TY - JOUR
T1 - Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis
AU - D’Agostino, Maria-Antonietta
AU - D'Agostino, Maria Antonietta
AU - Alten, Rieke
AU - Mysler, Eduardo
AU - Le Bars, Manuela
AU - Ye, June
AU - Murthy, Bindu
AU - Heitzmann, Julia
AU - Vadanici, Radu
AU - Ferraccioli, Gianfranco
PY - 2017
Y1 - 2017
N2 - 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 (Cmin) 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/m2; overweight, 25 to < 30 kg/m2; obese, ≥ 30 kg/m2) 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 Cmin 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.
AB - 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 (Cmin) 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/m2; overweight, 25 to < 30 kg/m2; obese, ≥ 30 kg/m2) 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 Cmin 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.
KW - Abatacept
KW - Adult
KW - Aged
KW - Antirheumatic Agents
KW - Arthritis, Rheumatoid
KW - Body Mass Index
KW - Body mass index
KW - DAS28
KW - Disease activity
KW - Double-Blind Method
KW - Drug Therapy, Combination
KW - Female
KW - Humans
KW - Injections, Intravenous
KW - Injections, Subcutaneous
KW - Male
KW - Methotrexate
KW - Middle Aged
KW - Pharmacokinetics
KW - Rheumatoid arthritis
KW - Severity of Illness Index
KW - Treatment Outcome
KW - Abatacept
KW - Adult
KW - Aged
KW - Antirheumatic Agents
KW - Arthritis, Rheumatoid
KW - Body Mass Index
KW - Body mass index
KW - DAS28
KW - Disease activity
KW - Double-Blind Method
KW - Drug Therapy, Combination
KW - Female
KW - Humans
KW - Injections, Intravenous
KW - Injections, Subcutaneous
KW - Male
KW - Methotrexate
KW - Middle Aged
KW - Pharmacokinetics
KW - Rheumatoid arthritis
KW - Severity of Illness Index
KW - Treatment Outcome
UR - http://hdl.handle.net/10807/168593
U2 - 10.1007/s10067-017-3788-1
DO - 10.1007/s10067-017-3788-1
M3 - Article
SN - 0770-3198
VL - 36
SP - 2655
EP - 2665
JO - Clinical Rheumatology
JF - Clinical Rheumatology
ER -