Efficacy of Etanercept in Elderly Patients with Rheumatoid Arthritis

Christopher J. Edwards¹, Katherine Roshak², Jack F Bukowski³, Ronald Pedersen⁴, Mazhar Thakur⁵, Lisa Marshall² and Heather Jones², ¹University Hospital Southampton, Southampton, United Kingdom, ²Inflammation & Immunology Global Medical Affairs, Pfizer, Collegeville, PA, ³Clinical Affairs, Pfizer, Collegeville, PA, ⁴Department of Biostatistics, Pfizer, Collegeville, PA, ⁵Pfizer Ltd, Sandwich, United Kingdom

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Aging, etanercept, rheumatoid arthritis (RA) and safety

Session Information

Date: Tuesday, November 7, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster III: Efficacy and Safety of Originator Biologics and Biosimilars

Session Type: ACR Poster Session C

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

Background/Purpose: Ageing is associated with declining immune cell function and age-related comorbidities.^1,2 In the US, the prevalence of rheumatoid arthritis (RA) is ~2% in individuals ≥65 y.³ As life expectancy increases, there is a growing clinical need for data on the efficacy and safety of commonly used treatments in elderly patients with RA. The aim of this study was to compare the efficacy of etanercept (ETN) in patients with RA aged <65 y vs those aged ≥65 y.

Methods: In a post-hoc study, efficacy data from the open-label period of 3 ETN (50 mg QW) studies in patients with RA (Treat-to-Target in Emerging Market RA Patient Populations study [T2T], NCT01578850; PRESERVE, NCT00565409; PRIZE, NCT00913458) were analyzed in 2 cohorts: <65 y and ≥65 y. Descriptive statistics of 28-joint Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) scores, Health Assessment Questionnaire Disability Index (HAQ-DI), and modified total Sharp Scores (mTSS) in observed cases were collated. Least squares means were calculated and P-values were from F-tests from an analysis of covariance models testing the age group effect with baseline as covariate.

Results: Mean baseline DAS28-ESR and HAQ-DI scores were marginally higher in patients ≥65 y vs <65 y (Table 1). Mean changes from baseline (Table 2) in DAS28-ESR scores showed no consistent trend, i.e., both higher and lower changes were observed at different times in patients ≥65 y vs <65 y. Mean HAQ-DI scores were higher in patients ≥65 y vs <65 y, and the mean changes from baseline were either similar or marginally smaller in patients ≥65 y vs <65 y. mTSS were also found to be higher in patients ≥65 y vs <65 y, whereas the mean changes from baseline showed only marginal differences for patients ≥65 y vs <65 y. The smaller number of patients in the ≥65 y cohort compared with the <65 y cohort was a study limitation.

Conclusion: There were no substantial differences in efficacy for ETN-treated patients ≥65 y vs <65 y.

References: 1. van Onna M, et al. BMC Musculoskelet Disord 2016;17:184. 2. Cross M, et al. Ann Rheum Dis 2014;73:1316-22. 3. Rasch EK, et al. Arthritis Rheum 2003;48:917-26.

Table 1. Baseline DAS-28 ESR and HAQ-DI scores
	Mean score (95% CI)
Study	DAS28-ESR		HAQ-DI
Study	<65 y	≥65 y	<65 y	≥65 y
T2T	6.36 (6.27, 6.46) n=416	6.57 (6.22, 6.92) n=34	1.52 (1.46, 1.58) n=440	1.59 (1.35, 1.83) n=37
PRESERVE	4.37 (4.34, 4.40) n=773	4.46 (4.34, 4.58) n=56	1.13 (1.09, 1.17) n=771	1.32 (1.14, 1.50) n=56
PRIZE	5.98 (5.86, 6.11) n=261	6.11 (5.75, 6.47) n=45	1.27 (1.19, 1.35) n=258	1.27 (1.06, 1.48) n=43

Table 2. Efficacy of ETN in patients with RA aged <65 y vs ≥65 y
Study	Visit	LS mean change from baseline (95% CI)
		DAS28-ESR		HAQ-DI		mTSS
		<65 y	≥65 y	<65 y	≥65 y	<65 y	≥65 y
T2T	Week 4	-1.60 (-169, -1.50) n=430	-1.71 (-2.04, -1.39) n=37	-0.45 (-0.50, -0.41) n=431	-0.34 (-0.50, -0.19) n=37	–	–
T2T	Week 24	-3.34 (-3.44, -3.24) n=412	-3.15 (-3.48, -2.81) n=35	-0.81 (-0.87, -0.76) n=413	-0.71 (-0.89, -0.53) n=35	–	–
PRESERVE	Week 4	-0.90 (-0.96, -0.84) n=725	-0.56 (-0.78, -0.34) n=53	-0.26 (-0.29, -0.23) n=729	-0.20 (-0.30, -0.10) n=54	0.33 (0.15, 0.51)*n=668	0.56 (-0.17, 1.29)*n=41
PRESERVE	Week 28	-1.81 (-1.88, -1.74) n=725	-1.64 (-1.90, -1.38) n=51	-0.54 (-0.57, -0.50) n=724	-0.43 (-0.56, -0.29) n=51	0.33 (0.15, 0.51)*n=668	0.56 (-0.17, 1.29)*n=41
PRIZE	Week 4	-2.02 (-2.17, -1.88) n=253	-1.89 (-2.27, -1.52) n=40	-0.55 (-0.61, -0.49) n=254	-0.34 (-0.49, -0.18) n=41	0.35 (-0.12, 0.81)^†n=167	0.27 (-0.78, 1.33)^†n=33
PRIZE	Week 26	-3.22 (-3.39, -3.06) n=235	-3.15 (-3.55, -2.75) n=41	-0.79 (-0.86, -0.72) n=230	-0.69 (-0.85, -0.52) n=38	0.35 (-0.12, 0.81)^†n=167	0.27 (-0.78, 1.33)^†n=33
*Week 36 data. ^†Week 52 data. Week 4 and 24/26/28 data are shown in this table for comparison at similar visits across the different studies. There were significant differences (P<0.05) between the <65 y vs ≥65 y cohorts at some visits: PRESERVE, Week 4, 8, and 12 for DAS28-ESR and Week 12 for HAQ-DI; PRIZE, Week 2, 4, 13, 39, and 52 for HAQ-DI.

Disclosure: C. J. Edwards, Celgene Corporation, Pfizer, Roche, Samsung, 2,Celgene Corporation, Pfizer, Roche, Samsung, 5,Abbott, GSK, Pfizer, Roche, 8; K. Roshak, Pfizer Inc, 3; J. F. Bukowski, Pfizer Inc, 1,Pfizer Inc, 3; R. Pedersen, Pfizer Inc, 1,Pfizer Inc, 3; M. Thakur, Pfizer Inc, 1,Pfizer Inc, 3; L. Marshall, Pfizer Inc, 1,Pfizer Inc, 3; H. Jones, Pfizer Inc, 1,Pfizer Inc, 3.

To cite this abstract in AMA style:

Edwards CJ, Roshak K, Bukowski JF, Pedersen R, Thakur M, Marshall L, Jones H. Efficacy of Etanercept in Elderly Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/efficacy-of-etanercept-in-elderly-patients-with-rheumatoid-arthritis/. Accessed .

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