scholarly journals AB0710 IXEKIZUMAB SIGNIFICANTLY IMPROVES SELF-REPORTED OVERALL HEALTH AS MEASURED BY SF-36 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS/RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS NAIVE TO BIOLOGICAL THERAPY: 52 WEEK RESULTS OF A PHASE 3 TRIAL

2019 ◽  
Author(s):  
James Cheng-Chung Wei ◽  
Filip van den Bosch ◽  
Jessica a. Walsh ◽  
Uta Kiltz ◽  
Theresa Hunter ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Biological Therapy ◽  
Axial Spondyloarthritis ◽  
Phase 3 ◽  
Sf 36

scholarly journals THU0395 EFFICACY OF IXEKIZUMAB ON DISEASE ACTIVITY AND QUALITY OF LIFE IN PATIENTS WITH ACTIVE NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS AND OBJECTIVE SIGNS OF INFLAMMATION, STRATIFIED BY BASELINE CRP/SACROILIAC JOINT MRI STATUS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 432-433
Author(s):  
W. P. Maksymowych ◽  
H. Marzo-Ortega ◽  
M. Ǿstergaard ◽  
L. S. Gensler ◽  
J. Ermann ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Treatment Group ◽  
Disease Activity ◽  
Sacroiliac Joint ◽  
Axial Spondyloarthritis ◽  
Physical Component Score ◽  
Research Support ◽  
Advisory Boards ◽  
Sf 36 ◽  
Active Sacroiliitis

Background:Ixekizumab (IXE), a high-affinity anti-interleukin-17A monoclonal antibody, is effective in patients (pts) with active non-radiographic axial spondyloarthritis (nr-axSpA), who had elevated C-reactive protein (CRP) and/or active sacroiliitis on magnetic resonance imaging (MRI).1Objectives:To determine if disease activity and patient-reported outcomes at Week 16 were similar between groups after stratifying pts by CRP/sacroiliac joint (SIJ) MRI status at baseline.Methods:COAST-X (NCT02757352) included pts with active nr-axSpA and objective signs of inflammation, i.e. presence of sacroiliitis on MRI (Assessment of Spondyloarthritis International Society [ASAS]/ Outcome Measures in Rheumatology criteria) or elevation of serum CRP (>5.0 mg/L). Pts were randomized 1:1:1 to receive subcutaneous 80 mg IXE every 4 weeks (Q4W) or Q2W, or placebo (PBO). Depending on the baseline values of CRP and MRI SIJ (Spondyloarthritis Research Consortium of Canada [SPARCC] score), pts in the intent-to-treat population (N=239) were divided into 3 subgroups (CRP >5 and MRI ≥2; CRP ≤5 and MRI ≥2; CRP >5 and MRI <2). Logistic regression analysis with treatment, subgroup, and treatment-by-subgroup interaction was used to detect treatment group differences in ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 (low disease activity), and Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) responses at Week 16. Analysis of covariance model with baseline value, treatment, subgroup, and treatment-by-subgroup interaction was used to detect the treatment group difference in change from baseline in Short Form-36 physical component score (SF-36 PCS).Results:The proportion of pts achieving ASAS40 (primary endpoint), ASDAS <2.1, and BASDAI50 (secondary endpoints) was higher in IXE treatment groups compared to PBO at Week 16 (Figure 1). The response rates in IXE-treated subjects were higher in all subgroups (CRP >5 and MRI ≥2; CRP ≤5 and MRI ≥2; CRP >5 and MRI <2) without consistent differences in efficacy between the subgroups. Similarly, pts in the IXE groups showed improvement in SF-36 PCS scores (secondary endpoint) versus pts on PBO at Week 16 (Figure 2).Conclusion:Pts with active nr-axSpA and objective signs of inflammation at baseline who were treated with IXE showed an overall improvement in the signs and symptoms of the disease. The efficacy was not different between pts with both elevated CRP and active sacroiliitis on MRI and pts with either elevated CRP or active sacroiliitis on MRI.References:[1]Deodhar A, et al.Lancet.2020.Disclosure of Interests:Walter P Maksymowych Grant/research support from: Received research and/or educational grants from Abbvie, Novartis, Pfizer, UCB, Consultant of: WPM is Chief Medical Officer of CARE Arthritis Limited, has received consultant/participated in advisory boards for Abbvie, Boehringer, Celgene, Eli-Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Received speaker fees from Abbvie, Janssen, Novartis, Pfizer, UCB., Helena Marzo-Ortega Grant/research support from: Janssen, Novartis, Consultant of: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Takeda, UCB, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Joerg Ermann Grant/research support from: Boehringer-Ingelheim, Pfizer, Consultant of: Abbvie, Eli Lilly, Janssen, Novartis,Pfizer, Takeda, UCB, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Soyi Liu Leage Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Gabriel Doridot Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Ann Leung: None declared, David Adams Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma

scholarly journals Quality of life in spondyloarthritis patients receiving biological therapy

