Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
C-reactive protein (CRP), an objective measure of active inflammation, has been associated with obesity, with both overweight and obese individuals more likely to have elevated CRP levels than their normal-weight counterparts. The objective of this analysis was to assess the relationship of elevated CRP with clinical response in non-overweight and non-obese subgroups of non-radiographic axial SpA (nr-axSpA) patients (pts).
Methods:
This post hoc analysis was performed in ABILITY-1, a phase 3, randomized, double-blind, multicenter study in pts with active nr-axSpA. Pts were randomized to receive adalimumab (ADA) 40 mg every other week (wk) or placebo (PBO) for 12 wks followed by open-label (OL) ADA for up to 156 wks. The MRI+/elevated CRP subpopulation included pts with a positive baseline MRI (Spondyloarthritis Research Consortium of Canada [SPARCC] score ≥2 for either the sacroiliac joints or spine) and/or elevated baseline CRP. Pts with BMI ≥25 kg/m2 were considered overweight; pts with BMI ≥30 kg/m2were considered obese. Clinical response variables were analyzed by BMI subgroups at wk 12.
Results:
BMI was <25 in 85/185 (45.9%) pts in the overall population (PBO/ADA, n=43/42) and in 57/142 (40.1%) in the MRI+/elevated CRP subpopulation (PBO/ADA, n=30/27); BMI was <30 in 149/185 (80.5%) pts in the overall population (PBO/ADA, n=70/79) and in 110/142 (77.5%) in the MRI+/elevated CRP subpopulation (PBO/ADA, n=52/58). In the overall population CRP was elevated in 43/100 (43%) pts with BMI ≥25 and in 22/36 (61.1%) pts with BMI ≥30. BMI and CRP were weakly correlated (0.23, P=0.002); however, in pts with elevated CRP, mean BMI was significantly higher than in pts with normal CRP (28.8 vs 25.0; P<0.0001). ASAS40 response at wk 12 was similar in the overall population and when excluding overweight and obese pts. (Table 1) A comparable effect was seen in the MRI+/elevated CRP subpopulation with the exception of a slightly higher ASAS40 response in the MRI+/elevated CRP subgroup with BMI <25; however, this should be interpreted with caution due to small sample size. (Table 2) ASAS40 response for the subgroup BMI ≥25 for the overall and MRI+/elevated CRP populations was consistent with the overall population (PBO 15.7% vs ADA 34.7%, and PBO 16.3% vs ADA 33.3%, respectively).
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Table 1. Clinical Response in the Overall Population at Week 12 |
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Overall Population (N = 185) |
BMI <25 kg/m2 (N = 85) |
BMI <30 kg/m2 (N = 149) |
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PBO N = 94 |
ADA N = 91 |
PBO N = 43 |
ADA N = 42 |
PBO N = 70 |
ADA N = 79 |
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Response Rate, n (%)a |
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ASAS40 |
14 (14.9) |
33 (36.3) |
6 (14.0) |
16 (38.1) |
9 (12.9) |
31 (39.2) |
|
ASAS20 |
29 (30.9) |
47 (51.6) |
12 (27.9) |
18 (42.9) |
18 (25.7) |
41(51.9) |
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BASDAI50 |
14 (14.9) |
32 (35.2) |
5 (11.6) |
15 (35.7) |
7 (10) |
30 (38.0) |
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ASAS PR |
5 (5.3) |
15 (16.5) |
1 (2.3) |
9 (21.4) |
1 (1.4) |
15 (19.0) |
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ASAS5/6 |
6 (6.4) |
28 (30.8) |
1 (2.3) |
14 (33.3) |
3 (4.3) |
28 (35.4) |
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Change from Baselineb,c |
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hs-CRP (mg/L) |
n=70 -0.4 (6.5) |
n=67 -5.0 (12.5) |
n=35 0.4 (5.8) |
n=32 -5.7 (15.7) |
n=52 0.1 (5.2) |
n=60 -5.0 (12.9) |
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SF-36v2 PCS |
n=93 2.0 (7.0) |
5.5 (9.0) |
n=42 1.7 (8.1) |
5.4 (10.1) |
n=69 1.1 (7.2) |
6.0 (9.4) |
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HAQ-S |
n=90 -0.1 (0.4) |
n=88 -0.3 (0.5) |
n=41 -0.2 (0.5) |
n=41 -0.3 (0.5) |
n=66 -0.1 (0.5) |
n=76 -0.3 (0.5) |
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SPARCC MRI Score, SI Joints |
n=84 -0.6 (6.2) |
n=84 -3.2 (8.3) |
n=40 -0.1 (6.1) |
n=39 3.4 (7.4) |
n=62 -0.6 (7.1) |
n=74 -3.6 (8.8) |
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SPARCC MRI Score, Spine |
n=83 -0.2 (3.3) |
n=85 -1.8 (4.5) |
n=39 0.2 (2.3) |
n=40 -1.0 (2.3) |
