Safety and Survival Associated with Biologic Therapies : First Report of the Biobadaguay on the Paraguayan-Uruguayan Registry of Adverse Events with Biologic Therapies
Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved..
OBJECTIVE: Analyze adverse events (AE) and survival associated with biologic therapies (BT) in the Biobadaguay, the Paraguayan Uruguayan registry of adverse events.
METHODS: Prospective, observational study of undetermined duration. Patients on BT at initiation and controls were included. Clinical, biological and treatment variables were registered.
RESULTS: A total of 826 registers were entered (650 BT and 176 controls); 70.9% were women and rheumatoid arthritis (RA) was the most frequent diagnosis (63.2%). The BT most often used was adalimumab and the main cause of discontinuation was loss of efficacy (42.1%). The incidence of AE of patients on BT was 143.9 (128.8-160.8) per 1000 patients/year. In the comparative study of AE related to diagnosis, juvenile idiopathic arthrosis (JIA) was associated with a higher overall number of AE (RTI = 2.3; 95%CI: 1.6-3.4; P = 4.27 ×10-6), whereas RA was associated with a higher number of serious AE (RTI = 2.2; 95% CI: 1.2-4.1; P =1.17 ×10-2). On the other hand, treatment with tocilizumab was associated with a higher rate of AE (RTI = 2.69; 95% CI: 1.9-3.82; P = 3.13 ×10-8). In JIA, treatment with corticosteroids and number of previous BT was associated with a decrease in BT survival.
CONCLUSION: In this first report of the Biobadaguay registry, the main cause of BT discontinuation was loss of efficacy. In terms of the diagnosis involved, RA and JIA were associated with a higher risk of AE. In this registry, variables related to a shorter survival of BT were identified.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
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| Enthalten in: |
Reumatologia clinica - 16(2020), 5 Pt 2 vom: 05. Sept., Seite 396-404 |
| Sprache: |
Englisch |
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| Weiterer Titel: |
Seguridad y supervivencia de las terapias biológicas: primer informe del registro paraguayo-uruguayo de acontecimientos adversos con terapias biológicas Biobadaguay |
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| Beteiligte Personen: |
de Abreu, Paloma [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 02.09.2021 Date Revised 02.09.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.reuma.2018.08.009 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM292245483 |
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| 245 | 1 | 0 | |a Safety and Survival Associated with Biologic Therapies |b First Report of the Biobadaguay on the Paraguayan-Uruguayan Registry of Adverse Events with Biologic Therapies |
| 246 | 3 | 3 | |a Seguridad y supervivencia de las terapias biológicas: primer informe del registro paraguayo-uruguayo de acontecimientos adversos con terapias biológicas Biobadaguay |
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| 500 | |a Date Revised 02.09.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved. | ||
| 520 | |a OBJECTIVE: Analyze adverse events (AE) and survival associated with biologic therapies (BT) in the Biobadaguay, the Paraguayan Uruguayan registry of adverse events | ||
| 520 | |a METHODS: Prospective, observational study of undetermined duration. Patients on BT at initiation and controls were included. Clinical, biological and treatment variables were registered | ||
| 520 | |a RESULTS: A total of 826 registers were entered (650 BT and 176 controls); 70.9% were women and rheumatoid arthritis (RA) was the most frequent diagnosis (63.2%). The BT most often used was adalimumab and the main cause of discontinuation was loss of efficacy (42.1%). The incidence of AE of patients on BT was 143.9 (128.8-160.8) per 1000 patients/year. In the comparative study of AE related to diagnosis, juvenile idiopathic arthrosis (JIA) was associated with a higher overall number of AE (RTI = 2.3; 95%CI: 1.6-3.4; P = 4.27 ×10-6), whereas RA was associated with a higher number of serious AE (RTI = 2.2; 95% CI: 1.2-4.1; P =1.17 ×10-2). On the other hand, treatment with tocilizumab was associated with a higher rate of AE (RTI = 2.69; 95% CI: 1.9-3.82; P = 3.13 ×10-8). In JIA, treatment with corticosteroids and number of previous BT was associated with a decrease in BT survival | ||
| 520 | |a CONCLUSION: In this first report of the Biobadaguay registry, the main cause of BT discontinuation was loss of efficacy. In terms of the diagnosis involved, RA and JIA were associated with a higher risk of AE. In this registry, variables related to a shorter survival of BT were identified | ||
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| 700 | 1 | |a Elizaur, Juan Gabriel |e verfasserin |4 aut | |
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