Pub Date : 2024-12-17DOI: 10.1016/S2665-9913(24)00298-4
Dominique Farge, Lucie Biard, Ben Weil, Virginie Girault, Pauline Lansiaux, Ingrid Munia, Séverine Loisel, Catney Charles, Judikael Saout, Matthieu Resche-Rigon, Anne Sophie Korganow, Clément Beuvon, Grégory Pugnet, Carlotta Cacciatore, Noémie Abisror, Jean Luc Taupin, Audrey Cras, Mark W Lowdell, Karin Tarte
<p><strong>Background: </strong>Patients with systemic lupus erythematosus (SLE) with inadequate responses to standard therapies have unmet therapeutic needs. The immunomodulatory, proangiogenic, and antifibrotic properties of mesenchymal stromal cells support their use in treating patients with SLE. We aimed to assess the safety of a single intravenous infusion of allogeneic umbilical cord-derived mesenchymal stromal cells in patients with severe SLE.</p><p><strong>Methods: </strong>This prospective, single-centre, open-label, dose-escalation, Bayesian phase 1 study was done at the Saint-Louis University Hospital (Paris, France). Eligible patients were aged 18-70 years, were diagnosed with SLE according to American College of Rheumatology criteria with positive antinuclear antibodies, had a baseline Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score of 6 or more, and had disease that was refractory to first and second line SLE therapies. Patients were to receive a single intravenous infusion of 1 × 10<sup>6</sup>, 2 × 10<sup>6</sup>, or 4 × 10<sup>6</sup> umbilical cord-derived mesenchymal stromal cells per kg (manufactured from a single umbilical cord) in cohorts of five patients per dose, starting at 2 × 10<sup>6</sup> cells per kg. The primary endpoint was the rate of treatment-related severe adverse events (grade ≥3) in the first 10 days after infusion of umbilical cord-derived mesenchymal stromal cells. People with lived experience were involved in study design, patient enrolment, and dissemination of the study findings. This study is registered with ClinicalTrials.gov, NCT03562065, and the EU Clinical Trials Register, EudraCT2017-001400-29.</p><p><strong>Findings: </strong>From May 14, 2019, to March 6, 2023, 29 patients were screened for eligibility, eight of whom were enrolled in the study. Enrolment was terminated early after inclusion of eight patients and no patients received the 1 × 10<sup>6</sup> dose of umbilical cord-derived mesenchymal stromal cells. Seven (88%) of eight participants were cisgender women and one (13%) was a cisgender man. The median age was 35 years (range 26-57) and the median SLE disease duration was 12 years (5-19). All patients received at least 2 × 10<sup>6</sup> cells per kg (range 2 × 10<sup>6</sup> to 4 × 10<sup>6</sup>). No severe adverse events and three infusion-related adverse events (two grade 1 and one grade 2) occurred in two patients in the first 10 days after infusion. After 12·4 months (range 12-13) of follow-up, no treatment-related severe adverse events and three non-treatment-related severe adverse events occurred in one patient after relapse.</p><p><strong>Interpretation: </strong>Our results suggest that a single infusion of 2 × 10<sup>6</sup> cells per kg or 4 × 10<sup>6</sup> cells per kg of allogeneic umbilical cord-derived mesenchymal stromal cells was safe in patients with severe SLE. Placebo-controlled trials are needed to c
{"title":"Allogeneic umbilical cord-derived mesenchymal stromal cells as treatment for systemic lupus erythematosus: a single-centre, open-label, dose-escalation, phase 1 study.","authors":"Dominique Farge, Lucie Biard, Ben Weil, Virginie Girault, Pauline Lansiaux, Ingrid Munia, Séverine Loisel, Catney Charles, Judikael Saout, Matthieu Resche-Rigon, Anne Sophie Korganow, Clément Beuvon, Grégory Pugnet, Carlotta Cacciatore, Noémie Abisror, Jean Luc Taupin, Audrey Cras, Mark W Lowdell, Karin Tarte","doi":"10.1016/S2665-9913(24)00298-4","DOIUrl":"https://doi.org/10.1016/S2665-9913(24)00298-4","url":null,"abstract":"<p><strong>Background: </strong>Patients with systemic lupus erythematosus (SLE) with inadequate responses to standard therapies have unmet therapeutic needs. The immunomodulatory, proangiogenic, and antifibrotic properties of mesenchymal stromal cells support their use in treating patients with SLE. We aimed to assess the safety of a single intravenous infusion of allogeneic umbilical cord-derived mesenchymal stromal cells in patients with severe SLE.