Pub Date : 2026-03-01Epub Date: 2025-11-19DOI: 10.1016/S2665-9913(25)00283-8
Prof Coziana Ciurtin PhD , Junjie Peng PhD , Ruby Taylor-Gotch BSc , Hannah Peckham PhD , Robert Wilson MRes , Muthana Al Obaidi MBBS , Prof Elizabeth C Jury PhD , PReS Childhood Sjögren's Interest Group
<div><h3>Background</h3><div>Childhood-onset Sjögren's disease is a rare and under-investigated rheumatic condition. The natural course of childhood-onset Sjögren's disease in adulthood in not known. This study aimed to evaluate long-term disease trajectories and complications of childhood-onset Sjögren's disease and explore management strategies.</div></div><div><h3>Methods</h3><div>This combined retrospective and prospective analysis of a childhood-onset Sjögren's disease cohort with long-term follow-up into adulthood was done in individuals aged 13–36 years with childhood-onset Sjögren's disease recruited from a single tertiary adolescent and young adult rheumatology service at University College London Hospital, UK. Participants were either approached consecutively during routine clinical appointments, or their data were collected retrospectively from the time of diagnosis to the time of transition to the service, and prospectively thereafter. We mapped the cohort onto clinical phenotypes defined by the Florida Scoring System at disease onset and stratified them based on the Newcastle Sjögren's Stratification Tool at last assessment. Disease activity, symptom severity, and damage trajectories were assessed using European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), and Sjögren's Syndrome Disease Damage Index (SSDDI), respectively. People with related lived experience were involved in the study design and implementation.</div></div><div><h3>Findings</h3><div>Between March 1, 2020, and June 30, 2024, we identified 30 children and young people diagnosed with childhood-onset Sjögren's disease based on expert opinion. Mean age at onset was 12·7 years (SD 3·3). 28 (93%) of 30 individuals were female and two (7%) were male. The most common disease manifestations at onset were fatigue (22 [73%] of 30 individuals), arthralgia (21 [70%]), dryness (17 [57%]), glandular swelling (15 [50%]), and skin rashes (ten [30%]). Diagnostic delay of more than 3 years from symptoms onset increased the prevalence of reported dryness (nine [100%] of nine <em>vs</em> eight [38%] of 21; p=0·0014). Children and young people with childhood-onset Sjögren's disease had two distinct disease activity and symptom trajectories (high ESSDAI: mean 3·9 [SD 2·2] <em>vs</em> low ESSDAI: mean 0·8 [1·1]; p<0·0001 and high ESSPRI: mean 5·6 [2·7] <em>vs</em> low ESSPRI: mean 3·1 [1·0]; p=0·036), which could not be predicted by sex or age at onset, symptom duration, or duration of follow-up. Damage accrual did not differ based on activity and symptom trajectory (p=0·080 and p=1·0, respectively). At last review, the median ESSDAI score was 2·0 (IQR 2·0–8·0) and the ESSPRI score was 5·3 (3·0–7·0). Four (13%) of 30 patients developed lymphoma and 17 (57%) accumulated damage (SSDDI score ≥1).</div></div><div><h3>Interpretation</h3><div>This preliminary evaluation of long-term
{"title":"Clinical phenotypes, classification, and long-term outcomes of childhood-onset Sjögren's disease into adulthood: a single-centre cohort study","authors":"Prof Coziana Ciurtin PhD , Junjie Peng PhD , Ruby Taylor-Gotch BSc , Hannah Peckham PhD , Robert Wilson MRes , Muthana Al Obaidi MBBS , Prof Elizabeth C Jury PhD , PReS Childhood Sjögren's Interest Group","doi":"10.1016/S2665-9913(25)00283-8","DOIUrl":"10.1016/S2665-9913(25)00283-8","url":null,"abstract":"<div><h3>Background</h3><div>Childhood-onset Sjögren's disease is a rare and under-investigated rheumatic condition. The natural course of childhood-onset Sjögren's disease in adulthood in not known. This study aimed to evaluate long-term disease trajectories and complications of childhood-onset Sjögren's disease and explore management strategies.