FRI0139 FILGOTINIB PROVIDED RAPID AND SUSTAINED RELIEF OF PAIN AND FATIGUE AND IMPROVED HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH RHEUMATOID ARTHRITIS AND INADEQUATE RESPONSE TO BIOLOGIC DMARDS: RESULTS FROM THE FINCH 2 STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 652-653
Author(s):  
D. Walker ◽  
T. Takeuchi ◽  
B. Bartok ◽  
S. Rao ◽  
I. H. Lee ◽  
...  
Keyword(s):  
Pain Scale ◽  
Inadequate Response ◽  
Health Related Quality ◽  
Research Support ◽  
Chugai Pharmaceutical ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
Time Point

Background:EULAR guidelines recommend a treat-to-target approach focusing on reducing inflammation to prevent joint damage, physical disability, and mortality.1However, patients consider reduction in pain and fatigue, along with maintenance of physical function, and improvement in health-related quality of life (HRQoL) important areas for improvement with RA treatment.2In the FINCH 2 study, filgotinib (FIL)—a potent, selective, oral small molecule Janus kinase 1 inhibitor—in combination with conventional synthetic (cs)DMARD therapy significantly improved the signs and symptoms of rheumatoid arthritis (RA) in patients with an inadequate response to a biologic (b)DMARD compared with placebo (PBO).3In addition, patients experienced significant improvements in HAQ-DI at week (W)12 and W24 with FIL 100 mg (p <0.001, p = 0.003) or 200 mg (p <0.001 for both) compared with PBO.3Objectives:To evaluate the rate and magnitude of change in patient-reported outcomes (PROs) from FINCH 2 assessing pain, HRQoL, and fatigue.Methods:Patients in this double-blind, randomised study (NCT02873936) received FIL 200 mg, FIL 100 mg, or PBO while continuing csDMARD therapy. PROs were collected prospectively on day 1 and at the W2, W4, W8, W12, W14, W16, W20, and W24 visits for assessment of pain (VAS pain scale) and on day 1 and at W4, W12, and W24 for assessment of fatigue (FACIT-Fatigue) and HRQoL (SF-36). Changes from baseline for each PRO at each time point up to W24 were analysed longitudinally using a mixed-effects model for repeated measures. P values for the difference between each FIL arm and PBO at each time point were calculated.Results:Among the 448 patients randomised and treated (FIL 200 mg, n = 147; FIL 100 mg, n = 153; PBO, n = 148) 381 (85.0%) completed the study. Baseline mean (SD) VAS pain scale was 67 (21.0), SF-36 physical component summary (PCS) was 31.1 (7.89), SF-36 mental component summary (MCS) was 44.3 (11.6), and FACIT-Fatigue score was 24.4 (11.6); baseline values did not vary between treatment groups. Significantly greater improvements in VAS pain scores