scholarly journals POS1045 Ixekizumab efficacy on spinal pain, disease activity and quality of life in patients with psoriatic arthritis presenting with symptoms suggestive of axial involvement

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 798-799
Author(s):  
A. Deodhar ◽  
D. D. Gladman ◽  
R. Bolce ◽  
D. Sandoval ◽  
S. Y. Park ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Sensitivity Analysis ◽  
Disease Activity ◽  
Research Support ◽  
Sf 36 ◽  
Axial Symptoms ◽  
Axial Pain ◽  
Baseline Values ◽  
Axial Involvement

Background:Many patients with psoriatic arthritis (PsA) experience back pain and stiffness, which may suggest axial involvement [1]. The prevalence of axial involvement in PsA varies between 25-70% [2]. Ixekizumab (IXE), a monoclonal antibody with high affinity for IL17-A, has been studied in Phase 3 trials in patients with PsA (SPIRIT-P1 [Biologic-naïve; NCT01695239] and SPIRIT-P2 [Inadequate response or intolerant to 1 or 2 TNF inhibitors (TNFi); NCT02349295]) [3] [4].Objectives:To determine the efficacy of IXE up to 52 weeks (Wks) in reducing axial symptoms in patients with active PsA presenting with symptoms suggestive of axial involvement.Methods:This post-hoc analysis included data from two subpopulations of patients with PsA (pooled SPIRIT-P1 and -P2). Symptoms suggestive of axial involvement were defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q2 (back pain) ≥4, and an average of Q5 + Q6 (intensity and duration of morning stiffness in the spine) ≥4 at baseline. Patients included in the sensitivity analysis subgroup 1 were, in addition to the above-mentioned overall analysis criteria, <45 years of age, while patients included in sensitivity analysis subgroup 2 were aged <45 but also had elevated C-reactive protein (CRP) (> 5 mg/l) at baseline. Efficacy of IXE was analysed using BASDAI questions, total BASDAI, mBASDAI (without Q3), and Ankylosing Spondylitis Disease Activity Score (ASDAS) change from baseline, as well as BASDAI50 response and Short-Form-36 physical component summary (SF-36 PCS) improvement, at Wks 16, 24 and 52. Treatment comparison was done using logistic regression for BASDAI50, and analysis of covariance (ANCOVA) model for other endpoints. Missing data for binary and continuous endpoints were imputed by non-responder imputation and modified baseline observation carried forward (mBOCF), respectively.Results:A total of 313 patients (placebo (PBO), N=151; IXE Q4W, N=162) met the overall analysis inclusion criteria. Baseline values for BASDAI and ASDAS related endpoints were balanced across treatment arms (Table 1). Improvement in axial symptoms were significantly greater in patients treated with IXE compared to PBO at Wks 16 and 24 (Figure 1. next page) Improvement in quality of life (QoL) measures (SF-36 PCS) were also significantly greater in patients treated with IXE compared to PBO at Wks 16 and 24 (Table 1). Similar results were observed for patients < 45 years, and in patients < 45 years with CRP > 5 mg/l at baseline (sensitivity analysis, data not shown).Table 1.Baseline values and change from baseline (mBOCF) in the overall analysis population at Wks 16, 24 and 52 for BASDAI and ASDAS related endpoints in patients with PsA and axial pain. Data presented as mean (SD) unless otherwise specified. ‡p<0.001 vs PBO.Conclusion:IXE is effective in reducing axial symptoms and improving QoL in patients with active PsA presenting with symptoms suggestive of axial involvement.References:[1]Yap KS. Ann Rheum Dis. 2018;77(11)[2]Feld J. Nat Rev Rheumatol. 2018;14[3]Orbai A. Clin Exp Rheumatol. 2020[online][4]Genovese MC. Rheumatol. 2018;57(11)Figure 1.Change from baseline (mBOCF) in BASDAI and ASDAS related endpoints in patients with PsA and axial pain in the overall analysis population. Data presented as mean (SD). ‡p<0.001 vs PBO.Acknowledgements:Edel Hughes, an employee of Eli Lilly and Company, provided editorial and writing support.Disclosure of Interests:Atul Deodhar Speakers bureau: Janssen, Novartis, Pfizer, Paid instructor for: Boeheringer Ingelheim, Pfizer, Consultant of: AbbVie, Amgen, Boeheringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Glaxo Smith Kline, Janssen, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Eli Lilly, Glaxo Smith Kline, Novartis, Pfizer, UCB, Dafna D Gladman Consultant of: Abbvie, Amgen, BMS, Galapagos, Gilead, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Grant/research support from: Abbvie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Rebecca Bolce Shareholder of: Employee and shareholder of Eli Lilly and Company, Employee of: Employee and shareholder of Eli Lilly and Company, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Currently employed by Eli Lilly and Company, So Young Park Shareholder of: Eli Lilly & Company, Employee of: Eli Lilly & Company, Soyi Liu Leage Shareholder of: Owns Lilly shares (company producing drug/devices for use in rheumatology), Employee of: Employee of Eli Lilly and Company, Peter Nash Speakers bureau: Honoraria for lectures on behalf Abbvie, BMS, Celgene, Roche, Sanofi, Lilly, Novartis, Janssen, Pfizer, Boehringer, Samsung, Consultant of: Advice on behalf Abbvie, BMS, Celgene, Roche, Sanofi, Lilly, Novartis, Janssen, Pfizer, Boehringer, Samsung, Grant/research support from: Research funding for clinical trials on behalf Abbvie, BMS, Celgene, Roche, Sanofi, Lilly, Novartis, Janssen, Pfizer, Boehringer, Samsung, Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Biocad, Gilead, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Eli Lilly, MSD, Novartis, and Pfizer.

