{"id":109123,"date":"2026-06-03T04:29:00","date_gmt":"2026-06-03T04:29:00","guid":{"rendered":"https:\/\/pakistaninewspaperlist.com\/news\/johnson-johnson-late-breaking-results-show-nipocalimab-significantly-reduced-systemic-lupus-erythematosus-sle-disease-activity-in-a-phase-2-study\/"},"modified":"2026-06-03T04:29:00","modified_gmt":"2026-06-03T04:29:00","slug":"johnson-johnson-late-breaking-results-show-nipocalimab-significantly-reduced-systemic-lupus-erythematosus-sle-disease-activity-in-a-phase-2-study","status":"publish","type":"post","link":"https:\/\/pakistaninewspaperlist.com\/news\/johnson-johnson-late-breaking-results-show-nipocalimab-significantly-reduced-systemic-lupus-erythematosus-sle-disease-activity-in-a-phase-2-study\/","title":{"rendered":"Johnson &#038; Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study"},"content":{"rendered":"<div id=\"main-body-container\" itemprop=\"articleBody\">\n<ul>\n<li><i>Nipocalimab \u2013 the first neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus \u2013 is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with this disease while preserving immune function<br \/><\/i><\/li>\n<li><i>Results demonstrated significant reduction of systemic lupus erythematosus disease activity which continued beyond the 24-week primary endpoint, and were sustained through Week 52 in the nipocalimab 15 mg\/kg group<\/i><sup><i>a<\/i><\/sup><\/li>\n<li><i>The Phase 3 study of nipocalimab is currently underway in people living with systemic lupus erythematosus \u2013 a debilitating autoantibody-driven disease which can lead to systemic organ damage <\/i><\/li>\n<\/ul>\n<p><b>BEERSE, BELGIUM , June  03, 2026  (GLOBE NEWSWIRE) &#8212;  <\/b>Johnson &amp; Johnson today announced nipocalimab met the primary endpoint of decreasing disease activity at 24 weeks as measured by SRI-4<sup>b<\/sup> and continued to demonstrate sustained reduction in disease activity in adults with moderate-to-severe systemic lupus erythematosus (SLE)<sup>a <\/sup>through 52 weeks in the Phase 2 JASMINE study as measured by both SRI-4<sup>b<\/sup> and LLDAS.<sup>c<\/sup><sup>,<\/sup><sup>1<\/sup> In addition, the study results showed greater response versus placebo plus background medication<sup>d<\/sup> in participants who tested positive for lupus-associated autoantibodies, which represents the vast majority (~80%)\u00a0of people\u00a0living with\u00a0SLE.<sup>e<\/sup><sup>,<\/sup><sup>1<\/sup> These findings will be featured in a late-breaking presentation at the European Alliance of Associations for Rheumatology (EULAR) 2026\u00a0Congress in London and are among\u00a0the\u00a038 abstracts\u00a0the Company is presenting across its Rheumatology portfolio.<b>\u00a0<\/b><\/p>\n<p>Nipocalimab is designed to selectively block the neonatal Fc receptor (FcRn), reducing levels of circulating pathogenic immunoglobulin G (IgG) autoantibodies and immune complexes associated with inflammation in SLE.<sup>2<\/sup><sup>,<\/sup><sup>3<\/sup><sup>,<\/sup><sup>4<\/sup> By reducing circulating IgG, including autoantibodies, nipocalimab is designed to target the underlying cause of disease while preserving critical immune functions.<sup>3<\/sup><sup>,<\/sup><sup>4<\/sup> JASMINE is the first clinical study\u00a0to demonstrate\u00a0efficacy of FcRn blockade in SLE and provides clinical, biomarker, and pharmacodynamic evidence supporting the continued investigation of nipocalimab as a potential treatment option for this disease.