Session Information
Date: Tuesday, November 10, 2015
Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: In
patients with active, NSAID-resistant, non-radiographic axial spondyloarthritis
(nr-axSpA) who participated in the multiphase, randomized, placebo
(PBO)-controlled EMBARK study (ClinicalTrials.gov identifier: NCT01258738),
health-related quality-of-life (HRQoL) and other patient-reported outcomes
(PROs) were evaluated after
12 wks of double-blind
(DB) etanercept (ETN) treatment1 and
92 wks of open-label (OL) ETN.
Methods: Patients who fulfilled Assessment of
SpondyloArthritis international Society classification criteria for axSpA, but
not modified New York radiographic criteria for ankylosing spondylitis, and
were unresponsive to ≥2 NSAIDs were randomized to receive ETN 50 mg/wk or
PBO for 12 wks, followed by ETN 50 mg/wk to wk 104 (ETN/ETN or PBO/ETN). Background
NSAID therapy was continued in all patients. Analyses
of a binary endpoint (ie,
minimal
clinically important difference [MCID; ≥0.05] in EQ-5D utility score at
wk 12) and continuous
endpoints (changes from wk 0 to wk 12 and wk 104 in pain/fatigue [nocturnal
back pain, MFI general fatigue], HRQoL [SF-36, ASQoL], utility [EQ-5D], and
work productivity [WPAI-AS]) were conducted
in the modified
intent-to-treat (mITT) population (all patients with wk-12 efficacy data who continued into OL
period, received ≥1 ETN dose in OL period, and had been included in DB mITT
population) with observed
cases. The Cochran-Mantel-Haenszel chi-square test was
used for between-group comparisons of the binary endpoint; ANCOVA was used for
between-group comparisons of continuous endpoints.
Results: Of
215 randomized patients (DB mITT), 205 patients entered the OL phase (ETN/ETN, n=100; PBO/ETN, n=105 [OL
mITT]) and 169
patients completed it (n=83; n=86). Improvements from wk
0 to wk 12 in most pain/fatigue, HRQoL, utility, and work productivity
assessments favored ETN versus PBO (table). In the OL phase, improving
trends from wk 0 to wk 104 were observed in the ETN/ETN group, whereas
improvements seen in patients who switched from PBO to ETN were comparable to
or greater than those in the former group. At wk 12, significantly greater
proportions of patients receiving ETN vs PBO achieved MCID in the EQ-5D utility
score (59% [52/88] vs 45% [42/94]; P<0.05, between-groups); at wk
104, 76% (57/75) and 81% (64/79) of patients in the ETN/ETN and PBO/ETN groups
achieved this endpoint.
|
Table. Long-term effects of ETN on PROs in patients with nr-axSpA in the EMBARK study* |
||||
|
Endpoint |
Mean (SD) at Wk 0 / Mean (SE) D from Wk 0 to Wk 12 |
Mean (SE) D from Wk 0 to Wk 104 |
||
|
ETN |
PBO |
ETN/ETN |
PBO/ETN |
|
|
Nocturnal back pain |
5.5 (2.6) / –2.0† (0.4) |
5.4 (2.5) / –0.9 (0.4) |
–3.8 (0.4) |
–3.7 (0.3) |
|
MFI general fatigue |
14.7 (3.5) / –1.2 (0.5) |
15.0 (3.5) –0.9 (0.4) |
–3.3 (0.5) |
–3.0 (0.5) |
|
SF-36, PCS (0-100) |
37.8 (8.9) / 6.2‡ (1.0) |
37.2 (8.1) / 3.8 (0.9) |
10.0 (1.0) |
10.4 (1.0) |
|
SF-36, MCS (0-100) |
42.3 (11.9) / 2.4 (1.3) |
43.5 (11.1) / 1.6 (1.2) |
4.9 (1.3) |
3.7 (1.1) |
|
ASQoL (0-18) |
8.6 (4.8) / –1.9 (0.5) |
8.4 (4.8) / –1.4 (0.5) |
–4.7 (0.5) |
–4.0 (0.5) |
|
EQ-5D VAS (0-100) |
56.5 (21.0) / 9.3‡ (3.0) |
56.4 (20.6) / 3.3 (2.8) |
19.8 (2.5) |
23.7 (2.7) |
|
EQ-5D utility score (0-1) |
0.52 (0.34) / 0.14 (0.04) |
0.57 (0.30) / 0.08 (0.03) |
0.29 (0.04) |
0.25 (0.03) |
|
WPAI-AS, absenteeism# (0-100%) |
9.1 (25.0) / –0.2 (4.4) |
11.8 (27.7) / –4.9 (4.3) |
–6.4 (3.5) |
–10.4 (4.7) |
|
WPAI-AS, presenteeism¶ (0-100%) |
44.9 (26.7) / –21.2‡ (4.7) |
42.2 (26.3) / –12.1 (4.7) |
–25.5 (3.7) |
–22.5 (3.5) |
|
*mITT population; observed cases. †P<0.01; ‡P<0.05, between-group comparisons. #% work time missed; ¶% impairment while working. ASQoL, AS quality of life; EQ-5D, EuroQol 5 Dimensions; MFI, Multidimensional Fatigue Inventory; SF-36: 36-item Short Form Health Survey; WPAI-AS: Work Productivity and Activity Index in ankylosing spondylitis. |
||||
Conclusion: Patients with early, active nr-axSpA
and an inadequate response to NSAIDs achieved sustained improvement in pain/fatigue,
HRQoL, utility, and work productivity over 104 weeks of etanercept treatment in
the EMBARK study. At study end, health outcome responses were generally
comparable regardless of original treatment assignment, suggesting that
etanercept has a favourable long-term impact on PROs in patients with nrAxSpa.
Reference: 1. Dougados M, et al. Arthritis
Rheum 2014;66:2091-102.
To cite this abstract in AMA style:
van Den Bosch F, Drescher E, Rosa J, Pedersen R, Bonin R, Vlahos B, Bukowski JF, Kotak S. Long-Term Effects of Etanercept on Patient-Reported Outcomes in Early Non-Radiographic Axial Spondyloarthritis: 104-Week Results of a Phase III Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/long-term-effects-of-etanercept-on-patient-reported-outcomes-in-early-non-radiographic-axial-spondyloarthritis-104-week-results-of-a-phase-iii-study/. Accessed .« Back to ACR/ARHP Annual Meeting 2015
ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-effects-of-etanercept-on-patient-reported-outcomes-in-early-non-radiographic-axial-spondyloarthritis-104-week-results-of-a-phase-iii-study/