</div></div><div><h3>Methods</h3><div>This combined retrospective and prospective analysis of a childhood-onset Sjögren's disease cohort with long-term follow-up into adulthood was done in individuals aged 13–36 years with childhood-onset Sjögren's disease recruited from a single tertiary adolescent and young adult rheumatology service at University College London Hospital, UK. Participants were either approached consecutively during routine clinical appointments, or their data were collected retrospectively from the time of diagnosis to the time of transition to the service, and prospectively thereafter. We mapped the cohort onto clinical phenotypes defined by the Florida Scoring System at disease onset and stratified them based on the Newcastle Sjögren's Stratification Tool at last assessment. Disease activity, symptom severity, and damage trajectories were assessed using European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), and Sjögren's Syndrome Disease Damage Index (SSDDI), respectively. People with related lived experience were involved in the study design and implementation.</div></div><div><h3>Findings</h3><div>Between March 1, 2020, and June 30, 2024, we identified 30 children and young people diagnosed with childhood-onset Sjögren's disease based on expert opinion. Mean age at onset was 12·7 years (SD 3·3). 28 (93%) of 30 individuals were female and two (7%) were male. The most common disease manifestations at onset were fatigue (22 [73%] of 30 individuals), arthralgia (21 [70%]), dryness (17 [57%]), glandular swelling (15 [50%]), and skin rashes (ten [30%]). Diagnostic delay of more than 3 years from symptoms onset increased the prevalence of reported dryness (nine [100%] of nine <em>vs</em> eight [38%] of 21; p=0·0014). Children and young people with childhood-onset Sjögren's disease had two distinct disease activity and symptom trajectories (high ESSDAI: mean 3·9 [SD 2·2] <em>vs</em> low ESSDAI: mean 0·8 [1·1]; p<0·0001 and high ESSPRI: mean 5·6 [2·7] <em>vs</em> low ESSPRI: mean 3·1 [1·0]; p=0·036), which could not be predicted by sex or age at onset, symptom duration, or duration of follow-up. Damage accrual did not differ based on activity and symptom trajectory (p=0·080 and p=1·0, respectively). At last review, the median ESSDAI score was 2·0 (IQR 2·0–8·0) and the ESSPRI score was 5·3 (3·0–7·0). Four (13%) of 30 patients developed lymphoma and 17 (57%) accumulated damage (SSDDI score ≥1).</div></div><div><h3>Interpretation</h3><div>This preliminary evaluation of long-term","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"8 3","pages":"Pages e204-e216"},"PeriodicalIF":16.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145582679","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 : 2026-03-01Epub Date: 2026-01-20DOI: 10.1016/S2665-9913(25)00371-6
Prof Andrew P Cope MD , Marianna Jasenecova MSc , Joana C Vasconcelos MSc , Sumera Qureshi MD , Dr Karin A van Schie PhD , Prof Andrew Filer MD , Prof Karim Raza MD , Prof Maria Antonietta D’Agostino MD , Prof Iain B McInnes MD , Prof Stefan Siebert MD , Prof John D Isaacs MD , Arthur G Pratt MD , Prof Benjamin A Fisher MD , Prof Christopher D Buckley MD , Prof Paul Emery MD , Prof Kulveer Mankia , Pauline Ho MD , Prof Maya H Buch MD , Prof Coziana Ciurtin MD , Prof Dirkjan van Schaardenburg MD , Vanessa Quick
<div><h3>Background</h3><div>Clinical trials aimed at preventing rheumatoid arthritis in individuals at risk have had variable results. The long-term outcomes of disease interception, however, are not known. We aimed to examine the long-term effect of therapeutic intervention, with emphasis on efficacy and safety.</div></div><div><h3>Methods</h3><div>The Arthritis Prevention In the Preclinical Phase of Rheumatoid arthritis with Abatacept (APIPPRA) phase 2b, randomised controlled trial recruited 213 anti-citrullinated protein antibody (ACPA) positive individuals with arthralgia in 28 hospital-based early arthritis clinics in the UK and three in the Netherlands, randomly assigning participants to 52 weekly subcutaneous injections of 125 mg abatacept (n=110) or placebo (n=103), with another 52 weeks of follow-up. The APIPPRA Long-Term Outcome (ALTO) study extended follow-up for between 4 and 8 years and study participants and clinical assessors remained masked to treatment group. The primary outcome was the time from randomisation to development of clinical synovitis in at least three joints, rheumatoid arthritis according to American College of Rheumatology–European Alliance of Associations for Rheumatology 2010 criteria, or first treatment with disease modifying anti-rheumatic drugs, whichever was met first. The primary outcome was also stratified by autoantibody profiles defined at the time of randomisation. People with lived experience of rheumatoid arthritis had input into the APIPPRA study design. The study was registered at ISRCTN (ISRCTN-12680338), and is completed.