</p><p><strong>Methods: </strong>This prospective, single-centre, open-label, dose-escalation, Bayesian phase 1 study was done at the Saint-Louis University Hospital (Paris, France). Eligible patients were aged 18-70 years, were diagnosed with SLE according to American College of Rheumatology criteria with positive antinuclear antibodies, had a baseline Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score of 6 or more, and had disease that was refractory to first and second line SLE therapies. Patients were to receive a single intravenous infusion of 1 × 10<sup>6</sup>, 2 × 10<sup>6</sup>, or 4 × 10<sup>6</sup> umbilical cord-derived mesenchymal stromal cells per kg (manufactured from a single umbilical cord) in cohorts of five patients per dose, starting at 2 × 10<sup>6</sup> cells per kg. The primary endpoint was the rate of treatment-related severe adverse events (grade ≥3) in the first 10 days after infusion of umbilical cord-derived mesenchymal stromal cells. People with lived experience were involved in study design, patient enrolment, and dissemination of the study findings. This study is registered with ClinicalTrials.gov, NCT03562065, and the EU Clinical Trials Register, EudraCT2017-001400-29.</p><p><strong>Findings: </strong>From May 14, 2019, to March 6, 2023, 29 patients were screened for eligibility, eight of whom were enrolled in the study. Enrolment was terminated early after inclusion of eight patients and no patients received the 1 × 10<sup>6</sup> dose of umbilical cord-derived mesenchymal stromal cells. Seven (88%) of eight participants were cisgender women and one (13%) was a cisgender man. The median age was 35 years (range 26-57) and the median SLE disease duration was 12 years (5-19). All patients received at least 2 × 10<sup>6</sup> cells per kg (range 2 × 10<sup>6</sup> to 4 × 10<sup>6</sup>). No severe adverse events and three infusion-related adverse events (two grade 1 and one grade 2) occurred in two patients in the first 10 days after infusion. After 12·4 months (range 12-13) of follow-up, no treatment-related severe adverse events and three non-treatment-related severe adverse events occurred in one patient after relapse.</p><p><strong>Interpretation: </strong>Our results suggest that a single infusion of 2 × 10<sup>6</sup> cells per kg or 4 × 10<sup>6</sup> cells per kg of allogeneic umbilical cord-derived mesenchymal stromal cells was safe in patients with severe SLE. Placebo-controlled trials are needed to c","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":15.0,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-05DOI: 10.1016/S2665-9913(24)00247-9
Ilana N Ackerman, Alexandra Gorelik, Danielle Berkovic, Rachelle Buchbinder
<p><strong>Background: </strong>Understanding how many people could be living with arthritis in the future is essential for planning health service needs and national health workforce requirements, and for arthritis advocacy and policy development. This study aimed to forecast the size of different populations with arthritis in Australia and associated health system expenditure, up to the year 2040.</p><p><strong>Methods: </strong>In this population-level forecasting study for Australia, prevalence data for arthritis, osteoarthritis, and rheumatoid arthritis were obtained from the Australian Bureau of Statistics 2022 National Health Survey. Prevalence rates for juvenile idiopathic arthritis were sourced from 2021 Census data. Overall, age-specific and sex-specific prevalence data were applied to national population projections to forecast arthritis, osteoarthritis, rheumatoid arthritis, and juvenile idiopathic arthritis populations for 2025, 2030, 2035, and 2040. The base case analysis considered medium population growth; sensitivity analyses considered low and high growth scenarios. Health system expenditure data from the Australian Institute of Health and Welfare were extrapolated to base case projections for the years 2025, 2030, 2035, and 2040, and were then inflated to future dollars. To understand the broader context and implications of our projections through the lens of lived experience, an arthritis consumer researcher and members of the Arthritis Australia Consumer Advisory Panel reviewed the arthritis burden estimates.