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Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis
This post hoc analysis of ACQUIRE (NCT00559585) explored the effect of baseline body mass index (BMI) on the pharmacokinetics of and clinical response to subcutaneous (SC) or intravenous (IV) abatacept in patients with rheumatoid arthritis (RA). ACQUIRE was a phase 3b, 6-month, double-blind, double-...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer London
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5681604/ https://www.ncbi.nlm.nih.gov/pubmed/28822046 http://dx.doi.org/10.1007/s10067-017-3788-1 |
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author | D’Agostino, Maria-Antonietta Alten, Rieke Mysler, Eduardo Le Bars, Manuela Ye, June Murthy, Bindu Heitzmann, Julia Vadanici, Radu Ferraccioli, Gianfranco |
author_facet | D’Agostino, Maria-Antonietta Alten, Rieke Mysler, Eduardo Le Bars, Manuela Ye, June Murthy, Bindu Heitzmann, Julia Vadanici, Radu Ferraccioli, Gianfranco |
author_sort | D’Agostino, Maria-Antonietta |
collection | PubMed |
description | This post hoc analysis of ACQUIRE (NCT00559585) explored the effect of baseline body mass index (BMI) on the pharmacokinetics of and clinical response to subcutaneous (SC) or intravenous (IV) abatacept in patients with rheumatoid arthritis (RA). ACQUIRE was a phase 3b, 6-month, double-blind, double-dummy study in which patients with RA were randomized (1:1) to SC (fixed - dose; 125 mg/week) or IV (weight-tiered; ~ 10 mg/kg/month) abatacept plus methotrexate. In this analysis, minimum abatacept plasma concentration (C(min)) was measured at 3 and 6 months, and clinical remission over 6 months was assessed by Disease Activity Score 28 (C-reactive protein; DAS28 [CRP], < 2.6), Simplified Disease Activity Index (SDAI, ≤ 3.3), and Clinical Disease Activity Index (CDAI, ≤ 2.8). Data were stratified by baseline BMI (underweight/normal, < 25 kg/m(2); overweight, 25 to < 30 kg/m(2); obese, ≥ 30 kg/m(2)) and administration route. Of the 1456/1457 patients for whom baseline BMIs were available, 526 (36%; SC 265, IV 261) patients were underweight/normal, 497 (34%; SC 249, IV 248) were overweight, and 433 (30%; SC 221, IV 212) were obese. Median C(min) abatacept concentration was ≥ 10 μg/mL (efficacy threshold) at 3 and 6 months in > 90% of patients across BMI groups with both administration routes. DAS28 (CRP), SDAI, and CDAI remission rates at 6 months were similar across BMI groups and 95% confidence intervals overlapped at all time points in both separate and pooled SC/IV analyses. Therapeutic concentrations of abatacept and clinical remission rates using stringent criteria were similar across patient BMIs and administration routes. |
format | Online Article Text |
id | pubmed-5681604 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Springer London |
record_format | MEDLINE/PubMed |
spelling | pubmed-56816042017-11-21 Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis D’Agostino, Maria-Antonietta Alten, Rieke Mysler, Eduardo Le Bars, Manuela Ye, June Murthy, Bindu Heitzmann, Julia Vadanici, Radu Ferraccioli, Gianfranco Clin Rheumatol Original Article This post hoc analysis of ACQUIRE (NCT00559585) explored the effect of baseline body mass index (BMI) on the pharmacokinetics of and clinical response to subcutaneous (SC) or intravenous (IV) abatacept in patients with rheumatoid arthritis (RA). ACQUIRE was a phase 3b, 6-month, double-blind, double-dummy study in which patients with RA were randomized (1:1) to SC (fixed - dose; 125 mg/week) or IV (weight-tiered; ~ 10 mg/kg/month) abatacept plus methotrexate. In this analysis, minimum abatacept plasma concentration (C(min)) was measured at 3 and 6 months, and clinical remission over 6 months was assessed by Disease Activity Score 28 (C-reactive protein; DAS28 [CRP], < 2.6), Simplified Disease Activity Index (SDAI, ≤ 3.3), and Clinical Disease Activity Index (CDAI, ≤ 2.8). Data were stratified by baseline BMI (underweight/normal, < 25 kg/m(2); overweight, 25 to < 30 kg/m(2); obese, ≥ 30 kg/m(2)) and administration route. Of the 1456/1457 patients for whom baseline BMIs were available, 526 (36%; SC 265, IV 261) patients were underweight/normal, 497 (34%; SC 249, IV 248) were overweight, and 433 (30%; SC 221, IV 212) were obese. Median C(min) abatacept concentration was ≥ 10 μg/mL (efficacy threshold) at 3 and 6 months in > 90% of patients across BMI groups with both administration routes. DAS28 (CRP), SDAI, and CDAI remission rates at 6 months were similar across BMI groups and 95% confidence intervals overlapped at all time points in both separate and pooled SC/IV analyses. Therapeutic concentrations of abatacept and clinical remission rates using stringent criteria were similar across patient BMIs and administration routes. Springer London 2017-08-18 2017 /pmc/articles/PMC5681604/ /pubmed/28822046 http://dx.doi.org/10.1007/s10067-017-3788-1 Text en © The Author(s) 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Article D’Agostino, Maria-Antonietta Alten, Rieke Mysler, Eduardo Le Bars, Manuela Ye, June Murthy, Bindu Heitzmann, Julia Vadanici, Radu Ferraccioli, Gianfranco Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis |
title | Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis |
title_full | Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis |
title_fullStr | Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis |
title_full_unstemmed | Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis |
title_short | Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis |
title_sort | body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5681604/ https://www.ncbi.nlm.nih.gov/pubmed/28822046 http://dx.doi.org/10.1007/s10067-017-3788-1 |
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