</div></div><div><h3>Findings</h3><div>Between April 26, 2021, and Jan 31, 2023, 143 APIPPRA study participants enrolled in ALTO: 71 in the abatacept group and 72 in the placebo group (mean age 48·2 years [SD 11·2], 112 [78%] females, 31 [22%] males, 116 [81%] White). Median follow-up time from randomisation was 55 months (IQR 23–74). Primary events increased by 54 to 119. The initial between-group difference in restricted mean arthritis-free survival time observed at 2 years in APIPPRA remained significant at 4 years (4·9 months 95% CI 0·1–9·6; p=0·044), although the magnitude of this difference diminished over time. Assessments of disease activity and patient reported outcomes revealed no significant differences between groups beyond the treatment period. However, although participants with a broad autoantibody profile at baseline were at highest risk of progressing, this subgroup responded better to abatacept. There were 18 serious adverse events in the abatacept group and 13 in the placebo group; none deemed related to study drug.</div></div><div><h3>Interpretation</h3><div>In this at-risk population, 1-year treatment with abatacept delayed progression to rheumatoid arthritis for up to 4 years. Those at highest risk of progression have a broad autoantibody profile but are more responsive to abatacept treatment.</div></div><div><h3>Funding</h3><div>Bristol Myers Squibb.</div></
{"title":"Long-term outcomes of abatacept in individuals at risk of developing rheumatoid arthritis (ALTO): a randomised, double-blind, placebo-controlled trial","authors":"Prof Andrew P Cope MD , Marianna Jasenecova MSc , Joana C Vasconcelos MSc , Sumera Qureshi MD , Dr Karin A van Schie PhD , Prof Andrew Filer MD , Prof Karim Raza MD , Prof Maria Antonietta D’Agostino MD , Prof Iain B McInnes MD , Prof Stefan Siebert MD , Prof John D Isaacs MD , Arthur G Pratt MD , Prof Benjamin A Fisher MD , Prof Christopher D Buckley MD , Prof Paul Emery MD , Prof Kulveer Mankia , Pauline Ho MD , Prof Maya H Buch MD , Prof Coziana Ciurtin MD , Prof Dirkjan van Schaardenburg MD , Vanessa Quick","doi":"10.1016/S2665-9913(25)00371-6","DOIUrl":"10.1016/S2665-9913(25)00371-6","url":null,"abstract":"<div><h3>Background</h3><div>Clinical trials aimed at preventing rheumatoid arthritis in individuals at risk have had variable results. The long-term outcomes of disease interception, however, are not known. We aimed to examine the long-term effect of therapeutic intervention, with emphasis on efficacy and safety.</div></div><div><h3>Methods</h3><div>The Arthritis Prevention In the Preclinical Phase of Rheumatoid arthritis with Abatacept (APIPPRA) phase 2b, randomised controlled trial recruited 213 anti-citrullinated protein antibody (ACPA) positive individuals with arthralgia in 28 hospital-based early arthritis clinics in the UK and three in the Netherlands, randomly assigning participants to 52 weekly subcutaneous injections of 125 mg abatacept (n=110) or placebo (n=103), with another 52 weeks of follow-up. The APIPPRA Long-Term Outcome (ALTO) study extended follow-up for between 4 and 8 years and study participants and clinical assessors remained masked to treatment group. The primary outcome was the time from randomisation to development of clinical synovitis in at least three joints, rheumatoid arthritis according to American College of Rheumatology–European Alliance of Associations for Rheumatology 2010 criteria, or first treatment with disease modifying anti-rheumatic drugs, whichever was met first. The primary outcome was also stratified by autoantibody profiles defined at the time of randomisation. People with lived experience of rheumatoid arthritis had input into the APIPPRA study design. The study was registered at ISRCTN (ISRCTN-12680338), and is completed.