Pub Date : 2026-02-02DOI: 10.1016/j.semarthrit.2026.152939
Jozélio Freire de Carvalho, Cezar Augusto Muniz Caldas
<p><strong>Background: </strong>Granulocyte colony-stimulating factor (G-CSF) and its PEGylated formulation (pegfilgrastim) are indispensable for preventing chemotherapy-induced neutropenia and for stem-cell mobilization. Beyond hematopoiesis, G-CSF modulates innate/adaptive immunity and may precipitate immune-mediated events in susceptible hosts. Clinical signals span large-vessel vasculitis/aortitis and non-vascular neutrophil-dominant phenotypes, yet timing, spectrum, and management remain variably characterized.</p><p><strong>Objective: </strong>To identify and synthesize primary clinical reports of autoimmune/rheumatic disease triggered or exacerbated by exogenous G-CSF (filgrastim or pegfilgrastim), describing phenotypes, latency, management, outcomes, and implications for practice.</p><p><strong>Methods: </strong>We performed a narrative review of primary clinical studies, including observational cohorts and case reports or short case series, identified through targeted searches of PubMed/MEDLINE, Scopus, and Embase, complemented by investigator-curated references. Eligible reports described autoimmune, inflammatory, or rheumatic manifestations occurring after exposure to exogenous G-CSF. Predefined phenotypes included large-vessel vasculitis/aortitis; neutrophilic dermatoses (e.g., Sweet's syndrome, neutrophilic dermatosis of the dorsal hands); cutaneous small-vessel vasculitis; inflammatory or crystal arthritis (e.g., calcium pyrophosphate deposition disease); pulmonary inflammatory injury (e.g., diffuse alveolar hemorrhage); and clear flares of established autoimmune disease. Narrative or mechanistic reviews and trials of GM-CSF pathway blockade were excluded from qualitative synthesis.</p><p><strong>Results: </strong>Twenty-four studies met inclusion criteria: two observational cohorts and twenty-two single-patient reports/short series. Cohorts quantified a low but reproducible burden of pegfilgrastim-associated aortitis, with stereotyped involvement of the aortic arch/proximal branches and typical latency of 7-15 days. Case-level data confirmed marked elevation of acute phase reactants, usually negative autoantibodies, favorable outcomes after G-CSF withdrawal with or without short glucocorticoid courses, and recurrence/migration on re-exposure. Non-vascular events clustered earlier (2-7 days) and included biopsy-proven Sweet's/NDDH, leukocytoclastic vasculitis, CPPD flares, and rare diffuse alveolar hemorrhage; granulomatous dermatitis and perioperative pyoderma gangrenosum were also observed. Re-exposure information suggested phenotype-specific risk: recurrent CPPD with pegfilgrastim was mitigated by switching to short-acting filgrastim; selected limited aortitis resolved without steroids; refractory aortitis responded to IL-6 blockade, enabling uninterrupted chemotherapy.</p><p><strong>Conclusions: </strong>Exogenous G-CSF can precipitate a coherent spectrum of immune-mediated toxicity with distinct, clinically actionable timing wi
{"title":"From Aortitis to Sweet's: The Immune Spectrum of G-CSF Adverse Events.","authors":"Jozélio Freire de Carvalho, Cezar Augusto Muniz Caldas","doi":"10.1016/j.semarthrit.2026.152939","DOIUrl":"https://doi.org/10.1016/j.semarthrit.2026.152939","url":null,"abstract":"<p><strong>Background: </strong>Granulocyte colony-stimulating factor (G-CSF) and its PEGylated formulation (pegfilgrastim) are indispensable for preventing chemotherapy-induced neutropenia and for stem-cell mobilization. Beyond hematopoiesis, G-CSF modulates innate/adaptive immunity and may precipitate immune-mediated events in susceptible hosts. Clinical signals span large-vessel vasculitis/aortitis and non-vascular neutrophil-dominant phenotypes, yet timing, spectrum, and management remain variably characterized.</p><p><strong>Objective: </strong>To identify and synthesize primary clinical reports of autoimmune/rheumatic disease triggered or exacerbated by exogenous G-CSF (filgrastim or pegfilgrastim), describing phenotypes, latency, management, outcomes, and implications for practice.