{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T20:20:26Z","timestamp":1793823626619,"version":"4.6.1"},"reference-count":23,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,11,19]],"date-time":"2025-11-19T00:00:00Z","timestamp":1763510400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To describe the real-world efficacy and safety of obinutuzumab in a heterogeneous systemic lupus erythematosus (SLE) population, including severe or refractory manifestations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We retrospectively analyzed 56 SLE patients who received a single dose of obinutuzumab (1000 mg) at Renji Hospital, Shanghai Jiao Tong University School of Medicine between October 2021 and March 2024. Patients were followed for 48 weeks. Outcomes included the proportion of patients achieving definitions of remission in systemic lupus erythematosus (DORIS), Lupus Low Disease Activity State (LLDAS), clinical stable, and flare. Changes in SLEDAI-2K, anti-dsDNA, complement levels, B cell counts, glucocorticoid dose, and adverse events were assessed. Subgroup analyses were performed to address population heterogeneity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At baseline, 35.7% of patients were newly diagnosed, 55.4% had relapsing\/refractory disease, and 8.9% were on maintenance therapy. By week 48, 37.5% achieved DORIS remission, 32.1% LLDAS, and 19.6% remained clinically stable. Mean SLEDAI-2K decreased from 11.75\u00a0\u00b1\u00a09.31 (range: 0 to 46) to 1.45\u00b1 1.93 (range: 0 to 8). Among 15 lupus nephritis patients, 86.7% achieved complete renal response. Significant hematologic improvement was observed in autoimmune hemolytic anemia and thrombocytopenia. B cell counts declined rapidly and began to repopulate from week 36. Glucocorticoids tapered from 43.04 \u00b1 18.19 (range: 0 to 60) to 8.95 \u00b1 9.78 (range: 0 to 50) mg\/day. Obinutuzumab was well tolerated, with infections observed in 14 cases (25.0%) and infusion reactions in 4 cases (7.1%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Obinutuzumab showed favorable efficacy and safety in SLE, including severe\/refractory manifestations, suggesting potential benefits for difficult-to-treat patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fimmu.2025.1702550","type":"journal-article","created":{"date-parts":[[2025,11,19]],"date-time":"2025-11-19T06:38:03Z","timestamp":1763534283000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["Obinutuzumab in systemic lupus erythematosus: a real-world experience"],"prefix":"10.3389","volume":"16","author":[{"given":"Chunmei","family":"Wu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yinglu","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shenshen","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanwei","family":"Lin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fang","family":"Du","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaodong","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheng","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liangjing","family":"Lu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuang","family":"Ye","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huihua","family":"Ding","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiong","family":"Fu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,11,19]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-immunol-101921-042422","article-title":"Systemic lupus erythematosus pathogenesis: interferon and beyond","volume":"41","author":"Caielli","year":"2023","journal-title":"Annu Rev Immunol"},{"key":"B2","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1080\/1744666X.2023.2145281","article-title":"B cell depletion and inhibition in systemic lupus erythematosus","volume":"19","author":"Krustev","year":"2023","journal-title":"Expert Rev Clin Immunol"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1002\/art.27233","article-title":"Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II\/III systemic lupus erythematosus evaluation of rituximab trial","volume":"62","author":"Merrill","year":"2010","journal-title":"Arthritis Rheum"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1002\/art.34359","article-title":"Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the lupus nephritis assessment with rituximab study","volume":"64","author":"Rovin","year":"2012","journal-title":"Arthritis Rheum"},{"key":"B5","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1111\/bjh.15232","article-title":"A tale of two antibodies: obinutuzumab versus rituximab","volume":"182","author":"Freeman","year":"2018","journal-title":"Br J Haematol"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2009-06-225979","article-title":"Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity","volume":"115","author":"M\u00f6ssner","year":"2010","journal-title":"Blood"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2410965","article-title":"Efficacy and safety of obinutuzumab in active lupus nephritis","volume":"392","author":"Furie","year":"2025","journal-title":"N