Session Information
Date: Tuesday, November 7, 2017
Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment III
Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose: Sustained remission is an important treatment goal in patients (pts) with non-radiographic axial SpA (nr-axSpA). Factors predicting successful remission maintenance are unknown. We sought to identify predictors of remission maintenance in nr-axSpA pts who achieved remission after open-label (OL) adalimumab (ADA) treatment in the ABILITY-3 trial (NCT01808118) and were subsequently randomized to continuation or withdrawal of ADA therapy.
Methods: ABILITY-3 enrolled adult pts with nr-axSpA with objective evidence of active MRI inflammation in the SI joints or spine or elevated high-sensitivity CRP at screening, active disease at baseline (ASDAS ≥2.1, BASDAI ≥4, and Patient’s Assessment of Total Back Pain score ≥ 4), and inadequate response to ≥2 NSAIDs (Table). Pts received ADA 40 mg every other wk during a 28-wk OL lead-in period. Pts who achieved sustained remission, defined as ASDAS inactive disease [ID] score <1.3 at wks 16, 20, 24, and 28, were randomized to double-blind withdrawal (placebo; PBO) or continued ADA for 40 wks during period 2 (study wk 68). Stepwise logistic regression was used to identify predictors of sustained remission in those in the continued ADA and withdrawal (PBO) groups who did not experience a flare (defined as ASDAS ≥2.1 at 2 consecutive study visits) during period 2. Remission maintenance in period 2 was assessed with the following: ASAS partial remission (PR; score ≤ 2.0) and ASDAS ID at wk 68, ASAS PR and ASDAS ID at every visit, and ASDAS ID for ≥5 of 10 visits.
Results: By wk 68, 100/145 (69%) ADA pts had not flared; shorter symptom duration and very low wk 28 ASDAS were associated with absence of flare. Of those without flare, 58% achieved ASAS PR and 78% ASDAS ID at wk 68; 33% achieved ASAS PR and 42% ASDAS ID at every visit. Very low wk 28 ASDAS predicted sustained remission at all subsequent visits (Figure 1A). By wk 68, 70/148 (47%) PBO pts had not flared; lower wk 28 ASDAS was associated with absence of flare. Of those without flare, 59% achieved ASAS PR and 70% ASDAS ID at wk 68; 29% achieved ASAS PR and 31% ASDAS ID at every visit (Figure 1B).
|
Table. Characteristics at Baseline and Wk 28
|
|||
|
Variable Baseline, mean (SD) |
Adalimumab (40 mg EOW) n=152 |
Placebo n=153 |
P Value |
|
Age, y |
34.7 (10.3) |
35.3 (10.2) |
0.611 |
|
Female, n (%) |
56 (37) |
60 (39) |
0.724 |
|
SpA symptom duration, y |
6.4 (6.9) |
7.1 (6.8) |
0.358 |
|
HLA-B27 positive, n (%) |
132 (87) |
134 (88) |
0.866 |
|
ASDAS |
3.5 (0.9) |
3.5 (0.8) |
0.851 |
|
BASDAI |
6.8 (1.4) |
6.8 (1.5) |
0.851 |
|
BASFI |
5.1 (2.3) |
5.0 (2.3) |
0.776 |
|
Hs-CRP, mg/L |
9.9 (14.1) |
9.1 (13.3) |
0.576 |
|
Pt total back pain |
7.0 (1.7) |
7.0 (1.8) |
0.946 |
|
PGA |
6.6 (1.5) |
6.4 (1.4) |
0.150 |
|
SPARCC SI joint score* |
8.5 (12.8) |
10.3 (13.4) |
0.226 |
|
SPARCC spine score |
3.3 (7.5) |
3.6 (7.2) |
0.671 |
|
Wk 28, mean (SD) |
|
||
|
ASDAS |
0.7 (0.4) |
0.6 (0.4) |
0.355 |
|
BASDAI |
0.8 (0.8) |
0.7 (0.7) |
0.145 |
|
BASFI |
0.7 (1.0) |
0.7 (1.2) |
0.994 |
|
Hs-CRP, mg/L |
1.5 (2.4) |
1.4 (1.8) |
0.647 |
|
Pt total back pain |
1.1 (1.4) |
1.0 (1.4) |
0.567 |
|
PGA |
0.8 (1.0) |
0.9 (1.1) |
0.386 |
|
SPARCC SI joint score† |
2.6 (6.1) |
2.5 (4.0) |
0.775 |
|
SPARCC spine score‡ |
1.2 (3.8) |
1.2 (3.8) |
0.889 |
|
ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; EOW, every other week; HLA-B27, human leukocyte antigen B27; hs-CRP, high-sensitivity C-reactive protein, PGA, physician global assessment of disease activity; Pt, patient; SI, sacroiliac; SpA, spondyloarthritis; SPARCC, Spondyloarthritis Research Consortium of Canada. P value using analysis of variance. *Adalimumab, n=150; placebo, n=151 †Adalimumab, n=145; placebo, n=148 ‡Adalimumab, n=149; placebo, n=150 |
|||
Conclusion: In nr-axSpA pts who achieved remission after 28-wk OL ADA therapy, very low ASDAS at week 28 predicted absence of flare in both the continued ADA and withdrawal group. With continued ADA, shorter symptom duration also predicted absence of flare, and achievement of very low ASDAS at week 28 predicted sustained remission using most remission definitions, suggesting early aggressive treatment may be beneficial in achieving sustained remission. No consistent predictors of sustained remission after ADA withdrawal were identified.
To cite this abstract in AMA style:
Sieper J, Landewé RBM, Magrey MN, Anderson JK, Zhong S, Wang X, Lertratanakul A. Predictors of Remission Maintenance up to Week 68 and Successful Therapy Discontinuation in Patients with Non-Radiographic Axial Spondyloarthritis Who Achieved Sustained Remission on 28-Week Open-Label Adalimumab Treatment [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/predictors-of-remission-maintenance-up-to-week-68-and-successful-therapy-discontinuation-in-patients-with-non-radiographic-axial-spondyloarthritis-who-achieved-sustained-remission-on-28-week-open-labe/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/predictors-of-remission-maintenance-up-to-week-68-and-successful-therapy-discontinuation-in-patients-with-non-radiographic-axial-spondyloarthritis-who-achieved-sustained-remission-on-28-week-open-labe/