FRI0278 IXEKIZUMAB IMPROVES SELF-REPORTED OVERALL FUNCTIONING AND HEALTH AS MEASURED BY THE ASAS HEALTH INDEX IN PATIENTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS: 52-WEEK RESULTS OF A PHASE 3 RANDOMIZED, ACTIVE AND PLACEBO-CONTROLLED TRIAL (COAST-X)

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 726-726
Author(s):  
U. Kiltz ◽  
J. A. Walsh ◽  
R. B. Vargas ◽  
T. Hunter ◽  
R. Bolce ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Regression Analysis ◽  
International Society ◽  
Axial Spondyloarthritis ◽  
Good Health ◽  
Health Index ◽  
Research Support ◽  
Open Label ◽  
Meaningful Improvement ◽  
Overall Functioning

Background:Ixekizumab has demonstrated efficacy in treating signs and symptoms of patients with non-radiographic axial spondyloarthritis (nr-axSpA).1The Assessment of SpondyloArthritis International Society Health Index (ASAS HI) is a composite measure consisting of 17 dichotomous items to assess overall functioning and health in patients with spondyloarthritis.2Objectives:To assess health outcomes using ASAS HI in patients with nr-axSpA treated with ixekizumab (IXE) for 52 weeks.Methods:COAST-X (NCT02757352) was a 52-week, randomized, double-blind, placebo (PBO)-controlled study enrolling adults with an established diagnosis of axSpA (ASAS classification criteria, but not modified New York criteria for sacroiliitis), had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4, back pain score ≥4, inflammation (sacroiliitis on magnetic resonance imaging [MRI] per ASAS criteria) or an elevated C-reactive protein [CRP] level >5 mg/L), and inadequate response or intolerance to nonsteroidal anti-inflammatory drugs. Patients were randomized 1:1:1 to receive PBO or 80 mg IXE every 4 weeks (Q4W) or every 2 weeks (Q2W). Changing background medications or switching to open-label IXE Q2W, or both, was allowed after week 16 at investigator discretion. Change from baseline in ASAS HI (score 0-17 with higher score indicating worse health) was analyzed using logistic regression analysis at Weeks 0, 4, 8, 16, 36, and 52. For the ASAS HI, the smallest detectable change was calculated as 3.0. Patients having an ASAS HI score ≤5 were defined as being in a good health state.3Comparisons between IXE treatments and PBO were made using logistic regression analysis. Non-responder imputation was used for missing data. Patients who switched to open label IXEQ2W were considered non-responders after they switched.Results:At baseline, ASAS HI scores were similar between the three groups (PBO 9.0 ± 3.7; IXE Q4W 8.6 ± 3.4; IXE Q2W 9.6 ± 3.4). Significantly more patients receiving IXE Q4W versus PBO achieved ASAS HI score ≤5 at Week 16 (p<0.05; Fig. A). From Week 36 to 52, significantly more patients receiving IXE Q4W and Q2W achieved ASAS HI score ≤5 (p<0.05; Fig. A). Significantly more patients receiving IXE Q2W versus PBO achieved a clinically meaningful improvement in ASAS HI score ≥3 at Week 16 (p<0.05; Fig. B). From Week 36 to 52 significantly more patients receiving IXE Q4W and Q2W achieved a clinically meaningful improvement in ASAS HI score ≥3 compared with PBO (p<0.05; Fig. B).Figure.Improvement in ASAS HI scores through Week 52.A: Proportion of patients who achieved an ASAS HI score ≤5 in patients with baseline ASAS HI score >5. B: Proportion of patients who achieved ≥3-point improvement in ASAS HI in patients with baseline ASAS HI score ≥3. ***p<0.001, **p<0.01, *p<0.05 versus PBO. Asterisk color indicates which IXE treatment group was compared with PBO. ASAS HI= Assessment of SpondyloArthritis International Society Health Index; IXE=ixekizumab; PBO=placebo; Q2W=every 2 weeks; Q4W=every 4 weeksConclusion:Ixekizumab improves overall functioning and health in patients with nr-axSpA as assessed by ASAS HI, with significantly more patients achieving good health status.References:[1]Deodhar A, van der Heijde D, Gensler LS, et al.Lancet. 2020; 395(10217):53-64.[2]Kiltz U, van der Heijde D, Boonen A, et al.Ann Rheum Dis. 2015;74(5):830-5.[3]Kiltz U, van der Heijde D, Boonen A, et al.Ann Rheum Dis. 2018;77(9):1311-7.Disclosure of Interests:Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jessica A. Walsh Grant/research support from: AbbVie, Pfizer, Janssen, Consultant of: AbbVie, Novartis, Eli Lilly and Company, UCB, Ruben Burgos Vargas: None declared, Theresa Hunter 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, David Sandoval 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, Ann Leung: None declared, Xiaoqi Li Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Emily Blue Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Juergen Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD (Schering Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis, and UCB Pharma, Consultant of: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma

scholarly journals Predictors of Assessment of Spondyloarthritis International Society (ASAS) Health Index in Axial Spondyloarthritis and Comparison of ASAS Health Index between Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis: Data from the Catholic Axial Spondyloarthritis COhort (CASCO)

2019 ◽  
Vol 8 (4) ◽  
pp. 467 ◽  
Author(s):  
Hong Ki Min ◽  
Jennifer Lee ◽  
Ji Hyeon Ju ◽  
Sung-Hwan Park ◽  
Seung-Ki Kwok
Keyword(s):  
Regression Analysis ◽  
Health Status ◽  
Ankylosing Spondylitis ◽  
Alcohol Consumption ◽  
International Society ◽  
Structural Damage ◽  
Axial Spondyloarthritis ◽  
Economic Status ◽  
Linear Regression Analysis ◽  
Health Index

The Assessment of Spondyloarthritis International Society (ASAS) health index (HI) is a novel tool for approaching disability, health, and functioning in spondyloarthritis (SpA). In the present study we compared ASAS HI between patients with ankylosing spondylitis (AS) and those with nonradiographic axial SpA (nr-axSpA). In addition, we identified predictors of ASAS HI. We designed this cross-sectional study using data from the Catholic Axial Spondyloarthritis COhort (CASCO), a prospective cohort from a single tertiary hospital. We compared baseline characteristics, including ASAS HI, between AS and nr-axSpA, and determined the frequency of each item constituting the ASAS HI. We used linear regression analysis to identify factors associated with ASAS HI. Total of 357 patients with axSpA—261 with AS and 96 with nr-axSpA—were included in analysis. AS patients were older and had higher ASAS HI than nr-axSpA. Among ASAS HI items, pain (item No. 1) and energy/drive (item No. 5) were the most common areas for which axSpA patients experienced discomfort. ASAS HI correlated with other SpA-related parameters such as BASDAI, ASDAS, and BASFI. Multivariable regression analysis of the axSpA group showed that high NSAID intake and mSASSS were positively associated with ASAS HI, whereas higher economic status and alcohol consumption were negatively associated with ASAS HI. Results were consistent in the AS group on subgroup analysis, whereas alcohol consumption was the only factor significantly associated with ASAS HI in the nr-axSpA group. In the present cohort study, patients with AS had poorer health status (higher ASAS HI) than those with nr-axSpA. Items proposed by AS patients (items No. 1 and 5) were the most frequently checked areas as axSpA patients feel discomfort, and this support that ASAS HI could practically assess actual discomfort of axSpA patient. ASAS HI was well correlated with known disease parameters, including activity, function, and quality of life; therefore, ASAS HI could be used in the future to represent the health status of SpA in a systematic way. Spinal structural damage (higher mSASSS), high NSAID intake, alcohol consumption, and economic status were predictors of ASAS HI in patients with axSpA, especially those with AS.

THU0384 IMPACT OF IXEKIZUMAB ON WORK PRODUCTIVITY IN NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS PATIENTS: RESULTS FROM THE COAST-X TRIAL AT 52 WEEKS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 426-426
Author(s):  
A. Deodhar ◽  
P. J. Mease ◽  
L. S. Gensler ◽  
P. Rahman ◽  
V. Navarro-Compán ◽  
...  
Keyword(s):  
Axial Spondyloarthritis ◽  
Work Productivity ◽  
Analysis Of Covariance ◽  
Full Time ◽  
Research Support ◽  
Open Label ◽  
Activity Impairment ◽  
Work Activity ◽  
Work Impairment ◽  
Part Time

