{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T17:27:49Z","timestamp":1789752469902,"version":"4.0.1"},"reference-count":42,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"8","license":[{"start":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T00:00:00Z","timestamp":1781136000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Visterra Inc"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["CJASN"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Key Points<\/jats:title>\n                    <jats:p>\n                      <jats:list list-type=\"bullet\">\n                        <jats:list-item>\n                          <jats:p>The phase 2 ENVISION trial evaluated efficacy and safety of intravenous sibeprenlimab, a selective A PRoliferation-Inducing Ligand inhibitor.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Because the trial was conducted during the coronavirus disease 2019 pandemic, we assessed if sibeprenlimab affected humoral responses to coronavirus disease 2019 infection or vaccine.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Sibeprenlimab treatment resulted in reduced pathogenic IgA and preserved protective humoral response to coronavirus disease 2019 vaccine and infection.<\/jats:p>\n                        <\/jats:list-item>\n                      <\/jats:list>\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In phase 2 ENVISION trial, sibeprenlimab, a selective A PRoliferation-Inducing Ligand inhibitor, significantly decreased proteinuria and stabilized eGFR in adults with IgA nephropathy. This exploratory substudy evaluated coronavirus disease 2019 (COVID-19) severity, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)\u2013specific antibody responses to vaccine and infection, and circulating B-cell populations in patients with IgA nephropathy treated with sibeprenlimab or placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Participants enrolled in ENVISION (NCT04287985) received 12 monthly intravenous infusions of sibeprenlimab (2, 4, or 8 mg\/kg) or placebo. COVID-19 infection and vaccination data were recorded for all participants. In a substudy, serum IgG responses to SARS-CoV-2 spike protein, its receptor binding domain (RBD), and nucleocapsid antigen were assessed, with further analysis of serum IgM and IgA and salivary IgA against RBD in a subset of participants. Circulating T cells and B-cell subsets were analyzed by flow cytometry.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Overall, symptomatic COVID-19 incidence was comparable between groups (33.3% sibeprenlimab versus 44.7% placebo), indicating no observable excess risk of COVID-19 infection with sibeprenlimab. Of 155 participants, 72 (sibeprenlimab\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =52; placebo\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =20) consented to the substudy. Within the substudy, COVID-19 seroconversion rates were 100% for IgG against SARS-CoV-2 RBD (IgG-RBD) after vaccination or infection. Peak IgG-RBD titers after mRNA vaccination exceeded protective thresholds in all COVID-19\u2013naive sibeprenlimab recipients, and IgG-RBD durability was comparable between sibeprenlimab and placebo. COVID-19\u2013specific IgG, IgA, and IgM antibody responses to infection were preserved, and IgA-RBD responses detected in saliva suggested preservation of mucosal immunity with sibeprenlimab. No meaningful perturbations in B or T cells were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>A PRoliferation-Inducing Ligand inhibition with sibeprenlimab reduced pathogenic IgA while preserving mucosal immunity and systemic antibody responses to COVID-19 vaccination and infection. The absence of B-cell perturbations and the apparent absence of an increased risk of impaired vaccine response suggest that sibeprenlimab may not confer clinically significant immunosuppressive risks; the substudy's size and exploratory design preclude definitive conclusions, warranting further evaluation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial registry name and registration number:<\/jats:title>\n                    <jats:p>ClinicalTrials.gov, NCT04287985.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2215\/cjn.0000001089","type":"journal-article","created":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T16:02:32Z","timestamp":1781193752000},"page":"1365-1375","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":1,"title":["Humoral Response to COVID-19 Vaccines and Infection during Sibeprenlimab Treatment of IgA Nephropathy"],"prefix":"10.2215","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0762-2270","authenticated-orcid":false,"given":"Kieran","family":"McCafferty","sequence":"first","affiliation":[{"name":"Barts Health, NHS Trust and Queen Mary University of London, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Barratt","sequence":"additional","affiliation":[{"name":"College of Life Sciences, University of Leicester, Leicester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4077-9747","authenticated-orcid":false,"given":"Yusuke","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0963-6270","authenticated-orcid":false,"given":"Adrian","family":"Liew","sequence":"additional","affiliation":[{"name":"Mount Elizabeth Novena Hospital, Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dana V.","family":"Rizk","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0292-5512","authenticated-orcid":false,"given":"Bobby","family":"Chacko","sequence":"additional","affiliation":[{"name":"Nephrology and Transplantation Unit, John Hunter Hospital, Newcastle, New South Wales, Australia"},{"name":"School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Kooienga","sequence":"additional","affiliation":[{"name":"Colorado Kidney Care, Denver, Colorado"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3906-7934","authenticated-orcid":false,"given":"Richard","family":"Lafayette","sequence":"additional","affiliation":[{"name":"Stanford Glomerular Disease Center, Stanford University Medical Center, Stanford, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7575-9877","authenticated-orcid":false,"given":"Muh Geot","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Renal Medicine, Concord Repatriation General Hospital, Concord, New South Wales, Australia"},{"name":"Concord Clinical School, University of Sydney, Concord, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0894-4009","authenticated-orcid":false,"given":"Marcela F.","family":"Pasetti","sequence":"additional","affiliation":[{"name":"Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-6536-3218","authenticated-orcid":false,"given":"Mallory C.","family":"Shriver","sequence":"additional","affiliation":[{"name":"Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristin","family":"Follman","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Certara, Radnor, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9805-0177","authenticated-orcid":false,"given":"Courtney","family":"Moc Willeford","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology, Certara, Radnor, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5534-2516","authenticated-orcid":false,"given":"Manisha","family":"Sahay","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Osmania General Hospital and Osmania Medical College, Hyderabad, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9147-7450","authenticated-orcid":false,"given":"Gerard","family":"Honig","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development and Commercialization, Inc., Princeton, New 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