</p><p><strong>Methods: </strong>We performed a narrative review of primary clinical studies, including observational cohorts and case reports or short case series, identified through targeted searches of PubMed/MEDLINE, Scopus, and Embase, complemented by investigator-curated references. Eligible reports described autoimmune, inflammatory, or rheumatic manifestations occurring after exposure to exogenous G-CSF. Predefined phenotypes included large-vessel vasculitis/aortitis; neutrophilic dermatoses (e.g., Sweet's syndrome, neutrophilic dermatosis of the dorsal hands); cutaneous small-vessel vasculitis; inflammatory or crystal arthritis (e.g., calcium pyrophosphate deposition disease); pulmonary inflammatory injury (e.g., diffuse alveolar hemorrhage); and clear flares of established autoimmune disease. Narrative or mechanistic reviews and trials of GM-CSF pathway blockade were excluded from qualitative synthesis.</p><p><strong>Results: </strong>Twenty-four studies met inclusion criteria: two observational cohorts and twenty-two single-patient reports/short series. Cohorts quantified a low but reproducible burden of pegfilgrastim-associated aortitis, with stereotyped involvement of the aortic arch/proximal branches and typical latency of 7-15 days. Case-level data confirmed marked elevation of acute phase reactants, usually negative autoantibodies, favorable outcomes after G-CSF withdrawal with or without short glucocorticoid courses, and recurrence/migration on re-exposure. Non-vascular events clustered earlier (2-7 days) and included biopsy-proven Sweet's/NDDH, leukocytoclastic vasculitis, CPPD flares, and rare diffuse alveolar hemorrhage; granulomatous dermatitis and perioperative pyoderma gangrenosum were also observed. Re-exposure information suggested phenotype-specific risk: recurrent CPPD with pegfilgrastim was mitigated by switching to short-acting filgrastim; selected limited aortitis resolved without steroids; refractory aortitis responded to IL-6 blockade, enabling uninterrupted chemotherapy.</p><p><strong>Conclusions: </strong>Exogenous G-CSF can precipitate a coherent spectrum of immune-mediated toxicity with distinct, clinically actionable timing wi","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"77 ","pages":"152939"},"PeriodicalIF":4.4,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146143468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: Immune checkpoint inhibitors (ICIs) are increasingly used in oncology, but concerns persist regarding flare risks of pre-existing rheumatologic diseases in patients receiving ICIs. This meta-analysis study aims to evaluate the incidence and severity of rheumatologic disease flares in patients with solid tumors treated with ICIs.
Methods: We searched PubMed and Embase through May 2024 to identify studies reporting the incidences of pre-existing rheumatologic disease flare due to ICIs for their cancer. A random-effects proportional meta-analysis was conducted to pool the incidence of grade 1-5 and grade 3-5 flares, stratified by rheumatologic disease types and ICI subtypes.
Results: In total, 31 studies comprising more than 700 patients were identified for meta-analyses. The pooled incidence of grade 1-5 flare was 33.8% (95% confidence interval [CI]: 25.8-42.2%), with a median onset of 38.5 days (IQR: 30.0-52.6) after ICI initiation. Grade 3-5 flare incidence rate was 4.2% (95% CI: 0.6-9.6). Flare incidences varied among rheumatologic diseases: 40.9% in rheumatoid arthritis, 46.4% in psoriatic arthritis, 11.3% in systemic sclerosis, and 3.8% in systemic lupus erythematosus, respectively. For disease flares, 83% (n = 134/161) received systemic corticosteroids, and 81% (n = 30/37) of such cases had clinical improvement. ICIs were permanently discontinued in 17% of flare cases.
Conclusions: Incidences of rheumatologic disease flare from ICIs vary depending on the underlying rheumatologic condition. This underscores the need for close communication between rheumatologists and oncologists to assess risk of flares prior to ICI initiation and manage both rheumatologic disease and cancer after the incidences of disease flares.