2019 ◽  
Vol 13 (4) ◽  
pp. 36-40
Author(s):  
A. I. Akulova ◽  
K. D. Dorogoikina ◽  
I. Z. Gaydukova ◽  
A. P. Rebrov
Keyword(s):  
Quality Of Life ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Disease Duration ◽  
Biological Therapy ◽  
Functional Disorders ◽  
Asas Criteria ◽  
Sf 36 ◽  
The Impact

Spondyloarthritides (SpAs) is a group of chronic inflammatory diseases of the spine, joints, and entheses characterized by common clinical, radiological, and genetic features. According to international guidelines, one of the main goals of SpA treatment is to ensure the longest possible preservation of the patient's quality of life (QOL). The use of biological agents (BAs) allows rapid clinical improvement and positively affects QOL in patients.Objective: to evaluate the efficacy of BAs on QOL in patients with SpA in real clinical practice.Patients and methods. A total of 280 patients with SpA were examined. The inclusion criteria were ≥18 years of age; compliance of the clinical picture of the disease with the ASAS criteria for axial SpA (2009) or peripheral SpA (2011); and signing the informed consent form. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS); the functional status of the patients was estimated by the Bath Ankylosing Spondylitis Functional Index (BASFI), and their spinal mobility was evaluated by the Bath Ankylosing Spondylitis Metrology Index (BASMI); ASAS HI was used to comprehensively evaluate the impact of SpA on the patient's health. The European QL EQ-5D-5L and the SF-36 questionnaire were applied to determine quality of life in the patients.Results and discussion. The patients' mean age was 40.19±11.9 years; there was a male preponderance (64%); the HLA-B7-pisitive patients were 78%. The median scores were 5.40 [3.12; 6.80] for BASDAI, 3.37 [2.58; 4.15] for ASDAS, 5.30 [2.60; 7.50] for BASFI, 4.00 [2.60; 6.15] for BASMI, and 9.00 [7.00; 12.00] for ASAS HI. Forty-four patients received a variety of BAs. Patients receiving and not receiving BAs were matched for age and gender; however, the patients on biological therapy (BT) had longer disease duration and lower disease activity according to the ASDAS. There were no statistically significantly difference between the two groups in disease activity according to the BASDAI and in functional disorders according to the BASFI; but there was a tendency towards lower values in the patients on BT. Comparison of QOL in the patients of the two groups revealed statistically significant differences in SF-36 pain scale scores (p=0.02) and EQ-5D-5L indicators (p<0.01).Conclusion. BT makes it possible to successfully achieve one of the main goals of treating patients with SpA, namely to preserve QOL. The patients receiving BAs had longer disease duration, while they were comparable to those not receiving this treatment in terms of the degree of functional disorders.

scholarly journals COMPARISON OF NON-RADIOGRAPHIC SPONDYLOARTHRITIS VERSUS ANKYLOSING SPONDYLITIS PATIENTS UNDERGOING BIOLOGICAL THERAPY – DATA FROM A ROMANIAN COHORT

2016 ◽  
Vol 25 (4) ◽  
pp. 173-180
Author(s):  
Claudia Deaconu ◽  
◽  
Daniela Opris ◽  
Ruxandra Ionescu ◽  
◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Duration ◽  
Biological Therapy ◽  
Axial Spondyloarthritis ◽  
Smoking Status ◽  
Disease Status ◽  
Inactive Disease ◽  
X Ray ◽  
Distinct Disease

Both non-radiographic spondyloarthritis (nr-SpA) and ankylosing spondylitis (AS) are medical conditions that belong to the axial spondyloarthritis spectrum; these two terms reveal the extent of sacroiliitis assessed by conventional x-ray or MRI. According to the latest classification criteria (ASAS, 2009), clinicians are able to differentiate patients with nr-SpA from AS and to follow their disease progression. The present study aims to compare the two patient categories undergoing biological therapy with an anti-TNF agent and indicate distinct disease features. We included 94 patients in treatment with IFX, ADL, ETA or GOL and monitored clinical, biological and disease activity parameters. The nr-SpA subgroup included a higher percentage of female patients; AS patients presented higher values of the CRP at follow-up visits; there were no significant differences between the two groups regarding the HLA-B27 presence, uveitis history or smoking status. Patients with an inactive disease status had a lower BMI, shorter disease duration and an early initiation of biological therapy, so that we suggest a close and regular monitoring of these two entities.

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