began at W2 and were maintained through W24 for patients who received either dose of FIL vs PBO (Fig 1A). FIL also significantly improved patients’ fatigue at W4, W12, and W24 compared with PBO for those receiving 200 mg doses, and at W4 and W12 for those receiving 100 mg doses (Fig 1B). HRQoL related to physical functioning (SF-36 PCS) was significantly enhanced at W4, W12, and W24 with both doses of FIL as compared with PBO (Fig 2A). Improvements to mental-health-related QoL (SF-36 MCS) were reported for FIL as early as W4 and maintained through W24, with statistically significant improvements at W4 and W12 for FIL 200 mg vs PBO (Fig 2B).Conclusion:In a patient population with refractory disease that had inadequate response to prior bDMARDs and had significant disease at baseline, FIL treatment—coadministered with csDMARD therapy—was able to provide rapid and sustained improvements in key measures of pain, HRQoL, and fatigue as reported by patients.References:[1]Smolen, et al.Ann Rheum Dis. 2017;76:960–77.[2]Fautrel, et al.Rheumatol Int.2018;38:935–47.[3]Genovese, et al.JAMA. 2019;322(4):315–25.Disclosure of Interests:David Walker Grant/research support from: Gilead, Consultant of: Gilead, Lilly, Pfizer, Roche, Speakers bureau: Lilly, Pfizer, Roche, Tsutomu Takeuchi Grant/research support from: AbbVie, Asahikasei Pharma Corp., Astellas Pharma, Inc., Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Mitsubishi-Tanabe Pharma Corp., Nipponkayaku Co. Ltd., Shionogi & Co., Ltd., Takeda Pharmaceutical Co., Ltd., UCB Japan, Consultant of: Astellas Pharma, Inc., Chugai Pharmaceutical Co, Ltd., Eli Lilly Japan,, Speakers bureau: Abbvie, AYUMI Pharmaceutical Corp., Bristol-Myers Squibb, Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan, Gilead Sciences, Inc., Mitsubishi-Tanabe Pharma Corp., Novartis Pharma K.K., Pfizer Japan Inc., Sanofi K.K., Dainippon Sumitomo Co., Ltd, Beatrix Bartok Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Shangbang Rao Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., I-Heng Lee Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Robin Besuyen Shareholder of: Galapagos, Employee of: Galapagos, Jacques-Eric Gottenberg Grant/research support from: BMS, Pfizer, Consultant of: BMS, Sanofi-Genzyme, UCB, Speakers bureau: Abbvie, Eli Lilly and Co., Roche, Sanofi-Genzyme, UCB, Mark C. Genovese Grant/research support from: Abbvie, Eli Lilly and Company, EMD Merck Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, Pfizer Inc., RPharm, Sanofi Genzyme, Consultant of: Abbvie, Eli Lilly and Company, EMD Merck Serono, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, RPharm, Sanofi Genzyme

