المؤلفون: Colombo GL, Di Matteo S, Martinotti C, Jugl SM, Gunda P, Naclerio M, Bruno GM

المصدر: ClinicoEconomics and Outcomes Research, Vol Volume 10, Pp 477-491 (2018)

مصطلحات موضوعية: Budget impact, Psoriasis, Psoriatic Arthritis, Ankylosing spondylitis, Italy, secukinumab, Medicine (General), R5-920, Therapeutics. Pharmacology, RM1-950

الوصف: Giorgio L Colombo,1,2 Sergio Di Matteo,2 Chiara Martinotti,2 Steffen M Jugl,3 Praveen Gunda,4 Mariantonietta Naclerio,5 Giacomo M Bruno2 1Department of Drug Science, Pavia University, Pavia, Italy; 2S.A.V.E. S.r.l. Studi Analisi Valutazioni Economiche Health Economics & Outcomes Research - research center, Milan, Italy; 3Novartis Pharma AG, Basel, Switzerland; 4Novartis Healthcare Private Limited, Hyderabad, India; 5Novartis Farma S.p.A, Origgio, Varese, Italy Objective: Secukinumab, a fully human monoclonal IgG1 antibody that selectively neutralizes the proinflammatory cytokine IL-17A, has been approved in Europe in 2015 for the treatment of adult patients with moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), and ankylosing spondylitis (AS). This analysis assessed the budget impact of introduction of secukinumab to the Italian market for all three indications from the perspective of the Italian National Health Service. Materials and methods: A cross-indication budget impact model was developed and included biologic-treated adult patients diagnosed with psoriasis, PsA, and AS. The analyses were conducted over a 3-year time horizon and included direct costs (drug therapy costs, administration costs, diseases-related costs, and adverse events costs). Model input parameters (epidemiology, market share projections, resource use, and costs) were obtained from the published literature and other Italian sources. The robustness of the results was tested via one-way sensitivity analyses: secukinumab cost, secukinumab market share, intravenous administration costs, and adverse events costs were varied by ±10%. Results: The total patient population for secukinumab over the 3-year timeframe was projected to be 6,648 in the first year, increasing to 12,001 in the third year, for all three indications combined (psoriasis, PsA, and AS). Compared to a scenario without secukinumab in the market, the introduction of secukinumab in the market for the treatment of psoriasis, PsA, and AS showed a cumulative 3-year incremental budget impact of -5%, corresponding to savings of €66.1 million and per patient savings of about €1,855. The majority of the cost savings came from the adoption of secukinumab in AS (58%), followed by PsA (29%) and psoriasis (13%). Sensitivity analyses confirmed the robustness of the results. Conclusion: Results from this cross-indication budget impact model show that secukinumab is a cost-saving option for the treatment of PsA, AS, and psoriasis patients in Italy. Keywords: budget impact, psoriasis, psoriatic arthritis, ankylosing spondylitis, Italy, secukinumab

وصف الملف: electronic resource

العلاقة: https://www.dovepress.com/budget-impact-model-of-secukinumab-for-the-treatment-of-moderate-to-se-peer-reviewed-article-CEORTest; https://doaj.org/toc/1178-6981Test

الوصول الحر: https://doaj.org/article/4d32083182ca4deeac0c936abff73ad4Test

المؤلفون: Coates, L, Nash, P, Kvien, TK, Gossec, L, Mease, PJ, Rasouliyan, L, Pricop, L, Jugl, SM, Gandhi, KK, Gaillez, C, Smolen, JS

