Body mass index and clinical response to intravenous or subcutaneous abatacept in patients with rheumatoid arthritis

Maria Antonietta D'Agostino, Maria-Antonietta D’Agostino, Rieke Alten, Eduardo Mysler, Manuela Le Bars, June Ye, Bindu Murthy, Julia Heitzmann, Radu Vadanici

Risultato della ricerca: Contributo in rivistaArticolo in rivista

16 Citazioni (Scopus)

Abstract

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.
Lingua originaleEnglish
pagine (da-a)2655-2665
Numero di pagine11
RivistaCLINICAL RHEUMATOLOGY
Volume36
DOI
Stato di pubblicazionePubblicato - 2017

Keywords

  • Abatacept
  • Adult
  • Aged
  • Antirheumatic Agents
  • Arthritis, Rheumatoid
  • Body Mass Index
  • Body mass index
  • DAS28
  • Disease activity
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Injections, Intravenous
  • Injections, Subcutaneous
  • Male
  • Methotrexate
  • Middle Aged
  • Pharmacokinetics
  • Rheumatoid arthritis
  • Severity of Illness Index
  • Treatment Outcome

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