Baseline Characteristics and Changes in Disease Activity at 12 Months in Patients Treated with Abatacept Versus Other Biologic Disease-Modifying Antirheumatic Drugs in Clinical Practice Setting

E Alemao¹, S Joo², M Frits³, C Iannaccone³, N Shadick³ and Michael Weinblatt³, ¹Bristol-Myers Squibb, Princeton, NJ, ²Bristol-Myers Squibb, Hopewell, NJ, ³Brigham and Women's Hospital, Boston, MA

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: Abatacept and rheumatoid arthritis (RA), Biologic agents

Session Information

Date: Tuesday, November 10, 2015

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

Session Type: ACR Poster Session C

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

Background/Purpose:
Biologic (b)DMARDs have advanced the standard of
care in RA, reducing unmet needs and increasing remission rates. Abatacept
(ABA) is approved for the management of moderate-to-severe RA. In clinical
trials, ABA showed efficacy similar to TNFi.¹ In clinical practice,
TNFi are the predominantly used bDMARDs in the management of RA, but data
comparing ABA to bDMARDs are limited. The primary objective was to assess baseline (BL) characteristics of RA patients (pts) receiving
ABA or other bDMARDs in clinical practice. The
secondary objective was to evaluate changes from BL to Month 12 in disease
activity measures (DAS28 [CRP], CDAI and SDAI) and pt-reported outcomes (PROs; physical
functioning [modified Health Assessment Questionnaire (mHAQ)], quality of life [EQ-5D]
and arthritis active/pain today). Methods: Data from pts enrolled in the Brigham and Women’s Hospital RA Sequential Study
(BRASS) registry, established in 2003, were analyzed. The registry comprises
mostly pts with established RA who were evaluated annually on clinical measures
and semi-annually on multiple clinical PROs and resource utilization
parameters. The current analysis is based on pts who had exposure to bDMARDs and
available data on at least one disease activity measure during 12-month follow-up
in the registry. Descriptive statistics were used to summarize BL differences
in demographics, disease activity measures and laboratory measurements between
RA pts prescribed ABA vs other bDMARDs. Mean change from BL to 12 months in
disease activity measures and PROs were assessed using univariate and
multivariate regression analyses that controlled for BL covariates, including BL
ABA vs bDMARD treatments. Results: 748 pts were included in the analysis: 102 (13.6%) received ABA and
646 (86.4%) received other bDMARDs; 83% of ABA pts had prior exposure to
bDMARDs. At BL, ABA pts (vs other bDMARD patients) were older (mean [SD] age:
59.5 [10.7] vs 54.8 [14.2] yrs; p=0.0015), with higher CRP levels (17.09 [41.5]
vs 8.1 [19.2] mg/L; p=0.0004), higher DAS28 (CRP) (4.42 [1.58] vs 3.68 [1.65];
p≤0.001), higher mHAQ
(0.59 [0.52] vs 0.37 [0.47]; p≤0.001) and lower EQ-5D (0.71 [0.15] vs 0.80 [0.17]; p≤0.001). After controlling for BL covariates,
the mean changes from BL to 12 months in disease activity measures and PROs
were comparable in ABA and other bDMARD pts (Table).

Table: Change from baseline to 12 months between ABA vs bDMARD on disease activity and patient-reported outcomes*
	bDMARD patients	ABA patients	p-value
	Mean (95% CI)	Mean (95% CI)	p-value
DAS28 (CRP)	–0.915 (–1.276, –0.554)	–0.606 (–1.123, –0.090)	0.147
CDAI	–8.406 (–11.819, –4.992)	–5.098 (–10.238, 0.042)	0.119
SDAI	–8.673 (–12.353, –4.994)	–7.004 (–12.348, –1.659)	0.299
mHAQ	–0.023 (–0.085, 0.039)	–0.038 (–0.137, 0.062)	0.239
EQ-5D	0.003 (–0.022, 0.028)	0.022 (–0.018, 0.063)	0.231
Arthritis active today	–0.285 (–0.708, 0.138)	–0.709 (–1.357, –0.061)	0.904
Arthritis pain today	–0.199 (–0.585, 0.187)	–0.595 (–1.187, –0.003)	0.944
*Negative values indicate a reduction in disease activity and improvement in patient-reported outcomes except for EQ-5D, where positive values indicate an improvement

Conclusion: RA pts prescribed abatacept (vs other bDMARDs) in clinical practice
tend to be older, with longer disease duration, higher disease activity scores,
higher acute-phase reactant and most had prior bDMARD exposure. Despite this, mean
changes from BL to 12 months in disease activity measures and PROs in pts on abatacept
and other biologic therapies were comparable.²

1. Schiff M, et al. Ann Rheum Dis 2014;73:86–94.

2. This abstract was first presented at the EULAR Congress, 10–13 June
2015, Rome, Italy (AB0448) and published in the corresponding supplement of Ann
Rheum Dis.

Disclosure: E. Alemao, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1; S. Joo, Bristol-Myers Squibb, 3,Bristol-Myers Squibb, 1; M. Frits, None; C. Iannaccone, None; N. Shadick, Amgen, Questcor, Crescendo Biosciences, UCB, Bristol-Myers Squibb, 2; M. Weinblatt, Amgen, Abbvie, Bristol-Myers Squibb, Lilly, Novartis, Merck, Pfizer, Roche, Crescendo, Myriad Genetics, UCB, 5,Bristol-Myers Squibb, Myriad Genetics, UCB, 2.

To cite this abstract in AMA style:

Alemao E, Joo S, Frits M, Iannaccone C, Shadick N, Weinblatt M. Baseline Characteristics and Changes in Disease Activity at 12 Months in Patients Treated with Abatacept Versus Other Biologic Disease-Modifying Antirheumatic Drugs in Clinical Practice Setting [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/baseline-characteristics-and-changes-in-disease-activity-at-12-months-in-patients-treated-with-abatacept-versus-other-biologic-disease-modifying-antirheumatic-drugs-in-clinical-practice-setting/. Accessed .

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