الوصف: Objectives Remission (REM) or low disease activity (LDA) states were compared in a clinical trial setting of the FUTURE 2 study (NCT01752634) using Disease Activity Index for Psoriatic Arthritis (DAPSA) and Minimal Disease Activity (MDA) composite indices in secukinumab treated PsA patients. Methods The proportion of patients reaching DAPSA-REM (cut-off ≤4) or REM+LDA (≤14), and very low disease activity (VLDA; achieving 7/7 criteria) or MDA (≥5/7), were compared in the overall population, by prior use of anti–TNF therapy, and by time since diagnosis using as observed data. The proportion of patients who met individual core component and other variables of interest were also computed to assess residual disease activity in DAPSA-REM/REM+LDA states and VLDA/MDA responses. The relationship between DAPSA/MDA and patient reported outcomes (PROs), including health-related quality of life, physical function, and fatigue were assessed using mixed model for repeated measures. Results More patients could achieve DAPSA-REM or DAPSA-REM+LDA status than VLDA or MDA responses, respectively, at all the time points in the overall population, irrespective of anti‒TNF status and time since diagnosis. Higher proportion of patients reaching DAPSA-REM or VLDA achieved more thresholds of core components (joints, pain, patient and physician global assessments, and function) than DAPSA-REM+LDA or MDA over Week 104. There were differences with numerically higher proportion of patients achieving patient global assessment ≤10 mm and ≤20 mm, and physician global assessment ≤10 mm with MDA than with DAPSA-REM+LDA, and patient pain VAS ≤15 mm, PASI ≤1, HAQ ≤0.5 with VLDA or MDA than with DAPSA-REM or DAPSA-REM+LDA, respectively, through 104 weeks. Improvements in PROs were significantly better for patients in DAPSA-REM+LDA versus DAPSA-moderate+high disease activity status, and for MDA responders versus non-responders. Conclusion These analysis add to the evidence that both DAPSA and MDA composite index measures can be used for evaluation of ...

العلاقة: https://ora.ox.ac.uk/objects/uuid:2bf9eb47-fec0-45b0-8b07-6e1b1802a7b4Test; https://doi.org/10.1016/j.semarthrit.2020.03.015Test

الإتاحة: https://doi.org/10.1016/j.semarthrit.2020.03.015Test
https://ora.ox.ac.uk/objects/uuid:2bf9eb47-fec0-45b0-8b07-6e1b1802a7b4Test

المؤلفون: Deodhar, A, Strand, V, Conaghan, P, Sullivan, E, Blackburn, S, Tian, H, Gandhi, K, Jugl, SM, Alten, R

الوصف: Background Symptoms and comorbidities of ankylosing spondylitis (AS) considerably reduce health-related quality of life (HRQoL) and ability to work. This real-world study assessed rates of tumour necrosis factor inhibitor (TNFi) use and switching, treatment failure, and associations between failing TNFi and HRQoL, work productivity and activity impairment (WPAI). Methods AS patients and their treating physicians completed questionnaires capturing patient demographics, clinical status, TNFi treatment history, reasons for switching TNFi, HRQoL and WPAI. Current TNFi was determined as “failing” if, after ≥3 months, physician-rated disease severity had worsened, remained severe, was “unstable/deteriorating”, physicians were dissatisfied with disease control and/or did not consider treatment a “success”. Results The analysis included 2866 AS patients from 18 countries. Of 2795 patients with complete treatment data, 916 (32.8%) patients had never received TNFi therapy, 1623 (58.1%) patients were receiving their 1st TNFi and 200 (7.2%) patients had ever received ≥2 TNFi (treatment switch). Primary or secondary lack of efficacy were the commonest reasons for switching, and the mean delay in switching after primary lack of efficacy was 11.1 months. 232 (15.4%) patients on TNFi were currently “failing” who, compared to those with treatment success, reported poorer HRQoL: 5-dimension EuroQoL (EQ-5D-3 L): 0.63 vs. 0.78; Medical Outcomes Study Short-Form Health Survey version 2 (SF-36v2) mental component summary (MCS): 41.8 vs. 46.3; physical component summary (PCS): 40.2 vs. 45.1; impaired work productivity: 46.4% vs. 25.0%; and activity: 44.5% vs. 29.6%; all P < 0.001. Conclusions Among AS patients, switching TNFi is uncommon and delayed by nearly 1 year despite primary lack of efficacy. Patients currently failing TNFi experience worse physical function, HRQoL and work productivity.

