title | Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry |
| title_full | Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry |
| title_fullStr | Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry |
| title_full_unstemmed | Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry |
| title_short | Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry |
| title_sort | comparative effectiveness of abatacept versus tumor necrosis factor inhibitors in patients with rheumatoid arthritis who are anti ccp positive in the united states corrona registry |
| topic | Anti-TNF DMARDs (biologic) Outcomes research Rheumatoid arthritis |
| url | http://link.springer.com/article/10.1007/s40744-019-0149-3 |
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