n=60 0.3 (2.1) |
n=75 -1.2 (2.7) |
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aNon-responder imputation. bMean (standard deviation). cObserved case analyses. ADA, adalimumab; ASAS, Assessment of SpondyloArthritis international Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BMI, body mass index; HAQ-S, Health Assessment Questionnaire modified for the Spondyloarthropathies; hs-CRP, high sensitivity C-reactive protein; MRI, magnetic resonance imaging; PBO, placebo; PR, partial remission; SI, sacroiliac; SPARCC, Spondyloarthritis Research Consortium of Canada; SF-36v2 PCS, Short Form-36 Health Status Survey Version 2 Physical Component Summary. |
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Table 2. Clinical Response in the MRI+/elevated CRP Subpopulation at Week 12 |
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MRI+/elevated CRP Subpopulation (N = 142) |
BMI <25 kg/m2 (N = 57) |
BMI <30 kg/m2 (N= 110) |
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PBO N = 73 |
ADA N = 69 |
PBO N = 30 |
ADA N = 27 |
PBO N =52 |
ADA N = 58 |
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Response Rate, n (%)a |
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ASAS40 |
10 (13.7) |
28 (40.6) |
3 (10.0) |
14 (51.9) |
5 (9.6) |
26 (44.8) |
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ASAS20 |
23 (31.5) |
41 (59.4) |
8 (26.7) |
15 (55.6) |
13 (25.0) |
35 (60.3) |
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BASDAI50 |
10 (13.7) |
27 (39.1) |
2 (6.7) |
13 (48.2) |
3 (5.8) |
25 (43.1) |
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ASAS PR |
4 (5.5) |
13 (18.8) |
0 |
7 (25.9) |
0 |
13 (22.4) |
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ASAS5/6 |
6 (8.2) |
24 (34.8) |
1 (3.3) |
12 (44.4) |
3 (5.8) |
24 (41.4) |
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Change from Baselineb,c |
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hs-CRP (mg/L) |
n=52 -0.9 (7.5) |
n=49 -6.8 (14.3) |
n=24 0.4 (7.1) |
n=19 -9.7 (19.6) |
n=36 -0.2 (6.1) |
n=43 -7.0 (14.8) |
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SF-36v2 PCS |
n=72 2.3 (6.8) |
6.9 (9.3) |
n=29 1.6 (7.7) |
8.3 (10.7) |
n=51 1.2 (6.9) |
7.6 (9.8) |
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HAQ-S |
n=69 -0.1 (0.4) |
n=68 -0.3 (0.5) |
n=28 -0.1 (0.4) |
n=27 -0.4 (0.6) |
n=48 -0.1 (0.4) |
n=57 -0.4 (0.5) |
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SPARCC MRI Score, SI Joints |
n=64 -0.9 (7.1) |
n=64 -4.3 (9.3) |
n=27 -0.2 (7.5) |
n=25 -5.6 (8.5) |
n=44 -0.9 (8.4) |
n=55 -5.0 (9.8) |
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SPARCC MRI Score, Spine |
n=63 -0.5 (3.7) |
n=65 -2.3 (5.0) |
n=26 -0.3 (2.4) |
n=26 -1.6 (2.7) |
n=42 0 (2.2) |
n=56 -1.7 (2.9) |
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aNon-responder imputation. bMean (standard deviation). cObserved case analyses. ADA, adalimumab; ASAS, Assessment of SpondyloArthritis international Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BMI, body mass index; HAQ-S, Health Assessment Questionnaire modified for the Spondyloarthropathies; hs-CRP, high sensitivity C-reactive protein; MRI, magnetic resonance imaging; PBO, placebo; PR, partial remission; SI, sacroiliac; SPARCC, Spondyloarthritis Research Consortium of Canada; SF-36v2 PCS, Short Form-36 Health Status Survey Version 2 Physical Component Summary. |
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Conclusion:
In ABILITY-1, ADA showed similar clinical responses in subgroups excluding overweight and obese pts compared to the overall study population. These data suggest nr-axSpA pts have a general inflammatory state which is unrelated to obesity-related CRP elevations and that response to ADA is not driven by CRP elevations related to obesity.
Disclosure:
P. J. Mease,
AbbVie, Amgen, Biogen Idec, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, and Vertex,
2,
AbbVie, Amgen, Biogen Idec, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, and Vertex,
5,
AbbVie, Amgen, Biogen Idec, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, and Vertex,
8;
D. Poddubnyy,
AbbVie, Janssen, MSD, Novartis, Pfizer, Roche, and UCB,
5,
AbbVie, Janssen, MSD, Novartis, Pfizer, Roche, and UCB,
8;
S. Chen,
AbbVie,
1,
AbbVie,
3;
J. K. Anderson,
AbbVie,
1,
AbbVie,
3.
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