<sup>1<\/sup><sup>,<\/sup><sup>5<\/sup><\/p>\n<p><b>A healthcare professional\u2019s perspective<\/b><br \/>\u201cThe consistent improvements observed across established disease activity measures and reductions in pathogenic immunoglobulin G autoantibodies are encouraging and support the continued investigation of nipocalimab as a targeted treatment approach for people living with systemic lupus erythematosus,\u201d said Richard Furie, M.D., Chief of the Division of Rheumatology at Northwell.<sup>f<\/sup> \u201cThese 52-week findings support the potential of\u00a0nipocalimab\u00a0to provide disease control over time for a broad population of autoantibody-positive adult patients living with moderate-to-severe systemic lupus erythematosus, a disease in which many patients experience ongoing disease activity and risk of irreversible organ damage.\u201d<\/p>\n<p><b>JASMINE Phase 2\u00a0clinical\u00a0findings<\/b><br \/>The Phase 2 JASMINE study is the first proof-of-concept for a FcRN blocker in SLE and\u00a0demonstrates\u00a0the potential of\u00a0nipocalimab\u00a0to reduce disease activity, with greater responses\u00a0observed\u00a0in autoantibody-positive patients.<sup>1<\/sup>\u00a0<\/p>\n<ul type=\"disc\">\n<li>The study met its primary endpoint at Week 24 (p=0.081), with a greater proportion of patients receiving nipocalimab 15 mg\/kg plus background medication achieving an SRI-4<sup>b<\/sup> response compared with placebo plus background medication (53.5% vs 46.7%; odds ratio (OR) 1.6 [90% confidence interval: 0.9-2.9]).<sup>1<\/sup><sup>,<\/sup><sup>6<\/sup><\/li>\n<li>In a pre-defined autoantibody-positive patient population<sup>e<\/sup>, greater SRI-4 response rates were\u00a0observed (58.2% vs. 36.1%; p=0.004) and greater achievement of LLDAS (38.9% vs. 18.0%; p=0.012) compared with placebo plus background medication at Week 52.<sup>6<\/sup><\/li>\n<li>At Week 52, a key secondary endpoint, 53.6% of patients receiving\u00a0nipocalimab\u00a015 mg\/kg achieved an SRI-4<sup>b <\/sup>response, compared with 39.7% for placebo plus background medication (p=0.020).<sup>6<\/sup><\/li>\n<li>More patients receiving\u00a0nipocalimab\u00a015 mg\/kg also achieved Lupus Low Disease Activity State (LLDAS)<sup>c<\/sup>, a key exploratory endpoint that enables a treat-to-target<sup>g<\/sup> approach, compared with placebo plus background medication (37.5% vs. 20.5%; p=0.013) at Week 52.<sup>6<\/sup><\/li>\n<\/ul>\n<p>Nipocalimab\u00a0had a safety profile consistent with\u00a0previous studies of nipocalimab and\u00a0no new safety signals were\u00a0identified.<sup>1<\/sup><sup>,<\/sup><sup>6<\/sup> The most common adverse reactions in patients with SLE treated with nipocalimab (\u226510%) were nasopharyngitis, headache, urinary tract infection, and nausea.<sup>7<\/sup><\/p>\n<p>\u201cFindings from the JASMINE study mark an important step in advancing research in systemic lupus erythematosus, a complex autoantibody disease that can have profound impact on daily life for people living with moderate to severe disease,\u201d said Mark Graham, Therapeutic Area Head, Immunology, Europe, Middle East and Africa, Johnson &amp; Johnson. \u201cThese results reflect our commitment to advancing the understanding of nipocalimab and supporting more research that may help address persistent unmet needs for people living with systemic lupus erythematosus.\u201d<\/p>\n<p>Nipocalimab\u00a0received\u00a0Fast Track Designation in SLE in the US earlier this year.