scholarly journals Work Productivity is Associated With Disease Activity and Functional Ability in Chinese Patients With Axial Spondyloarthritis Using A Smart-Phone Management System: A Prospective Cohort Study

2020 ◽  
Author(s):  
Yanyan Wang ◽  
Xiaofei Liu ◽  
Wenji Chen ◽  
Shiyan Mo ◽  
Xiaojian Ji ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Work Disability ◽  
Global Assessment ◽  
Clinical Characteristics ◽  
Axial Spondyloarthritis ◽  
Work Productivity ◽  
Smart Phone ◽  
Activity Impairment ◽  
Work Impairment

Abstract Background: Axial spondyloarthritis usually affects young people and often leads to disability. We used the interactive mobile health tool to evaluate clinical characteristics and loss of work efficiency in China, and to analyze the association between the clinical characteristics and work disability in patients with axial spondyloarthritis.Methods: In total, 1187 patients with axial spondyloarthritis were included. Demographic properties, pharmacotherapy, disease activity, functionality and spinal mobility were studied and compared in both work disability and non- work disability patients. Logistic regressions were used to investigate the associations between the risk of work disability and clinical characteristics. The relationships between Work Productivity and Activity Impairment scores and clinical characteristics were assessed using Spearman correlation coefficients. Results: Of the participants, 60 or 5.05% were unemployed. The predictive factors for the occurrence of work disability were suffering from inflammatory bowel disease, higher Physician’s global assessment and higher Assessment of Spondyloarthritis International Society health index (ASASHI) scores (OR value was 3.35, 1.32 and 1.45 respectively). Absenteeism, presenteeism, overall work impairment and activity impairment in all employed patients were 10.40%, 23.53%, 30.57% and 25.35% respectively. Factors significantly associated with higher presenteeism, overall work impairment and activity impairment loss were Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Ankylosing Spondylitis Disease Activity Score, ASASHI, nocturnal pain, total back pain, and Patient’s global assessment (r >0.5), while non-steroidal anti-inflammatory drugs treatment were significantly associated with a lower absenteeism loss. An increased ASDAS score was related to a decrease in work productivity.Conclusions: We used a Smart-Phone Management System to determine that axial spondyloarthritis had a significant influence on working conditions in China, and that the factors related to the disease had a significant correlation with the risk and severity of lost work productivity. SpAMS is found be a time- and cost-saving disease management tool which can help patients with AS independently manage their disease and provide valuable data to their clinicians.

scholarly journals Real-world evidence of the impact of adalimumab on work productivity and sleep measures in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

2020 ◽  
Vol 12 ◽  
pp. 1759720X2094908
Author(s):  
Maria G. Tektonidou ◽  
Gkikas Katsifis ◽  
Athanasios Georgountzos ◽  
Athina Theodoridou ◽  
Eftychia-Maria Koukli ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Real World ◽  
Sleep Problems ◽  
Work Productivity ◽  
Routine Care ◽  
Activity Impairment ◽  
Work Impairment

Objective: Our aim was to evaluate the effect of adalimumab on work productivity measures, overall activity impairment, and sleep quality in patients with active moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) treated in routine care settings in Greece and determine factors associated with work impairment and sleep disturbance. Methods: Patients with active moderate to severe RA ( n = 184), PsA ( n = 166), and AS ( n = 150) were enrolled in this 24-month, prospective, observational study at 80 hospital outpatient clinics and private practices throughout Greece. Patients received adalimumab alone or in combination with standard antirheumatic therapies according to routine care. Work productivity and sleep were assessed through two patient-reported outcome measures: the Work Productivity and Activity Impairment–General Health questionnaire and the Medical Outcomes Study Sleep Scale (MOS-SS). Pearson correlation coefficients were estimated to assess the association of work impairment and sleep disturbances with disease activity scores. Results: In the overall population, adalimumab significantly lowered absenteeism [mean (95% confidence interval) reduction, 18.9% (13.3–24.5%); n = 100]; presenteeism [40.0% (33.8–46.3%); n = 98], overall work productivity impairment [46.8% (40.4–53.2%); n = 94], activity impairment [47.0% (44.3–49.6); n = 421], and the MOS-SS sleep problems index [31.6 (29.5–34.1); n = 421] after 24-month treatment ( p < 0.001). Significant improvements were also noted across the RA, PsA, and AS subpopulations ( p < 0.05). Improvements in overall work impairment and sleep disturbance positively correlated with improvements in disease activity measures. Conclusion: Adalimumab improves work productivity and sleep problems while lowering disease activity in patients with moderate to severe RA, PsA, and AS managed in real-world settings.