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

Health-Related Quality of Life in Patients with Ankylosing Spondylitis: Relationship with Disease-Related Variables

2020 ◽  
Vol 16 (4) ◽  
pp. 311-318 ◽  
Author(s):  
Gehan Elolemy ◽  
Ahmed Aboughanima ◽  
Sahar Ganeb ◽  
Haytham Elziat
Keyword(s):  
Quality Of Life ◽  
Ankylosing Spondylitis ◽  
Physical Health ◽  
Disease Activity ◽  
Functional Status ◽  
Spinal Mobility ◽  
Peripheral Arthritis ◽  
Radiographic Severity ◽  
Sf 36

Background: Ankylosing spondylitis (AS) is a chronic progressive inflammatory disease leading to functional limitations and subsequently impaired quality of life (QoL). Despite the fact that QoL was recognized as a significant perception, it was excluded from the core domains (defined by the Assessment of Spondyloarthritis International Society), because of ambiguity of measurement choice. Aim: To assess QoL in patients with AS using a generic; Short Form-36 (SF-36) and a diseasespecific; Ankylosing Spondylitis quality of life (ASQoL) instruments and to explore its relationship to the clinical characteristics, disease activity, functional status, and radiographic severity. Methods: A total of 47 AS patients who fulfilled modified New York criteria were included. Disease activity, functional status, spinal mobility, and radiographic severity were assessed by Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Bath AS Metrology Index (BASMI) and Bath AS Radiology Index (BASRI) respectively. SF-36 and ASQoL instruments evaluated Qol. Results: Physical health was more affected especially in patients with peripheral arthritis by SF-36 (p=0.008) and ASQoL (p=0.022) scores. Both SF-36 total and ASQoL scores correlated significantly with BASDAI (r = -0.329, p = 0.024 and r = 0.420, p = 0.003), BASFI (r = -0.399, p = 0.005 and r = 0.513, p=0.001) and BASMI (r = -0.382, p = 0.008 and r = 0.482, p= 0.001) respectively. Conclusion: QoL was impaired in AS patients with highest impact on physical health especially in association with peripheral arthritis. SF-36 and ASQol have a comparable achievement in the evaluation of QoL in AS patients and both physical function and spinal mobility were identified as predictors of poor QoL.