</div></div><div><h3>Findings</h3><div>Between April 26, 2021, and Jan 31, 2023, 143 APIPPRA study participants enrolled in ALTO: 71 in the abatacept group and 72 in the placebo group (mean age 48·2 years [SD 11·2], 112 [78%] females, 31 [22%] males, 116 [81%] White). Median follow-up time from randomisation was 55 months (IQR 23–74). Primary events increased by 54 to 119. The initial between-group difference in restricted mean arthritis-free survival time observed at 2 years in APIPPRA remained significant at 4 years (4·9 months 95% CI 0·1–9·6; p=0·044), although the magnitude of this difference diminished over time. Assessments of disease activity and patient reported outcomes revealed no significant differences between groups beyond the treatment period. However, although participants with a broad autoantibody profile at baseline were at highest risk of progressing, this subgroup responded better to abatacept. There were 18 serious adverse events in the abatacept group and 13 in the placebo group; none deemed related to study drug.</div></div><div><h3>Interpretation</h3><div>In this at-risk population, 1-year treatment with abatacept delayed progression to rheumatoid arthritis for up to 4 years. Those at highest risk of progression have a broad autoantibody profile but are more responsive to abatacept treatment.</div></div><div><h3>Funding</h3><div>Bristol Myers Squibb.</div></","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"8 3","pages":"Pages e171-e180"},"PeriodicalIF":16.4,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146041852","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 : 2026-02-27DOI: 10.1016/S2665-9913(25)00378-9
Dirk Foell, Marija Jelusic, Erdal Sag, Alessandro Consolaro, Michael Poelzl, Jordi Anton
Despite major scientific advances, delivering high-quality care for children with inflammatory rheumatic and musculoskeletal diseases remains challenging. The field of paediatric rheumatology lies at the intersection of different disciplines, and requires excellent highly specialised medical expertise based on rapidly deepening knowledge in rheumatology and immunology. At the same time, this field relies on compassionate paediatricians understanding the needs of developing children as a vulnerable population. Training pathways and professional recognition vary widely between countries, and formal subspecialty accreditation is available inconsistently. Based on a Europe-wide expert survey, this Viewpoint examines why paediatric rheumatology is still not universally recognised as a distinct subspecialty and how insufficient access to formal accreditation leads to fragmented representation and low visibility of this discipline. We argue that stronger international advocacy involving patients and families is urgently required to support the sustainable development of the field and to ensure equitable, evidence-based, developmentally and psychologically appropriate care for all affected children.
{"title":"Paediatric rheumatology care in Europe: setting children and adolescents into focus.","authors":"Dirk Foell, Marija Jelusic, Erdal Sag, Alessandro Consolaro, Michael Poelzl, Jordi Anton","doi":"10.1016/S2665-9913(25)00378-9","DOIUrl":"https://doi.org/10.1016/S2665-9913(25)00378-9","url":null,"abstract":"<p><p>Despite major scientific advances, delivering high-quality care for children with inflammatory rheumatic and musculoskeletal diseases remains challenging. The field of paediatric rheumatology lies at the intersection of different disciplines, and requires excellent highly specialised medical expertise based on rapidly deepening knowledge in rheumatology and immunology. At the same time, this field relies on compassionate paediatricians understanding the needs of developing children as a vulnerable population. Training pathways and professional recognition vary widely between countries, and formal subspecialty accreditation is available inconsistently. Based on a Europe-wide expert survey, this Viewpoint examines why paediatric rheumatology is still not universally recognised as a distinct subspecialty and how insufficient access to formal accreditation leads to fragmented representation and low visibility of this discipline. We argue that stronger international advocacy involving patients and families is urgently required to support the sustainable development of the field and to ensure equitable, evidence-based, developmentally and psychologically appropriate care for all affected children.</p>","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":16.4,"publicationDate":"2026-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147345454","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 : 2026-02-18DOI: 10.1016/S2665-9913(26)00039-1
