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 originale | Inglese |
|---|---|
| pagine (da-a) | 2655-2665 |
| Numero di pagine | 11 |
| Rivista | Clinical Rheumatology |
| Volume | 36 |
| Numero di pubblicazione | 12 |
| DOI | |
| Stato di pubblicazione | Pubblicato - 2017 |
All Science Journal Classification (ASJC) codes
- Reumatologia
Keywords
- Abatacept
- Adult
- Aged
- Antirheumatic Agents
- Arthritis
- Body Mass Index
- Body mass index
- Combination
- DAS28
- Disease activity
- Double-Blind Method
- Drug Therapy
- Female
- Humans
- Injections
- Intravenous
- Male
- Methotrexate
- Middle Aged
- Pharmacokinetics
- Rheumatoid
- Rheumatoid arthritis
- Severity of Illness Index
- Subcutaneous
- Treatment Outcome