scholarly journals 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

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

scholarly journals POS0919 BIMEKIZUMAB SHOWS SUSTAINED LONG-TERM IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES AND QUALITY OF LIFE IN ANKYLOSING SPONDYLITIS: 3-YEAR RESULTS FROM A PHASE 2B STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 720.2-721
Author(s):  
X. Baraliakos ◽  
M. Dougados ◽  
K. Gaffney ◽  
R. Sengupta ◽  
M. Magrey ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ankylosing Spondylitis ◽  
Patient Reported Outcomes ◽  
Morning Stiffness ◽  
Spinal Pain ◽  
Research Support ◽  
Sf 36 ◽  
Patient Reported ◽  
Full Analysis

Background:Bimekizumab (BKZ), a monoclonal antibody that selectively inhibits interleukin (IL)-17A and IL-17F, has demonstrated clinical efficacy and safety in patients with ankylosing spondylitis (AS) treated over a period up to 96 weeks.1,2Objectives:To report 3-year interim patient-reported outcomes (PROs) in patients with active AS treated with BKZ in a phase 2b dose-ranging study (BE AGILE; NCT02963506) and its open-label extension (OLE; NCT03355573).Methods:BE AGILE study design has been described previously.1 Patients treated with BKZ 160 mg or 320 mg every 4 weeks (Q4W) at Week 48 in BE AGILE were eligible for OLE entry. All OLE patients received BKZ 160 mg Q4W. Outcome measures are reported for the OLE full analysis set (patients who entered the OLE and had ≥1 dose of BKZ and ≥1 valid efficacy variable measurement in the OLE), and include: BASDAI, BASDAI50 responder rate, BASFI, fatigue (BASDAI Q1), morning stiffness (mean of BASDAI Q5 + 6), total spinal pain (numeric rating scale [NRS]), SF-36 PCS and MCS, and ASQoL. Missing data were imputed using multiple imputation (MI; based on the missing at random assumption) for continuous variables and non-responder imputation (NRI) for dichotomous variables.Results:262/303 (86%) patients randomised at BE AGILE study baseline (BL) completed Week 48 on BKZ 160 mg or 320 mg, of whom 255/262 (97%) entered the OLE (full analysis set: 254). From baseline to Week 48 in BE AGILE, BKZ-treated patients showed clinically relevant improvements in disease activity (BASDAI, BASDAI50), physical function (BASFI), fatigue, morning stiffness, spinal pain, and quality of life (SF-36 PCS and MCS, ASQoL) (Figure 1). Group-level improvements in all reported continuous efficacy measures exceeded published minimally important difference (MID), minimum clinically important improvement (MCII), and/or minimum clinically important difference (MCID) thresholds (Figure 1).3,4 Efficacy in all reported outcome measures was maintained or continued to improve from Week 48 to Week 144 or 156 (Figure 1).Conclusion:BKZ treatment was associated with sustained and consistent efficacy in patients with active AS over 3 years, including patient-reported disease activity, physical function, fatigue, morning stiffness, spinal pain, and quality of life.References:[1]van der Heijde D. Ann Rheum Dis 2020;79:595–604.[2]Baraliakos X. Arthritis Rheumatol 2020;72 (suppl 10).[3]Ogdie A. Arthritis Care Res 2020;72 (S10):47–71.[4]Maruish ME. User’s manual for the SF-36v2 Health Survey (3rd ed). 2011; Lincoln, RI: QualityMetric Incorporated.Acknowledgements:This study was funded by UCB Pharma. Editorial services were provided by Costello Medical.Disclosure of Interests:Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Paid instructor for: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, UCB Pharma, Maxime Dougados Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Karl Gaffney Speakers bureau: AbbVie, Eli Lilly, Novartis, UCB Pharma, Consultant of: AbbVie, Eli Lilly, Novartis, UCB Pharma, Grant/research support from: AbbVie, Gilead, Eli Lilly, Novartis, UCB Pharma, Raj Sengupta Speakers bureau: AbbVie, Biogen, Celgene, MSD, Novartis, UCB Pharma, Consultant of: AbbVie, Biogen, Celgene, Eli Lilly, MSD, Novartis, UCB Pharma, Grant/research support from: AbbVie, Celgene, UCB Pharma, Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, UCB Pharma, Natasha de Peyrecave Employee of: UCB Pharma, Marga Oortgiesen Employee of: UCB Pharma, Thomas Vaux Employee of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Valerie Ciaravino Employee of: UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB Pharma

scholarly journals Time in remission and low disease activity state (LDAS) are associated with a better quality of life in patients with systemic lupus erythematosus: results from LUMINA (LXXIX), a multiethnic, multicentre US cohort

