{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T22:12:55Z","timestamp":1779228775360,"version":"3.51.4"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,1,8]],"date-time":"2025-01-08T00:00:00Z","timestamp":1736294400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,1,8]],"date-time":"2025-01-08T00:00:00Z","timestamp":1736294400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"GSK","award":["215349"],"award-info":[{"award-number":["215349"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Rheumatol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The real-world effectiveness of intravenous (IV) belimumab in treating systemic lupus erythematosus (SLE) has been demonstrated in various countries through the OBSErve (evaluation Of use of Belimumab in clinical practice SEttings) program. Here we describe the clinical effectiveness of IV belimumab for treating SLE in real-world clinical practice in the Russian Federation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In the retrospective, observational OBSErve Russia study (GSK Study 215349), eligible physicians enrolled adults with SLE receiving IV belimumab as part of their standard care. De-identified data were collected from patient medical records from September 2021 to March 2022. The primary outcome was the physician-assessed overall clinical response at 6\u00a0months post-index versus index (belimumab initiation) among patients receiving belimumab for \u22656\u00a0months. Other endpoints included change in Safety of Estrogens in Lupus Erythematosus National Assessment \u2013 SLE Disease Activity Index (SELENA-SLEDAI) score and glucocorticoid use.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Overall, 59 patients initiated IV belimumab, mainly due to the previous regimen not being effective and to decrease glucocorticoid use (76.3% each); 15.3% of patients started belimumab within the first year of SLE diagnosis. Only 13.6% of patients discontinued belimumab within the first 6\u00a0months, mainly due to loss to follow-up and loss of insurance\/reimbursement. At 6\u00a0months post-index, among patients who completed \u22656\u00a0months of belimumab therapy (full analysis set, <jats:italic>n<\/jats:italic>\u2009=\u200953), 90.6% and 60.4% had an overall clinical improvement of \u226520% and \u226550%, respectively. Mean (standard deviation, SD) change in SELENA-SLEDAI score from index to 6\u00a0months post-index was \u22125.9 (4.3). Mean (SD) glucocorticoid dose decreased from 12.2 (7.3) mg\/day at index to 8.6 (5.1) mg\/day at 6\u00a0months post-index (<jats:italic>n<\/jats:italic>\u2009=\u200950).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Patients with SLE receiving IV belimumab for 6\u00a0months in real-world settings in the Russian Federation experienced overall clinical improvements and reductions in glucocorticoid use, which is an important long-term strategy of SLE treatment.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41927-024-00452-0","type":"journal-article","created":{"date-parts":[[2025,1,8]],"date-time":"2025-01-08T10:02:21Z","timestamp":1736330541000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Real-world effectiveness of intravenous belimumab in adults with systemic lupus erythematosus: results of the observational OBSErve study in the Russian Federation"],"prefix":"10.1186","volume":"9","author":[{"given":"Alexander Mikhailovich","family":"Lila","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena Aleksandrovna","family":"Aseeva","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alyona Igorevna","family":"Zagrebneva","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irina Borisovna","family":"Vinogradova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruzana Ramilovna","family":"Samigullina","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Munther","family":"Khamashta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tamer","family":"Elfishawy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2600-9383","authenticated-orcid":false,"given":"Lindsey","family":"Teichman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Debora","family":"dos Santos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juliana","family":"Queiroz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Larisa Alexandrovna","family":"Kniazeva","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saeed","family":"Noibi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,1,8]]},"reference":[{"issue":"6","key":"452_CR1","doi-asserted-by":"publisher","first-page":"605","DOI":"10.1038\/s41590-020-0677-6","volume":"21","author":"GC Tsokos","year":"2020","unstructured":"Tsokos GC. Autoimmunity and organ damage in systemic lupus erythematosus. Nat Immunol. 