Background:Patients with non-radiographic axial spondyloarthritis (nr-axSpA) experience impairments in health-related quality of life comparable to those seen in ankylosing spondylitis, including impacts on work productivity. Ixekizumab (IXE) is a high-affinity monoclonal antibody that selectively targets interleukin-17A and effectively treats axial spondyloarthritis.1,2,3Objectives:This analysis evaluated the effect of IXE treatment for 52 weeks on work productivity and activity impairment as measured by absenteeism, presenteeism, overall work impairment, and activity impairment in patients with active nr-axSpA.Methods:COAST-X (NCT02757352) was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group outpatient study investigating the efficacy and safety of 80 mg IXE every 2 weeks (Q2W) and every 4 weeks (Q4W) compared to placebo (PBO) in 303 patients naïve to biologic disease-modifying anti-rheumatic drugs with active nr-axSpA during a 52-week treatment period. From Weeks 16 through 44, if patients’ disease activity required escalation of treatment at investigator discretion, patients were switched to open-label IXE Q2W or subsequent tumor necrosis factor inhibitor treatment. Analysis was performed for the intent-to-treat population, which included data up to the time of biologic switching. Patients who switched to open-label IXE were considered non-responders. Changes from baseline in work productivity were measured for patients reporting full- or part-time work at Weeks 16 and 52 with the Work Productivity and Activity Impairment (WPAI) Questionnaire for Spondyloarthritis and analyzed with an analysis of covariance model including treatment, geographic region, screening magnetic resonance imaging and C-reactive protein level status, and baseline value as factors. Missing data was imputed using the modified baseline observation carried forward.Results:A majority of patients (63.5–65.7%) reported part-time or full-time paid work at baseline, with baseline scores for presenteeism and overall work activity slightly higher for patients in the PBO arm (p<0.05). Patients treated with IXE Q4W had significantly greater improvement than PBO in activity impairment at Weeks 16 (p=0.003) and 52 (p=0.004), presenteeism at Weeks 16 (p=0.007) and 52 (p=0.003), and overall work impairment at Weeks 16 (p=0.014) and 52 (p=0.005; Figure). Patients treated with IXE Q2W had significantly greater improvement than PBO in activity impairment at Weeks 16 (p=0.007) and 52 (p=0.006; Figure). Patients treated with either IXE regimen had numeric improvements in all WPAI measures compared to those receiving PBO at Weeks 16 and 52 (Figure).Conclusion:Patients with nr-axSpA treated with either IXE regimen had significant improvements in activity impairment compared to PBO. Patients receiving IXE Q4W also had significant improvements in presenteeism and overall work impairment.References:[1]Sieper, et al. (2016)Clin Exp Rheumatol.34(6):975-83.[2]Van der Heijde, et al. (2018)Lancet. 392(10163):2441-51.[3]Deodhar, et al. (2019)Arthritis Rheumatol.71(4):599-611.Figure.Changes from baseline in A) Absenteeism, B) Presenteeism, C) Overall Work Impairment, and D) Activity Impairment.Disclosure of Interests: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, Philip J Mease Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, Pfizer, Sun Pharma, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Galapagos, Gilead, Novartis, Pfizer, Sun Pharma, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer, UCB Pharma, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Proton Rahman Grant/research support from: Janssen and Novartis, Consultant of: Abbott, AbbVie, Amgen, BMS, Celgene, Lilly, Janssen, Novartis, and Pfizer., Speakers bureau: Abbott, AbbVie, Amgen, BMS, Celgene, Lilly, Janssen, Novartis, Pfizer, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, 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, Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Sandoval 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, Baojin Zhu Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Ann Leung: None declared, Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB

scholarly journals Predictive Factors of Clinical Response of Infliximab Therapy in Active Nonradiographic Axial Spondyloarthritis Patients

2015 ◽  
Vol 2015 ◽  
pp. 1-7
Author(s):  
Zhiming Lin ◽  
Zetao Liao ◽  
Jianlin Huang ◽  
Maixing Ai ◽  
Yunfeng Pan ◽  
...  
Keyword(s):  
New York ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Clinical Response ◽  
Predictive Factors ◽  
Roc Curve ◽  
Axial Spondyloarthritis ◽  
Infliximab Therapy ◽  
Infliximab Treatment ◽  
Nonradiographic Axial Spondyloarthritis