Paul Dalmas, Lionel Galicier, Mikael Ebbo, Nicolas Schleinitz
{"title":"Anti-BCMA CAR T-cell for IgG4-related disease: is this necessary?","authors":"Paul Dalmas, Lionel Galicier, Mikael Ebbo, Nicolas Schleinitz","doi":"10.1016/S2665-9913(26)00039-1","DOIUrl":"https://doi.org/10.1016/S2665-9913(26)00039-1","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":16.4,"publicationDate":"2026-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146776748","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 : 2026-02-09DOI: 10.1016/S2665-9913(25)00313-3
Nadia E Aikawa, Ana C Medeiros-Ribeiro, Sandra G Pasoto, Leonard V K Kupa, Luciana P C Seguro, Ana P Luppino-Assad, Eduardo F Borba, Carla G S Saad, Emily F N Yuki, Danieli C O Andrade, Andrea Y Shimabuco, Karina R Bonfiglioli, Diogo S Domiciano, Julio C B Moares, Samuel K Shinjo, Percival D Sampaio-Barros, Henrique A M Giardini, João C S de Oliveira, Isabele P B Antonelli, Renata L P Mello, Thais B Gorayeb, Lucas G N Farias, Andrea A Negrini, Fernanda G G Chaer, Ana C S L Praxedes, Marta H Lopes, Clovis A Silva, Eloisa Bonfa
<p><strong>Background: </strong>Patients with autoimmune rheumatic diseases are at high risk of developing herpes zoster due to immunosuppressive treatment. We evaluated the effect of a recombinant zoster vaccine in patients with autoimmune rheumatic diseases compared with placebo and in healthy controls.</p><p><strong>Methods: </strong>This single-centre, double-blind, randomised, placebo-controlled, phase 4, non-inferiority, study was done at a tertiary centre in Brazil. Eligible patients were aged 18 years or older with an autoimmune rheumatic disease diagnosis. All patients had to have been managed with glucocorticoids, immunosuppressives, or disease-modifying antirheumatic drugs, provided the doses were stable for at least 4-12 weeks before the initial study visit. Patients were randomly assigned (1:1) to receive two doses of recombinant zoster vaccine or placebo, 6 weeks apart, according to computer-generated sequences, without blocks or stratification. Investigators and participants were masked to treatment allocation. Healthy controls were also included from the same centre and received two doses of the recombinant zoster vaccine. Following the double-blind phase, patients with autoimmune rheumatic diseases who initially received placebo entered an open-label phase and received two doses of the vaccine. The primary outcome was the number of patients with autoimmune rheumatic diseases with worsening of disease activity (flare) up to day 84 after the first dose of the recombinant zoster vaccine compared with placebo in the double-blind phase of the study. Non-inferiority of recombinant zoster vaccine would be declared if the upper boundary of the one-sided 95% CI for the rate of worsening in disease activity in the group receiving recombinant zoster vaccine versus the placebo group was less than 5%. The primary analysis (flare rates) and the safety analysis were done in all participants who received at least one vaccine dose. There was no involvement of people with lived experience of autoimmune rheumatic diseases in the study design. The study is registered with ClinicalTrials.gov (NCT05879419) and is complete.</p><p><strong>Findings: </strong>Between May 25, 2023, and Nov 27, 2024, 1192 patients were enrolled in the study and were randomly assigned to receive either the recombinant zoster vaccine (n=590) or placebo (n=602). 559 (95%) of 590 patients in the recombinant vaccine group and 577 (96%) of 602 in the placebo group received at least one dose of the recombinant zoster vaccine or placebo and were included in the primary outcome and safety analyses; 891 (78%) of 1136 were female, 245 (22%) were male, 555 (49%) were of African descent, and 552 (49%) were White. An additional 393 healthy controls were enrolled in the study: 380 received both doses of the recombinant zoster vaccine and were included in the safety analyses. For the primary outcome of worsening of disease activity (flare) up to day 84 for patients with autoimmune rheumati