</p><p><strong>Findings: </strong>With population growth and ageing, 5·39 million (95% CI 5·19-5·58) people are projected to have arthritis in Australia in 2040, representing an increase of 31% from 4·11 million (3·95-4·27) in 2025. By 2040, 3·11 million (2·99-3·23) people are expected to have osteoarthritis, 749 000 (652 000-846 000) are expected to have rheumatoid arthritis, and about 8500 children and adolescents are expected to have juvenile idiopathic arthritis. The age-standardised rate of osteoarthritis is forecast to increase for males from 6·28% in 2025 to 7·03% in 2040, and for females from 10·82% to 12·18% over this period. The age-standardised rate of rheumatoid arthritis is forecast to increase for males from 1·56% in 2025 to 1·75% in 2040, and for females from 2·62% in 2025 to 2·94% in 2040. Little change is anticipated in the number of children and adolescents with juvenile idiopathic arthritis (estimated at 8500 individuals in 2040). Based on current spending levels of AU$2100 per person with osteoarthritis and $1918 per person with rheumatoid arthritis, annual health system expenditure for osteoarthritis and rheumatoid arthritis is conservatively forecast to exceed AU$11·92 billion by 2040.</p><p><strong>Interpretation: </strong>Using the latest national-level data, this study has generated contemporary projections of the substantial burden of arthritis (both population size and health-care costs) in Aust
{"title":"The projected burden of arthritis among adults and children in Australia to the year 2040: a population-level forecasting study.","authors":"Ilana N Ackerman, Alexandra Gorelik, Danielle Berkovic, Rachelle Buchbinder","doi":"10.1016/S2665-9913(24)00247-9","DOIUrl":"https://doi.org/10.1016/S2665-9913(24)00247-9","url":null,"abstract":"<p><strong>Background: </strong>Understanding how many people could be living with arthritis in the future is essential for planning health service needs and national health workforce requirements, and for arthritis advocacy and policy development. This study aimed to forecast the size of different populations with arthritis in Australia and associated health system expenditure, up to the year 2040.</p><p><strong>Methods: </strong>In this population-level forecasting study for Australia, prevalence data for arthritis, osteoarthritis, and rheumatoid arthritis were obtained from the Australian Bureau of Statistics 2022 National Health Survey. Prevalence rates for juvenile idiopathic arthritis were sourced from 2021 Census data. Overall, age-specific and sex-specific prevalence data were applied to national population projections to forecast arthritis, osteoarthritis, rheumatoid arthritis, and juvenile idiopathic arthritis populations for 2025, 2030, 2035, and 2040. The base case analysis considered medium population growth; sensitivity analyses considered low and high growth scenarios. Health system expenditure data from the Australian Institute of Health and Welfare were extrapolated to base case projections for the years 2025, 2030, 2035, and 2040, and were then inflated to future dollars. To understand the broader context and implications of our projections through the lens of lived experience, an arthritis consumer researcher and members of the Arthritis Australia Consumer Advisory Panel reviewed the arthritis burden estimates.</p><p><strong>Findings: </strong>With population growth and ageing, 5·39 million (95% CI 5·19-5·58) people are projected to have arthritis in Australia in 2040, representing an increase of 31% from 4·11 million (3·95-4·27) in 2025. By 2040, 3·11 million (2·99-3·23) people are expected to have osteoarthritis, 749 000 (652 000-846 000) are expected to have rheumatoid arthritis, and about 8500 children and adolescents are expected to have juvenile idiopathic arthritis. The age-standardised rate of osteoarthritis is forecast to increase for males from 6·28% in 2025 to 7·03% in 2040, and for females from 10·82% to 12·18% over this period. The age-standardised rate of rheumatoid arthritis is forecast to increase for males from 1·56% in 2025 to 1·75% in 2040, and for females from 2·62% in 2025 to 2·94% in 2040. Little change is anticipated in the number of children and adolescents with juvenile idiopathic arthritis (estimated at 8500 individuals in 2040). Based on current spending levels of AU$2100 per person with osteoarthritis and $1918 per person with rheumatoid arthritis, annual health system expenditure for osteoarthritis and rheumatoid arthritis is conservatively forecast to exceed AU$11·92 billion by 2040.</p><p><strong>Interpretation: </strong>Using the latest national-level data, this study has generated contemporary projections of the substantial burden of arthritis (both population size and health-care costs) in Aust","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":15.0,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142796397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-05DOI: 10.1016/S2665-9913(24)00233-9