{"title":"Flare incidences of pre-existing rheumatologic diseases in patients with solid tumors receiving immune checkpoint inhibitors: A systematic review and meta-analysis.","authors":"Kenji Yamada, Takemichi Matsui, Toshiaki Takahashi, Yoshito Nishimura, Yu Fujiwara","doi":"10.1016/j.semarthrit.2026.152938","DOIUrl":"https://doi.org/10.1016/j.semarthrit.2026.152938","url":null,"abstract":"<p><strong>Objectives: </strong>Immune checkpoint inhibitors (ICIs) are increasingly used in oncology, but concerns persist regarding flare risks of pre-existing rheumatologic diseases in patients receiving ICIs. This meta-analysis study aims to evaluate the incidence and severity of rheumatologic disease flares in patients with solid tumors treated with ICIs.</p><p><strong>Methods: </strong>We searched PubMed and Embase through May 2024 to identify studies reporting the incidences of pre-existing rheumatologic disease flare due to ICIs for their cancer. A random-effects proportional meta-analysis was conducted to pool the incidence of grade 1-5 and grade 3-5 flares, stratified by rheumatologic disease types and ICI subtypes.</p><p><strong>Results: </strong>In total, 31 studies comprising more than 700 patients were identified for meta-analyses. The pooled incidence of grade 1-5 flare was 33.8% (95% confidence interval [CI]: 25.8-42.2%), with a median onset of 38.5 days (IQR: 30.0-52.6) after ICI initiation. Grade 3-5 flare incidence rate was 4.2% (95% CI: 0.6-9.6). Flare incidences varied among rheumatologic diseases: 40.9% in rheumatoid arthritis, 46.4% in psoriatic arthritis, 11.3% in systemic sclerosis, and 3.8% in systemic lupus erythematosus, respectively. For disease flares, 83% (n = 134/161) received systemic corticosteroids, and 81% (n = 30/37) of such cases had clinical improvement. ICIs were permanently discontinued in 17% of flare cases.</p><p><strong>Conclusions: </strong>Incidences of rheumatologic disease flare from ICIs vary depending on the underlying rheumatologic condition. This underscores the need for close communication between rheumatologists and oncologists to assess risk of flares prior to ICI initiation and manage both rheumatologic disease and cancer after the incidences of disease flares.</p>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"77 ","pages":"152938"},"PeriodicalIF":4.4,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146126341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-28DOI: 10.1016/j.semarthrit.2026.152936
Xiaonan Wang
{"title":"Letter to “Development of a prediction model for progression of rheumatoid arthritis-associated interstitial lung disease using serologic and clinical factors: The prospective KORAIL cohort”","authors":"Xiaonan Wang","doi":"10.1016/j.semarthrit.2026.152936","DOIUrl":"10.1016/j.semarthrit.2026.152936","url":null,"abstract":"","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"77 ","pages":"Article 152936"},"PeriodicalIF":4.4,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146078671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-23DOI: 10.1016/j.semarthrit.2026.152931
Sung Hae Chang , Misti L. Paudel , Eun Young Lee , Jeffrey A. Sparks
{"title":"Response to Wang regarding correspondence to “Development of a prediction model for progression of rheumatoid arthritis-associated interstitial lung disease using serologic and clinical factors: The prospective KORAIL cohort”","authors":"Sung Hae Chang , Misti L. Paudel , Eun Young Lee , Jeffrey A. Sparks","doi":"10.1016/j.semarthrit.2026.152931","DOIUrl":"10.1016/j.semarthrit.2026.152931","url":null,"abstract":"","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"77 ","pages":"Article 152931"},"PeriodicalIF":4.4,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146078675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-23DOI: 10.1016/j.semarthrit.2026.152933
Ruiyan Xie , Lai Yee Cheong , Danting Zhang , Kevin C.H. Wu , Shirley C.W. Chan , Ivan Au , Kathy S.M. Leung , Joseph T.K. Wu , Tak Mao Chan , Desmond Y.H. Yap
Objectives
The relationships between vaccines and the development of systemic lupus erythematosus (SLE) and related organ involvements remain unclear.
Methods
We analyzed data from the Vaccine Adverse Event Reporting System (VAERS) during the period of 1990 to 2025 to determine the incidence of vaccine-associated SLE over time. The relationships between vaccines and the development of SLE and organ involvements were assessed by disproportionality and case-control analyses.
Results
1976 (0.017%) cases of vaccine-associated lupus were identified amongst 11,301,263 adverse events (AEs) reported in VAERS (1990-2025). Median time from vaccination to symptom onset was 8 (0-8,070) days. The most common manifestations are musculoskeletal and connective tissue disorders (82.94%) followed by skin and subcutaneous tissue lesions (10.83%), while kidney and nervous system involvements are rare. 702 (40.48%) patients had serious outcomes, and 22 (3.13%) died. Human papilloma virus (HPV) vaccine is associated with lupus AEs, especially musculoskeletal/connective tissue disorders, kidney and nervous system involvements. Hepatitis B virus (HBV) vaccine also shows correlations with lupus AEs, particularly musculoskeletal/connective tissue disorders. COVID-19, influenza and zoster vaccines show no relationship with lupus AEs and specific organ involvements. Recombinant protein vaccines show significant links with lupus AEs.
Conclusion
Vaccine-associated lupus is uncommon and manifestations are generally mild. HPV and HBV vaccines show strong associations with lupus AEs with distinct organ involvements.
