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 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

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

The Effect of Intravenous Golimumab on Health-related Quality of Life in Rheumatoid Arthritis: 24-week Results of the Phase III GO-FURTHER Trial

2014 ◽  
Vol 41 (6) ◽  
pp. 1067-1076 ◽  
Author(s):  
Clifton O. Bingham ◽  
Michael Weinblatt ◽  
Chenglong Han ◽  
Timothy A. Gathany ◽  
Lilianne Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Physical Function ◽  
Phase Iii ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related ◽  
Disease Effect

Objective.To evaluate the effects of intravenous (IV) golimumab 2 mg/kg + methotrexate (MTX) on patient-reported measures of health-related quality of life (HRQOL) in patients with active rheumatoid arthritis (RA) despite prior MTX therapy.Methods.In this randomized, multicenter, double-blind, placebo-controlled, phase III trial, adults with RA were randomly assigned to receive IV placebo (n = 197) or golimumab 2 mg/kg (n = 395) infusions at Week 0, Week 4, and every 8 weeks thereafter. All patients continued stable oral MTX (15–25 mg/wk). HRQOL assessments included Health Assessment Questionnaire-Disability Index (HAQ-DI; physical function), Medical Outcomes Study Short Form-36 questionnaire physical/mental component summary (SF-36 PCS/MCS) scores, EQ-5D assessment of current health state, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire, and disease effect on productivity [10-cm visual analog scale (VAS)].Results.Mean HAQ-DI improvements from baseline were significantly greater with golimumab + MTX than placebo + MTX at Week 14 and Week 24 (p < 0.001). Significantly greater improvements in all 8 individual SF-36 subscores and both the SF-36 PCS and MCS scores (p < 0.001) also accompanied golimumab + MTX therapy. Improved EQ-5D and EQ-5D VAS (p < 0.001) and FACIT-Fatigue (p < 0.001) scores were also observed for golimumab + MTX-treated patients at Week 12, Week 16, and Week 24, and greater proportions of golimumab + MTX-treated patients had clinically meaningful improvements in these measures. Greater reductions in disease effect on productivity were observed with golimumab + MTX versus placebo + MTX at Week 24 (p < 0.001). Improvements in physical function, HRQOL, fatigue, and productivity significantly correlated with disease activity improvement.Conclusion.In active RA, IV golimumab + MTX significantly improved physical function, HRQOL, fatigue, and productivity using multiple measurement tools; all correlated with improvements in disease activity (NCT00973479, EudraCT 2008-006064-11).

scholarly journals Health-related Quality of Life Outcomes of Adalimumab for Patients with Early Rheumatoid Arthritis: Results from a Randomized Multicenter Study

2011 ◽  
Vol 39 (1) ◽  
pp. 63-72 ◽  
Author(s):  
VIBEKE STRAND ◽  
ANNE M. RENTZ ◽  
MARY A. CIFALDI ◽  
NAIJUN CHEN ◽  
SANJOY ROY ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Short Form ◽  
Health Related Quality ◽  
Link Type ◽  
Early Ra ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Objective.Rheumatoid arthritis (RA) is associated with significant impairments in health-related quality of life (HRQOL). We evaluated patient-reported outcomes including HRQOL outcomes following adalimumab plus methotrexate (MTX) therapy in patients with early RA.Methods.PREMIER was a phase III, multicenter, randomized, double-blind, active-comparator clinical trial in early RA. Patients aged ≥ 18 years were randomly assigned to receive adalimumab 40 mg every other week (eow) plus weekly MTX, weekly MTX, or adalimumab 40 mg eow for 104 weeks. American College of Rheumatology (ACR) criteria were used to evaluate clinical efficacy and response. Outcomes were assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), Short-Form 36 Health Survey (SF-36), Short-Form 6 Dimension (SF-6D), visual analog scale (VAS) assessments of global disease activity (patient’s global assessment; PtGA) and pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Health Utility Index Mark 3 (HUI-3).Results.Of 799 patients enrolled, 268 received adalimumab plus MTX, 257 received MTX monotherapy, and 274 received adalimumab monotherapy. Patients treated with adalimumab plus MTX demonstrated significant baseline to Week 104 improvements in HAQ-DI (p < 0.0001), SF-36 Physical Component Summary (p < 0.0001), 4 SF-36 domains [physical function (p < 0.0001), bodily pain (p <0.0001), vitality (p = 0.0139), role limitations-physical (p = 0.0005)], SF-6D (p = 0.0152), VAS-PtGA (p < 0.0001), VAS-pain (p < 0.0001), FACIT-F (p < 0.0001), and HUI-3 (p = 0.0034) scores versus patients treated with MTX monotherapy. Both SF-6D and HUI-3 were found to be sensitive preference-based measures for assessing the effects of treatment on multidimensional function. No clinically meaningful differences between adalimumab and MTX monotherapy groups were observed for most measures. For each measure, there was significant association between HRQOL improvement and ACR clinical response.Conclusion.Adalimumab plus MTX significantly improved physical functioning and HRQOL in patients with early RA over 2 years of treatment. (ClinicalTrials.gov identifier NCT00195663).