Brooke Conley, Jane Linton, Jonathan Bullen, Ivan Lin, Rachel Toovey, Jennifer Persaud, Penny O'Brien, Ryan Prehn, Janet Bromley, Nola Gregory, Trevor Pickett, Lennelle Papertalk, Charmaine Green, Wanda Flanagan, Samantha Bunzli
<p><strong>Background: </strong>Globally, osteoarthritis, rheumatoid arthritis, and gout (arthritis conditions) result in considerable pain and suffering and disproportionately affect First Nations Peoples, who are more likely than non-First Nations Peoples to have an arthritis condition and to experience a higher burden of disease. Access to culturally appropriate health information supports the health and wellbeing of First Nations Peoples. The aim of this study was to identify evidence-based, culturally appropriate recommendations to inform the development of arthritis educational resources for Aboriginal and Torres Strait Islander Peoples (First Nations Peoples in Australia).</p><p><strong>Methods: </strong>This mixed-methods study using community-based participatory action research had three phases: interviews (research yarns) with Aboriginal people to explore their informational needs and preferences for arthritis educational resources; systematic reviews and synthesis of education recommendations from high-quality arthritis clinical practice guidelines; and integration and interpretation of datasets from the first two phases. Details of the three systematic reviews have been published previously. We only included clinical practice guidelines that met our inclusion criterion of high quality, assessed using the Appraisal of Guidelines for Research and Evaluation II instrument.</p><p><strong>Findings: </strong>Between Dec 24, 2020, and Nov 2, 2022, 30 Aboriginal people participated in research yarns. 21 (70%) participants were female and nine (30%) were male, with median age 60 years (range 22-75). All participants identified as Aboriginal and no participants identified as Torres Strait Islander. Research yarn data was combined with education recommendations from 18 clinical practice guidelines. Synthesis of the two datasets generated the following recommendations for inclusion in educational resources: the impact of arthritis on health and wellbeing, when and how to access care, management options (eg, benefits and risks), and disease knowledge (eg, prognosis and addressing misconceptions). In addition, educational resources should be jargon-free and include positive lived experience stories, flags, and colourful local art. Educational resources should be created by Aboriginal people and delivered by health professionals, family, or Aboriginal Community members in the form of brochures, videos, or yarning circles.</p><p><strong>Interpretation: </strong>The recommendations from this study will inform the development of arthritis educational resources for Aboriginal Peoples. The findings can also support health professionals to deliver evidenced-based arthritis care to Aboriginal Peoples. Internationally, a community-based participatory action research approach can be applied to develop educational resources for First Nations Peoples and communities.</p><p><strong>Funding: </strong>Australian Commonwealth Government through Arthritis Australia
{"title":"Integrating evidence from lived experience of Aboriginal people and clinical practice guidelines to develop arthritis educational resources: a mixed-methods study.","authors":"Brooke Conley, Jane Linton, Jonathan Bullen, Ivan Lin, Rachel Toovey, Jennifer Persaud, Penny O'Brien, Ryan Prehn, Janet Bromley, Nola Gregory, Trevor Pickett, Lennelle Papertalk, Charmaine Green, Wanda Flanagan, Samantha Bunzli","doi":"10.1016/S2665-9913(24)00233-9","DOIUrl":"https://doi.org/10.1016/S2665-9913(24)00233-9","url":null,"abstract":"<p><strong>Background: </strong>Globally, osteoarthritis, rheumatoid arthritis, and gout (arthritis conditions) result in considerable pain and suffering and disproportionately affect First Nations Peoples, who are more likely than non-First Nations Peoples to have an arthritis condition and to experience a higher burden of disease. Access to culturally appropriate health information supports the health and wellbeing of First Nations Peoples. The aim of this study was to identify evidence-based, culturally appropriate recommendations to inform the development of arthritis educational resources for Aboriginal and Torres Strait Islander Peoples (First Nations Peoples in Australia).