2020;21(6):605\u201314.","journal-title":"Nat Immunol"},{"issue":"1","key":"452_CR2","doi-asserted-by":"publisher","first-page":"e000239","DOI":"10.1136\/lupus-2017-000239","volume":"4","author":"Z Touma","year":"2017","unstructured":"Touma Z, Gladman DD. Current and future therapies for SLE: obstacles and recommendations for the development of novel treatments. Lupus Sci Med. 2017;4(1):e000239.","journal-title":"Lupus Sci Med"},{"key":"452_CR3","doi-asserted-by":"publisher","first-page":"67","DOI":"10.3899\/jrheum.190259","volume":"48","author":"MB Urowitz","year":"2021","unstructured":"Urowitz MB, Gladman DD, Ibanez D, Su J, Mursleen S, Sayani A, et al. Effect of disease activity on organ damage progression in systemic lupus erythematosus: University of Toronto Lupus Clinic Cohort. J Rheumatol. 2021;48:67\u201373.","journal-title":"J Rheumatol"},{"key":"452_CR4","doi-asserted-by":"publisher","first-page":"736","DOI":"10.1136\/annrheumdis-2019-215089","volume":"78","author":"A Fanouriakis","year":"2019","unstructured":"Fanouriakis A, Kostopoulou M, Alunno A, Aringer M, Bajema I, Boletis JN, et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis 2019;78:736\u201345.","journal-title":"Ann Rheum Dis"},{"key":"452_CR5","doi-asserted-by":"publisher","first-page":"1705","DOI":"10.1177\/09612033211028653","volume":"30","author":"RA Levy","year":"2021","unstructured":"Levy RA, Gonzalez-Rivera T, Khamashta M, Fox NL, Jones-Leone A, Rubin B, et al. 10 Years of belimumab experience: what have we learnt? Lupus 2021;30:1705\u201321.","journal-title":"Lupus"},{"key":"452_CR6","unstructured":"GSK. Benlysta prescribing information [online]. 2022. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761043s021lbl.pdf. Accessed 9 Nov 2022."},{"key":"452_CR7","doi-asserted-by":"publisher","first-page":"3918","DOI":"10.1002\/art.30613","volume":"63","author":"R Furie","year":"2011","unstructured":"Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzova D, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum 2011;63:3918\u201330.","journal-title":"Arthritis Rheum"},{"key":"452_CR8","doi-asserted-by":"publisher","first-page":"112","DOI":"10.1002\/art.41900","volume":"74","author":"E Ginzler","year":"2022","unstructured":"Ginzler E, Guedes Barbosa LS, D\u2019Cruz D, Furie R, Maksimowicz-Mckinnon K, Oates J, et al. Phase III\/IV, randomized, fifty-two-week study of the efficacy and safety of belimumab in patients of Black African Ancestry with systemic lupus erythematosus. Arthritis Rheumatol. 2022;74:112\u201323.","journal-title":"Arthritis Rheumatol"},{"key":"452_CR9","doi-asserted-by":"publisher","first-page":"1016","DOI":"10.1002\/art.40049","volume":"69","author":"W Stohl","year":"2017","unstructured":"Stohl W, Schwarting A, Okada M, Scheinberg M, Doria A, Hammer AE, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two-week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol 2017;69:1016\u201327.","journal-title":"Arthritis Rheumatol"},{"key":"452_CR10","doi-asserted-by":"publisher","first-page":"1385","DOI":"10.1177\/0961203320947814","volume":"29","author":"A Babini","year":"2020","unstructured":"Babini A, Cappuccio AM, Caprarulo C, Casado G, Eimon A, Figueredo H, et al. Evaluation of belimumab treatment in patients with systemic lupus erythematosus in a clinical practice setting: results from a 24-month OBSErve study in Argentina. Lupus 2020;29:1385\u201396.","journal-title":"Lupus"},{"key":"452_CR11","doi-asserted-by":"publisher","first-page":"e000118","DOI":"10.1136\/lupus-2015-000118","volume":"3","author":"CE Collins","year":"2016","unstructured":"Collins CE, Dall\u2019Era M, Kan H, Macahilig C, Molta C, Koscielny V, et al. Response to belimumab among patients with systemic lupus erythematosus in clinical practice settings: 24-month results from the OBSErve study in the USA. Lupus Sci Med 2016;3:e000118.","journal-title":"Lupus Sci Med"},{"key":"452_CR12","doi-asserted-by":"publisher","first-page":"271","DOI":"10.1007\/s40744-016-0047-x","volume":"3","author":"A Schwarting","year":"2016","unstructured":"Schwarting A, Schroeder JO, Alexander T, Schmalzing M, Fiehn C, Specker C, et al. First real-world insights into belimumab use and outcomes in routine clinical care of systemic lupus erythematosus in Germany: results from the OBSErve Germany Study. Rheumatol Ther 2016;3:271\u201390.","journal-title":"Rheumatol Ther"},{"key":"452_CR13","doi-asserted-by":"publisher","first-page":"865","DOI":"10.1007\/s00296-017-3682-9","volume":"37","author":"Z Touma","year":"2016","unstructured":"Touma Z, Sayani A, Pineau CA, Fortin I, Matsos M, Ecker GA, et al. Belimumab use, clinical outcomes and glucocorticoid reduction in patients wuth systemic lupus erythematosus receiving belimumab in clinical practice settings: results from the OBSErve Canada Study. Rheumatol Int. 2016;37:865\u201373.","journal-title":"Rheumatol Int"},{"key":"452_CR14","first-page":"w20022","volume":"149","author":"J von Kempis","year":"2019","unstructured":"von Kempis J, Duetsch S, Reuschling N, Villiger R, Villiger PM, Vallelian F, et al. Clinical outcomes in patients with systemic lupus erythematosus treated with belimumab in clinical practice settings: a retrospective analysis of results from the OBSErve