<sup>8<\/sup> The Phase 3 GARDENIA study is ongoing.<sup>9<\/sup><\/p>\n<p><b>Editor\u2019s Notes:\u00a0<\/b><\/p>\n<ol style=\"list-style-type:lower-alpha;\">\n<li>Nipocalimab is not approved by the European Medicines Agency for SLE.<\/li>\n<li>The SLE Responder Index 4 (SRI-4) is a composite measure used to assess treatment response in patients with SLE during clinical studies. It comprises criteria from three different internationally validated indices, SELENA-SLE Disease Activity Index (SELENA-SLEDAI), Physician Global Assessment (PGA) and the British Isles Lupus Assessment Group (BILAG) 2004.<sup>10<\/sup><\/li>\n<li>Lupus Low Disease Activity State (LLDAS) definition: (1) SLE Disease Activity Index (SLEDAI)-2K \u22644, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no haemolytic anaemia or gastrointestinal activity; (2) no new lupus disease activity compared with the previous assessment; (3) a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI physician global assessment (scale 0-3) \u22641; (4) a current prednisolone (or equivalent) dose \u22647.5 mg daily; and (5) well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents.<sup>11<\/sup><\/li>\n<li>Protocol-permitted background medications include oral corticosteroids, antimalarials, and no more than two of the following immunomodulatory drugs: azathioprine, mycophenolate mofetil, mycophenolic acid, oral methotrexate.<sup>1,<\/sup><sup>9,<\/sup><sup>12<\/sup><\/li>\n<li>The autoantibody-positive population was defined as participants who met \u22651 of the following during screening: 1) positive anti-dsDNA, 2) positive anti-Smith, 3) positive ANA and positive for anti-Ro, anti-RNP, or had a history of anti-dsDNA.<sup>1<\/sup><\/li>\n<li>Dr. Richard Furie has provided consulting, advisory and speaking services to\u202fJohnson &amp; Johnson. He has not been paid for any media work.<\/li>\n<li>Treat-to-target in SLE is a therapeutic strategy in which treatment is guided by regular assessment of disease activity and adjusted to achieve a predefined target\u2014primarily remission, or low disease activity if remission is not attainable\u2014to improve long-term outcomes and prevent organ damage.<sup>13<\/sup><\/li>\n<\/ol>\n<p><b>ABOUT\u00a0JASMINE\u00a0\u00a0<\/b><br \/>JASMINE\u00a0(<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ClglVfMmHN-hSsT7LzBuvIW4UAjBDeUFVIH1SsYW588kEqgGpMvM_msRxcLmksdxn-ARkr0Js39BqLrvD5wg0eo1IBd8lUcQLDhHO5KVtNlk3jGUtFXse1tQBohIvu10lPsx1I6_1JFcaMH6oPei6fy_LuZUptUMsVrRYM6LL0IIz18UDaKIaZGUZEAorSbj72ySOCNZjoKgGYMFyu7yN88XnWuKLdkBeYiyBlisgmJjmzbAbqmkUiBJRgF7qfn_D_T-8luf4yXJy2zuTzYr8RSBs45HcX8VecSQYxrn7Js5GFOwDA2vcgGxtiwzL0izWUm7pOcu5BzwcdrkOrLrNxDgGPe5nfk7XvDuQKC4EtGavTJ14OQtDWOrr9o3bXb6DUFTq6m5AHe3NAcXCLAC7Bfy8L1hCLRjcTGQXy0LrHGoDddNPhgmR1RLmEemCE7H2nCQQ5PI74p3KC4t7UGqd1YWKblM1VbAYEI3qJ8I3U89xpp1I45d-gHog9_ieSis17yRoMn8suoP8WF9UdbGNJTerZ0O9cPCrDILb0Of31em0afdOALK47x0dpcGL8NK_wIqwj7ZUTp4Cv8lA7NzE5HF-HrDC-qx7Xy08YAT5ZD2OebFj5kaizVHpYhEDQ3c\" rel=\"nofollow\" target=\"_blank\" title=\"NCT04882878\">NCT04882878<\/a>\/2020-005569-14)\u00a0is a\u00a0Phase 2,\u00a0multicentre,\u00a0randomised, double-blind, placebo-controlled, parallel-group, dose-ranging\u00a0study\u00a0to evaluate\u00a0nipocalimab\u00a0in\u00a0228\u00a0adult participants with active systemic lupus erythematosus (SLE).