وصف الملف: text

العلاقة: https://eprints.whiterose.ac.uk/156808/3/s41927-020-0118-z.pdfTest; Deodhar, A, Strand, V, Conaghan, P orcid.org/0000-0002-3478-5665 et al. (6 more authors) (2020) Unmet needs in ankylosing spondylitis patients receiving tumour necrosis factor inhibitor therapy; results from a large multinational real-world study. BMC Rheumatology, 4 (1). 19. ISSN 2520-1026

الإتاحة: https://eprints.whiterose.ac.uk/156808Test/
https://eprints.whiterose.ac.uk/156808/3/s41927-020-0118-z.pdfTest

المؤلفون: Strand, V, Deodhar, A, Alten, R, Sullivan, E, Blackburn, S, Tian, H, Gandhi, KK, Jugl, SM, Conaghan, PG

الوصف: Background/Objective: Patients with ankylosing spondylitis (AS) experience symptoms and comorbidities that impact their health-related quality of life (HRQoL) and ability to work. This real-world, global survey was conducted among AS patients receiving tumor necrosis factor inhibitors (TNFis) to evaluate both the frequency and severity of persistent symptoms, and the impact of pain and fatigue on HRQoL, employment status, and work activity. Methods: Patients with AS and their treating physicians from 13 countries across 5 continents completed questionnaires capturing demographics, patient symptoms, current disease status, HRQoL, current therapy, employment status, and Work Productivity and Activity Impairment. Results: Seven hundred five patients who had been receiving a TNFi for 3 months or more and completed both Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) pain and fatigue domains were included in the analysis; of these, 37.6% reported high BASDAI pain scores and 41.3% high BASDAI fatigue scores. Medical Outcomes Study–Short Form, 36-item version 2 domain, 5-dimensional EuroQoL Questionnaire, and 5-dimensional EuroQoL visual analog scale scores were significantly lower (p < 0.0001), and Work Productivity and Activity Impairment scores significantly higher (p < 0.0001), in patients with high levels of pain or fatigue than low levels. Conclusions: Globally, levels of pain and fatigue remained high in AS patients receiving TNFi treatment, which were significantly associated with reduced HRQoL and work productivity. Such persistent symptoms in usual care suggest a substantial unmet need in AS pharmacologic and nonpharmacologic therapeutic pathways.

وصف الملف: text

العلاقة: https://eprints.whiterose.ac.uk/162594/9/Pain_and_Fatigue_in_Patients_With_Ankylosing.98555.pdfTest; Strand, V, Deodhar, A, Alten, R et al. (6 more authors) (2020) Pain and Fatigue in Patients With Ankylosing Spondylitis Treated With Tumor Necrosis Factor Inhibitors: Multinational Real-World Findings. JCR: Journal of Clinical Rheumatology. ISSN 1076-1608

الإتاحة: https://eprints.whiterose.ac.uk/162594Test/
https://eprints.whiterose.ac.uk/162594/9/Pain_and_Fatigue_in_Patients_With_Ankylosing.98555.pdfTest

المؤلفون: Conaghan, PG, Alten, R, Deodhar, A, Sullivan, E, Blackburn, S, Tian, H, Gandhi, K, Jugl, SM, Strand, V

الوصف: Background/Objective: The incidence of pain and/or fatigue in people with psoriatic arthritis (PsA) is associated with reduced health-related quality of life (HRQoL) and the ability to work, despite modern advanced therapeutic approaches. This real-world, international study examined these relationships in patients with PsA treated with tumour necrosis factor inhibitors (TNFi). Methods: Data from 13 countries were analysed. Patients with PsA and their physicians completed questionnaires capturing demographics, current therapy, current disease status, HRQoL and work status via Medical Outcomes Study 36-Item Short-Form version 2 (SF-36v2), 3-level 5-dimension EuroQoL questionnaire, Health Assessment Questionnaire Disability Index, and Work Productivity and Activity Impairment (WPAI) questionnaire. Results: 640 patients with PsA were included who had been receiving TNFi for ≥3 months and had completed SF-36v2 bodily pain and vitality domains. Of these, 33.1%, 29.2% and 37.7% of patients reported no, moderate and severe pain, respectively, and 31.9%, 22.5% and 45.6% of patients reported low, moderate and severe fatigue, respectively. Scores across HRQoL variables and WPAI were significantly different across pain and fatigue cohorts (all p<0.0001), with HRQoL and WPAI measures considerably worse in patients with moderate to severe pain or fatigue than those with low pain or fatigue. Conclusions: Despite treatment with biologic agents such as TNFi, data from this global study demonstrated that substantial pain and/or fatigue persist in patients with PsA and that these are significantly associated with reduced HRQoL, physical function and work productivity. These findings suggest that there is an unmet need for additional PsA therapies.

