Session Information
Date: Monday, November 6, 2017
Title: Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster II
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: Certolizumab pegol (CZP) is a PEGylated Fab’ fragment of a humanized anti-TNF antibody with high affinity to TNF. RAPID-axSpA trial investigated the efficacy and safety of CZP in patients with axSpA, including ankylosing spondylitis (AS) and non-radiographic (nr)-axSpA, and has shown CZP to improve the signs and symptoms of axSpA over 4 years.
Objective: To investigate the effectiveness of CZP in a real word setting in axSpA patients including AS and nr-axSpA.
Methods: Multicentric cohort of axial spondyloarthritis patients treated with CZP according with the clinical practice. Study was approved by local Ethics Committee. Maximum time of observation is 12 months. Clinical response was assessed by BASDAI and ASDAS.
Results:
336 patients with axSpA were included and 333 were classified: 228 (68.5%) patients with AS, 95 (28,5%) patients with nr-axSpA and 10 (3%) patients with pheripheral SpA. The baseline characteristics of the patients are shown in Table 1.
Table 1. Baseline demographic and clinical characteristics of the patients with ankylosing spondyloarthritis and patients with non-radiographic axial SpA.
|
AS |
nr-axSpA |
|
|
Age (mean, yr) |
46.4±11.9 (N=207) |
43.8±12.1 (N=77) |
|
Male sex |
63.2% (N=228) |
45.3% (N=95) |
|
Evolution of the disease (median, yr) |
5.6 (N=207) |
2.2 (N=77) |
|
Never smokers |
75.1% (N=201) |
80.2% (N=86) |
|
HLA-B27 positive |
73.7% (N=190) |
59.7% (N=72) |
|
Uveitis ever |
30.2% (N=159) |
11.7 (N=60) |
|
Peripheral arthritis |
25% (N=228) |
37.9% (N=95) |
|
Enthesitis |
43.6% (N=133) |
45.9% (N=74) |
|
Biologics treatment previous 0 1 >1 |
(N=165) 23.0% 40.0% 36.9% |
(N=65) 32.3% 35.4% 32.3% |
|
BASDAI mean±SD 0-10 NRS |
6.3±1.6 (N=190) |
5.9±1.4 (N=73) |
|
BASFI mean±SD |
5.9±2.0 (N=164) |
4.9±2.0 (N=61) |
|
ASDAS mean |
3.9±2.6 (N=227) |
3.1±2.6 (N=95) |
|
CRP mean (mg/L) |
12.1 (N=227) |
9.0 (N=95) |
|
Treatment with NSAIDs |
83.0% (N=206) |
84.4% (N=77) |
|
Treatment with DMARDs |
35.9% (N=206) |
35.0% (N=77) |
No statistically significant differences were observed in BASDAI and ASDAS between both subpopulation (AS and nr-axSpA) (Table 2). In the last visit of the patients, BASDAI50 was observed in 39.7% of AS pacients and 44.6% of nr-axSpA. 29.1% and 45.7% of the patients presented ASDAS remission within the AS and nr-axSpA population, respectively.
Table 2. Evolution of clinical variables of activity
|
AS |
nr-axSpA |
|||
|
Baseline |
Last visit |
Baseline |
Last visit |
|
|
BASDAI evolution |
6.3±1.6 (N=190) |
3.9±2.2 (N=190) |
5.9±1.4 (N=73) |
3.6±2.1 (N=70) |
|
ASDAS evolution |
3.9±2.6 (N=227) |
2.6±2.4 (N=227) |
3.1±2.6 (N=95) |
1.9±1.6 (N=94) |
|
CRP mean |
12.1 (N=227) |
6,8 (N=334) |
9.0 (N=95) |
4,0 (N=94) |
Conclusion:
In this nationwide real-life study, effectiveness of CZP was demonstrated in both Radiographic and Non-Radiographic Axial Spondyloarthritis.
This publication has been possible thanks to a grant of UCB Pharma to the technical companies which have been managing the data collection and the statistical analyses. The results are independent of UCB Pharma.
To cite this abstract in AMA style:
Gonzalez CM, Expósito R, García-Portales R, Urruticoechea-Arana A, Lamua JR, Navarro MDP, Rey Rey JS, Fernández M, Morcillo M. Certolizumab Pegol Effectiveness in Radiographic and Non-Radiographic Axial Spondyloarthritis. a Natiowide Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/certolizumab-pegol-effectiveness-in-radiographic-and-non-radiographic-axial-spondyloarthritis-a-natiowide-study/. Accessed .« Back to ACR/ARHP Annual Meeting 2017
ACR Meeting Abstracts - https://acrabstracts.org/abstract/certolizumab-pegol-effectiveness-in-radiographic-and-non-radiographic-axial-spondyloarthritis-a-natiowide-study/