<sup>5<\/sup>\u00a0Adults aged 18-65 years with moderate-to-severe SLE,\u00a0defined by established measures of disease activity, who were positive for antinuclear antibodies (ANA), anti-double-stranded DNA (anti-dsDNA), and\/or anti-Smith antibodies,\u00a0and had not responded to at least one standard-of-care treatment were enrolled.<sup>5<\/sup>\u00a0Participants were randomised 1:1:1 to receive intravenous\u00a0nipocalimab\u00a0at 5 or 15 mg\/kg,\u00a0or placebo every\u00a02\u00a0weeks through Week 52, in addition to protocol-permitted background medications.<sup>5<\/sup>\u00a0The primary endpoint was the SLE Responder Index-4 (SRI-4) composite response at Week 24.<sup>5<\/sup> Pharmacodynamic effects and safety, including adverse events, were assessed through Week 58.<sup>5<\/sup><\/p>\n<p><b>ABOUT\u00a0SYSTEMIC LUPUS ERYTHEMATOSUS\u00a0\u00a0<\/b><br \/>Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that occurs when the body&#8217;s immune system mistakenly attacks its own healthy tissues.<sup>14<\/sup> This can lead to inflammation and damage in many parts of the body, including the skin, joints, heart, lungs, kidneys, and brain.<sup>4<\/sup>\u00a0SLE affects nine times more women than men, often striking initially\u00a0between\u00a0the ages of 15-44.<sup>15<\/sup>\u00a0In addition to systemic organ damage, other complications of SLE can include end-stage renal failure, scarring cutaneous lesions, neurological damage, and various forms of cardiovascular disease.<sup>4<\/sup>\u00a0People living with SLE often face reduced health-related quality of life, due to\u00a0severe fatigue,\u00a0mood disturbances,\u00a0joint\u00a0pain and\u00a0swelling,\u00a0and\u00a0rashes, including the hallmark butterfly-shaped facial rash,\u00a0as well as complications of long-term glucocorticoid use.<sup>16<\/sup>\u00a0Severe fatigue is the most widely reported and debilitating symptom of SLE, affecting up to 80% of people with SLE.<sup>14<\/sup> SLE is the most common form of lupus, affecting\u00a03\u00a0to\u00a05\u00a0million people worldwide, approximately 70% of lupus cases.<sup>14<\/sup><sup>,<\/sup><sup>17<\/sup> It is estimated that\u00a050,000 to 270,000 people in the EU are affected by SLE.<sup>18<\/sup><\/p>\n<p><b>ABOUT NIPOCALIMAB<\/b>\u00a0<br \/>Nipocalimab\u00a0is an\u00a0investigational\u00a0immunoselective\u00a0treatment\u00a0designed to target, bind with high affinity, and block\u00a0FcRn, reducing circulating IgG antibodies that drive disease while also preserving key immune functions.<sup>1<\/sup> Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic disease, Rare Autoantibody diseases and Maternal\u00a0Foetal\u00a0diseases mediated by maternal alloantibodies in which\u00a0blockade of IgG binding to\u00a0FcRn\u00a0in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the\u00a0foetus.<sup>5<\/sup><sup>,<\/sup><sup>19<\/sup><sup>,<\/sup><sup>20<\/sup><sup>,<\/sup><sup>21<\/sup><sup>,<\/sup><sup>22<\/sup><sup>,<\/sup><sup>23<\/sup><sup>,<\/sup><sup>24<\/sup><sup>,<\/sup><sup>25<\/sup><sup>,<\/sup><sup>26<\/sup><sup>,<\/sup><sup>27<\/sup><\/p>\n<p>The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:\u202f\u202f\u202f\u00a0<\/p>\n<ul type=\"disc\">\n<li>EU EMA Orphan medicinal product designation for\u00a0haemolytic\u00a0disease of the foetus\u00a0and newborn (HDFN) in October 2019 and\u00a0foetal\u00a0and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025\u00a0<\/li>\n<li>U.S. FDA Fast Track designation in HDFN and warm autoimmune haemolytic\u00a0anaemia\u00a0(wAIHA) in July 2019, generalised myasthenia gravis\u00a0(gMG)\u00a0in