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000955 ◽  
Author(s):  
Manuel Francisco Ugarte-Gil ◽  
Guillermo J Pons-Estel ◽  
Luis M Vila ◽  
Gerald McGwin ◽  
Graciela S Alarcón
Keyword(s):  
Quality Of Life ◽  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Short Form ◽  
Systemic Lupus ◽  
Low Disease Activity ◽  
Sf 36 ◽  
Activity State

AimsTo determine whether the proportion of time systemic lupus erythematosus patients achieve remission/low disease activity state (LDAS) is associated with a better quality of life (QoL).Patients and methodsPatients from a well-established multiethnic, multicentre US cohort were included: remission: Systemic Lupus Activity Measure (SLAM) score=0, prednisone≤5 mg/day and no immunosuppressants); LDAS not in remission, SLAM score≤3, prednisone≤7.5 mg/day, no immunosuppressants; the combined proportion of time patients were in these states was the independent variable. The endpoints were the Physical and Mental Components Summary measures (PCS and MCS, respectively) and the individual subscales of the Short Form (SF)-36 at the last visit. Linear regression was used to estimate the association between the proportion of follow-up time in remission/LDAS and the SF-36 measures with and without adjustment for possible confounders.ResultsFour hundred and eighty-three patients were included. The per cent of time on remission/LDAS was associated with better QoL after adjusting for potential confounders; for the PCS the parameter estimate was 9.47 (p<0.0001), for the MCS 5.89 (p=0.0027), and for the subscales they ranged between 7.51 (p=0.0495) for mental health and 31.79 (p<0.0001) for role physical.ConclusionsThe per cent of time lupus patients stay on remission/LDAS is associated with a better QoL as measured by SF-36.

scholarly journals Durability of Stretta Radiofrequency Treatment for GERD: Results of an 8-Year Follow-Up

2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Luca Dughera ◽  
Gianluca Rotondano ◽  
Maria De Cento ◽  
Paola Cassolino ◽  
Fabio Cisarò
Keyword(s):  
Quality Of Life ◽  
Clinical Evaluation ◽  
Upper Endoscopy ◽  
Follow Up Study ◽  
Energy Delivery ◽  
Sf 36 ◽  
Significant Amelioration ◽  
Baseline Values

From June 2002 to March 2013 26 patients that underwent Stretta procedure (16 females, 10 males) reached to date an eight-year follow-up. Primary end point of the study was to verify the durability of the procedure at this time. All patients underwent clinical evaluation by upper endoscopy, oesophageal pressure, and pH studies. For each patient 8-year data were compared to those recorded at baseline and at 4 years. There was a significant decrease in both heartburn and GERD HRQL scores at 4 years (P=0.001) and at 8 years (P=0.003) as well as a significant increase of QoL scores at each control time (mental SF-36 and physical SF-36,P=0.001). After 4 and 8 years, 21 patients (80.7%,P=0.0001) and 20 patients (76.9%,P=0.0001) were completely off PPIs. Median LES pressure did not show significant amelioration at 4 and 8 years and mean oesophageal acid exposure significantly improved at 4 years (P=0.001) but returned to baseline values after 8 years. This further follow-up study of ours from four to eight years confirms that RF energy delivery for GERD provides durable improvement in symptoms and in quality of life and reduces antireflux drugs consumption.

scholarly journals IMPACT OF DIFFERENT LEVELS OF DISEASE ACTIVITY IN PAINFUL PROFILE AND QUALITY OF LIFE IN PEOPLE WITH RHEUMATOID ARTHRITIS

