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

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

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

BMC Rheumatology ◽

10.1186/s41927-021-00218-y ◽

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.

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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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2018-213590 ◽

2018 ◽

Vol 77 (11) ◽

pp. 1578-1584 ◽

Cited By ~ 13

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.

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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

10.21203/rs.3.rs-103585/v1 ◽

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.

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AB0814 SUSTAINED IMPROVEMENTS IN PHYSICAL FUNCTION, QUALITY OF LIFE, AND WORK PRODUCTIVITY WITH IXEKIZUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AND PREVIOUS INADEQUATE RESPONSE TO TUMOUR NECROSIS FACTOR-INHIBITORS: 3-YEAR RESULTS FROM SPIRIT-P2 TRIAL

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2087 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1709-1710

Author(s):

A. M. Orbai ◽

J. Gratacos-Masmitja ◽

E. Dokoupilova ◽

B. Combe ◽

A. Constantin ◽

...

Keyword(s):

Quality Of Life ◽

Physical Function ◽

Work Productivity ◽

Inadequate Response ◽

Research Support ◽

Activity Impairment ◽

Sf 36 ◽

Intent To Treat ◽

Treat Population

Background:Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets IL-17A, has shown improvements compared to placebo (PBO) not only in disease activity but also in various patient-reported outcomes (PROs) assessing physical function, quality of life (QoL), and work productivity in PsA patients treated for 24 weeks and sustained up to 52 weeks.1, 2Objectives:To report the effects of treatment with IXE on these PROs after up to 3 years of treatment.Methods:In SPIRIT-P2 (NCT02349295), a Phase 3 trial, 363 adult patients with active PsA and prior inadequate response or intolerance to 1 or 2 TNF inhibitors (TNFis) were randomized 1:1:1 to IXE 80 mg every 4 weeks (IXEQ4W; N=122) or every 2 weeks (IXEQ2W; N=123), or PBO (N=118) in the double-blind treatment period (Weeks 0-24). Both IXE regimens had a starting dose of 160 mg. Results are reported from a subset of the intent-to-treat population who were randomized to IXE at baseline (Week 0). The following PROs were assessed during Weeks 0-156: HAQ-DI (minimally clinically important difference [MCID] an improvement ≥0.35), medical outcomes survey Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS), European Quality of Life 5 Dimensions Visual Analog Scale (EQ-5D VAS), and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (WPAI-SHP; absenteeism, presenteeism, work productivity, and activity impairment). Missing values were imputed by observed analysis and modified baseline observation carried forward (mBOCF) for continuous data or by modified non-responder imputation (mNRI) for categorical data.Results:Mean baseline scores for SF-36 (PCS and MCS), EQ-5D VAS, and WPAI-SHP (Figure 1) and HAQ-DI (mean [SD]: IXEQ4W=1.2 [0.6]; IXEQ2W=1.2 [0.6]), indicated impaired physical function and QoL. The percentage of patients of who completed 156 weeks of the study in IXEQ4W and IXEQ2W arms were 57.4% (n=70) and 44.7% (n=55), respectively. Patients receiving IXE treatment up to 3 years reported sustained improvements in SF-36 (PCS and MCS), EQ-5D VAS, and WPAI-SHP (presenteeism, work productivity, and activity impairment) (Figure 1). Observed HAQ-DI mean change from baseline in IXEQ4W: -0.46 (0.62) and IXEQ2W: -0.48 (0.55). The percentage of IXE treated patients achieving MCID for HAQ-DI (improvement ≥0.35) was sustained at 3 years (Figure 2).Figure 1.Summary of Patient-Reported Outcomes presented as change from baseline at Week 156 (Observed and mBOCF): Intent-to-Treat Population (Patients Randomized to IXE at Baseline)Figure 2.Patients achieving HAQ-DI MCID Response up to Week 156 (Observed) and at Week 156 (mNRI) among patients with HAQ-DI≥0.35 at baseline: Intent-to-Treat Population (Patients Randomized to IXE at Baseline)Conclusion:Improvements in PROs, measuring physical and mental function, quality of life, and work productivity are maintained up to 3 years with IXE treatment in patients with active PsA who have had an inadequate response or intolerance to 1 or 2 TNFis.References:[1]Nash P, et al. Lancet. 2017;389(10086):2317-2327.[2]Genovese MC, et al. Rheumatology (Oxford). 2018;57(11):2001-2011.Disclosure of Interests:Ana-Maria Orbai Grant/research support from: Abbvie, Eli Lilly and Company, Celgene, Novartis, Janssen, Horizon, Consultant of: Eli Lilly; Janssen; Novartis; Pfizer; UCB. Ana-Maria Orbai was a private consultant or advisor for Sun Pharmaceutical Industries, Inc, not in her capacity as a Johns Hopkins faculty member and was not compensated for this service., Jordi Gratacos-Masmitja Grant/research support from: a grant from Pfizzer to study implementation of multidisciplinary units to manage PSA in SPAIN, Consultant of: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Speakers bureau: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Eva Dokoupilova Grant/research support from: Eli Lilly and Abbvie, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Arnaud Constantin Grant/research support from: Study was sponsored by Sanofi Genzyme, Consultant of: Consulting fees from Abbvie, BMS, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, Amanda M. Gellett Shareholder of: Eli Lilly and company, Employee of: Eli Lilly and company, Aubrey Trevelin Sprabery Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Julie Birt 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, 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