{"title":"Vaccine-associated lupus and related organ involvements: A pharmacovigilance analysis of VAERS database 1990–2025","authors":"Ruiyan Xie , Lai Yee Cheong , Danting Zhang , Kevin C.H. Wu , Shirley C.W. Chan , Ivan Au , Kathy S.M. Leung , Joseph T.K. Wu , Tak Mao Chan , Desmond Y.H. Yap","doi":"10.1016/j.semarthrit.2026.152933","DOIUrl":"10.1016/j.semarthrit.2026.152933","url":null,"abstract":"<div><h3>Objectives</h3><div>The relationships between vaccines and the development of systemic lupus erythematosus (SLE) and related organ involvements remain unclear.</div></div><div><h3>Methods</h3><div>We analyzed data from the Vaccine Adverse Event Reporting System (VAERS) during the period of 1990 to 2025 to determine the incidence of vaccine-associated SLE over time. The relationships between vaccines and the development of SLE and organ involvements were assessed by disproportionality and case-control analyses.</div></div><div><h3>Results</h3><div>1976 (0.017%) cases of vaccine-associated lupus were identified amongst 11,301,263 adverse events (AEs) reported in VAERS (1990-2025). Median time from vaccination to symptom onset was 8 (0-8,070) days. The most common manifestations are musculoskeletal and connective tissue disorders (82.94%) followed by skin and subcutaneous tissue lesions (10.83%), while kidney and nervous system involvements are rare. 702 (40.48%) patients had serious outcomes, and 22 (3.13%) died. Human papilloma virus (HPV) vaccine is associated with lupus AEs, especially musculoskeletal/connective tissue disorders, kidney and nervous system involvements. Hepatitis B virus (HBV) vaccine also shows correlations with lupus AEs, particularly musculoskeletal/connective tissue disorders. COVID-19, influenza and zoster vaccines show no relationship with lupus AEs and specific organ involvements. Recombinant protein vaccines show significant links with lupus AEs.</div></div><div><h3>Conclusion</h3><div>Vaccine-associated lupus is uncommon and manifestations are generally mild. HPV and HBV vaccines show strong associations with lupus AEs with distinct organ involvements.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"77 ","pages":"Article 152933"},"PeriodicalIF":4.4,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146078670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-23DOI: 10.1016/j.semarthrit.2026.152925
Francesco Carubbi , Alessia Alunno , Salvatore Di Bartolomeo , Maria Ester Carugno , Fabiana Di Vincenzo , Marianna Litterio , Claudio Ferri
Objectives
Immunoglobulin (Ig)G4-related disease (IgG4-RD) can affect any organ, but coronary artery involvement (CAI) is a potentially life-threatening manifestation of this disease. In this scoping review, we critically appraised the literature on IgG4-related CAI, aiming to explore clinical, radiological and histopathological characteristics as well as treatment strategies and prognosis.
Methods
A comprehensive search was performed on January 02, 2025 in PubMed® to identify studies describing individuals with IgG4-related CAI, including both coronaritis (true arteritis of the coronary vessel wall) and periarteritis (peri-coronary involvement), and considering case reports, case series, retrospective cohort studies and observational studies. Two reviewers independently conducted the revision of literature under the guidance of the methodologist to identify eligible studies. Data extraction included clinical presentation, imaging findings, histopathology, treatment, and outcomes. Given the heterogeneity of the studies, descriptive statistical analysis was used whenever possible to summarise the data.
Results
Out of 964 screened references, 143 articles met the above-mentioned inclusion criteria. Most CAI cases were included in case reports (90.2 %), 7 % in case series and 2.8 % in retrospective cohort studies or observational studies. CAI predominantly affected males in the sixth decade of life and frequently coexisted with aortic and large vessel involvement. All segments of the coronary arterial tree could be involved, even the smallest branches. Images detected by various methods revealed several types of lesions: stenosis, wall-thickening, aneurysm, ectasia, pseudotumor, pseudoaneurysm, dissection, and soft tissue masses. Increase serum IgG4 levels and increased inflammatory markers were reported. Histopathology was consistent with IgG4-RD in all coronary samples obtained. Glucocorticoid therapy, alone or combined with immunosuppressants and/or surgical interventions, was the most commonly reported treatment. Rituximab seemed to be an effective therapy for IgG4-related CAI even without associated glucocorticoids. Despite treatment, relapse and progression of coronary lesions were noted in some cases.
Conclusions
Early identification and multidisciplinary management og IgG4-related CAI are crucial to reduce morbidity and mortality. Available data on the response to various treatments are limited, as dedicated coronary artery imaging was not consistently obtained soon enough after treatment to assess response. In addition, long-term follow-up was not available for all patients. Further studies are required to understand the real prevalence, natural history, optimal diagnostic strategies, and therapeutic approaches for this serious condition.