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 Impact of biological therapy on work outcomes in patients with axial spondyloarthritis: results from the British Society for Rheumatology Biologics Register (BSRBR-AS) and meta-analysis

2018 ◽  
Vol 77 (11) ◽  
pp. 1578-1584 ◽  
Author(s):  
Joanna Shim ◽  
Gareth T Jones ◽  
Ejaz M I Pathan ◽  
Gary J Macfarlane
Keyword(s):  
Biological Therapy ◽  
Axial Spondyloarthritis ◽  
Meta Analysis ◽  
Work Productivity ◽  
Work Outcomes ◽  
British Society ◽  
Activity Impairment ◽  
Work Impairment ◽  
Biologics Register

ObjectivesTo quantify, among patients with axial spondyloarthritis (axSpA), the benefit on work outcomes associated with commencing biologic therapy.MethodsThe British Society for Rheumatology Biologics Register in Axial Spondyloarthritis (BSRBRAS) recruited patients meeting Assessment of SpondyloArthritis International Society criteria for axSpA naïve to biological therapy across 83 centres in Great Britain. Work outcomes (measured using the Work Productivity and Activity Impairment Index) were compared between those starting biological therapy at the time of recruitment and those not. Differences between treatment groups were adjusted using propensity score matching. Results from BSRBR-AS were combined with other studies in a meta-analysis to calculate pooled estimates.ResultsOf the 577 participants in this analysis who were in employment, 27.9% were starting biological therapy at the time of recruitment. After propensity score adjustment, patients undergoing biological therapy, at 12-month follow-up, experienced significantly greater improvements (relative to non-biological therapy) in presenteeism (−9.4%, 95% CI −15.3% to –3.5%), overall work impairment (−13.9%, 95% CI −21.1% to –6.7%) and overall activity impairment (−19.2%, 95% CI −26.3% to –12.2%). There was no difference in absenteeism (−1.5%, 95% CI −8.0 to 4.9). Despite these improvements, impact on work was still greater in the biological treated cohort at follow-up. In the meta-analysis including 1109 subjects across observational studies and trials, treatment with biological therapy was associated with significantly greater improvements in presenteeism, work impairment and activity impairment, but there was no difference in absenteeism.ConclusionsThere is consistent evidence that treatment with biological therapy significantly improves work productivity and activity impairment in people with axSpA. However, there remain substantial unmet needs in relation to work.

scholarly journals Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Atul Deodhar ◽  
Philip Mease ◽  
Helena Marzo-Ortega ◽  
Theresa Hunter ◽  
David Sandoval ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
Work Productivity ◽  
Analysis Of Covariance ◽  
Activity Impairment ◽  
Work Activity ◽  
Work Impairment ◽  
Link Type ◽  
Dosing Regimens

Abstract Background Patients with non-radiographic axial spondyloarthritis experience negative impacts on sleep, work productivity, and activity impairment. Ixekizumab, a monoclonal antibody selectively targeting interleukin-17A, has shown efficacy in treating the signs and symptoms of non-radiographic axial spondyloarthritis. This analysis evaluated the effect of ixekizumab treatment on sleep, work productivity, and activity impairment in patients with non-radiographic axial spondyloarthritis. Methods COAST-X (NCT02757352) was a 52-week, phase 3, multicenter, randomised placebo-controlled trial evaluating 80-mg ixekizumab every 2 weeks and every 4 weeks in patients with active non-radiographic axial spondyloarthritis. Sleep disturbance was measured with the Jenkins Sleep Evaluation Questionnaire (JSEQ) and analysed using mixed-effects models for repeated measures. Work productivity and activity impairment were measured using the Work Productivity and Activity Impairment Questionnaire for Spondyloarthritis and analysed using analysis of covariance. Absenteeism, presenteeism, and overall work impairment were assessed for patients reporting paid work; activity impairment was assessed regardless of work status. Results Overall, patients treated with both dosing regimens of ixekizumab reported numerically greater improvements in sleep than placebo through Week 52. At Weeks 16 and 52, patients treated with ixekizumab every 4 weeks had significantly greater improvements in presenteeism (p = 0.007 and p = 0.003, respectively) and overall work impairment (p = 0.014 and p = 0.005, respectively) and numeric improvements in absenteeism than placebo. Patients treated with ixekizumab every 2 weeks had numerically greater improvements in absenteeism, presenteeism, and overall work impairment than placebo. Both dosing regimens of ixekizumab were associated with significantly greater improvements in activity impairment than placebo (ixekizumab every 4 weeks: p = 0.003 at Week 16 and p = 0.004 at Week 52; ixekizumab every 2 weeks: p = 0.007 at Week 16 and p = 0.006 at Week 52). Conclusions Treatment with ixekizumab improved sleep, work productivity, and activity impairment in patients with nr-axSpA. Improvements in presenteeism and overall work impairment were sustained and consistent in the patients treated with ixekizumab every 4 weeks from Week 16 to Week 52. Improvements in activity impairment were sustained and consistent in both ixekizumab-treated groups from Week 16 to Week 52. Trial registration NCT02757352, May 2, 2016.