December 2021, FNAIT in March 2024,\u00a0Sj\u00f6gren\u2019s disease (SjD) in March 2025, and\u00a0systemic lupus\u00a0erythematosus\u00a0(SLE)\u00a0in January\u00a02026\u00a0<\/li>\n<li>U.S. FDA Orphan drug status for\u00a0wAIHA\u00a0in December 2019, HDFN in June 2020,\u00a0gMG\u00a0in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023\u00a0<\/li>\n<li>U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for\u00a0SjD\u00a0in November 2024\u00a0<\/li>\n<li>U.S. FDA granted Priority Review in gMG in Q4 2024 and in wAIHA in Q2 2026\u00a0<\/li>\n<\/ul>\n<p><b>ABOUT JOHNSON &amp; JOHNSON<\/b>\u00a0<br \/>At Johnson &amp; Johnson,\u00a0we believe health is everything. Our strength in healthcare innovation empowers us to build a\u00a0world where complex diseases are prevented, treated, and cured,\u00a0where treatments are smarter and less invasive, and\u00a0solutions are personal. Through our\u00a0expertise\u00a0in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.\u00a0\u00a0\u00a0<\/p>\n<p>Learn more at<u>\u00a0<\/u><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=qQLy_wUg5ZA1KPen4SfrD73MU9lviaKUMTJK7ogWPa9iEhVqQ-dEkDWV6f26xCh9SuUMdk_6ZOeWehpf5F9I9-JrnhPDWUe-MBtPIUyQk_zsbIucYhXgjgkgjfpnnfKw0ycvw2-bgpBH9306D8vNvA==\" rel=\"nofollow\" target=\"_blank\" title=\"www.jnj.com\/innovativemedicine\/emea\/\">www.jnj.com\/innovativemedicine\/emea\/<\/a><u>\u00a0<\/u>\u00a0<\/p>\n<p>Follow us at<u>\u202f<\/u><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=M-vNUGQnyF7d87iblOcp4TFih6Lc5sMmlWp-IF5nUgr9f5HvCcKKEsE1WA_95Y-HTjB2CGMz6qDT9Y72K9eoyD897SKgBrRusqsd3qbDDh0XH00hPVbfErRZ2b7WoTgt7gBgQpRamPSRk9xAF-8znxJqTMEd3xEuMiSzfVOR8N8O0Udpgpc7J_4e4CqDMjEn\" rel=\"nofollow\" target=\"_blank\" title=\"www.linkedin.com\/jnj-innovative-medicine-emea\">www.linkedin.com\/jnj-innovative-medicine-emea<\/a><u>.<\/u>\u00a0<\/p>\n<p>Janssen Research &amp; Development, LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC are Johnson &amp; Johnson companies.\u00a0<\/p>\n<p><b>Cautions Concerning Forward-Looking Statements\u00a0<\/b><br \/>\u202f\u00a0<br \/><i>This press release\u00a0contains\u00a0\u201cforward-looking statements\u201d as defined in the Private Securities Litigation Reform Act of 1995\u00a0regarding\u00a0product development and the potential benefits and treatment impact of\u00a0nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of\u00a0Johnson &amp; Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in\u00a0behavior\u00a0and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in\u00a0Johnson &amp; Johnson\u2019s most recent Annual Report on Form 10-K, including in the sections captioned \u201cCautionary Note Regarding Forward-Looking Statements\u201d and \u201cItem 1A. Risk Factors,\u201d and in\u00a0Johnson &amp; Johnson\u2019s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from\u00a0Johnson &amp; Johnson.\u00a0Johnson &amp;\u00a0Johnson\u00a0does not undertake to update any forward-looking statement\u00a0as a result of\u00a0new information\u00a0or future events or developments.