study in Switzerland. Swiss Med Wkly. 2019;149:w20022.","journal-title":"Swiss Med Wkly"},{"key":"452_CR15","first-page":"312","volume":"19","author":"J Cort\u00e9s-Hern\u00e1ndez","year":"2022","unstructured":"Cort\u00e9s-Hern\u00e1ndez J, Fern\u00e1ndez-Cid CM, Ankdreu S\u00e1nchez JL, Al\u00e9n JC, Garc\u00eda-Aparicio AM, \u00c1lvarez ED, et al. Reduction of disease activity, corticosteroids use, and healthcare resource utilisation in patients with systemic lupus erythematosus treated with belimumab in clinical practice settings: oBSErve Spain multicentre study. Reumatolog\u00eda Cl\u00ednica 2022;19:312\u201318.","journal-title":"Reumatolog\u00eda Cl\u00ednica"},{"key":"452_CR16","unstructured":"GSK. Benlysta prescribing information [online]. 2023. https:\/\/grls.rosminzdrav.ru\/Grls_View_v2.aspx?routingGuid=25aa9bb3-99be-40fb-9bfa-04be32a79f2e. Accessed 5 Apr 2023."},{"key":"452_CR17","doi-asserted-by":"publisher","first-page":"2550","DOI":"10.1056\/NEJMoa051135","volume":"353","author":"M Petri","year":"2005","unstructured":"Petri M, Kim MY, Kalunian KC, Grossman J, Hahn BH, Sammaritano LR, et al. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med 2005;353:2550\u201358.","journal-title":"N Engl J Med"},{"key":"452_CR18","doi-asserted-by":"publisher","first-page":"949","DOI":"10.1007\/s40744-020-00243-2","volume":"7","author":"CE Collins","year":"2020","unstructured":"Collins CE, Cortes-Hernandez J, Garcia MA, von Kempis J, Schwarting A, Touma Z, et al. Real-world effectiveness of belimumab in the treatment of systemic lupus erythematosus: pooled analysis of multi-country data from the OBSErve studies. Rheumatol Ther 2020;7:949\u201365.","journal-title":"Rheumatol Ther"},{"key":"452_CR19","doi-asserted-by":"publisher","first-page":"355","DOI":"10.1136\/annrheumdis-2017-211631","volume":"77","author":"F Zhang","year":"2018","unstructured":"Zhang F, Bae SC, Bass D, Chu M, Egginton S, Gordon D, et al. A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea. Ann Rheum Dis 2018;77:355\u201363.","journal-title":"Ann Rheum Dis"},{"key":"452_CR20","doi-asserted-by":"publisher","first-page":"2184","DOI":"10.1002\/art.39682","volume":"68","author":"RF van Vollenhoven","year":"2016","unstructured":"van Vollenhoven RF, Petri M, Wallace DJ, Roth DA, Molta CT, Hammer AE, et al. Cumulative corticosteroid dose over fifty-two weeks in patients with systemic lupus erythematosus: pooled analyses from the Phase III belimumab trials. Arthritis Rheumatol 2016;68:2184\u201392.","journal-title":"Arthritis Rheumatol"}],"container-title":["BMC Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s41927-024-00452-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s41927-024-00452-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s41927-024-00452-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,8]],"date-time":"2025-01-08T22:03:26Z","timestamp":1736373806000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcrheumatol.biomedcentral.com\/articles\/10.1186\/s41927-024-00452-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,8]]},"references-count":20,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["452"],"URL":"https:\/\/doi.org\/10.1186\/s41927-024-00452-0","relation":{},"ISSN":["2520-1026"],"issn-type":[{"value":"2520-1026","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,8]]},"assertion":[{"value":"16 April 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 December 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 January 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was conducted in accordance with the Guidelines for Good Pharmacoepidemiology Practices and the Declaration of Helsinki 2008 and approved by the Ethics Committee at the City Clinical Hospital No 52 of the Department of Healthcare of Moscow for the Moscow Rheumatology Centre site, the Ethics Committee at the North-West State Medical University named after I.I. Mechnikov of the Ministry of Health of the Russian Federation for the North-western State Medical University named after I.I. Mechnikov site, the Ethics Committee at the Ulyanovsk Regional Clinical Hospital for the Ulyanovsk Regional Clinical Hospital site, and the Ethics Committee at the Research Institute of Rheumatology named after V.A. Nasonova for the Research Institute of Rheumatology site. The requirement for patient informed consent was waived by the corresponding Ethics Committees listed above for each involved center as the study was non-interventional, and patient data were de-identified.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"AML, EAA, AIZ, IBV, and RRS have received grants from GSK during the conduct of the study. MK, LT, JQ, and SN are employees of GSK. DdS and TE were employees of GSK at the time of the study. MK, TE, and SN hold financial equities in GSK. LAK is a former employee of GSK and a current employee of No. 1 Medical Center, Department of Rheumatology, Kursk, Russian Federation.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"4"}}