scholarly journals FRI0128 FILGOTINIB PROVIDED RAPID AND SUSTAINED IMPROVEMENTS IN FUNCTIONAL STATUS, PAIN, HEALTH-RELATED QUALITY OF LIFE, AND FATIGUE IN PATIENTS WITH RHEUMATOID ARTHRITIS AND INADEQUATE RESPONSE TO METHOTREXATE: RESULTS FROM THE FINCH 1 STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 645.2-646
Author(s):  
A. Kivitz ◽  
Y. Tanaka ◽  
S. Lee ◽  
L. Ye ◽  
H. Hu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Pain Scale ◽  
Inadequate Response ◽  
Health Related Quality ◽  
Research Support ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
Time Point

Background:In the FINCH 1 study, filgotinib (FIL)—an oral, potent, selective Janus kinase 1 inhibitor—in combination with methotrexate (MTX) provided significant improvements in the signs and symptoms of rheumatoid arthritis (RA) in patients (pts) with inadequate response to MTX.1While EULAR guidelines recommend a treat-to-target approach focusing on reducing inflammation to prevent joint damage, physical disability, and mortality, pts consider control of pain and fatigue, along with maintenance of physical function and health-related quality of life (HRQoL), to be important aspects for their care.2,3Objectives:To evaluate the rate and magnitude of change in patient-reported outcomes (PROs) from FINCH 1.Methods:In the FINCH 1 study (NCT02889796), pts with active RA received oral FIL 200 mg + MTX, FIL 100 mg + MTX, PBO + MTX, or subcutaneous adalimumab (ADA) 40 mg + MTX for up to 52 weeks (W); pts receiving PBO at W24 were rerandomised 1:1 to FIL 100 or 200 mg. PROs included the HAQ-DI and VAS pain scale, SF-36, and FACIT-Fatigue questionnaire. The change from baseline (CFB) at each time point was assessed up to W52 for each treatment group. The mixed-effects model for repeated measures was used to compare each FIL group with PBO for the CFB at each time point through W24. The logistic regression model was used to compare each FIL group with PBO for the proportion of pts achieving the minimum clinically important difference (MCID) of ≥0.22 reduction in CFB in HAQ-DI at each time point through W24.Results:Of 1755 pts randomised and treated (475 FIL 200 mg + MTX; 480 FIL 100 mg + MTX; 325 ADA + MTX; and 475 PBO + MTX), 1417 (80.7%) received study drug through W52. As early as W2 through W24, pts receiving either dose of FIL experienced nominally significantly greater (p <0.001) CFB in HAQ-DI and VAS pain scale than those receiving PBO; CFB improvements were maintained through W52 (Fig 1A, B). At W2, compared with PBO (40.2%), a nominally significantly greater proportion of pts achieved the HAQ-DI MCID in both the FIL 200 (52.5%; p <0.001) and 100 mg (46.7%; p = 0.043) groups. This benefit vs PBO was maintained up to W24 and the proportion of pts who achieved a HAQ-DI reduction of ≥0.22 remained ≥75.8% in the FIL 200 mg group and ≥71.5% in the FIL 100 mg group from W12 through W52. FIL provided nominally significantly greater improvement in HRQoL vs PBO at W4 and W12 for both the CFB of the SF-36 Physical Component Summary (PCS) (p <0.001) and Mental Component Summary (MCS) (p ≤0.006); nominal significance was also seen at W24 for CFB of SF-36 PCS (Fig 2A, B). By W4, pts receiving either dose of FIL reported a nominally significantly greater mean CFB in FACIT-Fatigue scores vs PBO (p <0.001); significance was maintained through W24 and improvement in reported fatigue continued through W52 in the FIL groups (Fig 2C). In general, CFB for HAQ-DI, VAS pain scale, and FACIT-Fatigue observed for the FIL groups was higher or comparable to ADA at various time points (Fig 1, 2).Conclusion:Both doses of FIL provided rapid and sustained improvements in functional status, pain, HRQoL, and fatigue compared with PBO for pts with RA and inadequate response to MTX throughout the 52-week period.References:[1]Combe BG, et al.Ann Rheum Dis.2019;78 (Suppl 2):A77.[2]Fautrel B, et al.Rheumatol Int.2018;38:935–47.[3]Smolen JS, et al.Ann Rheum Dis.2017;76:960–77.Disclosure of Interests:Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim,,Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin, Susan Lee Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Lei Ye Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Hao Hu Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Robin Besuyen Shareholder of: Galapagos, Employee of: Galapagos, 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