Objectives.To evaluate the efficiency and the predictive factors of clinical response of infliximab in active nonradiographic axial spondyloarthritis patients.Methods.Active nonradiographic patients fulfilling ESSG criteria for SpA but not fulfilling modified New York criteria were included. All patients received infliximab treatment for 24 weeks. The primary endpoint was ASAS20 response at weeks 12 and 24. The abilities of baseline parameters and response at week 2 to predict ASAS20 response at weeks 12 and 24 were assessed using ROC curve and logistic regression analysis, respectively.Results.Of 70 axial SpA patients included, the proportions of patients achieving an ASAS20 response at weeks 2, 6, 12, and 24 were 85.7%, 88.6%, 87.1%, and 84.3%, respectively. Baseline MRI sacroiliitis score (AUC = 0.791;P=0.005), CRP (AUC = 0.75;P=0.017), and ASDAS (AUC = 0.778,P=0.007) significantly predicted ASAS20 response at week 12. However, only ASDAS (AUC = 0.696,P=0.040) significantly predicted ASAS20 response at week 24. Achievement of ASAS20 response after the first infliximab infusion was a significant predictor of subsequent ASAS20 response at weeks 12 and 24 (waldχ2=6.87,P=0.009, and waldχ2=5.171,P=0.023).Conclusions.Infliximab shows efficiency in active nonradiographic axial spondyloarthritis patients. ASDAS score and first-dose response could help predicting clinical efficacy of infliximab therapy in these patients.

scholarly journals FRI0303 PERIPHERAL SYMPTOMS ARE ASSOCIATED WITH LESS SPINAL RADIOGRAPHIC PROGRESSION IN PATIENTS WITH EARLY AXIAL SPONDYLOARTHRITIS: RESULTS FROM THE GERMAN SPONDYLOARTHRITIS INCEPTION COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 741-741
Author(s):  
M. Torgutalp ◽  
M. Protopopov ◽  
F. Proft ◽  
J. Sieper ◽  
V. Rios Rodriguez ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Ankylosing Spondylitis ◽  
Radiographic Progression ◽  
Axial Spondyloarthritis ◽  
Smoking Status ◽  
Hla B27 ◽  
Research Support ◽  
Sum Score ◽  
Multivariable Regression

Background:Peripheral symptoms (PS), such as arthritis, enthesitis, and dactylitis, are common in axial spondyloarthritis (axSpA); data showing the association of PS and spinal radiographic progression in axSpA are controversial.Objectives:To analyze the association of PS and spinal radiographic progression in patients with axSpA.Methods:A total of 210 patients with axSpA (115 with radiographic and 95 with non-radiographic axSpA) were selected for analysis. Spinal radiographs were scored by two readers in a random order according to the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). Pelvic radiographs were scored according to the grading system of the modified New York criteria; a sacroiliitis sum score was calculated as a sum of the grades for both sacroiliac joints. Mann-Whitney and Fisher exact tests were performed for group comparisons. A multivariable regression analysis was performed to analyze the influence of PS on radiographic progression.Results:Of the 101 (48.1%) patients with PS, 78 had peripheral arthritis, 48 - enthesitis, 12 - dactylitis. 32 patients had ≤1 PS. Patients with PS were older, less frequently HLA-B27 positive, compared with patients with no PS (73 (73.0%) vs. 93 (85.3%), p=0.028), had higher disease activity (time-averaged ASDAS over 2 years 2.6 ± 0.9 vs. 2.3 ± 0.9; p=0.032), worse physical function (BASFI 3.5 ± 2.3 vs. 2.3 ± 2.2, p<0.001), higher exposure to disease modifying anti-rheumatic drugs (39 (38.6%) vs. 22 (20.2%), p=0.003) and lower baseline radiographic sacroiliitis sum score (3.8 ± 1.9 vs. 4.4 ± 2.1, p=0.026); other baseline characteristics were similar. Patients with PS had lower absolute progression in mSASSS after 2 years of follow-up than those without (0.28 ± 1.39 vs 1.15 ± 2.9, p=0.045); 7.9% of patients with PS had a progression of mSASSS by ≥2 points compared to 20.2% in patients without PS (p=0.011). Radiographic progression of sacroiliitis was similar in both groups. In a multivariable regression analysis, presence of PS was associated with a lower mSASSS progression and lower odds for the mSASSS progression by ≥2 points after 2 years of follow-up: β=-0.98 (95% -1.68 to -0.28) OR=0.33 (95% CI 0.12 to 0.91), respectively – Table 1.Table 1.Association of peripheral symptoms with radiographic progression in axial spondyloarthritis after 2 years of follow-up.Multivariable linear regression analysisOutcomeβ (95 %CI)mSASSS change score−0.98 (-1.68 to -0.28)*Change of the sacroiliitis sum score−0.06 (-0.32 to 0.20)**Multivariable logistic regression analysisOutcomeOdds ratio (95 %CI)Progression of mSASSS by ≥2 points0.33 (0.12 to 0.91)*Progression of sacroiliitis by at least 1 grade in opinion of both readers0.84 (0.33 to 2.09)**mSASSS - modified Stoke Ankylosing Spondylitis Spine Score.*Adjusted for the smoking status, HLA-B27 status, NSAIDs intake, baseline syndesmophytes, and time-averaged ASDAS.**Adjusted for the smoking status, HLA-B27 status, NSAIDs intake, sacroiliitis sum score at baseline, and time-averaged ASDAS.Conclusion:Presence of PS is associated with distinct characteristics of SpA including slower radiographic spinal progression which might be explained partly by the numerically lower mSASSS score at baseline.Acknowledgments:GESPIC has been financially supported by the German Federal Ministry of Education and Research (BMBF). As funding by BMBF was reduced in 2005 and stopped in 2007, financial support has been obtained from Abbott / Abbvie, Amgen, Centocor, Schering-Plough, and Wyeth. Since 2010 GESPIC is supported by Abbvie.Dr. Murat Torgutalp was supported by the Scientific and Technological Research Council of Turkey (TUBITAK).Disclosure of Interests:Murat Torgutalp: None declared, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, 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

