scholarly journals Measuring treatment effect on psoriatic arthritis-related domains: insights from the SPIRIT-H2H study at weeks 24 and 52

2021 ◽  
Author(s):  
Frank Behrens ◽  
Soyi Liu Leage ◽  
Christophe Sapin ◽  
Celine El Baou ◽  
Inmaculada De La Torre ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Severity Index ◽  
Psoriasis Area Severity Index ◽  
American College Of Rheumatology ◽  
Related Quality ◽  
Health Related ◽  
Musculoskeletal Manifestations ◽  
Response Groups

Abstract Introduction Improvements in both musculoskeletal and non-musculoskeletal manifestations are important treatment goals in psoriatic arthritis (PsA). Objective These post hoc analyses determined whether additional benefits related to various PsA domains are observed in patients simultaneously achieving 50% improvement in American College of Rheumatology criteria (ACR50) and 100% improvement in Psoriasis Area Severity Index (PASI100), the primary endpoint of the SPIRIT-H2H study. Methods Patients with active PsA and psoriasis in SPIRIT-H2H (N = 566) were categorised into two sets of four response groups irrespective of treatment allocation (approved dosages of ixekizumab or adalimumab): patients who simultaneously achieved ACR50 and PASI100 response, achieved ACR50 response only, achieved PASI100 response only, or did not achieve ACR50 or PASI100 response after 24 and 52 weeks of treatment. Patients achieving simultaneous ACR50 and PASI100 response were compared with the other patient response groups at the corresponding time point for efficacy and health-related quality of life (HRQoL) outcomes. Results Patients simultaneously achieving ACR50 and PASI100 responses at week 24 or 52 showed higher rates of ACR70 response, minimal disease activity, Disease Activity in Psoriatic Arthritis ≤ 4, resolution of enthesitis and dactylitis, and HRQoL improvement at weeks 24 and 52, respectively, than the other corresponding response groups at both time points. Conclusion High levels of disease control, such as those obtained with simultaneous achievement of ACR50 and PASI100 response, were linked to better outcomes across a wide range of endpoints that are important for patients with PsA. Patients meeting this combined endpoint showed more comprehensive and thus greater control of disease activity. Trial registration NCT03151551 Key Points• Treatment goals for patients with psoriatic arthritis emphasise the importance of improving both musculoskeletal and non-musculoskeletal manifestations of the disease.• A combined endpoint considering both these manifestations, achievement of at least 50% improvement in American College of Rheumatology criteria and 100% improvement in Psoriasis Area Severity Index, was linked with achievement of a number of other endpoints relevant to psoriatic arthritis, including health-related quality of life that are important to patients with psoriatic arthritis.• Patients meeting the combined endpoint were more likely to achieve a disease state of remission, which is the stated aim of treatment for psoriasis.

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

2021 ◽  
Author(s):  
Alexis Ogdie ◽  
Jessica A. Walsh ◽  
Soumya D. Chakravarty ◽  
Steven Peterson ◽  
Kim Hung Lo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Productivity Loss ◽  
Health Related Quality ◽  
Functional Capability ◽  
Related Quality ◽  
Health Related ◽  
Eq Vas

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

scholarly journals Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients

2019 ◽  
Vol 47 (6) ◽  
pp. 854-864 ◽  
Author(s):  
Ana-Maria Orbai ◽  
Iain B. McInnes ◽  
Laura C. Coates ◽  
M. Elaine Husni ◽  
Dafna D. Gladman ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Complete Resolution ◽  
Severity Index ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Tender Joint ◽  
Related Quality ◽  
Health Related ◽  
Future 2

Objective.To compare the efficacy of secukinumab with that of placebo across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and Outcome Measures in Rheumatology (GRAPPA-OMERACT) individual psoriatic arthritis (PsA) core domains using pooled data from 4 phase III PsA studies and 1 phase III ankylosing spondylitis (AS) study.Methods.Data were pooled from 2049 patients with PsA participating in 4 on-label phase III PsA studies (FUTURE 2–5), and the efficacy of each GRAPPA-OMERACT PsA core domain (musculoskeletal disease activity, skin disease activity, pain, patient’s global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation) was assessed using multiple measures and definitions specific to each domain. The MEASURE 2 study, a phase III clinical trial in patients with AS, was used to assess improvement in spine symptoms at Week 16.Results.Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16. Notably, among patients treated with secukinumab 300 mg, 34.3% and 19.5% achieved complete resolution of swollen and tender joint counts, respectively; 53.2% and 61.5% achieved complete resolution of enthesitis and dactylitis, respectively; and 33.2% achieved 100% improvement in Psoriasis Area and Severity Index (all p < 0.05 vs placebo); similar improvements were shown for all other core domains.Conclusion.This analysis suggests that secukinumab can benefit people with PsA across the clinical phenotypic spectrum commonly encountered in this disease.