</p><p><strong>Methods: </strong>This mixed-methods study using community-based participatory action research had three phases: interviews (research yarns) with Aboriginal people to explore their informational needs and preferences for arthritis educational resources; systematic reviews and synthesis of education recommendations from high-quality arthritis clinical practice guidelines; and integration and interpretation of datasets from the first two phases. Details of the three systematic reviews have been published previously. We only included clinical practice guidelines that met our inclusion criterion of high quality, assessed using the Appraisal of Guidelines for Research and Evaluation II instrument.</p><p><strong>Findings: </strong>Between Dec 24, 2020, and Nov 2, 2022, 30 Aboriginal people participated in research yarns. 21 (70%) participants were female and nine (30%) were male, with median age 60 years (range 22-75). All participants identified as Aboriginal and no participants identified as Torres Strait Islander. Research yarn data was combined with education recommendations from 18 clinical practice guidelines. Synthesis of the two datasets generated the following recommendations for inclusion in educational resources: the impact of arthritis on health and wellbeing, when and how to access care, management options (eg, benefits and risks), and disease knowledge (eg, prognosis and addressing misconceptions). In addition, educational resources should be jargon-free and include positive lived experience stories, flags, and colourful local art. Educational resources should be created by Aboriginal people and delivered by health professionals, family, or Aboriginal Community members in the form of brochures, videos, or yarning circles.</p><p><strong>Interpretation: </strong>The recommendations from this study will inform the development of arthritis educational resources for Aboriginal Peoples. The findings can also support health professionals to deliver evidenced-based arthritis care to Aboriginal Peoples. Internationally, a community-based participatory action research approach can be applied to develop educational resources for First Nations Peoples and communities.</p><p><strong>Funding: </strong>Australian Commonwealth Government through Arthritis Australia","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":15.0,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142796439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-05DOI: 10.1016/S2665-9913(24)00349-7
Cesar A Hincapié
{"title":"Arthritis burden projections: a call to action in Australia and beyond.","authors":"Cesar A Hincapié","doi":"10.1016/S2665-9913(24)00349-7","DOIUrl":"https://doi.org/10.1016/S2665-9913(24)00349-7","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":15.0,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142796435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-05DOI: 10.1016/S2665-9913(24)00335-7
Katherine A Collins
{"title":"The inclusion of Indigenous voices in health research.","authors":"Katherine A Collins","doi":"10.1016/S2665-9913(24)00335-7","DOIUrl":"https://doi.org/10.1016/S2665-9913(24)00335-7","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":15.0,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142796396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-25DOI: 10.1016/S2665-9913(24)00300-X
Wei-Zhen Tang , Kang-Jin Huang , Tai-Hang Liu
{"title":"Efficacy of combined immunomodulators in preventing uveitis relapses in patients with Behçet's disease on corticosteroids","authors":"Wei-Zhen Tang , Kang-Jin Huang , Tai-Hang Liu","doi":"10.1016/S2665-9913(24)00300-X","DOIUrl":"10.1016/S2665-9913(24)00300-X","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"6 12","pages":"Page e822"},"PeriodicalIF":15.0,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-25DOI: 10.1016/S2665-9913(24)00301-1
Zhenyu Zhong , Peizeng Yang
{"title":"Efficacy of combined immunomodulators in preventing uveitis relapses in patients with Behçet's disease on corticosteroids – Authors' reply","authors":"Zhenyu Zhong , Peizeng Yang","doi":"10.1016/S2665-9913(24)00301-1","DOIUrl":"10.1016/S2665-9913(24)00301-1","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"6 12","pages":"Pages e822-e823"},"PeriodicalIF":15.0,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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