scholarly journals OP0107 ETANERCEPT WITHDRAWAL AND RE-TREATMENT IN PATIENTS WITH INACTIVE NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS AT 24 WEEKS: RESULTS OF RE-EMBARK, AN OPEN-LABEL, PHASE IV TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 70.1-70
Author(s):  
F. Van den Bosch ◽  
J. C. C. Wei ◽  
P. Nash ◽  
F. J. Blanco ◽  
D. Graham ◽  
...  
Keyword(s):  
Axial Spondyloarthritis ◽  
Inactive Disease ◽  
Inadequate Response ◽  
Proportional Hazard ◽  
Research Support ◽  
Open Label ◽  
Link Type ◽  
Cox Proportional Hazard ◽  
Open Label Phase ◽  
Phase Iv

Background:In the RE-EMBARK trial (NCT02509026), etanercept (ETN)-treated patients with non-radiographic axial spondyloarthritis (nr-axSpA) who achieved inactive disease (defined as Ankylosing Spondylitis Disease Activity Score with C-reactive protein [ASDAS CRP] <1.3) in Period 1 (P1)1discontinued ETN for ≤40 weeks.Objectives:To assess the proportion of patients with inactive disease after P1 who experienced disease flare (ASDAS with erythrocyte sedimentation rate [ASDAS ESR] ≥2.1) within 40 weeks of ETN withdrawal and to estimate time to flare following ETN withdrawal.Methods:RE-EMBARK was a multicenter, open-label, Phase IV trial of ETN in patients with active nr-axSpA (meeting Assessment in SpondyloArthritis international Society criteria and with ASDAS CRP ≥2.1) and an inadequate response to ≥2 nonsteroidal anti-inflammatory drugs (NSAIDs) while taking a stable dose of 1 NSAID for ≥2 weeks before the first ETN dose. All patients received ETN (50 mg/week) plus NSAID for the first 24 weeks (P1). At week 24, patients with inactive disease discontinued ETN for ≤40 weeks (Period 2 [P2]). Those who experienced flare during P2 were re-treated with ETN for 12 weeks in Period 3 (P3). Kaplan-Meier (KM) analysis and Cox proportional hazard models were used to 1) estimate the probability of experiencing flare within a given time period, and 2) compare data between RE-EMBARK and the EMBARK trial (NCT01258738) of patients with nr-axSpA who met RE-EMBARK P2 entry criteria (achieved inactive disease after 24 weeks of ETN treatment) and continued treatment for a further ≤40 weeks.Results:Of the 209 patients in P1 (mean age, 33 years; women, 46%; white, 89%), 119 (57%) entered P2. The proportion of patients experiencing ≥1 flare increased from 22% (25/112) at P2 week 4 to 67% (77/115) at P2 week 40. Overall, 75% (86/115) of patients in P2 experienced flare and 50% experienced flare within 16 weeks (95% CI: 13-24 weeks, KM analysis). Conversely, data from the comparator EMBARK trial suggested that <25% of patients receiving continuous ETN treatment over 40 weeks experienced flare. Cox proportional hazard model analysis showed an 85% relative risk reduction of experiencing flare during P2 in patients with inactive disease who continued ETN treatment vs those who discontinued. By P3 end 62% (54/87) of patients re-treated with ETN re-achieved inactive disease; 50% of patients who re-achieved inactive disease in P3 did so within 5 weeks (95% CI: 4-8 weeks, KM analysis). The observed trend of clinical improvement (P1), worsening (P2), and improvement (P3) was reflected in other clinical measures (Figure) plus measures of joint damage (Spondyloarthritis Research Consortium of Canada Sacroiliac Joint magnetic resonance imaging score) and quality of life (EQ-5D visual analog scale score); mean (standard deviation) score changes from each study period baseline–end were –6.1 (11.7) [P1], +1.5 (4.4) [P2], –2.0 (8.8) [P3] and +27.7 (26.7) [P1], –26.4 (30.5) [P2], +32.1 (26.3) [P3], respectively. There were no unexpected safety signals.Conclusion:For patients with nr-axSpA who achieved inactive disease with ETN and then discontinued treatment, a quarter maintained treatment-free inactive disease for 40 weeks and 50% maintained an ASDAS ESR score of <2.1 for ≥16 weeks. Re-starting ETN allowed 62% of patients who flared to re-achieve inactive disease within 12 weeks.References:[1]Van den Bosch F, et al.Ann Rheum Dis2019;78:896-7Acknowledgments:Medical writing support was provided by Lorna Forse, PhD, of Engage Scientific Solutions and was funded by Pfizer.Disclosure of Interests:Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, James Cheng-Chung Wei Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer Inc, Sanofi-Aventis, UCB Pharma, Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Francisco J. Blanco Grant/research support from: Sanofi-Aventis, Lilly, Bristol MS, Amgen, Pfizer, Abbvie, TRB Chemedica International, Glaxo SmithKline, Archigen Biotech Limited, Novartis, Nichi-iko pharmaceutical Co, Genentech, Jannsen Research & Development, UCB Biopharma, Centrexion Theurapeutics, Celgene, Roche, Regeneron Pharmaceuticals Inc, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, Ltd, Gilead Sciences Inc, Consultant of: Lilly, Bristol MS, Pfizer, Daniela Graham Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Chuanbo Zang Shareholder of: Pfizer, Employee of: Pfizer, Edmund Arthur Shareholder of: Pfizer, Employee of: Pfizer, Cecilia Borlenghi Shareholder of: Pfizer, Employee of: Pfizer, Bonnie Vlahos Shareholder of: Pfizer, Employee of: Pfizer, 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

The relationship between platelet to albumin ratio and disease activity in axial spondyloarthritis patients

2021 ◽  
Author(s):  
Yukai Huang ◽  
Weiming Deng ◽  
Xia Pan ◽  
Meng Liu ◽  
Zheng Zhong ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Regression Analysis ◽  
Disease Activity ◽  
Logistic Regression Analysis ◽  
Axial Spondyloarthritis ◽  
Diagnostic Value ◽  
Active Group ◽  
Youden Index ◽  
Binary Logistic Regression Analysis ◽  
Albumin Ratio

ABSTRACT Objectives The study aims to investigate the clinical significance of platelet to albumin ratio (PAR), neutrophil to albumin ratio (NAR), and monocyte to albumin ratio (MAR) in axial spondyloarthritis (axSpA). Methods Two hundred and ninety-seven axSpA patients and 71 healthy volunteers were recruited. AxSpA patients were divided into inactive group and active group. Spearman’s correlation, receiver operating characteristic (ROC) curves, and binary logistic regression analysis were conducted. Results Albumin was lower in axSpA group, while neutrophil, platelet, monocyte, NAR, PAR, and MAR were higher (p &lt; .05). Albumin was negatively correlated with BASDAI and BASFI (p &lt; .05). Platelet, NAR, PAR, MAR, ESR, and CRP were all positively correlated with BASDAI and BASFI (p &lt; .05). Albumin was lower in axSpA of active group, while platelet, NAR, PAR, MAR, ESR, and CRP were higher (p &lt; .05). ROC curve indicated that the AUC of PAR for axSpA of active group was higher than that of other variables. The optimal cut-off value of PAR was 6.354, with Youden index of 0.337, specificity of 55.4%, and sensitivity of 78.4%. Logistic regression analysis result suggested that PAR was an independent indicator for axSpA disease activity. Conclusions PAR had a high diagnostic value for axSpA of active group. PAR was a novel and reliable indicator for axSpA disease activity.

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