{"title":"IgG4 related coronary artery involvement: A scoping review of the literature","authors":"Francesco Carubbi , Alessia Alunno , Salvatore Di Bartolomeo , Maria Ester Carugno , Fabiana Di Vincenzo , Marianna Litterio , Claudio Ferri","doi":"10.1016/j.semarthrit.2026.152925","DOIUrl":"10.1016/j.semarthrit.2026.152925","url":null,"abstract":"<div><h3>Objectives</h3><div>Immunoglobulin (Ig)G4-related disease (IgG4-RD) can affect any organ, but coronary artery involvement (CAI) is a potentially life-threatening manifestation of this disease. In this scoping review, we critically appraised the literature on IgG4-related CAI, aiming to explore clinical, radiological and histopathological characteristics as well as treatment strategies and prognosis.</div></div><div><h3>Methods</h3><div>A comprehensive search was performed on January 02, 2025 in PubMed® to identify studies describing individuals with IgG4-related CAI, including both coronaritis (true arteritis of the coronary vessel wall) and periarteritis (peri-coronary involvement), and considering case reports, case series, retrospective cohort studies and observational studies. Two reviewers independently conducted the revision of literature under the guidance of the methodologist to identify eligible studies. Data extraction included clinical presentation, imaging findings, histopathology, treatment, and outcomes. Given the heterogeneity of the studies, descriptive statistical analysis was used whenever possible to summarise the data.</div></div><div><h3>Results</h3><div>Out of 964 screened references, 143 articles met the above-mentioned inclusion criteria. Most CAI cases were included in case reports (90.2 %), 7 % in case series and 2.8 % in retrospective cohort studies or observational studies. CAI predominantly affected males in the sixth decade of life and frequently coexisted with aortic and large vessel involvement. All segments of the coronary arterial tree could be involved, even the smallest branches. Images detected by various methods revealed several types of lesions: stenosis, wall-thickening, aneurysm, ectasia, pseudotumor, pseudoaneurysm, dissection, and soft tissue masses. Increase serum IgG4 levels and increased inflammatory markers were reported. Histopathology was consistent with IgG4-RD in all coronary samples obtained. Glucocorticoid therapy, alone or combined with immunosuppressants and/or surgical interventions, was the most commonly reported treatment. Rituximab seemed to be an effective therapy for IgG4-related CAI even without associated glucocorticoids. Despite treatment, relapse and progression of coronary lesions were noted in some cases.</div></div><div><h3>Conclusions</h3><div>Early identification and multidisciplinary management og IgG4-related CAI are crucial to reduce morbidity and mortality. Available data on the response to various treatments are limited, as dedicated coronary artery imaging was not consistently obtained soon enough after treatment to assess response. In addition, long-term follow-up was not available for all patients. Further studies are required to understand the real prevalence, natural history, optimal diagnostic strategies, and therapeutic approaches for this serious condition.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"77 ","pages":"Article 152925"},"PeriodicalIF":4.4,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146078672","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Transparent reporting of randomized controlled trials (RCTs) is essential to ensure research integrity. While registration practices of RCTs are improving, concerns remain regarding the adequacy of outcome registration and the consistency of outcome reporting in publications.
Objectives
To evaluate the adequacy of primary outcome registration and the consistency of outcome reporting between registry entries and publications in rheumatology RCTs.
Methods
We conducted a meta-research study including primary reports of RCTs in rheumatology published from 2009 to 2022. We assessed whether primary outcomes were adequately registered (presence of SPIRIT-based criteria: measurement, analysis metric, and time points). For adequately registered outcomes, we evaluated consistency between the registry and the published report. Logistic regression was used to explore factors associated with inadequate registration and inconsistent reporting.
Results
We analyzed 947 RCTs involving 1679 primary outcomes. Only 38% of trials adequately described all their primary outcomes in the registry. Of these adequately registered trials, 67% reported their primary outcomes consistently in the corresponding publication, meaning just 25% of trials met both criteria. The most common gap in outcome description was missing participant-level analysis metric, while the most prevalent inconsistency was related to changes in the timing of outcome assessment.
Registration of adequately described primary outcome improved between 2009 and 2013 before plateauing, while consistency in reporting showed no improvement over time.
Conclusion
Despite improvements in trial registration practices, major gaps persist in outcome specification and reporting consistency in rheumatology RCTs.