2014 ◽  
Vol 2 (1) ◽  
Author(s):  
Selena Márcia Dubois Mendes ◽  
Bárbara Liliane Lôbo Queiroz ◽  
Larissa Vieira Santana ◽  
Abrahão Fontes Baptista ◽  
Mittermayer Barreto Santiago ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Pain Perception ◽  
Short Form ◽  
Care Service ◽  
Cross Sectional ◽  
Sf 36 ◽  
Different Levels

Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disease with impact on increasing the morbidity and mortality rates. Different levels of disease activity (LDA) have been established, however, its impact on pain and quality of life have yet to be been evidenced. The aim of this study was to evaluate the relationship of different levels of disease activity on the painful profile and quality of life (QOL) of patients diagnosed with RA. This was a cross-sectional study, conducted in RA patients attending an Educational Outpatient Care Service in Salvador, Bahia, Brazil. The LDA was defined according to values of Erythrocyte Sedimentation Rate (ESR), Visual Analog Scale (VAS), and number of swollen and sore joints, according to the Disease Activity Score in 28 joints (DAS28). Types of pain were assessed using the Douleur Neuropathique en 4 questions (DN4). To evaluate QOL, the Short Form (36) Health Survey (SF-36) and Health Assessment Questionnaire (HAQ) were applied. The association between LDA, QOL and painful profile was verified using One Way-ANOVA and Bonferroni correction post-test. A high LAD was observed in 67.7% of the 96 patients  evaluated in this study. Pain sensation was reported by 94.8 % of participants with 40.6 % reporting it as nociceptive and 80.2% as intense. It was also observed that the higher LAD found the higher was the pain intensity reported (p=0.001) and lower QOL scores (p<0.001). Although the LDA did not correlate with the type of pain (p=0.611), it was correlated with the total score obtained in the QOL from the HAQ (p=0.001). The greatest impact on QOL evaluated through the SF-36 were physical (p<0.001) and functional capacity (p<0.001). In conclusion, RA patients who had high LDA reported more severe pain perception and obtained the lowest scores in the assessment of quality of life.

scholarly journals Cost Effectiveness of TNF-αInhibitors in Rheumatoid Arthritis

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Cynthia Said ◽  
Bernard Coleiro ◽  
Maurice Zarb Adami ◽  
Lilian M. Azzopardi ◽  
Anthony Serracino Inglott
Keyword(s):  
Quality Of Life ◽  
Disease Activity ◽  
Surgical Intervention ◽  
Policy Makers ◽  
Dmard Therapy ◽  
Das 28 ◽  
Sf 36 ◽  
The Mean ◽  
Short Timeframe

Background.TNF-αinhibitors have shown to be effective in reducing disease activity and improving the quality of life. Due to the high costs associated with acquisition of this treatment, this study was undertaken to evaluate the ICER of TNF-αantagonists (etanercept, adalimumab, and infliximab) in improving the quality of life.Methods.The HAQ and SF-36 were administered at phases 1, 2, and 3, in order to assess the improvement in the QOL. Suppression of disease activity was assessed through the DAS-28.Results.Statistically significant improvements (P<0.05) were noted for the SF-36 and HAQ after 3 months and for the DAS-28 after 6 months of TNF-αinhibitor therapy. The mean ICER per 10% improvement in the HAQ, DAS-28, and SF-6D were €1976.5, €2086.5, and €2316.4, respectively, following 6 months of TNF-αintervention. Most favorable ICERs were reported from a patient who had to undergo surgical intervention whilst on DMARD therapy.Conclusion.Significant improvement was observed in patients’ quality of life, after a short timeframe of 6 months. Such data is useful information in the light of convincing policy makers, in terms of providing access to the medications to individual patients on national health service schemes.

scholarly journals AB0881-HPR EVALUATION OF NURSING CARE PLANS FOR RHEUMATOID ARTHRITIS PATIENTS: NURSING 2.0 PROJECT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1464.1-1464
Author(s):  
L. Lopez Pedraza ◽  
M. Rodero ◽  
G. Candelas ◽  
C. Lajas ◽  
T. Mulero López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Visual Analog Scale ◽  
Analog Scale ◽  
Research Support ◽  
Face To Face ◽  
Care Plans ◽  
Baseline Visit