<\/i>\u00a0<\/p>\n<p align=\"left\"><b>FOR EUROPEAN AND UK MEDICAL AND TRADE MEDIA ONLY<\/b><\/p>\n<p>CP-584333<br \/>June 2026<\/p>\n<p>###<\/p>\n<p><strong>REFERENCES<\/strong><\/p>\n<hr\/>\n<p><sup>1<\/sup> Richard A Furie, et al. Nipocalimab in SLE: First-in-class efficacy and safety results demonstrating proof of concept for FcRn blockade from the Phase 2 JASMINE-SLE study. Presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress. Available at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYP0p4ZNtAH62WozmHJpEXeXzJo4ZRELh_C8x2edMoYjrw3BxopuwHrlo-HrVZoHy5qvrXOghSKsvKt_60eXJKyOwvboCxx2pUFwEjs58k1oKyDQoF3WOATlBOw2kPYRRAvxyhhumiBMcYUZG32ooy3OXGvUwCojcPFZiObtuZQFfoqYusXmEHor1bK9F06Lqw-INycpQO1H5Ex56pxU7TTCMCkBrGAsDAr0I8ASDmI2rJIa7pcAtdnzXxmsHpIAop7vkMqTMl09dsqpZ9qxxZbI=\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/distribution-congress.eular.org\/from.storage?image=15rRXWmdOAJ77zPlkD-rQh9bm46QHwQV<\/a>. <br \/><sup>2<\/sup> Tsang-A-Sjoe MWP, Bultink IEM. New developments in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Dec 24;60(6):21-28. <br \/><sup>3<\/sup> Seth,\u00a0N et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties.\u00a0MAbs.\u00a02025;17(1):2461191\u00a0<br \/><sup>4<\/sup> National Institute of Arthritis and Musculoskeletal and Skin Disease. (2022) Systemic Lupus Erythematosus (Lupus). Available at: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYHoONDCkP5Lw3bNXHNXNjgYL80zt0mYw9ZUOPv8mjV0tXOLjMHn_2H1ZulErv_kjQhAOXI39ROzmmV0kGz32gCEoQIds736P4Xwb8jIRmqV1AAk6AclKweMeW_Iia4BZZGvOTIZGTJyfyYjKnlaBwdM=\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/www.niams.nih.gov\/health-topics\/lupus<\/a>. Last accessed: June 2026.\u00a0<br \/><sup>5<\/sup> ClinicalTrials.gov Identifier: NCT04882878. Available at: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYFYM5So_pTMdKNu4JTsQBZhMOMPXYVAudWZvaJ3ETIEMei_vBKM5A3XY01f7e9DXVZg-4hLOYYi007m095ajtpOj3DW1lzoLzjP7xgyXamDOYV9xid2ATT2Sbz7xARtQk67Jmrp2xlQnC0lLA_qNvNo=\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/clinicaltrials.gov\/study\/NCT04882878<\/a>. Last accessed: June 2026.\u00a0<br \/><sup>6<\/sup> Richard A Furie, et al. [abstract] Nipocalimab in SLE: First-in-class efficacy and safety results demonstrating proof of concept for FcRn blockade from the Phase 2 JASMINE-SLE study. Presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress. Available at Oral Abstract Presentation #LB0007<br \/><sup>7<\/sup> J&amp;J. Data on File<br \/><sup>8<\/sup> Johnson &amp; Johnson (2026). Johnson &amp; Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE). Available at: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYGIRrt4zbGtbqcllD7S7zSAMPyEmAfmg6QOK62IV0Sa8aBlkkxTu2MN98cTjGuM5hKjkwBkV1MLhIgNujtIcsj80g9zePFmr4nimYfXI-fkGEoPKAzuh6cPuqhQ3ClB5y1M1VFFqAtWDCkRr5npYs1_NUziYoFUDDzYQDOPtgcUChD3ZEc7NSae511mt5rXT9hWfS7SP2634GTZP2EF_IqGhQlA4cFE9SXdUubiy3U1ATc17HhUniq2ixok1y05DJiIa6RtZ5TFXX5C8g95Igsgcby5btXkZXd0OPkagsy7MEtYsDCRZjSaEq1AxxBlS_y-v9SkH1PNSX03iqGMIwx7T4PwDakwXdqIlim7y1-T6p-CEbaLLEs4PqPma_At6N_AfLxheHlJOujCj8x3_pCV8OeU-MOWvCkUmbUnRMbheW3eYyVTt4nDlR4KN4xn9Rw==\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/www.jnj.com\/media-center\/press-releases\/johnson-johnson-therapy-nipocalimab-granted-u-s-fda-fast-track-designation-in-systemic-lupus-erythematosus-sle<\/a>. Last accessed: June 2026.\u00a0<br \/><sup>9<\/sup> ClinicalTrials.gov. NCT07438496. 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Remission and low disease activity in systemic lupus erythematosus.\u00a0Rare Dis Orphan Drugs J. 2025;4:28.<br \/><sup>14<\/sup> Lupus Foundation of America. Understanding Lupus. Available at: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYHTZ3kcd1VBNM6rr0m6um4TpqUtgj77mRWgM3JacqE273eGdXxRyPOLRphtj_8_U6_WsDnpFdV06-WRtRkskAobqAr7omEA1eccKKYDVIHxY31TjNW2melKcJ1z2gX2NJQ==\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/www.lupus.org\/understanding-lupus<\/a>. Last accessed:\u00a0June 2026.