{"title":"Adequacy of trial registration and consistency in outcome reporting in rheumatology RCTs: A meta-research study","authors":"Diana Buitrago-Garcia , Samia Mehouachi , Thomas Agoritsas , Michele Iudici , Denis Mongin","doi":"10.1016/j.semarthrit.2026.152926","DOIUrl":"10.1016/j.semarthrit.2026.152926","url":null,"abstract":"<div><h3>Introduction</h3><div>Transparent reporting of randomized controlled trials (RCTs) is essential to ensure research integrity. While registration practices of RCTs are improving, concerns remain regarding the adequacy of outcome registration and the consistency of outcome reporting in publications.</div></div><div><h3>Objectives</h3><div>To evaluate the adequacy of primary outcome registration and the consistency of outcome reporting between registry entries and publications in rheumatology RCTs.</div></div><div><h3>Methods</h3><div>We conducted a meta-research study including primary reports of RCTs in rheumatology published from 2009 to 2022. We assessed whether primary outcomes were adequately registered (presence of SPIRIT-based criteria: measurement, analysis metric, and time points). For adequately registered outcomes, we evaluated consistency between the registry and the published report. Logistic regression was used to explore factors associated with inadequate registration and inconsistent reporting.</div></div><div><h3>Results</h3><div>We analyzed 947 RCTs involving 1679 primary outcomes. Only 38% of trials adequately described all their primary outcomes in the registry. Of these adequately registered trials, 67% reported their primary outcomes consistently in the corresponding publication, meaning just 25% of trials met both criteria. The most common gap in outcome description was missing participant-level analysis metric, while the most prevalent inconsistency was related to changes in the timing of outcome assessment.</div><div>Registration of adequately described primary outcome improved between 2009 and 2013 before plateauing, while consistency in reporting showed no improvement over time.</div></div><div><h3>Conclusion</h3><div>Despite improvements in trial registration practices, major gaps persist in outcome specification and reporting consistency in rheumatology RCTs.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"77 ","pages":"Article 152926"},"PeriodicalIF":4.4,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146078674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-22DOI: 10.1016/j.semarthrit.2026.152934
Arthur Mageau , Valdrin Shala , Clémence David , Tiphaine Goulenok , Thomas Papo , Pascale Nicaise-Roland , Karim Sacre
Introduction
International guidelines state that all immunocompromised adults should be vaccinated with the recombinant varicella zoster virus (VZV) vaccine. We aimed to assess the risk factors for herpes zoster (HZ) in patients with systemic lupus erythematosus (SLE).
Methods
Electronic medical records of all SLE patients registered at our referral centre were analysed at the time of clinical visit between July and December 2024. Demographic, medical history, laboratory and treatment data were extracted using a standardised data collection form. Herpes zoster incidence and associated factors were identified.
Results
A total of 224 SLE patients (female 93.8 %, median age 48 [38;56] years) were included. Of these, 30 (n = 30/224, 13.4 %) had HZ. The incidence was 0.81 for 100 patient-years. Univariable analysis showed that gamma globulin level (OR 0.81, 95 %CI 0.70–0.92), duration of steroid treatment (OR 1.07, 95 % CI 1.03–1.11), immunosuppressive (IS) drugs (OR 2.41, 95 % CI 1.06–6.05), duration of IS treatment (OR 1.05, 95 % CI 1.00–1.09) and biologics (OR 3.50, 95 % CI 1.53–7.93) were significantly associated with HZ. In a multivariable logistic regression analysis, only gamma globulin level (OR 0.86, 95 % CI 0.74–0.98) remained independently associated with HZ. The ROC curve for gamma globulin levels showed significant associations with HZ (AUC = 0.71 (0.59–0.82)), with a threshold of 10.3 g/L providing the best discrimination between SLE patients with and without HZ.
Conclusion
A reduced level gammaglobulin - with a cut-off of 10.3 g/L - is associated with HZ in SLE and may identify SLE patients who should be prioritized for VZV vaccination.