FRI0115 FILGOTINIB PROVIDED RAPID AND SUSTAINED IMPROVEMENTS IN FUNCTIONAL STATUS, PAIN, AND HEALTH-RELATED QUALITY OF LIFE, AND REDUCED FATIGUE OVER TIME IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO ARE METHOTREXATE-NAÏVE: RESULTS FROM THE FINCH 3 STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 638-639
Author(s):  
R. Alten ◽  
W. Rigby ◽  
A. Pechonkina ◽  
Z. Yin ◽  
K. Hasegawa ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Functional Status ◽  
Health Related Quality ◽  
Research Support ◽  
P Values ◽  
Chugai Pharmaceutical ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Background:In the FINCH 3 study, filgotinib (FIL)—a potent, selective, oral small molecule Janus kinase 1 inhibitor1—in combination with methotrexate (MTX), demonstrated significant improvements in the signs and symptoms of rheumatoid arthritis (RA) vs MTX alone in patients (pts) who were MTX-naïve.2For pts with RA, rapid control of pain and fatigue along with maintenance of physical function and health-related quality of life (HRQoL) are important outcomes of their care.3Thus, patient-reported outcomes (PROs) can provide physicians with evidence to guide treatment decisions beyond the guideline-recommended treatment targets of reducing immune inflammation to prevent joint damage, physical disability, and mortality.4Objectives:To evaluate the rate and magnitude of change in PROs assessing functional status, pain, HRQoL, and fatigue from FINCH 3.Methods:In the FINCH 3 study (NCT02886728), pts with active RA who were MTX-naïve received FIL 200 mg daily + MTX, FIL 100 mg + MTX, FIL 200 mg (+ placebo [PBO]), or MTX (+ PBO) for up to 52 weeks. PROs were recorded prospectively and included HAQ-DI (functional status) and VAS pain scale (day 1, week [W]2, W4, W8, W12, W16, W20, W24, W30, W36, W44, W52), SF-36 (HRQoL), and FACIT-Fatigue (day 1, W4, W12, W24, W36, W52). The least squares mean of the change from baseline (CFB) at each time point up to W52 and p values (each FIL arm vs MTX) were analysed using a mixed-effects model for repeated measures. For HAQ-DI, the proportion of pts who achieved the minimum clinically important difference (MCID; reduction ≥0.22) between each FIL arm and MTX was analysed using logistic regression analysis. P values for the comparisons of PROs were not adjusted for multiplicity, except for HAQ-DI CFB at W24 for FIL 200 mg + MTX and FIL 100 mg + MTX vs MTX.Results:Of the 1249 pts randomised and treated (FIL 200 mg + MTX, n = 416; FIL 100 mg + MTX, n = 207; FIL 200 mg, n = 210; MTX, n = 416), 1025 (82.1%) completed the study. Compared with MTX alone, a nominally significantly greater CFB in functional status and pain from W2 to W24 was observed in all FIL arms; the benefit was sustained from W30 to W52 (Fig 1). By W2, a nominally significantly greater proportion of pts achieved the HAQ-DI MCID or greater (≥0.22) in all FIL arms (FIL 200 mg + MTX: 61.9%, p <0.001; FIL 100 mg + MTX: 58.5%, p <0.001; FIL 200 mg: 53.9%, p = 0.004) compared with MTX (42.2%). By W8, ≥72% of pts in all FIL arms vs 63% of pts in the MTX arm achieved the HAQ-DI MCID; a numerically greater proportion of pts in FIL arms vs MTX achieved HAQ-DI MCID through W52. SF-36 physical component summary and FACIT-Fatigue scores were nominally significantly improved with FIL treatment vs MTX alone at various time points (Fig 2A, B). Improvements in SF-36 mental component summary scores were nominally significant for pts in all FIL arms vs MTX alone as early as W4, and the CFB reached at W12 for FIL arms was generally sustained up to W52 (Fig 2A).Conclusion:For pts with moderate to severe RA who were MTX-naïve, FIL—with or without concomitant MTX—led to more rapid and sustained improvements in functional status, pain, fatigue, and HRQoL, compared with MTX alone.References:[1]Van Rompaey, et al.J Immunol. 2013;131:3568–77.[2]Westhovens, et al.Arthritis Rheumatol. 2019;71 (suppl 10):1606–8.[3]Fautrel B, et al.Rheumatol Int.2018;38:935–47.[4]Smolen JS, et al.Ann Rheum Dis.2017;76:960–77.Disclosure of Interests:Rieke Alten Grant/research support from: Pfizer, Galapagos, Galapagos NV, Gilead, Gilead Sciences, Inc., Novartis, Consultant of: Pfizer, Speakers bureau: Pfizer, William Rigby Consultant of: Gilead Sciences, Inc., Alena Pechonkina Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Zhaoyu Yin Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Ken Hasegawa Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Thijs Hendrikx Shareholder of: Galapagos (share/warrant holder), Employee of: Galapagos, Tatsuya Atsumi Grant/research support from: Eli Lily Japan K.K., Alexion Pharmaceuticals, Inc., Bristol-Myers Squibb Co., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Astellas Pharma Inc., Consultant of: Gilead Sciences, Inc., Eli Lilly Japan K.K., UCB Japan Co. Ltd., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Speakers bureau: Eli Lilly Japan K.K., UCB Japan Co. Ltd., Bristol-Myers Squibb Co., AbbVie Inc., Eisai Co. Ltd., Otsuka Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Takeda Pharmaceutical Co., Ltd., Astellas Pharma Inc., Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead

scholarly journals FRI0592 IMPACT OF INDIVIDUAL SYMPTOMS OF PSORIATIC ARTHRITIS ON PHYSICAL COMPONENT SCORE AND MENTAL COMPONENT SCORE OF SF-36 AS A MEASURE OF HEALTH RELATED QUALITY OF LIFE (QOL): AN OBSERVATIONAL COHORT STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 901.1-902
Author(s):  
M. Skougaard ◽  
T. Schjødt Jørgensen ◽  
M. J. Jensen ◽  
C. Ballegaard ◽  
J. Guldberg-Møller ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Advisory Board ◽  
Health Related Quality ◽  
Research Support ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Background:Patients with Psoriatic Arthritis (PsA) experience diverse symptoms including skin and nail psoriasis, swollen and tender joints, enthesitis, and fatigue that have shown to impair health related quality of life (QoL). We hypothesized that different elements of disease influence SF-36 physical (PCS) and mental (MCS) component summary scores differently.Objectives:The objective of the study was to assess the interaction between change in disease activity (DAS28CRP), PsA symptoms (psoriasis [PsO], nail PsO, enthesitis, fatigue, pain, and physical function) with changes in PCS and MCS scores in a PsA patient cohort exploring effect of treatment on clinical manifestations and patient-reported outcome (PRO).Methods:Data were obtained from the PIPA cohort (1) at baseline and after 4 months of treatment. Patients’ characteristics were described as medians with interquartile ranges (IQRs) and numbers with percentages. Data were presented as changes between baseline and follow-up with delta (Δ) values on xyz-plots. Associations between PCS and MCS scores, DAS28CRP, and PsA symptoms were described with fitted linear regression plane models. PCS and MCS were derived from 8 domains of SF-36 and ranged from 0-100 with lower values reflecting more impaired QoL.Results:71 PsA patients were included in the study. 40 (56%) patients were female with a mean age of 50 (IQR 41-60) years and disease duration of 2.15 (IQR 0.2-9) years. Figure 1 shows associations between PsA symptoms, DAS28CRP, and PCS (green regression plane) and MCS (blue regression plane). For all PROs; pain, fatigue and physical function, improvements in both ΔPCS and Δ MCS scores were associated with improvements in either Δpain, ΔPsAID fatigue, and/or ΔHAQ, and to a larger extent than improvements in ΔDAS28CRP. Improvements in Δnail PsO (regression coefficient (RC): -0.22) and ΔPASI (RC: -0.31) positively impacts ΔMCS, without a clear association in PCS scores (RC: 0.13 and 0.38 for Δnail PsO and ΔPASI, respectively). Improvement in inflammatory features SPARCC enthesitis and DAS28CRP showed improvement in both ΔPCS and ΔMCS.Figure 1.Association between disease activity, individual symptoms and PCS/MCS PCS; physical component summary (green regression plane), MCS; mental component summary (blue regression plane). Arrows indicate the positive improvement vector. SF-36: short form-36, CI: Confidence Interval, DAS28CRP: disease activity score with 28 joints and c-reactive protein, PASI: Psoriasis Area Severity Index, SPARCC: Spondyloarthritis Research Consortium of Canada enthesitis index, VAS: visual analogue scale, PsAID: Psoriatic Arthritis Impact of Disease, HAQ: Health Assessment QuestionnaireConclusion:Pain and fatigue are well-known factors to impair QoL in PsA patient. Here we show that diminishing these factors, pain and fatigue, improved both PCS and MCS scores more than changes in DAS28CRP. Improvements in skin and nail manifestations impacted MCS scores and are as important as changes in joint manifestations which affect PCS and MCS scores equally.References:[1] Hojgaard P et al. Pain mechanisms and ultrasonic inflammatory activity as prognostic factors in patients with psoriatic arthritis (…) BMJ Open. 20Disclosure of Interests:Marie Skougaard: None declared, Tanja Schjødt Jørgensen Speakers bureau: Abbvie, Pfizer, Roche, Novartis, UCB, Biogen, and Eli Lilly, Mia Joranger Jensen: None declared, Christine Ballegaard: None declared, Jørgen Guldberg-Møller Speakers bureau: Novartis, Ely Lilly, AbbVie, BK Ultrasound, Alexander Egeberg Grant/research support from: Pfizer, Eli Lilly, Novartis, AbbVie, Janssen Pharmaceuticals, the Danish National Psoriasis Foundation and the Kgl Hofbundtmager Aage Bang Foundation, Consultant of: UCB Pharma (Advisory Board), Speakers bureau: AbbVie, Almirall, Leo Pharma, Samsung Bioepis Co. Ltd., Pfizer, Eli Lilly, Novartis, Galderma, Dermavant, UCB Pharma, Mylan, Bristol-Myers Squibb and Janssen Pharmaceuticals, Robin Christensen: None declared, Joseph F. Merola Consultant of: Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB Pharma, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and LEO Pharma, Laura C Coates: 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, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Lars Erik Kristensen Consultant of: UCB Pharma (Advisory Board), Sannofi (Advisory Board), Abbvie (Advisory Board), Biogen (Advisory Board), Speakers bureau: AbbVie, Amgen, Biogen, Bristol-Myers Squibb,Celgene, Eli Lilly, Gilead, Forward Pharma, Janssen Pharmaceuticals, MSD, Novartis, Pfizer, and UCB Pharma