Background:A better quality of care for chronic patients is only obtainable through multidisciplinary teams. In recent years, rheumatology nurses have been involved in the remote monitoring of aged Rheumatoid Arthritis (RA) patients, as their high levels of multi-morbidity and disability make routine contacts too complex for patients and caregivers. Nursing health care should be evidence-based and organized to optimize the professionals’ time.Objectives:To develop a pilot study of two Nursing Care Plans (NCP) in Rheumatology consultations for Rheumatoid arthritis patients, exploring the satisfaction, disease activity, adherence and quality of life of the patients.Methods:This is a non-randomised interventional study. All the stablished RA patients attending our clinics were offered one of the care plans, based on clinic characteristics, functional status, social needs, social support, preferences and health literacy. They are focused on three fundamental axes: adaptation, adherence and safety of the patient. We evaluated the two NCP that were created: (1) Elderly established RA face to face/phone visit, (2) Active young established RA face to face/phone visit. The study included a first baseline visit and a second visit at six months. Outcomes were adherence to treatment: using the Morisky Green questionnaire, disease activity; through the erythrocyte sedimentation rate (ESR), patient satisfaction; using the LOPSS questionnaire and quality of life: using the EUROQOL 5D questionnaire, Visual analog scale of the attention received and Visual analog scale of the care received. Final visit were compared to baseline visit in both groups. The paired Wilcoxon or McNemar test were used.Results:We included 48 patients, 16 from the NCP 1 and 32 from the NCP 2. All patients except one from the NCP 2 were followed-up and ended the study. The mean age of the participants was 56 years. 77.5% were women. 30.6% had an active smoking habit. 46% had universitary studies. 53.1 had an active labor situation. Regarding the main outcomes: a)Disease activity, a slight decrease in activity was observed between baseline and 6 months, but without statistically significant differences. b) Quality of life, we detected some improvement in all care plans in the EQ-index and in the Visual analog scale (VAE) but there were no statistically significant variations. c) Therapeutic adherence, we show the results in the Morinsky Green questionnaire. We obtained statistical significant decrease in the percentage of patients that forgot to take their prescribed medications after 6 months (p=0.04), and we also saw an increase in the percentage of patients taking medications at established times (up to 100% in all groups). d) Patient satisfaction with NCP obtained at the end of study, we used the LOPPS questionnaire. We obtained at six months a punctuation less than 1.5 (ordinal scale that 1 is good 5 is bad). e) Satisfaction of the care received by patients over the phone assessed at the end of study, it was almost 100%, being 75% of the patients scores 9 or over. f) Satisfaction with the care plans assessed at the end of study, the score given by patients was almost 90%, being 75% of the patients scores 8 or over.Conclusion:After applying the NCP in both groups, we found positive results after 6 months and mainly regarding the therapeutic adherence. The program was well evaluated by the patients in terms of satisfaction of the care provided.References:[1]Garner S, Lopatina E, Rankin JA, et al. Nurse-led care for patients with rheumatoid arthritis: A systematic review of the effect on quality of care. J Rheumatol 2017; 44: 757–765.[2]Uthman I, Almoallim H, Buckley CD, et al. Nurse-led care for the management of rheumatoid arthritis: a review of the global literature and proposed strategies for implementation in Africa and the Middle East. Rheumatology International 2020; 1: 3.[3]Bech B, Primdahl J, Van Tubergen A, et al. 2018 update of the EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis. Ann Rheum Dis 2020; 79: 61–68.Disclosure of Interests:Leticia Lopez Pedraza Grant/research support from: Pfizer, María Rodero Grant/research support from: Pfizer, Gloria Candelas Grant/research support from: Pfizer, Cristina Lajas Grant/research support from: Pfizer, Teresa Mulero López Grant/research support from: Pfizer, Ana María Perez Saez Grant/research support from: Pfizer, Leticia León Grant/research support from: Pfizer, Zulema Rosales Grant/research support from: Pfizer, Benjamin Fernandez Grant/research support from: Pfizer, Lydia Abasolo Grant/research support from: Pfizer, Luis Rodriguez Rodriguez Grant/research support from: Pfizer

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