国际指南指出，所有免疫功能低下的成年人都应接种重组水痘带状疱疹病毒（VZV）疫苗。我们旨在评估系统性红斑狼疮（SLE）患者发生带状疱疹（HZ）的危险因素。方法对2024年7月至12月在我院转诊中心登记的所有SLE患者的电子病历进行分析。使用标准化数据收集表提取人口统计、病史、实验室和治疗数据。确定带状疱疹发病率及相关因素。结果共纳入224例SLE患者，女性占93.8%，中位年龄48[38；56]岁。其中30例（n = 30/224, 13.4%）患有HZ。100例患者年的发病率为0.81。单变量分析显示，γ球蛋白水平（OR 0.81, 95% CI 0.70-0.92）、类固醇治疗持续时间（OR 1.07, 95% CI 1.03-1.11）、免疫抑制（IS）药物（OR 2.41, 95% CI 1.06-6.05）、IS治疗持续时间（OR 1.05, 95% CI 1.00-1.09）和生物制剂（OR 3.50, 95% CI 1.53-7.93）与HZ显著相关。在多变量logistic回归分析中，只有丙种球蛋白水平（OR 0.86, 95% CI 0.74-0.98）仍然与HZ独立相关。γ -球蛋白水平的ROC曲线显示与HZ有显著相关性（AUC = 0.71 (0.59-0.82)）， 10.3 g/L的阈值是区分合并和不合并HZ的SLE患者的最佳阈值。结论：降低的丙种球蛋白水平（临界值为10.3 g/L）与SLE患者的HZ相关，可以确定哪些SLE患者应该优先接种VZV疫苗。
{"title":"Risk factors for herpes zoster in patients with systemic lupus erythematosus","authors":"Arthur Mageau , Valdrin Shala , Clémence David , Tiphaine Goulenok , Thomas Papo , Pascale Nicaise-Roland , Karim Sacre","doi":"10.1016/j.semarthrit.2026.152934","DOIUrl":"10.1016/j.semarthrit.2026.152934","url":null,"abstract":"<div><h3>Introduction</h3><div>International guidelines state that all immunocompromised adults should be vaccinated with the recombinant varicella zoster virus (VZV) vaccine. We aimed to assess the risk factors for herpes zoster (HZ) in patients with systemic lupus erythematosus (SLE).</div></div><div><h3>Methods</h3><div>Electronic medical records of all SLE patients registered at our referral centre were analysed at the time of clinical visit between July and December 2024. Demographic, medical history, laboratory and treatment data were extracted using a standardised data collection form. Herpes zoster incidence and associated factors were identified.</div></div><div><h3>Results</h3><div>A total of 224 SLE patients (female 93.8 %, median age 48 [38;56] years) were included. Of these, 30 (<em>n</em> = 30/224, 13.4 %) had HZ. The incidence was 0.81 for 100 patient-years. Univariable analysis showed that gamma globulin level (OR 0.81, 95 %CI 0.70–0.92), duration of steroid treatment (OR 1.07, 95 % CI 1.03–1.11), immunosuppressive (IS) drugs (OR 2.41, 95 % CI 1.06–6.05), duration of IS treatment (OR 1.05, 95 % CI 1.00–1.09) and biologics (OR 3.50, 95 % CI 1.53–7.93) were significantly associated with HZ. In a multivariable logistic regression analysis, only gamma globulin level (OR 0.86, 95 % CI 0.74–0.98) remained independently associated with HZ. The ROC curve for gamma globulin levels showed significant associations with HZ (AUC = 0.71 (0.59–0.82)), with a threshold of 10.3 g/L providing the best discrimination between SLE patients with and without HZ.</div></div><div><h3>Conclusion</h3><div>A reduced level gammaglobulin - with a cut-off of 10.3 g/L - is associated with HZ in SLE and may identify SLE patients who should be prioritized for VZV vaccination.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"77 ","pages":"Article 152934"},"PeriodicalIF":4.4,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146078669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-22DOI: 10.1016/j.semarthrit.2026.152930
Amir Haddad, Devy Zisman
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Pub Date : 2026-01-22DOI: 10.1016/j.semarthrit.2026.152928
Itay Marmor , Rotem Semo-Oz , Amir Hendel , Guy Hazan , Kevin Baszis , Anthony French , Cuoghi Edens , Irit Tirosh , Yonatan Butbul , Liora Harel , Gil Amarilyo
Objective
To classify Still’s disease (known as “systemic JIA”) course into monophasic, polyphasic and chronic-persistent disease, using data collected before and after the introduction of biologic IL-1/6 inhibitors, and identify predictors for a non-monophasic disease.
Methods
A multi-center, retrospective chart review from 3 hospitals in Israel and 2 in the US, involving patients diagnosed with Still’s disease between 1998–2021, with a minimum follow-up of 1 year.
Results
Eighty-two patients met the inclusion criteria, with a median follow up time of 2.8 years (1.1–17). Fifty-two (63.4%) were females; mean age at diagnosis was 6.4 ± 4.4 years. Fifty-nine (72%) were diagnosed in 2012 or later, when IL-1 and IL-6 inhibitors became widely used. The rates of monophasic, polyphasic and persistent disease were 34.1%, 46.3% and 19.5%, respectively, with a higher-than-expected rate of polyphasic disease. The proportion of a non-monophasic (polyphasic or persistent) disease decreased from 78.2% in cases diagnosed before 2012 to 61% in cases diagnosed after 2012 albeit not statistically significant (p = 0.22). In a multivariate logistic regression model, an active disease 3 months from diagnosis was an independent risk factor for a non-monophasic disease course (OR 4.16 [1.33–15.2], p = 0.02).