scholarly journals AB0786 IMPACT OF PSORIASIS SEVERITY ON HEALTH-RELATED QUALITY OF LIFE IN EARLY PSORIATIC ARTHRITIS: RESULTS FROM REAL WORLD DATA, THE DEPAR STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1691.2-1692
Author(s):  
F. R. Kasiem ◽  
M. R. Kok ◽  
I. Tchetverikov ◽  
K. Wervers ◽  
J. Hazes ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Severe Psoriasis ◽  
First Year ◽  
Health Related Quality ◽  
Real World Data ◽  
Related Quality ◽  
Health Related ◽  
Psoriasis Severity

Background:Psoriasis is an important feature of psoriatic arthritis (PsA). Psoriasis itself is known to have a significant impact on Health-related Quality of life (HRQoL)1, however its role within PsA is less well understood. In daily practice, assessment of psoriasis may not always be a priority for rheumatologists, having been trained to focus on articular involvement. In order to assess whether psoriasis deserves more attention from rheumatologists, the aim of this study is to evaluate the influence of psoriasis on HRQoL in early PsA patients.Objectives:To describe the evolution of psoriasis severity during the first year of follow up in patients with early PsA and to evaluate the impact of psoriasis severity on HRQoL.Methods:Real world data were used from the Dutch south west Psoriatic Arthritis cohort (DEPAR) study, consisting of newly diagnosed PsA patients included between July 2013 and February 2019. Psoriasis severity was assessed using the Psoriasis Area and Severity Index (PASI) and categorized in: no psoriasis (PASI 0), mild psoriasis (PASI<7), moderate psoriasis (PASI 7-12) and severe psoriasis (PASI>12). Musculoskeletal disease severity was measured with the Disease Activity in PSoriatic Arthritis (DAPSA) score as contrast for psoriasis severity. DAPSA was categorized in: remission (REM[DAPSA≤4]), low disease activity (LDA[DAPSA≤14]), moderate disease activity (MDA[DAPSA≤28]) and high disease activity (HDA[DAPSA>28]).2General HRQoL was assesed with the Short-Form 36 (SF-36[Physical component scale and Mental component scale]). Skin-specific HRQoL was measured with the Skindex-17 (psychosocial scale and symptoms scale).Results:In total, 435 patients were included. Mean (sd) age was 49.7 (13.4) years and 53% (n=229) was male. Psoriasis severity does not fluctuate much over the course of the first year and the majority of patients had mild psoriasis (Figure 1). HRQoL worsened with increasing psoriasis severity, when measured by the Skindex17. This reduction in HRQoL was not seen when measured with the SF-36 (Figure 2).Figure 1.Psoriasis severity categories during the first year of follow up. No psoriasis (PASI 0), mild psoriasis (PASI<7), moderate psoriasis (PASI 7-12) and severe psoriasis (PASI>12).Figure 2.A, B: Median Skindex17 psychosocial score and symptoms score per psoriasis severity category and DAPSA category at baseline. C,D: Mean SF36 Physical component scale (PCS) score and Mental component scale (MCS) score per psoriasis severity category and DAPSA category at baseline. No psoriasis (PASI 0), mild psoriasis (PASI<7), moderate psoriasis (PASI 7-12) and severe psoriasis (PASI>12). REM (DAPSA<4), LDA (DAPSA<14), MDA (DAPSA<28) and HDA (DAPSA>28)Conclusion:In early PsA patients, psoriasis severity is mostly mild, but considerably impacts HRQoL when measured using a skin specific questionnaire. For optimal management of PsA patients, we therefore recommend rheumatologists to additionally acquire information on the degree of psoriatic involvement. In our opinion, this information is valuable for the adequate assessment of HRQoL.References:[1]Strober B, Greenberg JD, Karki C, Mason M, Guo N, Hur P, et al. Impact of psoriasis severity on patient-reported clinical symptoms, health-related quality of life and work productivity among US patients: real-world data from the Corrona Psoriasis Registry. BMJ Open. 2019;9(4):e027535.[2]Schoels MM, Aletaha D, Alasti F, Smolen JS. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis. 2016;75(5):811-8.Disclosure of Interests:Fazira R. Kasiem: None declared, Marc R Kok Grant/research support from: BMS and Novartis, Consultant of: Novartis and Galapagos, Ilja Tchetverikov: None declared, Kim Wervers: None declared, Johanna Hazes: None declared, Jolanda Luime: None declared, Marijn Vis Grant/research support from: Novartis, Pfizer – grant/research support, Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Novartis, Pfizer – consultant

Fibromyalgia influences health-related quality of life and disease activity in psoriatic arthritis

2021 ◽  
Author(s):  
Harish Kancharla ◽  
Siddharth Jain ◽  
Sushant Mishra ◽  
Nupoor Acharya ◽  
Sandeep Grover ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

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

Effects of adalimumab therapy on musculoskeletal manifestations and health-related quality of life in patients with active psoriatic arthritis

2013 ◽  
Vol 23 (3) ◽  
pp. 529-537 ◽  
Author(s):  
Shigeyoshi Tsuji ◽  
Mari Higashiyama ◽  
Masahiro Inaoka ◽  
Tetsuya Tomita ◽  
Akinori Yokomi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Health Related Quality ◽  
Adalimumab Therapy ◽  
Related Quality ◽  
Health Related ◽  
Musculoskeletal Manifestations
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