Better Health-Related Quality of Life and Work Capacity in Patients Achieving Inactive Disease and Clinical Response in Patients with Non-Radiographic Axial Spondyloarthritis

Maxime Dougados¹, Desiree van der Heijde², Wen-Chan Tsai³, Diego Saaibi⁴, Randi Bonin⁵, Lisa Marshall⁶, Heather Jones⁷, Ronald Pedersen⁸, Bonnie Vlahos⁹ and Miriam Tarallo¹⁰, ¹Rheumatology, Paris Descartes University, Paris, France, ²Leiden University Medical Center, Leiden, Netherlands, ³Kaohsiung Medical University, Kaohsiung City, Taiwan, ⁴MEDICITY S.A.S, Bucaramanga, Colombia, ⁵Clinical Affairs, Pfizer, Collegeville, PA, ⁶Inflammation Global Medical Affairs, Pfizer, Collegeville, PA, ⁷Inflammation & Immunology, Pfizer, Collegeville, PA, ⁸Department of Biostatistics, Pfizer, Collegeville, PA, ⁹GIPB - Clinical Sciences, Pfizer, Collegeville, PA, ¹⁰GHV, Pfizer, Rome, Italy

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: axial spondyloarthritis, etanercept, non-radiographic and treatment

Session Information

Date: Tuesday, November 15, 2016

Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster III

Session Type: ACR Poster Session C

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

Background/Purpose: Few studies have evaluated the relationship between disease activity/clinical response and patient-reported outcomes (PROs) of pain, fatigue, health-related quality of life (HRQoL), and work productivity in patients with non-radiographic axial spondyloarthritis. In post hoc analyses of findings of the EMBARK study, this association was assessed in patients with active, NSAID-resistant, nr-axSpA.^1-3(ClinicalTrials.gov identifier: NCT01258738).

Methods: Patients who satisfied Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA (not modified NY radiographic criteria) were randomized to receive etanercept (ETN) 50 mg/wk or placebo (PBO) to wk 12, followed by ETN 50 mg/wk to wk 104. Patients were grouped based on Ankylosing Spondylitis Disease Activity Score (ASDAS) disease activity state (inactive disease [ID] vs active disease) and ASAS40 response (responders vs non-responders) at wk 12 and 104 regardless of treatment group assignment. Changes in least square (LS) means for PROs of pain, fatigue, HRQoL, and work productivity from baseline (BL) to wk 12 and 104 were compared between groups in the modified intent-to-treat (mITT) population with observed cases (ANCOVA; no imputation of missing data).

Results: At wk 12, 61/214 (29%) of patients receiving ETN or PBO achieved ASDAS-ID; 51/213 (24%) achieved ASAS40 response. At wk 104, 123/205 (60%) of patients overall achieved ASDAS-ID and 121/205 (59%) were ASAS40 responders. Patients with ASDAS-ID at wk 12 and 104 had significantly less BL pain and greater HRQoL (SF-36 PCS and AsQoL) than those with active disease; those achieving ASDAS-ID at wk 104 had better BL EQ-5D (P<0.05, all). ASAS40 responders at wk 12 had significantly less total back pain and better health utility (EQ-5D) at BL vs non-responders; ASAS40 responders at wk 104 had significantly less pain and greater HR-QoL (SF-36 PCS) at BL (P<0.05, all). Significantly greater improvements were observed in pain/fatigue (nocturnal back pain, MFI general fatigue), utility (EQ-5D VAS), HR-QoL (SF-36 and ASQoL), and work productivity (WPAI-AS presenteeism) among patients with ASDAS-ID vs active disease (table). ASAS40 response was similarly associated with significantly greater improvements in these PROs.

Table. Changes in LS means from BL to wk 12 and wk 104 for PROs in nr-axSpA patients with ASDAS inactive vs active disease.
PRO	LS Mean Change (SE)
	Wk 12		Wk 104
	ASDAS Inactive Disease	ASDAS Active Disease	ASDAS Inactive Disease	ASDAS Active Disease
Nocturnal back pain (0–10 VAS)	-4.1^† (0.3)	-1.0 (0.2)	-4.6^† (0.2)	-2.1 (0.2)
MFI general fatigue (4-20)	-2.2^* (0.4)	-0.5 (0.3)	-4.6^† (0.4)	-0.5 (0.5)
EQ-5D (0–100 VAS)	20.6^† (2.5)	1.9 (1.6)	26.9^† (1.4)	12.0 (1.9)
SF-36 PCS (0–100)	9.3^† (0.8)	3.0 (0.5)	13.1^† (0.6)	4.7 (0.9)
SF-36 MCS (0–100)	4.7 (1.2)	2.1 (0.8)	6.3^† (0.9)	0.5 (1.2)
ASQoL (0–18)	-3.7^† (0.5)	-1.3 (0.3)	-5.6^† (0.3)	-1.8 (0.5)
WPAI-AS absenteeism (0–100% work time missed)	-7.4 (3.4)	0.0 (2.5)	-8.8 (0.8)	-7.3 (1.4)
WPAI-AS presenteeism (0–100% impairment while working)	-27.1^† (3.6)	-4.7 (2.6)	-28.8^† (2.0)	-9.5 (3.7)
*P≤0.001; ^†P≤0.0001 ASQoL, ankylosing spondylitis quality of life; EQ-5D, EuroQol 5-Dimensions; MCS, mental component summary; MFI, Multidimensional Fatigue Inventory; PCS, physical component summary; VAS, visual analog scale; SF-36, 36-item Short Form Health survey; WPAI-AS: Work Productivity and Activity Index in ankylosing spondylitis

Conclusion: In patients with early, active nr-axSpA and an inadequate response to NSAIDs who participated in the EMBARK study, achievement of inactive disease and clinical response were associated with meaningful improvements in PROs of pain, fatigue, and HRQOL. Moreover, improvement in patients’ symptoms resulted in improvement in their capacity to work. References: 1. Dougados M, et al. Arthritis Rheum 2014;66:2091-102. 2. Makysmowych WP, et al. Ann Rheum Dis 2015; Aug 12 [Epub ahead of print]. 3. Dougados M, et al. J Rheumatol. 2015;42:1835-41.

Disclosure: M. Dougados, Pfizer, AbbVie, Celgene, Eli Lilly, Novartis, Roche, and Sanofi-Aventis, 5,Pfizer, AbbVie, UCB, Merck, 8; D. van der Heijde, AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boeringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, 5,Director: Imaging Rheumatology bv, 9; W. C. Tsai, AbbVie, Pfizer, Roche, 5; D. Saaibi, None; R. Bonin, Pfizer Inc, 1,Pfizer Inc, 3; L. Marshall, Pfizer Inc, 1,Pfizer Inc, 3; H. Jones, Pfizer Inc, 1,Pfizer Inc, 3; R. Pedersen, Pfizer Inc, 1,Pfizer Inc, 3; B. Vlahos, Pfizer Inc, 1,Pfizer Inc, 3; M. Tarallo, Pfizer Inc, 1,Pfizer Inc, 3.

To cite this abstract in AMA style:

Dougados M, van der Heijde D, Tsai WC, Saaibi D, Bonin R, Marshall L, Jones H, Pedersen R, Vlahos B, Tarallo M. Better Health-Related Quality of Life and Work Capacity in Patients Achieving Inactive Disease and Clinical Response in Patients with Non-Radiographic Axial Spondyloarthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/better-health-related-quality-of-life-and-work-capacity-in-patients-achieving-inactive-disease-and-clinical-response-in-patients-with-non-radiographic-axial-spondyloarthritis/. Accessed .

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