背景：自身免疫性风湿病患者由于免疫抑制治疗，发生带状疱疹的风险很高。我们评估了重组带状疱疹疫苗在自身免疫性风湿病患者中的效果，并与安慰剂和健康对照进行了比较。方法：这项单中心、双盲、随机、安慰剂对照、4期、非劣效性研究在巴西的一个三级研究中心进行。符合条件的患者年龄在18岁或以上，诊断为自身免疫性风湿病。所有患者必须使用糖皮质激素、免疫抑制剂或改善疾病的抗风湿药物，前提是在初始研究访问前至少4-12周剂量稳定。根据计算机生成的序列，患者被随机分配（1:1）接受两剂重组带状疱疹疫苗或安慰剂，间隔6周，没有分组或分层。调查人员和参与者对治疗分配不知情。来自同一中心的健康对照者也接受了两剂重组带状疱疹疫苗。在双盲阶段之后，最初接受安慰剂的自身免疫性风湿病患者进入开放标签阶段，并接受两剂疫苗。主要结局是在双盲研究阶段，与安慰剂相比，在第一次接种重组带状疱疹疫苗后84天，自身免疫性风湿病患者的疾病活动性恶化（发作）的数量。如果接受重组带状疱疹疫苗组与安慰剂组的疾病活动性恶化率的单侧95% CI的上边界小于5%，则宣布重组带状疱疹疫苗的非劣效性。初步分析（爆发率）和安全性分析是在所有接种了至少一剂疫苗的参与者中进行的。在研究设计中没有涉及有自身免疫性风湿病生活经历的人。该研究已在ClinicalTrials.gov注册（NCT05879419），并且已经完成。研究结果：在2023年5月25日至2024年11月27日期间，1192名患者被纳入研究，并被随机分配接受重组带状疱疹疫苗（n=590）或安慰剂（n=602）。重组疫苗组590名患者中有559名（95%）和安慰剂组602名患者中有577名（96%）接受了至少一剂重组带状疱疹疫苗或安慰剂，并被纳入主要结局和安全性分析；1136人中女性891人（78%），男性245人（22%），非洲裔555人（49%），白人552人（49%）。另外393名健康对照者被纳入研究：380人接受了两剂重组带状疱疹疫苗，并被纳入安全性分析。对于自身免疫性风湿性疾病患者疾病活动性恶化（发作）至第84天的主要结局，重组带状疱疹疫苗组与安慰剂组相比无劣效性。重组带状疱疹疫苗组的559例患者中有80例（14%）发生耀斑，而安慰剂组的557例患者中有84例（15%）发生耀斑，相当于耀斑率的组间差异为- 0.2% （95% CI - 4.7至2.2；非效性= 0.0018）。与健康对照组相比，自身免疫性风湿病患者两种疫苗剂量后报告的不良事件较少（第一次剂量后：重组带状疱疹疫苗组559例中有430例[77%]，安慰剂组577例中有179例[31%]，健康对照组380例中有341例[90%]；第二次剂量后：402例[72%]，148例[26%]，307例[81%]）。在第一剂（5例[1%]vs 6例[1%]vs无）和第二剂（9例[2%]vs 5例[1%]vs 2例[1%]）接种重组带状疱疹疫苗后，各组的严重不良事件相似。解释：重组带状疱疹疫苗在免疫抑制的自身免疫性风湿病患者中具有可接受的安全性，并且对短期疾病活动无显著影响。资助：葛兰素史克公司和圣保罗国家安全基金 o de Amparo 。
{"title":"Recombinant herpes zoster vaccine in patients with autoimmune rheumatic diseases in Brazil: a double-blind, randomised, placebo-controlled, phase 4, non-inferiority study.","authors":"Nadia E Aikawa, Ana C Medeiros-Ribeiro, Sandra G Pasoto, Leonard V K Kupa, Luciana P C Seguro, Ana P Luppino-Assad, Eduardo F Borba, Carla G S Saad, Emily F N Yuki, Danieli C O Andrade, Andrea Y Shimabuco, Karina R Bonfiglioli, Diogo S Domiciano, Julio C B Moares, Samuel K Shinjo, Percival D Sampaio-Barros, Henrique A M Giardini, João C S de Oliveira, Isabele P B Antonelli, Renata L P Mello, Thais B Gorayeb, Lucas G N Farias, Andrea A Negrini, Fernanda G G Chaer, Ana C S L Praxedes, Marta H Lopes, Clovis A Silva, Eloisa Bonfa","doi":"10.1016/S2665-9913(25)00313-3","DOIUrl":"https://doi.org/10.1016/S2665-9913(25)00313-3","url":null,"abstract":"<p><strong>Background: </strong>Patients with autoimmune rheumatic diseases are at high risk of developing herpes zoster due to immunosuppressive treatment. We evaluated the effect of a recombinant zoster vaccine in patients with autoimmune rheumatic diseases compared with placebo and in healthy controls.</p><p><strong>Methods: </strong>This single-centre, double-blind, randomised, placebo-controlled, phase 4, non-inferiority, study was done at a tertiary centre in Brazil. Eligible patients were aged 18 years or older with an autoimmune rheumatic disease diagnosis. All patients had to have been managed with glucocorticoids, immunosuppressives, or disease-modifying antirheumatic drugs, provided the doses were stable for at least 4-12 weeks before the initial study visit. Patients were randomly assigned (1:1) to receive two doses of recombinant zoster vaccine or placebo, 6 weeks apart, according to computer-generated sequences, without blocks or stratification. Investigators and participants were masked to treatment allocation. Healthy controls were also included from the same centre and received two doses of the recombinant zoster vaccine. Following the double-blind phase, patients with autoimmune rheumatic diseases who initially received placebo entered an open-label phase and received two doses of the vaccine. The primary outcome was the number of patients with autoimmune rheumatic diseases with worsening of disease activity (flare) up to day 84 after the first dose of the recombinant zoster vaccine compared with placebo in the double-blind phase of the study. Non-inferiority of recombinant zoster vaccine would be declared if the upper boundary of the one-sided 95% CI for the rate of worsening in disease activity in the group receiving recombinant zoster vaccine versus the placebo group was less than 5%. The primary analysis (flare rates) and the safety analysis were done in all participants who received at least one vaccine dose. There was no involvement of people with lived experience of autoimmune rheumatic diseases in the study design. The study is registered with ClinicalTrials.gov (NCT05879419) and is complete.