scholarly journals Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Yoshiya Tanaka ◽  
Tsutomu Takeuchi ◽  
Hiroyuki Izutsu ◽  
Yuichiro Kaneko ◽  
Daisuke Kato ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Daily Activity ◽  
Global Assessment ◽  
Work Productivity ◽  
Phase 3 ◽  
Activity Impairment ◽  
Link Type ◽  
Asian Patients ◽  
Domain Scores

Abstract Background Peficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety in the treatment of patients with rheumatoid arthritis (RA). This study evaluated the effect of peficitinib on patient- and physician-reported outcomes in Asian patients with RA and an inadequate response to prior disease-modifying antirheumatic drugs (DMARDs). Methods Patients from two randomized, placebo-controlled, double-blind, phase 3 trials (RAJ3 and RAJ4) received once-daily peficitinib 100 mg, peficitinib 150 mg, or placebo, alone or in combination with DMARDs (RAJ3), or in combination with methotrexate (RAJ4). Mean changes in Work Productivity and Activity Impairment (WPAI) questionnaire domain scores from baseline, and percentages of patients achieving minimal clinically important differences (MCIDs) for patient- and physician-reported outcomes (WPAI, Health Assessment Questionnaire – Disability Index [HAQ-DI], and Subject’s Global Assessment of Pain [SGAP]), and Physician’s Global Assessment of disease activity (PGA) were evaluated at weeks 4, 8, 12, and 12/early termination (ET). Results Data from 1025 patients were analyzed. At week 12/ET in both studies, patients who received peficitinib 100 mg or 150 mg reported significantly improved WPAI domain scores from baseline (except for absenteeism in RAJ4) compared with placebo (both doses, p<0.05). A higher proportion of peficitinib- versus placebo-treated patients achieved MCID in WPAI, HAQ-DI, SGAP, and PGA in studies RAJ3 and RAJ4. Significant differences with peficitinib versus placebo were evident in both studies as early as week 4 in HAQ-DI (peficitinib 150 mg only), SGAP, and PGA, and week 8 in WPAI loss of work productivity and daily activity impairment. At week 12/ET, significantly higher proportions of patients receiving peficitinib versus placebo achieved MCID in HAQ-DI, SGAP, PGA, and WPAI domains of presenteeism (RAJ3 only), loss of work productivity (RAJ3 only), and daily activity impairment (p<0.05 for all comparisons). Conclusions Peficitinib 100 mg or 150 mg administered daily over 12 weeks resulted in clinically meaningful improvements in outcomes that are important to RA patients, including pain, physical function, and work productivity and activity. These observations were reinforced through similar improvements in physicians’ rating of disease activity. Trial registration RAJ3: ClinicalTrials.gov, NCT02308163, registered 4 December 2014. RAJ4: ClinicalTrials.gov, NCT02305849, registered 3 December 2014.

scholarly journals P269 Real-world impact of biological therapies on work impairment and quality of life in Inflammatory Bowel Disease patients

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S303-S304
Author(s):  
P Thomas ◽  
N Den Broeder ◽  
R West ◽  
M Russel ◽  
J Jansen ◽  
...  
Keyword(s):  
Disease Activity ◽  
Biological Therapy ◽  
Work Productivity ◽  
Clinical Disease ◽  
Total Work ◽  
Activity Impairment ◽  
Work Impairment ◽  
Clinical Disease Activity ◽  
Inflammatory Bowel