\u00a0<br \/><sup>15<\/sup> \u00a0Gu\u00e9ry JC. Why Is Systemic Lupus Erythematosus More Common in Women? Joint Bone Spine. 2019 May;86(3):297-299. <br \/><sup>16<\/sup> \u00a0Centers for Disease Control and Prevention. (2024). Symptoms of lupus<i>.<\/i>\u00a0Available at:<i>\u202f<\/i><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYJBF2BPsaIYiD6u-4YGdqiJS-2nBCNJsBf-pyS9Dr64pLUe-0csj9ERGeVqXaXSYxnzXe_QpBAO-37ikUZNHauIzjPauGSpYHM6DpAVkkqkOPJ3n69lcpmKGdy0kWwEFeg==\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/www.cdc.gov\/lupus\/signs-symptoms\/<\/a>. Last accessed: June 2026.\u00a0<br \/><sup>17<\/sup> Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study Annals of the Rheumatic Diseases Lupus Foundation of America. Lupus facts and statistics. 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Available at:\u202f<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYBE1uDed6vOmFpmouFk2EXVYwDB8OIw02NoALQmGOcBlqTuTgQfktwEvH7gc3Q9mv0XocnbkF1Rnsb8AGPhgy7EbId80KkauVTkLGVlptZ2INOYu8MScgutqKgiWBFMqMHQfOaBopJAapsERXk8wdm8=\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/www.clinicaltrials.gov\/study\/NCT05912517<\/a>. Last accessed:\u00a0June 2026.\u00a0<br \/><sup>24<\/sup> ClinicalTrials.gov Identifier: NCT04968912. Available at:\u202f<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYFYM5So_pTMdKNu4JTsQBZhMOMPXYVAudWZvaJ3ETIEMyxn_5RgnxdCi-DQEoOFHjG2mWztwDWrrF_jk5ld3nufp6fYJhvEmSgukvb-EQbI1vYn01WW9FmO50WCOEJa50DeT682Kd0X_JDmSCPbYyjs=\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/clinicaltrials.gov\/study\/NCT04968912<\/a>. Last accessed:\u00a0June 2026.\u00a0<br \/><sup>25<\/sup> ClinicalTrials.gov Identifier: NCT06449651. Available at:\u202f<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYFYM5So_pTMdKNu4JTsQBZhMOMPXYVAudWZvaJ3ETIEM8LtBecmy8LBKCO1PO_77E0BCuk5HDv-LiRA8BWbEU65gGMjlHctYZwXUAzrht527oT-f6l74jsR6AMFKa2KpmQmiArbW_YBUHeQfseefvN4=\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/clinicaltrials.gov\/study\/NCT06449651<\/a>. Last accessed:\u00a0June 2026.\u00a0<br \/><sup>26<\/sup> ClinicalTrials.gov Identifier: NCT06533098. Available at:\u202f<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYFYM5So_pTMdKNu4JTsQBZhMOMPXYVAudWZvaJ3ETIEM8CrzcQKHqo2CKJ2d78NWr8ETzWOzDtSncYmHEJbwe8XYCU7Wb20M2yxuGznzqJf2uemQ-F4GkKcl802wReBE7QGkAE3BohIucvMAcu1dYmg=\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/clinicaltrials.gov\/study\/NCT06533098<\/a>. Last accessed:\u00a0June 2026.\u00a0<br \/><sup>27<\/sup> ClinicalTrials.gov Identifier: NCT04951622. Available at:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bUrSR0sXt4BilqHMD7JCYFYM5So_pTMdKNu4JTsQBZhI5xXyXRsp4dHHT8WDqMPt1eJ3q8uyySDuz3-xOCcdX524TyWlf1Erjea2EFOjjiXIbGgrlOqOz5Esde_20TTPys4YI_t1UYyF35h1YJYaeOTos_ivijbI5n3AJh7K74w=\" rel=\"nofollow\" target=\"_blank\" title=\"\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04951622<\/a> Last accessed: June 2026.<\/p>\n<pre\/>\n            <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Nipocalimab \u2013 the first neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus \u2013 is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with this disease while preserving immune function Results demonstrated significant reduction of systemic lupus erythematosus disease activity which continued beyond the 24-week primary endpoint, and were 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