scholarly journals Neutral theory: applicability and neutrality of using generic health-related quality of life tools in diseases or conditions where specific tools are available

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ravi Jandhyala
Keyword(s):  
Rare Disease ◽  
Neutral Theory ◽  
Health Related Quality ◽  
Poor Hrqol ◽  
Sf 36 ◽  
Disease Condition ◽  
Related Quality ◽  
Health Related ◽  
Sensitivity Specificity

Abstract Background Health-related quality of life (HRQoL) tools are limited by the indicators included in the construct and variation in interpretation by different researchers. Neutral Theory describes the ideal construct that includes all relevant indicators and, therefore, complete accuracy, or neutrality. Neutral Theory can thereby provide the framework to develop or test constructs. To assess the application of Neutral Theory, the neutrality of generic tools (SF-36 and EQ-5D) at measuring HRQoL was compared to disease/condition-specific tools, with the latter considered surrogates for the Neutral construct. Methods Full descriptions of all disease/condition-specific HRQoL tools published on PubMed (to 01-Jul-19) were sourced. For each tool, the number of items with and without a direct match within the SF-36 and EQ-5D was recorded and the sensitivity/specificity calculated. Results The SF-36 and EQ-5D did not achieve a sensitivity/specificity both > 50% against any of the 163 disease/condition-specific tools identified. At 20% prevalence of poor HRQoL, the false positive rate (FPR) was > 75% for all but two tools against the SF-36 and six tools against the EQ-5D. Increasing poor HRQoL to 80%, 47 tools for the SF-36 and 48 tools for the EQ-5D had a FPR < 50%. For rare disease tools (< 1/2000 population; n = 17), sensitivity/specificity ranged from 0 to 40%/5–31% for the SF-36 and 0–22%/29–100% for the EQ-5D. For non-rare (n = 75) and symptom-specific tools (n = 71) sensitivity/specificity was: 0–100%/0–100% (SF-36) and 0–50%/0–100% (EQ-5D); and 0–60%/0–19% (SF-36) and 0–25%/0–100% (EQ-5D), respectively. No concordance was recorded for 18% (2/11) of results from studies of rare disease tools versus the SF-36 (no data vs EQ-5D). For non-rare, disease-specific tools, results were discordant for 30% (25/84) and 35% (23/65) of studies against the SF-36 and EQ-5D, respectively. For symptom-specific tools, corresponding results were 36% (24/66) and 16% (5/31). Conclusions Generic HRQoL tools appear poorly correlated with disease/condition-specific tools, which indicates that adoption of Neutral Theory in the development and assessment of HRQoL tools could improve their relevance, accuracy, and utility in economic evaluations of health interventions.

scholarly journals Health-related quality of life in ICU survivors—10 years later

