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.
Highlights
More than 60% of patients with rheumatoid arthritis (RA) are classified as overweight or obese according to body mass index (BMI; > 25 kg/m2) [1, 2]
A meta-analysis found that Disease Activity Score in 28 joints (DAS28) and functional disability (Heath Assessment Questionnaire) score were both significantly higher in patients with RA who were obese (BMI > 30 kg/m2) versus non-obese (BMI ≤ 30 kg/m2); radiographic progression was negatively associated with obesity (p < 0.05) [6]
There were numerical differences in the proportions of patients achieving DAS28 (CRP) remission at month 6 when stratified by baseline BMI; the 95% confidence intervals (CIs) overlapped across BMI groups (Table 2)
Summary
More than 60% of patients with rheumatoid arthritis (RA) are classified as overweight or obese according to body mass index (BMI; > 25 kg/m2) [1, 2]. Whereas women who are overweight or obese have been found to be at increased risk of RA at a younger age [4], a higher BMI has been independently associated with a lower risk of structural damage progression [5]. An epidemiological study showed that, following 6 months of treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), patients with a BMI ≥ 25 kg/ m2 had a > 50% lower chance of achieving a good response and a > 40% lower chance of achieving remission than patients with a BMI < 25 kg/m2 [7]. A recent metaanalysis of 3368 adults with RA showed that, following treatment with either biologic DMARDs (bDMARDs) or csDMARDs, patients who were obese (BMI ≥ 30 kg/m2) were 40% less likely to have achieved disease remission and 50% less likely to have achieved sustained remission than those who were non-obese (BMI < 30 kg/m2) [8]
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