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Loss of Work Productivity and Quality of Life in Patients With Autoimmune Bullous Dermatoses

Journal of Cutaneous Medicine and Surgery ◽

10.1177/1203475415582317 ◽

2015 ◽

Vol 19 (6) ◽

pp. 546-554 ◽

Cited By ~ 6

Author(s):

K. Heelan ◽

S. L. Hitzig ◽

S. Knowles ◽

A. M. Drucker ◽

N. Mittmann ◽

...

Keyword(s):

Quality Of Life ◽

Dermatology Life Quality Index ◽

Quality Index ◽

Life Quality ◽

Work Productivity ◽

Activity Impairment ◽

Work Impairment ◽

Life Quality Index ◽

The Impact

Background: Little is known about quality of life and work productivity in autoimmune bullous dermatoses (AIBDs). Objective: To determine the impact of AIBDs on quality of life and work productivity. Methods: An observational cross-sectional study took place between February and May 2013 at an AIBD tertiary referral centre. Ninety-four patients were included. All participants completed the Dermatology Life Quality Index and the Work Productivity and Activity Impairment–Specific Health Problem questionnaires. Results: Responders to treatment had less impairment ( P < .001) than nonresponders. Patients with severe AIBD had significantly more impairment that those with mild ( P < .001) and moderate ( P = .002) AIBD. Greater impairment was associated with higher percentage of work missed. Those with a higher Dermatology Life Quality Index score had greater work impairment and overall activity impairment ( P = .041, P = .024). Nonresponders had increased impairment while working ( P < .001), overall work impairment ( P < .001), and activity impairment ( P < .001). Severely affected patients had worse impairment in all Work Productivity and Activity Impairment Questionnaire domains. Conclusions: AIBD has the potential to be a large burden on ability to work and quality of life. Larger studies are needed to clarify how these domains change over time and whether or not they improve with treatment.

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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)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1361 ◽

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

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Abstract P134: Higher Optimal Lifestyle Score is Associated with Greater Workplace Productivity

Circulation ◽

10.1161/circ.125.suppl_10.ap134 ◽

2012 ◽

Vol 125 (suppl_10) ◽

Author(s):

Jackie L Boucher ◽

Jeffrey J VanWormer ◽

Heather R Britt ◽

James M Peacock ◽

Kevin J Graham

Keyword(s):

Productivity Loss ◽

Work Productivity ◽

Economic Benefits ◽

Lifestyle Factor ◽

Full Time ◽

Lifestyle Habits ◽

Activity Impairment ◽

Cross Sectional ◽

Workplace Productivity ◽

The Impact

Introduction: Unhealthy lifestyles are associated with low workplace productivity, but lifestyle risks tend to cluster and the impact of this is not well studied. This analysis examined the cross-sectional association between an optimal lifestyle score (OLS) and overall workplace productivity in the Heart of New Ulm Project. Hypothesis: It was hypothesized that a higher OLS would be associated with higher workplace productivity relative to a lower OLS. Methods: Complete data was available from 2,987 adults age 18-85 years (with ≥0.40 FTE work agreement) without self-reported diabetes or heart disease, who underwent a cardiovascular risk factor screening in 2009. For each participant, an OLS of 0-4 total points was created by summing one point for each of the following factors: non-smoker, ≥150 min/wk of moderately equivalent physical activity, 1-14 alcoholic drinks/wk, and ≥5 serv/d of fruits and vegetables. Overall productivity loss combined absenteeism and presenteeism from the Work Productivity and Activity Impairment questionnaire, reflecting the percentage loss of all available work hours (per work agreement) due to health reasons. Results: After adjustment for age, sex, body mass index, and Perceived Stress Scale score, least squares adjusted mean±SE productivity loss was 9.9±1.9% for an OLS of 0, 5.7±0.6% for an OLS of 1, 4.9±0.4% for an OLS of 2, 4.9±0.4% for an OLS of 3, and 4.7±1.0% for an OLS of 4 (p for trend <0.001). Post hoc comparisons revealed that OLS’s of 0 were significantly different (p =0.05) from all other OLS’s, while OLS’s of 1, 2, 3, or 4 were statistically indistinguishable (p=0.05) from one another. Conclusions: A beneficial threshold of having at least one optimal lifestyle factor was observed. When productivity loss is converted to lost dollars under the assumptions that all employees work full time with an annual salary of $50,000, an OLS of 0 (-$4,950/employee) has over two-fold higher annual estimated workplace productivity losses relative to an OLS of 4 (-$2,350/employee). Employees with no optimal lifestyle habits, however, represent a very small proportion (1.5% of this analysis; 46 of 2,987) of the total workforce. As such, greater absolute economic benefits may be realized by focusing interventions primarily on supporting the maintenance of existing optimal lifestyle habits.