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
José G. M. Hofhuis ◽  
Augustinus J. P. Schrijvers ◽  
Tjard Schermer ◽  
Peter E. Spronk
Keyword(s):  
Effect Size ◽  
Reference Population ◽  
Health Related Quality ◽  
Sf 36 ◽  
Icu Discharge ◽  
Related Quality ◽  
Health Related ◽  
Surgical Icu

AbstractMany Intensive Care (ICU) survivors experience long lasting impairments in physical and psychological health as well as social functioning. The objective of our study was to evaluate these effects up to 10 years after ICU discharge. We performed a long-term prospective cohort study in patients admitted for longer than 48 h in a medical-surgical ICU. We evaluated health-related quality of life (HRQOL) before ICU admission using the Short-form-36 (SF-36), at ICU discharge, at hospital discharge and at 1, 2, 5 and 10 years follow up (all by patients). Changes in HRQOL were assessed based on linear mixed modeling. We included a total of 749 patients (from 2000 to 2008). During 10 years 475 (63.4%) patients had died, 125 (16.7%) patients were lost to follow up and 149 (19.9%) patients could be evaluated. The mean scores of four HRQOL dimensions (i.e., physical functioning (p < 0.001; mean 54, SD 32, effect size 0.77, 95% CI [0.54–1.0]), role-physical (p < 0.001; mean 44, SD 47, effect size 0.65, 95% CI [0.41–0.68] general health (p < 0.001; mean 52, SD 27, effect size 0.48; 95% CI 0.25–0.71) and social functioning (p < 0.001; mean 72, SD 32, effect size 0.41, 95% CI [0.19–0.64]) were still lower 10 years after ICU discharge compared with pre-admission levels (n = 149) and with an age reference population. Almost all SF-36 dimensions changed significantly over time from ICU discharge up to 10 years after ICU discharge. Over the 10 year follow up physical functioning of medical-surgical ICU survivors remains impaired compared with their pre-admission values and an age reference population. However, effect sizes showed no significant differences suggesting that surviving patients largely regained their age-specific HRQOL at 10 years.

scholarly journals Impact of malnutrition on health-related quality of life in persons receiving dialysis: a prospective study

2021 ◽  
pp. 1-24
Author(s):  
Daniela Viramontes-Hörner ◽  
Zoe Pittman ◽  
Nicholas M Selby ◽  
Maarten W Taal
Keyword(s):  
Quality Of Life ◽  
Prospective Study ◽  
Health Related Quality ◽  
Poor Hrqol ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
The Impact ◽  
Over Time

Abstract Health-related quality of life (HRQoL) is severely impaired in persons receiving dialysis. Malnutrition has been associated with some measures of poor HRQoL in cross-sectional analyses in dialysis populations, but no studies have assessed the impact of malnutrition and dietary intake on change in multiple measures of HRQoL over time. We investigated the most important determinants of poor HRQoL and the predictors of change in HRQoL over time using several measures of HRQoL. We enrolled 119 haemodialysis and 31 peritoneal dialysis patients in this prospective study. Nutritional assessments (Subjective Global Assessment [SGA], anthropometry and 24-hour dietary recalls) and HRQoL questionnaires (Short Form-36 [SF-36] mental [MCS] and physical component scores [PCS] and European QoL-5 Dimensions [EQ5D] health state [HSS] and visual analogue scores [VAS]) were performed at baseline, 6 and 12 months. Mean age was 64(14) years. Malnutrition was present in 37% of the population. At baseline, malnutrition assessed by SGA was the only factor independently (and negatively) associated with all four measures of HRQoL. No single factor was independently associated with decrease in all measures of HRQoL over 1 year. However, prevalence/development of malnutrition over one year was an independent predictor of 1-year decrease in EQ5D HSS and 1-year decrease in fat intake independently predicted the 1-year decline in SF-36 MCS and PCS, and EQ5D VAS. These findings strengthen the importance of monitoring for malnutrition and providing nutritional advice to all persons on dialysis. Future studies are needed to evaluate the impact of nutritional interventions on HRQoL and other long-term outcomes.