scholarly journals Performance of the Dutch SF-36 version 2 as a measure of health-related quality of life in patients with rheumatoid arthritis

2013 ◽  
Vol 11 (1) ◽  
pp. 77 ◽  
Author(s):  
Peter M ten Klooster ◽  
Harald E Vonkeman ◽  
Erik Taal ◽  
Liseth Siemons ◽  
Lidy Hendriks ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

scholarly journals High levels of interleukin-6 in patients with rheumatoid arthritis are associated with greater improvements in health-related quality of life for sarilumab compared with adalimumab

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Vibeke Strand ◽  
Susan H. Boklage ◽  
Toshio Kimura ◽  
Florence Joly ◽  
Anita Boyapati ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Physical Functioning ◽  
Interleukin 6 ◽  
Phase Iii ◽  
Health Related Quality ◽  
Sf 36 ◽  
Related Quality ◽  
Health Related

Abstract Background Increased levels of cytokines, including interleukin-6 (IL-6), reflect inflammation and have been shown to be predictive of therapeutic responses, fatigue, pain, and depression in patients with rheumatoid arthritis (RA), but limited data exist on associations between IL-6 levels and health-related quality of life (HRQoL). This post hoc analysis of MONARCH phase III randomized controlled trial data evaluated the potential of baseline IL-6 levels to differentially predict HRQoL improvements with sarilumab, a fully human monoclonal antibody directed against both soluble and membrane-bound IL-6 receptor α (anti-IL-6Rα) versus adalimumab, a tumor necrosis factor α inhibitor, both approved for treatment of active RA. Methods Baseline serum IL-6 levels in 300/369 randomized patients were categorized into low (1.6–7.1 pg/mL), medium (7.2–39.5 pg/mL), and high (39.6–692.3 pg/mL) tertiles. HRQoL was measured at baseline and week (W)24 and W52 by Short Form 36 (SF-36) physical/mental component summary (PCS/MCS) and domain scores, Functional Assessment of Chronic Illness Therapy -fatigue, and duration of morning stiffness visual analog scale (AM-stiffness VAS). Linear regression of changes from baseline in HRQoL (IL-6 tertile, treatment, region as a stratification factor, and IL-6 tertile-by-treatment interaction as fixed effects) assessed predictivity of baseline IL-6 levels, with low tertile as reference. Pairwise comparisons of improvements between treatment groups were performed by tertile; least squares mean differences and 95% CIs were calculated. Similar analyses evaluated W24 patient-level response on minimum clinically important differences (MCID). Results At baseline, patients with high versus medium or low IL-6 levels (n = 100, respectively) reported worse (nominal p < 0.05) SF-36 MCS and role-physical, bodily pain, social functioning, role-emotional domain, and AM-stiffness VAS scores. There was a greater treatment effect with sarilumab versus adalimumab in high tertile versus low tertile groups in SF-36 PCS, physical functioning domain, and AM-stiffness VAS (nominal interaction p < 0.05). PCS improvements ≥MCID were higher in high (odds ratio [OR] 6.31 [2.37, 16.81]) versus low (OR 0.97 [0.43, 2.16]) tertiles with sarilumab versus adalimumab (nominal interaction p < 0.05). Adverse events between IL-6 tertiles were similar. Conclusions Patients with high baseline IL-6 levels reported better improvements in PCS, physical functioning domain, and AM-stiffness scores with sarilumab versus adalimumab and safety consistent with IL-6R blockade. Trial registration NCT02332590. Registered on 5 January 2015

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

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