</p><p><strong>Findings: </strong>Between May 25, 2023, and Nov 27, 2024, 1192 patients were enrolled in the study and were randomly assigned to receive either the recombinant zoster vaccine (n=590) or placebo (n=602). 559 (95%) of 590 patients in the recombinant vaccine group and 577 (96%) of 602 in the placebo group received at least one dose of the recombinant zoster vaccine or placebo and were included in the primary outcome and safety analyses; 891 (78%) of 1136 were female, 245 (22%) were male, 555 (49%) were of African descent, and 552 (49%) were White. An additional 393 healthy controls were enrolled in the study: 380 received both doses of the recombinant zoster vaccine and were included in the safety analyses. For the primary outcome of worsening of disease activity (flare) up to day 84 for patients with autoimmune rheumati","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":16.4,"publicationDate":"2026-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146183013","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 : 2026-02-06DOI: 10.1016/S2665-9913(25)00344-3
Madeleine Ngandeu-Singwe, Jan René Nkeck, Aghiles Hamroun, Francky Teddy Endomba, Caroline Ngoufack-Tientcheu, Aude Laetitia Ndoadoumgue, Baudelaire Talongong Fojo, Anderson T Ngouo, Dahlia Noelle Tounouga, Jeriel Pascal Nkeck, Emilie Letticia Youda, Estelle Amandine Well, Jean Joel Bigna
<p><strong>Background: </strong>Hyperuricaemia is not currently included in major global health surveillance frameworks, including the Global Burden of Diseases, Injuries, and Risk Factors Study, despite its well established clinical associations with non-communicable diseases. The absence of harmonised, comparable sex-specific prevalence estimates of hyperuricaemia across countries has limited its visibility in public health planning and prevention strategies. We aimed to provide the first standardised, sex-specific, global, regional, and national estimates of hyperuricaemia prevalence and cases from 2000 to 2023.</p><p><strong>Methods: </strong>For this systematic review and modelling analysis, we searched PubMed, EMBASE, and Global Index Medicus for population-based studies reporting hyperuricaemia prevalence in adults between Jan 1, 2000, and April 8, 2025, without any language restrictions. Accounting for age, sex, hyperuricaemia diagnostic thresholds, urbanisation, and national income, prevalence estimates were generated with Bayesian hierarchical metaregression for 200 countries and territories from 2000 to 2023, with uncertainty expressed as 95% credible intervals (CrIs). No individuals with lived experience of hyperuricaemia were involved in the design or conduct of the study. The protocol was registered with PROSPERO (CRD420251145761).</p><p><strong>Findings: </strong>We included 402 reports (420 studies) comprising 709 prevalence data points from 7 488 451 adults in 34 countries. Globally, the prevalence of hyperuricaemia increased from 6·7% (95% CrI 5·0-9·5) to 11·2% (8·2-15·2) in women and from 12·3% (9·8-17·0) to 18·6% (14·6-25·1) in men between 2000 and 2023. Prevalent cases of hyperuricaemia rose from 126 million (95% CrI 93-178) to 305 million (222-414) in women and from 226 million (180-312) to 500 million (392-676) in men, with population growth and ageing explaining roughly half the increase. Prevalence was consistently higher in high-income and urban settings, and increased with age in both men and women, with sex differences narrowing in older age groups. Prevalence rose in all regions, with the largest absolute increases in Polynesia and Micronesia among women (9·2 [95% CrI 2·9-10·9] percentage points) and in East Asia among men (10·8 [10·7-10·9] percentage points). In 2023, regional prevalence in women ranged from 4·0% (95% CrI 2·8-5·9) in North Africa and the Middle East to 42·6% (17·3-61·9) in Polynesia and Micronesia, and in men it ranged from 7·5% (4·9-11·2) in central Asia to 36·5% (12·0-66·8) in Polynesia and Micronesia. South Asia had the highest number of prevalent cases in 2023 (102 million [95% CrI 33-196] women and 120 million [37-266] men). At the country level, between 2000 and 2023, prevalence increased in 199 countries and territories among women and in 195 countries and territories among men. In 2023, country-level prevalence ranged from 1·4% (95% CrI 1·0-2·1) in Yemen to 55·8% (22·6-75·8) in the Cook Islan
