Pub Date : 2026-02-05DOI: 10.1016/S2665-9913(25)00316-9
Chiara Tani, Chiara Cardelli, Luca Moroni, Margherita Zen, Francesca Bottazzi, Micaela Fredi, Alessandra Bortoluzzi, Matteo Piga, Flavia Riccio, Fulvia Ceccarelli, Ginevra De Marchi, Lucia Manfredi, Rita Mulè, Edoardo Biancalana, Mariele Gatto, Laura Coladonato, Paola Conigliaro, Maria Gerosa, Andrea Picchianti Diamanti, Giuseppe Alvise Ramirez, Filippo Vesentini, Giovanni Zanframundo, Chiara Orlandi, Ettore Silvagni, Elisabetta Chessa, Marica Trevisani, Miki Palmerini, Pietro Francesco Gavino Pilo, Sara Ferrigno, Anna Chiara Di Lollo, Silvia Noviello, Alberto Lo Gullo, Maria Ilenia De Andres, Serena Guiducci, Giacomo Emmi, Federica Maiolini, Rossella De Angelis, Roberto Felice Caporali, Florenzo Iannone, Gianluca Moroncini, Luca Quartuccio, Fabrizio Conti, Francesco Ciccia, Marcello Govoni, Franco Franceschini, Lorenzo Cavagna, Luca Iaccarino, Lorenzo Dagna, Marta Mosca
<p><strong>Background: </strong>Anifrolumab is a type I interferon receptor antagonist approved for the treatment of systemic lupus erythematosus (SLE). However, real-world evidence on its use, especially from large, unselected cohorts, is scarce. The ongoing REVEAL study is designed to collect real-world data on anifrolumab use. The data reported here are the pre-specified 6-month interim analysis, which aims to provide a phenotypic characterisation of a large real-world cohort of patients with SLE initiating anifrolumab, and to evaluate early treatment response in routine clinical practice.</p><p><strong>Methods: </strong>REVEAL is a 5-year, multicentre, prospective observational study conducted in 25 tertiary rheumatology centres across Italy. A pre-specified interim analysis was planned when the first 50 patients completed the first 6 months of follow-up; this analysis includes all patients who initiated anifrolumab by the data cutoff of Feb 10, 2025. Patients with SLE were consecutively enrolled on the day of their first infusion of anifrolumab, prescribed according to clinical judgement and Italian indications for use. Eligible patients were aged 18 years or older, had a clinical diagnosis of SLE fulfilling at least one set of established classification criteria valid at the time of diagnosis (1997 American College of Rheumatology [ACR], 2012 Systemic Lupus International Collaborating Clinics, or 2019 European Alliance of Associations for Rheumatology-ACR), had active disease warranting anifrolumab treatment (including compassionate use programmes), and were naive to anifrolumab. Data were collected at baseline and at 1 month, 3 months, and 6 months. The primary outcome was the number of patients reaching remission (defined according to the Definition of Remission in SLE criteria as a clinical SLEDAI-2K score of 0, physician global assessment score of <0·5 [on a 0-3 scale], with a prednisone-equivalent dose ≤5 mg per day, and stable antimalarials or immunosuppressants), Lupus Low Disease Activity State (LLDAS; defined as a SLEDAI-2K ≤4 [with no activity in major organ systems and no new disease activity], physician global assessment ≤1·0, and a prednisone-equivalent dose ≤7·5 mg per day), and LLDAS5 (a modified version of the LLDAS with a prednisone-equivalent dose ≤5 mg per day) at 6 months. Adverse and serious adverse events were also recorded. No people with lived experience of SLE were involved in designing or conducting the study. This study is registered with ClinicalTrials.gov (NCT07215754) and with the Italian Medicines Agency (Agenzia Italiana del Farmaco; ID number 247) and recruitment is ongoing.</p><p><strong>Findings: </strong>Between May 25, 2023, and Feb 10, 2025, 236 patients were recruited and included in this interim analysis. Of these, 219 (93%) were female, 17 (7%) were male, 218 (92%) were White, and the median age was 46·9 years (IQR 36·0-53·6). At baseline, the median SLEDAI-2K was 7 (IQR 6-9), and the main indication
{"title":"Patient profiles and early response in patients with systemic lupus erythematosus initiating anifrolumab: interim analysis from the ongoing multicentre observational REVEAL study.","authors":"Chiara Tani, Chiara Cardelli, Luca Moroni, Margherita Zen, Francesca Bottazzi, Micaela Fredi, Alessandra Bortoluzzi, Matteo Piga, Flavia Riccio, Fulvia Ceccarelli, Ginevra De Marchi, Lucia Manfredi, Rita Mulè, Edoardo Biancalana, Mariele Gatto, Laura Coladonato, Paola Conigliaro, Maria Gerosa, Andrea Picchianti Diamanti, Giuseppe Alvise Ramirez, Filippo Vesentini, Giovanni Zanframundo, Chiara Orlandi, Ettore Silvagni, Elisabetta Chessa, Marica Trevisani, Miki Palmerini, Pietro Francesco Gavino Pilo, Sara Ferrigno, Anna Chiara Di Lollo, Silvia Noviello, Alberto Lo Gullo, Maria Ilenia De Andres, Serena Guiducci, Giacomo Emmi, Federica Maiolini, Rossella De Angelis, Roberto Felice Caporali, Florenzo Iannone, Gianluca Moroncini, Luca Quartuccio, Fabrizio Conti, Francesco Ciccia, Marcello Govoni, Franco Franceschini, Lorenzo Cavagna, Luca Iaccarino, Lorenzo Dagna, Marta Mosca","doi":"10.1016/S2665-9913(25)00316-9","DOIUrl":"https://doi.org/10.1016/S2665-9913(25)00316-9","url":null,"abstract":"<p><strong>Background: </strong>Anifrolumab is a type I interferon receptor antagonist approved for the treatment of systemic lupus erythematosus (SLE). However, real-world evidence on its use, especially from large, unselected cohorts, is scarce. The ongoing REVEAL study is designed to collect real-world data on anifrolumab use. The data reported here are the pre-specified 6-month interim analysis, which aims to provide a phenotypic characterisation of a large real-world cohort of patients with SLE initiating anifrolumab, and to evaluate early treatment response in routine clinical practice.