Real-World Sarilumab Use and Rule Testing to Predict Treatment Response in Patients with Rheumatoid Arthritis : Findings from the RISE Registry
© 2023. The Author(s)..
INTRODUCTION: Clinical trial findings may not be generalizable to routine practice. This study evaluated sarilumab effectiveness in patients with rheumatoid arthritis (RA) and tested the real-world applicability of a response prediction rule, derived from trial data using machine learning (based on C-reactive protein [CRP] > 12.3 mg/l and seropositivity [anticyclic citrullinated peptide antibodies, ACPA +]).
METHODS: Sarilumab initiators from the ACR-RISE Registry, with ≥ 1 prescription on/after its FDA approval (2017-2020), were divided into three cohorts based on progressively restrictive criteria: Cohort A (had active disease), Cohort B (met eligibility criteria of a phase 3 trial in RA patients with inadequate response/intolerance to tumor necrosis factor inhibitors [TNFi]), and Cohort C (characteristics matched to the phase 3 trial baseline). Mean changes in Clinical Disease Activity Index (CDAI) and Routine Assessment of Patient Index Data 3 (RAPID3) were evaluated at 6 and 12 months. In a separate cohort, predictive rule was tested based on CRP levels and seropositive status (ACPA and/or rheumatoid factor); patients were categorized into rule-positive (seropositive with CRP > 12.3 mg/l) and rule-negative groups to compare the odds of achieving CDAI low disease activity (LDA)/remission and minimal clinically important difference (MCID) over 24 weeks.
RESULTS: Among sarilumab initiators (N = 2949), treatment effectiveness was noted across cohorts, with greater improvement noted for Cohort C at 6 and 12 months. Among the predictive rule cohort (N = 205), rule-positive (vs. rule-negative) patients were more likely to reach LDA (odds ratio: 1.5 [0.7, 3.2]) and MCID (1.1 [0.5, 2.4]). Sensitivity analyses (CRP > 5 mg/l) showed better response to sarilumab in rule-positive patients.
CONCLUSIONS: In real-world setting, sarilumab demonstrated treatment effectiveness, with greater improvements in the most selective population, mirroring phase 3 TNFi-refractory and rule-positive RA patients. Seropositivity appeared a stronger driver for treatment response than CRP, although optimization of the rule in routine practice requires further data.
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
Rheumatology and therapy - 10(2023), 4 vom: 22. Aug., Seite 1055-1072 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Curtis, Jeffrey R [VerfasserIn] |
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| Links: |
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| Themen: |
ACPA |
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| Anmerkungen: |
Date Revised 16.11.2023 published: Print-Electronic ErratumIn: Rheumatol Ther. 2023 Nov 13;:. - PMID 37955805 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1007/s40744-023-00568-8 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM358510236 |
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| 100 | 1 | |a Curtis, Jeffrey R |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Real-World Sarilumab Use and Rule Testing to Predict Treatment Response in Patients with Rheumatoid Arthritis |b Findings from the RISE Registry |
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| 500 | |a Date Revised 16.11.2023 | ||
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| 500 | |a ErratumIn: Rheumatol Ther. 2023 Nov 13;:. - PMID 37955805 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a INTRODUCTION: Clinical trial findings may not be generalizable to routine practice. This study evaluated sarilumab effectiveness in patients with rheumatoid arthritis (RA) and tested the real-world applicability of a response prediction rule, derived from trial data using machine learning (based on C-reactive protein [CRP] > 12.3 mg/l and seropositivity [anticyclic citrullinated peptide antibodies, ACPA +]) | ||
| 520 | |a METHODS: Sarilumab initiators from the ACR-RISE Registry, with ≥ 1 prescription on/after its FDA approval (2017-2020), were divided into three cohorts based on progressively restrictive criteria: Cohort A (had active disease), Cohort B (met eligibility criteria of a phase 3 trial in RA patients with inadequate response/intolerance to tumor necrosis factor inhibitors [TNFi]), and Cohort C (characteristics matched to the phase 3 trial baseline). Mean changes in Clinical Disease Activity Index (CDAI) and Routine Assessment of Patient Index Data 3 (RAPID3) were evaluated at 6 and 12 months. In a separate cohort, predictive rule was tested based on CRP levels and seropositive status (ACPA and/or rheumatoid factor); patients were categorized into rule-positive (seropositive with CRP > 12.3 mg/l) and rule-negative groups to compare the odds of achieving CDAI low disease activity (LDA)/remission and minimal clinically important difference (MCID) over 24 weeks | ||
| 520 | |a RESULTS: Among sarilumab initiators (N = 2949), treatment effectiveness was noted across cohorts, with greater improvement noted for Cohort C at 6 and 12 months. Among the predictive rule cohort (N = 205), rule-positive (vs. rule-negative) patients were more likely to reach LDA (odds ratio: 1.5 [0.7, 3.2]) and MCID (1.1 [0.5, 2.4]). Sensitivity analyses (CRP > 5 mg/l) showed better response to sarilumab in rule-positive patients | ||
| 520 | |a CONCLUSIONS: In real-world setting, sarilumab demonstrated treatment effectiveness, with greater improvements in the most selective population, mirroring phase 3 TNFi-refractory and rule-positive RA patients. Seropositivity appeared a stronger driver for treatment response than CRP, although optimization of the rule in routine practice requires further data | ||
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| 650 | 4 | |a RISE registry | |
| 650 | 4 | |a Real-world | |
| 650 | 4 | |a Rheumatoid arthritis | |
| 650 | 4 | |a Sarilumab | |
| 650 | 4 | |a Seronegative | |
| 650 | 4 | |a Seropositive | |
| 650 | 4 | |a Treatment response | |
| 700 | 1 | |a Yun, Huifeng |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Lang |e verfasserin |4 aut | |
| 700 | 1 | |a Ford, Stephanie S |e verfasserin |4 aut | |
| 700 | 1 | |a van Hoogstraten, Hubert |e verfasserin |4 aut | |
| 700 | 1 | |a Fiore, Stefano |e verfasserin |4 aut | |
| 700 | 1 | |a Ford, Kerri |e verfasserin |4 aut | |
| 700 | 1 | |a Praestgaard, Amy |e verfasserin |4 aut | |
| 700 | 1 | |a Rehberg, Markus |e verfasserin |4 aut | |
| 700 | 1 | |a Choy, Ernest |e verfasserin |4 aut | |
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