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

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x20949088 ◽

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.

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Descriptive study on the lost productivity in breast cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.6542 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 6542-6542

Author(s):

L. Bordeleau ◽

D. Warr ◽

P. Goodwin ◽

N. Lathia ◽

O. Jugovic ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Work Productivity ◽

Full Time ◽

Breast Cancer Patients ◽

Activity Impairment ◽

Cross Sectional ◽

Breast Cancer Chemotherapy ◽

Lost Productivity

6542 Background: There is a paucity of data assessing the potential impact of breast cancer diagnosis on the productivity of affected women. The objective was to identify and quantify lost productivity, health utilities and quality of life experienced in women diagnosed with breast cancer. Methods: A consecutive cross-sectional cohort of women with breast cancer (at any stage) attending outpatient clinics at Mount Sinai Hospital/Princess Margaret Hospital were eligible and consented to participate in the study. Women completed questionnaires assessing demographic and disease related information, work productivity and activity impairment utility (EQ5D VAS) and quality of life (FACT-B). Results: Data from 103 patients age 56.5 ± 11.9 years (mean +SD) were collection. Distribution of stage at diagnosis was as follows: 0 (31%), I (26%), II (10%), III (5%), IV (17%), unknown (11%). Time since diagnosis was 30.0 ± 39.1 months. Most women had recently been on active treatment for their breast cancer: chemotherapy (47%), hormone manipulation (23%), herceptin (6%), radiation (27%) and unknown (15%). 9% of women had metastatic disease, 35% had an income between $0 and $30,000. 58% of women were working full time for pay before their diagnosis, whereas only 19% were working full time for pay at the time of the assessment. At the time of the assessment, 18% were on disability leave. 8.7% of the women retired between the times of their diagnosis to the current assessment. Of those still working, a mean of 8.7 ± 11.6 days were missed from work in the previous 30 days due to problems related to breast cancer. The average number of days that employed patients actually worked (N=27) was 16.0 ± 9.0 days (range 4–30 days). 8% of patients required paid health care assistance during the past 4 weeks. 44% of patients had a spouse as an unpaid caregiver, followed by child/parent (20%) and friend (13%). Mean overall health rated by the respondents using the EQ5D VAS was 73.2 ± 16.3. The FACT-B mean was 68.0 ± 12.5 (range 27 to 98). Conclusion: Breast cancer negatively impacts work productivity and overall activity. The significant use of both paid and unpaid assistance would amount to significant societal costs which are currently not included in most cost-effectiveness analyses. No significant financial relationships to disclose.

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Hospice Caregiver Burden and Work Productivity: An Exploratory Analysis

Innovation in Aging ◽

10.1093/geroni/igab046.3699 ◽

2021 ◽

Vol 5 (Supplement_1) ◽

pp. 1044-1045

Author(s):

Megan Thomas Hebdon ◽

Jiayun Xu ◽

Djin Tay ◽

Maija Reblin ◽

Kristin Cloyes ◽

...

Keyword(s):

Caregiver Burden ◽

Work Productivity ◽

Secondary Data ◽

Well Being ◽

Study Data ◽

Work Environments ◽

Future Research ◽

Full Time ◽

Activity Impairment ◽

Dependent Variables

Abstract Hospice caregivers experience burden that impacts their physical, emotional, and social well-being. Little is known about how caregiver burden impacts occupational well-being through employment and work productivity. Thus, our purpose was to explore the relationships between caregiver burden and dimensions of work productivity/impairment (absenteeism, presenteeism, activity impairment, and overall impairment) among working hospice cancer caregivers. This is a secondary data analysis of baseline data from a larger study of caregiver communication and bereavement. Study data including demographics, preparedness for caregiving, caregiver burden, and work productivity/impairment were analyzed using descriptive statistics, correlation analysis, and stepwise multiple linear regression. Dimensions of work productivity/impairment were dependent variables, and age and preparedness for caregiving were covariates. Working caregivers (N=54) had an average age of 52 (SD: 12.65), and were primarily White (83%), female (70%), married (69%), employed full-time (70%) and had a household income of $50,000 or more (65%). Greater caregiver burden was significantly associated with lower preparedness for caregiving (r=-.41, p<.01), and greater activity impairment (r=.50, p<.01), presenteeism (r=.44, p<.01), and overall impairment (r=.36, p<.05), but not absenteeism. Caregiver burden predicted activity impairment (b=1.72 [.72, 2.71], p<.01), presenteeism (b=1.44 [.33, 2.55], p<.01), and overall impairment (b=1.42 [.09, 2.74], p<.05), even after controlling for age and preparation for caregiving. More burdened caregivers may be having more challenges with work productivity. Additional research is needed to examine these relationships in a larger, more diverse sample. Future research should also investigate how supportive work environments and leave policies reduce caregiver burden and promote work productivity.

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