ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1583

Body Mass Index Does Not Affect Response to Subcutaneous or Intravenous Abatacept in Patients with Rheumatoid Arthritis  

MA D'Agostino1, R Alten2, E Mysler3, M Le Bars4, J Ye5, B Murthy5, J Heitzmann6, R Vadanici4 and G Ferraccioli7, 1Hôpital Ambroise Paré, Boulogne-Billancourt, France, 2Schlosspark-Klinik University Medicine, Berlin, Germany, 3Organización Médica de Investigación, Buenos Aires, Argentina, 4Bristol-Myers Squibb, Rueil-Malmaison, France, 5Bristol-Myers Squibb, Princeton, NJ, 6Excelya, Boulogne-Billancourt, France, 7Catholic University of the Sacred Heart, Rome, Italy

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , ,

Session Information

Date: Monday, November 14, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: High BMI is associated with reduced remission rates with anti-TNF agents in RA.1,2 In ACQUIRE (NCT00559585), SC and IV abatacept (ABA) achieved similar ACR20 responses at 6 months (M)3 and therapeutic trough concentrations4 across body weight groups in patients (pts) with RA. This post hoc analysis explored clinical outcomes reflecting disease status and pharmacokinetics with SC (fixed dose) or IV (weight-tiered) ABA by BMI.

Methods: In ACQUIRE, pts with RA and MTX inadequate response were randomized (1:1) to SC (125 mg/week) or IV (~10 mg/kg/M) ABA plus MTX. Disease status over 6 M was assessed by DAS28 (CRP) (<2.6), SDAI (≤3.3) and CDAI (≤2.8) remission, mean change in Pt Global Assessment, TJC and SJC, and high-sensitivity CRP (hsCRP). Trough (Cmin) serum ABA concentrations were measured at 3 and 6 M. Data were analyzed by baseline BMI (underweight/normal, <25 kg/m2; overweight, 25–<30 kg/m2; obese, ≥30 kg/m2) and ABA administration route.

Results: 526 pts (SC 265, IV 261) were underweight/normal; 497 (SC 249, IV 248) overweight; 433 (SC 221, IV 212) obese. Baseline characteristics did not differ by administration route, and for the pooled SC/IV group were similar by BMI (Table 1). Clinical outcomes by BMI at 6 M were similar for SC and IV groups measured by the % of pts in DAS28 (Figure 1), SDAI (underweight/normal, 9.1 vs 10.6%; overweight, 12.0 vs 11.8%; obese, 11.9 vs 9.8%) and CDAI (underweight/normal, 9.0 vs 11.8%; overweight, 13.1 vs 13.7%; obese, 14.3 vs 11.8%) remission; 95% CIs overlapped at all time points. There were no differences in the other outcomes by BMI, except for hsCRP, but this had no impact on remission rates. Results were consistent for the pooled SC/IV group. Although SC ABA Cmin concentrations decreased with BMI increase, >90% of pts had concentrations >10 μg/mL (efficacy threshold) across BMI groups at 3 and 6 M for both SC and IV ABA (Figure 2).

Conclusion: The clinical efficacy of SC and IV abatacept was independent of BMI, even when stringent remission criteria were used. Across BMI groups, >90% pts achieved therapeutic trough concentrations, irrespective of SC or IV administration.   1.    Gremese E, et al. Arthritis Care Res 2013;65:94–100. 2.    Iannone F, et al. Joint Bone Spine 2015;82:187–91. 3.    Genovese MC, et al. Arthritis Rheum 2011;63:2854–64. 4.    Murthy B, et al. Ann Rheum Dis 2011;70(Suppl 3):460 [FRI0347].    

Table 1. Baseline Characteristics by BMI Group (pooled SC and IV)
 

Underweight/normal, <25 kg/m2 (n=526)

Overweight, 25–<30 kg/m2 (n=497)

Obese, ≥30 kg/m2 (n=433)

BMI, kg/m2

22.0 (2.1)

27.4 (1.4)

35.2 (5.2)

Age, years

47.5 (14.4)

51.3 (12.2)

51.6 (11.2)

Females, %

83.1

78.9

85.7

Caucasians, %

70.9

76.3

77.1

RA duration, years

8.3 (8.2)

7.7 (7.5)

6.9 (8.2)

TJC/68

28.5 (13.5)

29.3 (13.6)

31.2 (14.1)

SJC/66

19.7 (9.5)

19.6 (8.7)

20.5 (9.2)

hsCRP, mg/dL

3.1 (3.4)

2.5 (2.6)

2.3 (2.5)

DAS28 (CRP)

6.2 (0.9)

6.2 (0.9)

6.3 (0.8)

PGA, 100 mm VAS

66.3 (19.5)

64.9 (20.3)

66.5 (20.9)

Data are mean (SD) unless indicated otherwise. hsCRP=high-sensitivity CRP; PGA=patient global assessment; VAS=visual analog scale
Disclosure: M. D'Agostino, Bristol-Myers Squibb, AbbVie, Pfizer, Novartis, MSD, 8,Elsevier, 7; R. Alten, Bristol-Myers Squibb, 2,Bristol-Myers Squibb, 8; E. Mysler, Bristol-Myers Squibb, Pfizer, AbbVie, Roche, Astra, Sanofi, Biogen, GSK, Lilly, 2,Bristol-Myers Squibb, Pfizer, Roche, Novartis, AbbVie, 8; M. Le Bars, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3; J. Ye, Bristol-Myers Squibb, 3; B. Murthy, Bristol-Myers Squibb, 1,Bristol-Myers Squibb, 3; J. Heitzmann, Excelya, 3; R. Vadanici, Bristol-Myers Squibb, 3; G. Ferraccioli, None.

To cite this abstract in AMA style:

D'Agostino M, Alten R, Mysler E, Le Bars M, Ye J, Murthy B, Heitzmann J, Vadanici R, Ferraccioli G. Body Mass Index Does Not Affect Response to Subcutaneous or Intravenous Abatacept in Patients with Rheumatoid Arthritis   [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/body-mass-index-does-not-affect-response-to-subcutaneous-or-intravenous-abatacept-in-patients-with-rheumatoid-arthritis/. Accessed .

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