Engl J Med"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-220920","article-title":"B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial","volume":"81","author":"Furie","year":"2022","journal-title":"Ann Rheum Dis"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2018-214819","article-title":"2019 European League Against Rheumatism\/American College of Rheumatology classification criteria for systemic lupus erythematosus","volume":"78","author":"Aringer","year":"2019","journal-title":"Ann Rheum Dis"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2020-216924","article-title":"2019 Update of the joint european league against rheumatism and european renal association-european dialysis and transplant association (EULAR\/ERA-EDTA) recommendations for the management of lupus nephritis","volume":"79","author":"Fanouriakis","year":"2020","journal-title":"Ann Rheum Dis"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ki.5002118","article-title":"The ISN\/RPS 2003 classification of lupus nephritis: an assessment at 3 years","volume":"71","author":"Markowitz","year":"2007","journal-title":"Kidney Int"},{"key":"B12","article-title":"Systemic lupus erythematosus disease activity index 2000","volume":"29","author":"Gladman","year":"2002","journal-title":"J Rheumatol"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209519","article-title":"A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS)","volume":"76","author":"van Vollenhoven","year":"2017","journal-title":"Ann Rheum Dis"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207726","article-title":"Definition and initial validation of a Lupus Low Disease Activity State (LLDAS)","volume":"75","author":"Franklyn","year":"2016","journal-title":"Ann Rheum Dis"},{"key":"B15","unstructured":"ACR meeting abstracts\n          Lupus low disease activity state: can we relax the definition and still achieve low risk of SLE-related damage?"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2020-218670","article-title":"New EULAR\/ACR 2019 SLE Classification Criteria: defining ominosity in SLE","volume":"80","author":"Whittall Garcia","year":"2021","journal-title":"Ann Rheum Dis"},{"key":"B17","doi-asserted-by":"publisher","DOI":"10.1002\/art.24741","article-title":"Frequency and determinants of flare and persistently active disease in systemic lupus erythematosus","volume":"61","author":"Nikpour","year":"2009","journal-title":"Arthritis Rheum"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2023.09.002","article-title":"KDIGO 2024 clinical practice guideline for the management of LUPUS NEPHRITIS","volume":"105","year":"2024","journal-title":"Kidney Int"},{"key":"B19","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2022.863177","article-title":"Case report: use of obinutuzumab as an alternative monoclonal anti-CD20 antibody in a patient with refractory immune thrombocytopenia complicated by rituximab-induced serum sickness and anti-rituximab antibodies","volume":"13","author":"Blase","year":"2022","journal-title":"Front Immunol"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1111\/bjh.17105","article-title":"Obinutuzumab in the treatment of autoimmune haemolytic anaemia and immune thrombocytopenia in patients with chronic lymphocytic leukaemia\/small lymphocytic lymphoma","volume":"192","author":"Herishanu","year":"2021","journal-title":"Br J Haematol"},{"key":"B21","unstructured":"ACR Meeting Abstracts\n          Predictors of Remission (on and off Treatment) and Lupus Low Disease Activity State (LLDAS) in Systemic Lupus Erythematosus (SLE): Data from a Multinational, Multicenter SLICC (Systemic Lupus International Collaborating Clinics) Cohort"},{"key":"B22","doi-asserted-by":"publisher","DOI":"10.1002\/art.40571","article-title":"Comparison of remission and lupus low disease activity state in damage prevention in a United States systemic lupus erythematosus cohort","volume":"70","author":"Petri","year":"2018","journal-title":"Arthritis Rheumatol Hoboken NJ"},{"key":"B23","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2025.1546306","article-title":"Transitioning from lupus low disease activity state to remission in systemic lupus erythematosus: real-world evidence","volume":"16","author":"Gao","year":"2025","journal-title":"Front Immunol"}],"updated-by":[{"DOI":"10.3389\/fimmu.2025.1764419","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T00:00:00Z","timestamp":1765843200000}}],"container-title":["Frontiers in Immunology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2025.1702550\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T14:42:53Z","timestamp":1765896173000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fimmu.2025.1702550\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,19]]},"references-count":23,"alternative-id":["10.3389\/fimmu.2025.1702550"],"URL":"https:\/\/doi.org\/10.3389\/fimmu.2025.1702550","relation":{},"ISSN":["1664-3224"],"issn-type":[{"value":"1664-3224","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,19]]},"article-number":"1702550"}}