Abstract Background Randomised controlled trials have reported improvement of work productivity and activity impairment (WPAI) as well as quality of life in biological-treated inflammatory bowel disease (IBD) patients. However, data beyond clinical trials are limited. Methods This multicentre prospective cohort study evaluated the effect of initiating biological or small molecule therapy on work impairment in IBD patients. Subjects completed the WPAI questionnaire and Short IBD questionnaire (SIBDQ) at biological therapy initiation and at week 26. Clinical disease activity was assessed using the Harvey Bradshaw Index and Simple Clinical Colitis Activity Index. Biochemical disease activity was assessed using C-reactive protein and faecal calprotectin. Data are presented as mean ± standard deviation. Results In total, 156 IBD patients were included for analysis (median age 40 years, 55% male, 55% Crohn’s disease). Of these patients, 28% started infliximab, 33% adalimumab, 19% vedolizumab, 18% ustekinumab, 1% tofacitinib and 1% golimumab. Concomitant medication use at baseline included 28% prednisone, 12% budesonide, 34% mesalamine, and 46% immunomodulator. At baseline, 58% had clinical disease activity and 58% had biochemical disease activity. In our cohort, 111 (71%) were employed and 17 (11%) patients reported partial or full occupational disability. The mean total work impairment at baseline was 52% ± 36%. During follow-up, 7 patients lost their job and 8 patients started employment. For the entire cohort, improvements in all WPAI domains were observed: mean 11%-points decrease in missed working hours, 4%-points decrease in impairment while working, 15%-points decrease in total work impairment and 15%-points decrease in total activity impairment. Parallel improvements were seen in SIBDQ scores (mean improvement 7.6 ± 11.3). At week 26, 66 (42%) patients achieved the minimal clinical important difference in total work impairment (improvement ≥7%-points). Patients with clinical disease activity at baseline and clinical response to the biological (n=32) showed a larger improvement in total work impairment compared with other subjects (n=86) (mean difference 29%-points versus 10%-points; p=0.036 (T-test)). Similarly, these patients showed greater improvement in SIBDQ scores compared to other subjects (mean 13.8 versus 5.4, respectively; p&lt;0.001 (T-test)). Conclusion IBD patients experienced substantial work impairment prior to initiating biological treatment. Improved work impairment scores were seen after initiation of biological therapy and patients with clinical response showed even greater improvements. These results underline the importance of IBD disease control to improve work productivity and participation.

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 OP0008 DEVELOPMENT AND VALIDATION OF AN ALTERNATIVE ANKYLOSING SPONDYLITIS DISEASE ACTIVITY SCORE WHEN PATIENT GLOBAL ASSESSMENT IS UNAVAILABLE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 6-6
Author(s):  
A. Ortolan ◽  
S. Ramiro ◽  
F. A. Van Gaalen ◽  
T. K. Kvien ◽  
R. B. M. Landewé ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Psychometric Properties ◽  
Global Assessment ◽  
Disease Activity Score ◽  
Validation Cohort ◽  
Patient Global Assessment ◽  
Activity Score ◽  
Research Support ◽  
Low Disease Activity

Background:Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index measuring disease activity in axial spondyloarthritis (axSpA). It includes questions from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Patient Global Assessment (PGA), and inflammation biomarkers. However, ASDAS calculation is not always possible because PGA is sometimes not collected.Objectives:To develop an alternative ASDAS to be used in research settings when PGA is unavailable.Methods:Longitudinal data from 4 axSpA cohorts and 2 RCTs were combined. Observations were randomly split in a development (N=1026) and a validation cohort (N=1059). Substitutes of PGA by BASDAI total score, single or combined individual BASDAI questions, and a constant value, were considered. In the development cohort, conversion factors for each substitute were defined by Generalized Estimating Equations. Validation was performed in the validation cohort according to the OMERACT filter, taking into consideration: 1) Truth (agreement with original-ASDAS in the continuous score, by intraclass correlation coefficient -ICC- and in disease activity states, by weighted kappa) 2) Discrimination (standardized mean difference –SMD- of ASDAS scores between high/low disease activity states defined by external anchors e.g Patient Acceptable Symptom State –PASS-; agreement -kappa- in the % of patients reaching ASDAS improvement criteria according to alternative vs. original formulae) 3) Feasibility.Results:Taking all psychometric properties into account and comparing the different formulae (Table), alternative-ASDAS using BASDAI total as PGA replacement proved to be: 1) truthful (agreement with original-ASDAS: ICC=0.98, kappa=0.90); 2) discriminative: it could discriminate between high/low disease activity states (e.g. scores between PASS no/yes: SMD=1.37 versus original-ASDAS SMD=1.43) and was sensitive to change (agreement with original-ASDAS in major improvement/clinically important improvement criteria: kappa=0.93/0.88; 3) feasible (BASDAI total often available; conversion coefficient≈1).Table.Psychometric properties of alternative ASDAS formulaeConclusion:Alternative-ASDAS using BASDAI total score as PGA replacement is the most truthful, discriminative and feasible instrument. This index enables ASDAS calculation in existing cohorts without PGA.Disclosure of Interests:Augusta Ortolan: None declared, Sofia Ramiro: None declared, Floris A. van Gaalen: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Adeline Ruyssen-Witrand Grant/research support from: Abbvie, Pfizer, Consultant of: Abbvie, BMS, Lilly, Mylan, Novartis, Pfizer, Sandoz, Sanofi-Genzyme, Astrid van Tubergen Consultant of: Novartis, Caroline Bastiaenen: None declared, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV

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