{"title":"Worldwide trends in hyperuricaemia from 2000 to 2023: a systematic review and modelling analysis.","authors":"Madeleine Ngandeu-Singwe, Jan René Nkeck, Aghiles Hamroun, Francky Teddy Endomba, Caroline Ngoufack-Tientcheu, Aude Laetitia Ndoadoumgue, Baudelaire Talongong Fojo, Anderson T Ngouo, Dahlia Noelle Tounouga, Jeriel Pascal Nkeck, Emilie Letticia Youda, Estelle Amandine Well, Jean Joel Bigna","doi":"10.1016/S2665-9913(25)00344-3","DOIUrl":"https://doi.org/10.1016/S2665-9913(25)00344-3","url":null,"abstract":"<p><strong>Background: </strong>Hyperuricaemia is not currently included in major global health surveillance frameworks, including the Global Burden of Diseases, Injuries, and Risk Factors Study, despite its well established clinical associations with non-communicable diseases. The absence of harmonised, comparable sex-specific prevalence estimates of hyperuricaemia across countries has limited its visibility in public health planning and prevention strategies. We aimed to provide the first standardised, sex-specific, global, regional, and national estimates of hyperuricaemia prevalence and cases from 2000 to 2023.</p><p><strong>Methods: </strong>For this systematic review and modelling analysis, we searched PubMed, EMBASE, and Global Index Medicus for population-based studies reporting hyperuricaemia prevalence in adults between Jan 1, 2000, and April 8, 2025, without any language restrictions. Accounting for age, sex, hyperuricaemia diagnostic thresholds, urbanisation, and national income, prevalence estimates were generated with Bayesian hierarchical metaregression for 200 countries and territories from 2000 to 2023, with uncertainty expressed as 95% credible intervals (CrIs). No individuals with lived experience of hyperuricaemia were involved in the design or conduct of the study. The protocol was registered with PROSPERO (CRD420251145761).</p><p><strong>Findings: </strong>We included 402 reports (420 studies) comprising 709 prevalence data points from 7 488 451 adults in 34 countries. Globally, the prevalence of hyperuricaemia increased from 6·7% (95% CrI 5·0-9·5) to 11·2% (8·2-15·2) in women and from 12·3% (9·8-17·0) to 18·6% (14·6-25·1) in men between 2000 and 2023. Prevalent cases of hyperuricaemia rose from 126 million (95% CrI 93-178) to 305 million (222-414) in women and from 226 million (180-312) to 500 million (392-676) in men, with population growth and ageing explaining roughly half the increase. Prevalence was consistently higher in high-income and urban settings, and increased with age in both men and women, with sex differences narrowing in older age groups. Prevalence rose in all regions, with the largest absolute increases in Polynesia and Micronesia among women (9·2 [95% CrI 2·9-10·9] percentage points) and in East Asia among men (10·8 [10·7-10·9] percentage points). In 2023, regional prevalence in women ranged from 4·0% (95% CrI 2·8-5·9) in North Africa and the Middle East to 42·6% (17·3-61·9) in Polynesia and Micronesia, and in men it ranged from 7·5% (4·9-11·2) in central Asia to 36·5% (12·0-66·8) in Polynesia and Micronesia. South Asia had the highest number of prevalent cases in 2023 (102 million [95% CrI 33-196] women and 120 million [37-266] men). At the country level, between 2000 and 2023, prevalence increased in 199 countries and territories among women and in 195 countries and territories among men. In 2023, country-level prevalence ranged from 1·4% (95% CrI 1·0-2·1) in Yemen to 55·8% (22·6-75·8) in the Cook Islan","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":16.4,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146151075","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 : 2026-02-06DOI: 10.1016/S2665-9913(26)00045-7
Jackie Duda
{"title":"Bad bones: how a landmark US FDA decision could help patients with osteoporosis.","authors":"Jackie Duda","doi":"10.1016/S2665-9913(26)00045-7","DOIUrl":"https://doi.org/10.1016/S2665-9913(26)00045-7","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":16.4,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146151009","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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