وصف الملف: text

العلاقة: https://eprints.whiterose.ac.uk/162589/3/e001240.full.pdfTest; Conaghan, PG orcid.org/0000-0002-3478-5665 , Alten, R, Deodhar, A et al. (6 more authors) (2020) Relationship of pain and fatigue with health-related quality of life and work in patients with psoriatic arthritis on TNFi: results of a multi-national real-world study. RMD Open, 6 (2). e001240. ISSN 2056-5933

الإتاحة: https://eprints.whiterose.ac.uk/162589Test/
https://eprints.whiterose.ac.uk/162589/3/e001240.full.pdfTest

المؤلفون: Emery, P, Van Keep, M, Beard, S, Graham, C, Miles, L, Jugl, SM, Gunda, P, Halliday, A, Marzo-Ortega, H

الوصف: Objective To determine the cost effectiveness of secukinumab, a fully human interleukin-17A inhibitor, for adults in the UK with active ankylosing spondylitis (AS) who have not responded adequately to previous treatment with conventional care (CC; biologic-naïve population) or previous biologic therapy (biologic-experienced population). Perspective and Setting UK National Health Service (NHS). Methods The model was structured as a 3-month decision tree leading into a Markov model. Comparators were licensed tumour necrosis factor inhibitors (including available biosimilars) and CC in the biologic-naïve and biologic-experienced populations, respectively. Clinical parameters captured treatment response, short-term disease activity and patient functioning, as well as long-term structural disease progression. Utilities were derived from secukinumab trial data. List prices were used for all drugs. The cost year was 2017 and costs and outcomes were discounted at 3.5%. Results In the biologic-naïve population, secukinumab dominated adalimumab and certolizumab pegol. Incremental cost-effectiveness ratios (ICERs) versus other comparators were either below £10,000 per quality-adjusted life-year (QALY) gained or south-west ICERs that implied cost effectiveness of secukinumab. In biologic-experienced patients, the ICER for secukinumab versus CC was £4927 per QALY gained. Treatment response rates, short-term treatment effects, long-term radiographic progression and biologic acquisition costs were key model drivers. Scenario analysis found results to be robust to changes in model structural assumptions. Probabilistic analysis identified greater uncertainty in results in the biologic-naïve population. Conclusions Even at list price, secukinumab appears to represent a cost-effective use of NHS resources for biologic-naïve and biologic-experienced patients with active AS. Further research on long-term radiographic progression outcomes would be valuable for future cost-effectiveness analyses in AS.

وصف الملف: text

العلاقة: https://eprints.whiterose.ac.uk/133723/7/Cost%20Effectiveness%20of%20Secukinumab%20for%20the%20Treatment%20of%20Active%20Ankylosing%20Spondylitis%20in%20the%20UK.pdfTest; Emery, P orcid.org/0000-0002-7429-8482 , Van Keep, M, Beard, S et al. (6 more authors) (2018) Cost Effectiveness of Secukinumab for the Treatment of Active Ankylosing Spondylitis in the UK. PharmacoEconomics, 36 (8). pp. 1015-1027. ISSN 1170-7690

الإتاحة: https://eprints.whiterose.ac.uk/133723Test/
https://eprints.whiterose.ac.uk/133723/7/Cost%20Effectiveness%20of%20Secukinumab%20for%20the%20Treatment%20of%20Active%20Ankylosing%20Spondylitis%20in%20the%20UK.pdfTest

المؤلفون: Coates, LC, Gladman, DD, Nash, P, FitzGerald, O, Kavanaugh, A, Kvien, TK, Gossec, L, Strand, V, Rasouliyan, L, Pricop, L, Ding, K, Jugl, SM, Gaillez, C

مصطلحات موضوعية: Clinical sciences, Immunology, Health services and systems, Public health, Science & Technology, Life Sciences & Biomedicine, Rheumatology, Psoriatic arthritis, Secukinumab