Conclusions
Drug-free remissions in chronic, non-monophasic Still’s disease may be more common than previously demonstrated. In the age of IL-1 and IL-6 inhibitors, a monophasic disease course may be more prevalent. This finding provides further evidence that cytokine blockers may potentially alter the natural history of this disease, and that early aggressive treatment may be warranted.
目的利用引入生物IL-1/6抑制剂前后收集的数据，将斯蒂尔氏病（称为“系统性JIA”）病程分为单相、多相和慢性持续性疾病，并确定非单相疾病的预测因素。方法对来自以色列3家医院和美国2家医院的多中心回顾性图表进行回顾，纳入1998-2021年间诊断为斯蒂尔氏病的患者，随访时间至少为1年。结果符合纳入标准的患者有82例，中位随访时间2.8年（1.1 ~ 17年）。女性52例（63.4%）；平均诊断年龄为6.4±4.4岁。当IL-1和IL-6抑制剂被广泛使用时，59例（72%）在2012年或之后被诊断出来。单期病、多期病和持续性病的发生率分别为34.1%、46.3%和19.5%，多期病的发生率高于预期。非单相（多相或持续性）疾病的比例从2012年之前诊断的78.2%下降到2012年之后诊断的61%，尽管没有统计学意义（p = 0.22）。在多因素logistic回归模型中，诊断后3个月的活动性疾病是非单相病程的独立危险因素（OR 4.16 [1.33-15.2], p = 0.02）。结论慢性非单相斯蒂尔氏病的无药缓解可能比以前所证明的更为常见。在使用IL-1和IL-6抑制剂的年龄，单相病程可能更为普遍。这一发现进一步证明细胞因子阻滞剂可能潜在地改变这种疾病的自然史，并且早期积极治疗可能是必要的。
{"title":"Reassessing the prevalence of monophasic, polyphasic and persistent disease courses in still’s disease","authors":"Itay Marmor , Rotem Semo-Oz , Amir Hendel , Guy Hazan , Kevin Baszis , Anthony French , Cuoghi Edens , Irit Tirosh , Yonatan Butbul , Liora Harel , Gil Amarilyo","doi":"10.1016/j.semarthrit.2026.152928","DOIUrl":"10.1016/j.semarthrit.2026.152928","url":null,"abstract":"<div><h3>Objective</h3><div>To classify Still’s disease (known as “systemic JIA”) course into monophasic, polyphasic and chronic-persistent disease, using data collected before and after the introduction of biologic IL-1/6 inhibitors, and identify predictors for a non-monophasic disease.</div></div><div><h3>Methods</h3><div>A multi-center, retrospective chart review from 3 hospitals in Israel and 2 in the US, involving patients diagnosed with Still’s disease between 1998–2021, with a minimum follow-up of 1 year.</div></div><div><h3>Results</h3><div>Eighty-two patients met the inclusion criteria, with a median follow up time of 2.8 years (1.1–17). Fifty-two (63.4%) were females; mean age at diagnosis was 6.4 ± 4.4 years. Fifty-nine (72%) were diagnosed in 2012 or later, when IL-1 and IL-6 inhibitors became widely used. The rates of monophasic, polyphasic and persistent disease were 34.1%, 46.3% and 19.5%, respectively, with a higher-than-expected rate of polyphasic disease. The proportion of a non-monophasic (polyphasic or persistent) disease decreased from 78.2% in cases diagnosed before 2012 to 61% in cases diagnosed after 2012 albeit not statistically significant (<em>p</em> = 0.22). In a multivariate logistic regression model, an active disease 3 months from diagnosis was an independent risk factor for a non-monophasic disease course (OR 4.16 [1.33–15.2], <em>p</em> = 0.02).</div></div><div><h3>Conclusions</h3><div>Drug-free remissions in chronic, non-monophasic Still’s disease may be more common than previously demonstrated. In the age of IL-1 and IL-6 inhibitors, a monophasic disease course may be more prevalent. This finding provides further evidence that cytokine blockers may potentially alter the natural history of this disease, and that early aggressive treatment may be warranted.</div></div>","PeriodicalId":21715,"journal":{"name":"Seminars in arthritis and rheumatism","volume":"77 ","pages":"Article 152928"},"PeriodicalIF":4.4,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146078519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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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