scholarly journals Effect of multimorbidity patterns on the decline in health-related quality of life: a nationwide prospective cohort study in Japan

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047812
Author(s):  
Takuya Aoki ◽  
Shunichi Fukuhara ◽  
Yasuki Fujinuma ◽  
Yosuke Yamamoto
Keyword(s):  
Quality Of Life ◽  
Cohort Study ◽  
Clinical Outcomes ◽  
Prospective Cohort ◽  
Summary Score ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

ObjectivesLongitudinal studies, which consider multimorbidity patterns, are useful for better clarifying the effect of multimorbidity on health-related quality of life (HRQoL) and for identifying the target population with poorer clinical outcomes among patients with multimorbidity. This study aimed to examine the effects of different multimorbidity patterns on the decline in HRQoL.DesignNationwide prospective cohort study.SettingJapanese adult residents.ParticipantsResidents aged ≥50 years selected by the quota sampling method.Primary outcome measureClinically relevant decline in HRQoL was defined as a 0.50 SD (5-point) decrease in the 36-Item Short Form Health Survey (SF-36) component summary scores for 1 year.ResultsIn total, 1211 participants completed the follow-up survey. Among the multimorbidity patterns identified using confirmatory factor analysis, multivariable logistic regression analyses revealed that high cardiovascular/renal/metabolic and malignant/digestive/urologic pattern scores were significantly associated with the clinically relevant decline in SF-36 physical component summary score (adjusted OR (aOR)=1.25, 95% CI: 1.08 to 1.44 and aOR=1.28, 95% CI: 1.04 to 1.58, respectively). High cardiovascular/renal/metabolic pattern score was also significantly associated with the clinically relevant decline in SF-36 role/social component summary score (aOR=1.23, 95% CI: 1.06 to 1.42).ConclusionsOur study revealed that multimorbidity patterns have different effects on the clinically relevant decline in HRQoL for 1 year. These findings can be useful in identifying populations at high risk and with poor clinical outcomes among patients with chronic diseases and multimorbidity for efficient resource allocation.

Factors Affecting Health-Related Quality of Life After the Arterial Switch Operation

2021 ◽  
Vol 12 (3) ◽  
pp. 344-351
Author(s):  
Julie Cleuziou ◽  
Anna-Katharina Huber ◽  
Martina Strbad ◽  
Masamichi Ono ◽  
Alfred Hager ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Short Form ◽  
Arterial Switch Operation ◽  
Health Related Quality ◽  
Switch Operation ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
Cardiac Medication

Background: Long-term morbidity and mortality outcomes of the arterial switch operation (ASO) in patients with transposition of the great arteries and Taussig-Bing anomaly are excellent. With an increasing number of patients reaching adolescence and adulthood, more attention is directed toward quality of life. Our study aimed to determine the health-related quality of life (hrQoL) outcomes in patients after the ASO and identify factors influencing their hrQoL. Methods: In this cross-sectional study, hrQoL of patients after ASO was assessed with the German version of the Short Form-36 (SF-36) and the potential association of specified clinical factors was analyzed. Patients of at least 14 years of age who underwent ASO in our institution from 1983 were considered eligible. Results: Of the 355 questionnaires sent to eligible patients, 261 (73%) were available for analysis. Compared to the reference population, patients who had undergone ASO had a significantly higher score in all subscales of the SF-36 except for vitality ( P < .01). Patients with an implanted pacemaker ( P = .002), patients who required at least one reoperation ( P < .001), and patients currently taking cardiac medication ( P < .004) or oral anticoagulation ( P = .036) had lower physical component scores compared to patients without these factors. Conclusions: Patients’ self-assessed and self-reported hrQoL after ASO (using German version of the Short Form 36) is very good. In this population, hrQoL is influenced by reoperation, the need for a pacemaker, and current cardiac medication or anticoagulant use. The development of strategies designed to mitigate or minimize the requirements for, and/or impact of these factors may lead to better hrQoL in this patient population.

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