الوصف: Background: Secukinumab has demonstrated sustained improvement in the signs and symptoms of psoriatic arthritis (PsA) over 2 years in the FUTURE 2 study (NCT01752634). This post hoc analysis assessed the ability of secukinumab to achieve Psoriatic Arthritis Disease Activity Score (PASDAS)-based remission or low disease activity (LDA) through 2 years among patients with PsA in the FUTURE 2 study. Methods: PASDAS (cut-off scores: remission ≤ 1.9; LDA > 1.9 and < 3.2; Moderate Disease Activity ≥ 3.2 and < 5.4; and high disease activity [HDA] ≥ 5.4) was assessed in the overall population (tumour necrosis factor inhibitor [TNFi]-naïve and TNFi-experienced), in patients stratified by prior TNFi use and by disease duration at weeks 16, 52 and 104. The impact of secukinumab on individual PASDAS core components and on the relationship between PASDAS states and patient-reported outcomes (PROs), including physical function, health-related quality of life (HRQoL) and work productivity, were also assessed. Data for the approved doses of secukinumab (300 and 150 mg) are reported. PASDAS scores and core components were reported as observed, and PROs were analysed using mixed models for repeated measures. Results: In the overall population, PASDAS remission and LDA were achieved in 15.6% and 22.9%, respectively, of patients treated with secukinumab 300 mg and in 15.2% and 19.2%, respectively, in the secukinumab 150 mg group versus 2.3% and 13.8%, respectively, with placebo at week 16. In the TNFi-naïve group, a higher proportion of patients achieved remission + LDA at week 16 with secukinumab 300 and 150 mg (46.2% and 42.9%, respectively) versus placebo (17.5%), with corresponding responses in TNFi-experienced patients being 22.6% and 19.4% versus 13.3%. Remission/LDA responses with secukinumab were sustained through 2 years. Patients achieving remission/LDA reported greater improvements in PROs than patients in HDA through 2 years. Conclusions: Secukinumab-treated patients achieved higher PASDAS-defined remissions or ...

العلاقة: Arthritis Research & Therapy; Coates, LC; Gladman, DD; Nash, P; FitzGerald, O; Kavanaugh, A; Kvien, TK; Gossec, L; Strand, V; Rasouliyan, L; Pricop, L; Ding, K; Jugl, SM; Gaillez, C, Secukinumab provides sustained PASDAS-defined remission in psoriatic arthritis and improves health-related quality of life in patients achieving remission: 2-year results from the phase III FUTURE 2 study, Arthritis Research & Therapy, 2018, 20 (1), pp. 272; http://hdl.handle.net/10072/399818Test

الإتاحة: https://doi.org/10.1186/s13075-018-1773-yTest
http://hdl.handle.net/10072/399818Test

المؤلفون: Gunda, P, Nikoglou, E, Jugl, SM, Murphy, A

المصدر: Value in Health ; volume 20, issue 9, page A532-A533 ; ISSN 1098-3015

مصطلحات موضوعية: Public Health, Environmental and Occupational Health, Health Policy

الإتاحة: https://doi.org/10.1016/j.jval.2017.08.758Test
https://api.elsevier.com/content/article/PII:S1098301517310926?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1098301517310926?httpAccept=text/plainTest

المؤلفون: Emery, P, van Keep, M, Beard, SM, Graham, CN, Miles, L, Jugl, SM, Gunda, P, Halliday, A, Marzo-Ortega, H

المصدر: Value in Health ; volume 20, issue 9, page A534 ; ISSN 1098-3015

مصطلحات موضوعية: Public Health, Environmental and Occupational Health, Health Policy

الإتاحة: https://doi.org/10.1016/j.jval.2017.08.765Test
https://api.elsevier.com/content/article/PII:S1098301517310999?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1098301517310999?httpAccept=text/plainTest

المؤلفون: Barbeau, M, Bianculli, PM, Nikoglou, E, Gunda, P, Jugl, SM, MacPherson, A

المصدر: Value in Health ; volume 20, issue 9, page A534-A535 ; ISSN 1098-3015

مصطلحات موضوعية: Public Health, Environmental and Occupational Health, Health Policy

الإتاحة: https://doi.org/10.1016/j.jval.2017.08.769Test
https://api.elsevier.com/content/article/PII:S1098301517311038?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1098301517311038?httpAccept=text/plainTest