</p><p><strong>Methods: </strong>REVEAL is a 5-year, multicentre, prospective observational study conducted in 25 tertiary rheumatology centres across Italy. A pre-specified interim analysis was planned when the first 50 patients completed the first 6 months of follow-up; this analysis includes all patients who initiated anifrolumab by the data cutoff of Feb 10, 2025. Patients with SLE were consecutively enrolled on the day of their first infusion of anifrolumab, prescribed according to clinical judgement and Italian indications for use. Eligible patients were aged 18 years or older, had a clinical diagnosis of SLE fulfilling at least one set of established classification criteria valid at the time of diagnosis (1997 American College of Rheumatology [ACR], 2012 Systemic Lupus International Collaborating Clinics, or 2019 European Alliance of Associations for Rheumatology-ACR), had active disease warranting anifrolumab treatment (including compassionate use programmes), and were naive to anifrolumab. Data were collected at baseline and at 1 month, 3 months, and 6 months. The primary outcome was the number of patients reaching remission (defined according to the Definition of Remission in SLE criteria as a clinical SLEDAI-2K score of 0, physician global assessment score of <0·5 [on a 0-3 scale], with a prednisone-equivalent dose ≤5 mg per day, and stable antimalarials or immunosuppressants), Lupus Low Disease Activity State (LLDAS; defined as a SLEDAI-2K ≤4 [with no activity in major organ systems and no new disease activity], physician global assessment ≤1·0, and a prednisone-equivalent dose ≤7·5 mg per day), and LLDAS5 (a modified version of the LLDAS with a prednisone-equivalent dose ≤5 mg per day) at 6 months. Adverse and serious adverse events were also recorded. No people with lived experience of SLE were involved in designing or conducting the study. This study is registered with ClinicalTrials.gov (NCT07215754) and with the Italian Medicines Agency (Agenzia Italiana del Farmaco; ID number 247) and recruitment is ongoing.</p><p><strong>Findings: </strong>Between May 25, 2023, and Feb 10, 2025, 236 patients were recruited and included in this interim analysis. Of these, 219 (93%) were female, 17 (7%) were male, 218 (92%) were White, and the median age was 46·9 years (IQR 36·0-53·6). At baseline, the median SLEDAI-2K was 7 (IQR 6-9), and the main indication","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":16.4,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144234","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 : 2026-02-05DOI: 10.1016/S2665-9913(25)00369-8
Martin Aringer
{"title":"Rapid remission and effect on organ manifestations with anifrolumab.","authors":"Martin Aringer","doi":"10.1016/S2665-9913(25)00369-8","DOIUrl":"https://doi.org/10.1016/S2665-9913(25)00369-8","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":16.4,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144214","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 : 2026-02-05DOI: 10.1016/S2665-9913(26)00044-5
Heather Van Epps
{"title":"Frailty care in England deemed deficient.","authors":"Heather Van Epps","doi":"10.1016/S2665-9913(26)00044-5","DOIUrl":"https://doi.org/10.1016/S2665-9913(26)00044-5","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":16.4,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146144212","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 : 2026-01-29DOI: 10.1016/S2665-9913(26)00004-4
Gregory C McDermott, Misti L Paudel, Marcy B Bolster, Kevin D Deane, Dinesh Khanna, Bryant R England, Jeffrey A Sparks
{"title":"Early screening for rheumatoid arthritis-associated interstitial lung disease: statistical nuances challenge the role of disease activity - Authors' reply.","authors":"Gregory C McDermott, Misti L Paudel, Marcy B Bolster, Kevin D Deane, Dinesh Khanna, Bryant R England, Jeffrey A Sparks","doi":"10.1016/S2665-9913(26)00004-4","DOIUrl":"https://doi.org/10.1016/S2665-9913(26)00004-4","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":" ","pages":""},"PeriodicalIF":16.4,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146100905","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 : 2026-01-26DOI: 10.1016/S2665-9913(26)00013-5
The Lancet Rheumatology Editors
{"title":"Thank you to The Lancet Rheumatology's peer reviewers in 2025","authors":"The Lancet Rheumatology Editors","doi":"10.1016/S2665-9913(26)00013-5","DOIUrl":"10.1016/S2665-9913(26)00013-5","url":null,"abstract":"","PeriodicalId":48540,"journal":{"name":"Lancet Rheumatology","volume":"8 2","pages":"Pages e78-e82"},"PeriodicalIF":16.4,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146045230","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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