scholarly journals The effect of intravenous golimumab on health-related quality of life and work productivity in patients with active psoriatic arthritis: results of the Phase 3 GO-VIBRANT trial

Author(s):  
Alexis Ogdie ◽  
Jessica A. Walsh ◽  
Soumya D. Chakravarty ◽  
Steven Peterson ◽  
Kim Hung Lo ◽  
...  

Abstract Introduction/objectives To evaluate changes in health-related quality of life (HRQoL) and productivity following treatment with intravenous (IV) golimumab in patients with psoriatic arthritis (PsA). Methods Patients were randomized to IV golimumab 2 mg/kg (n=241) at Weeks 0, 4, then every 8 weeks (q8w) through Week 52 or placebo (n=239) at Weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at Weeks 24, 28, then q8w through Week 52. Change from baseline in EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, and the Work Limitations Questionnaire (WLQ) was assessed. Relationships between these outcomes and disease activity and patient functional capability were evaluated post hoc. Results At Week 8, change from baseline in EQ-5D-5L index (0.14 vs 0.04), EQ-VAS (17.16 vs 3.69), daily productivity VAS (−2.91 vs −0.71), and WLQ productivity loss score (−2.92 vs −0.78) was greater in the golimumab group versus the placebo group, respectively. At Week 52, change from baseline was similar in the golimumab and placebo-crossover groups (EQ-5D-5L index: 0.17 and 0.15; EQ-VAS: 21.61 and 20.84; daily productivity VAS: −2.89 and −3.31; WLQ productivity loss: −4.49 and −3.28, respectively). HRQoL and productivity were generally associated with disease activity and functional capability, with continued association from Week 8 through Week 52. Conclusion IV golimumab resulted in early and sustained improvements in HRQoL and productivity from Week 8 through 1 year in patients with PsA. HRQoL and productivity improvements were associated with improvements in disease activity and patient functional capability. Key Points• In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year• Improvements in HRQoL and productivity outcomes in patients with PsA treated with IV golimumab were associated with improvements in disease activity and patient functional capability outcomes• IV golimumab is an effective treatment option for PsA that can mitigate the negative effects of the disease on HRQoL and productivity

Author(s):  
Harish Kancharla ◽  
Siddharth Jain ◽  
Sushant Mishra ◽  
Nupoor Acharya ◽  
Sandeep Grover ◽  
...  

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 901.1-902
Author(s):  
M. Skougaard ◽  
T. Schjødt Jørgensen ◽  
M. J. Jensen ◽  
C. Ballegaard ◽  
J. Guldberg-Møller ◽  
...  

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


Author(s):  
Christina Y. Le ◽  
Clodagh M. Toomey ◽  
Carolyn A. Emery ◽  
Jackie L. Whittaker

Knee trauma can lead to poor health-related quality of life (HRQoL) and osteoarthritis. We aimed to assess HRQoL 3–12 years following youth sport-related knee injury considering HRQoL and osteoarthritis determinants. Generic (EQ-5D-5L index, EQ-VAS) and condition-specific (Knee injury and Osteoarthritis Outcome Score quality of life subscale, KOOS QOL) HRQoL were assessed in 124 individuals 3–12 years following youth sport-related knee injury and 129 uninjured controls of similar age, sex, and sport. Linear regression examined differences in HRQoL outcomes by injury group. Multivariable linear regression explored the influence of sex, time-since-injury, injury type, body mass index, knee muscle strength, Intermittent and Constant Osteoarthritis Pain (ICOAP) score, and Godin Leisure-Time Exercise Questionnaire (GLTEQ) moderate-to-strenuous physical activity. Participant median (range) age was 23 years (14–29) and 55% were female. Injury history was associated with poorer KOOS QOL (−8.41; 95%CI −10.76, −6.06) but not EQ-5D-5L (−0.0074; −0.0238, 0.0089) or EQ-VAS (−3.82; −8.77, 1.14). Injury history (−5.14; −6.90, −3.38), worse ICOAP score (−0.40; −0.45, −0.36), and anterior cruciate ligament tear (−1.41; −2.77, −0.06) contributed to poorer KOOS QOL. Worse ICOAP score contributed to poorer EQ-5D-5L (−0.0024; −0.0034, −0.0015) and higher GLTEQ moderate-to-strenuous physical activity to better EQ-VAS (0.10; 0.03, 0.17). Knee trauma is associated with poorer condition-specific but not generic HRQoL 3–12 years post-injury.


Author(s):  
Dalifer Freites Nuñez ◽  
Alfredo Madrid-García ◽  
Leticia Leon ◽  
Gloria Candelas ◽  
Mercedes Núñez ◽  
...  

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Lourdes Carhuapoma ◽  
Radhika Avadhani ◽  
Noeleen Ostapkovich ◽  
Karen Lane ◽  
Nichol McBee ◽  
...  

Introduction: Recovery in intracerebral hemorrhage (ICH) is prolonged and unpredictable, resulting in challenges in estimating health-related quality of life (HRQoL). We describe HRQoL and patient disposition for ICH survivors with similar clinical characteristics to ICH patients who had withdrawal of life-sustaining treatment (WoLST). Methods: Using MISTIE III trial data (N = 499), we performed a matched cohort analysis using a published modified severity index (mSI) to compare ICH survivors (N = 379) with WoLST patients (N = 61). We used multivariable logistic regression adjusting for age, Glasgow Coma Score, deep ICH location, stability ICH and intraventricular hemorrhage volume and ≥ 3 comorbidities to create the mSI. After matching survivors with equal mSI to WoLST patients, we compared EuroQoL (EQ) visual analog scale (VAS) scores (US norm 69-76; range 0-100) by mSI quartile and patient disposition. Results: We matched 224 survivors to WoLST patients by mSI (range 0-6.5), with data at all timepoints. Given the large mSI range, EQ VAS scores and patient disposition were evaluated by mSI quartile groups. The median (interquartile range [IQR]) EQ VAS score increase for all mSI groups from day 30 (D30) to 180 (D180) was 20 (0-35.5, p < 0.0001), and 23.5 (5-40, p < 0.0001) for D30 to 365 (D365). The highest percentage of survivors for all mSI groups were home by D365 (G1 55%, G2 88%, G3 84.5%, G4 90%). Median (IQR) EQ VAS scores by mSI quartile, patient disposition and timepoint are reported below. Conclusion: ICH survivors, matching WoLST individuals, in all mSI groups demonstrated improvement in HRQoL over time, and the majority were home by D365. This study challenges current practice of identifying poor outcomes in concert with decision making employing WoLST in ICH. If goals of care are to include return to home and HRQoL, these results strongly suggest that prognostication can be improved. Prospective studies of ICH prognostication and decision making are needed.


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