{"id":32473,"date":"2025-06-16T17:32:00","date_gmt":"2025-06-16T12:02:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=32473"},"modified":"2025-06-18T15:19:18","modified_gmt":"2025-06-18T09:49:18","slug":"igg4-related-disease-treatment-landscape","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/igg4-related-disease-treatment-landscape","title":{"rendered":"IgG4-Related Disease: A Niche Autoimmune Disorder with Expanding Drug Development Interest"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3b555c33cda\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a3b555c33cda\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/igg4-related-disease-treatment-landscape\/#UPLIZNA_First_FDA-Approved_Therapy_for_IgG4-RD_Treatment\" >UPLIZNA: First FDA-Approved Therapy for IgG4-RD Treatment<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/igg4-related-disease-treatment-landscape\/#IgG4-RD_Treatment_Pipeline_Highlights_Obexelimab_and_Rilzabrutinib\" >IgG4-RD Treatment Pipeline Highlights: Obexelimab and Rilzabrutinib<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/igg4-related-disease-treatment-landscape\/#Recent_Developments_in_IgG4-RD_Treatment_Space\" >Recent Developments in IgG4-RD Treatment Space<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/igg4-related-disease-treatment-landscape\/#Roadblocks_in_IgG4-RD_Treatment\" >Roadblocks in IgG4-RD Treatment<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/igg4-related-disease-treatment-landscape\/#Future_of_IgG4-RD_Treatment_Looks_Promising\" >Future of IgG4-RD Treatment Looks Promising<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>IgG4-related disease (IgG4-RD) was first identified as a systemic condition between 2001 and 2003 in a group of Japanese patients. Subsequently, in 2011, Japan\u2019s Ministry of Health, Labor and Welfare introduced the first diagnostic criteria for the disease.<\/p>\n\n\n\n<p>Although specific data on the period prevalence of IgG4-RD in the United States is limited, findings from long-term research at Massachusetts General Hospital led DelveInsight to estimate that approximately <strong>57,000<\/strong> individuals in the US were <a href=\"https:\/\/www.delveinsight.com\/report-store\/igg4-related-disease-epidemiology-forecast\">diagnosed with IgG4-RD<\/a> in 2024. This number is projected to rise throughout the forecast period (2025\u20132034), driven by increased disease awareness from new therapies, a growing elderly population, and improvements in diagnostics, especially in understanding the disease&#8217;s pathophysiology and identifying biomarkers.<\/p>\n\n\n\n<p>Notably, about 20\u201330% of diagnosed patients do not receive systemic treatment, choosing instead either surgical intervention or a watchful waiting approach.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-uplizna-first-fda-approved-therapy-for-igg4-rd-treatment\"><span class=\"ez-toc-section\" id=\"UPLIZNA_First_FDA-Approved_Therapy_for_IgG4-RD_Treatment\"><\/span><strong>UPLIZNA: First FDA-Approved Therapy for IgG4-RD Treatment<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In April 2025, <strong>Amgen <\/strong>announced that the FDA had approved <strong>UPLIZNA <\/strong>as the <a href=\"https:\/\/www.delveinsight.com\/report-store\/igg4-related-disease-market\">first treatment for adults with IgG4-RD<\/a>. UPLIZNA is a humanized monoclonal antibody designed to selectively and durably deplete CD19+ B cells, including plasmablasts and certain plasma cells, that play a key role in the disease\u2019s progression. While its exact mechanism of action in IgG4-RD remains unclear, the treatment regimen consists of two initial doses followed by maintenance infusions every six months.<\/p>\n\n\n\n<p>UPLIZNA received <strong>Breakthrough Therapy Designation<\/strong> from the FDA for IgG4-RD, highlighting both the serious nature of the condition and the urgent need for effective treatments. Its approval is based on findings from the <strong>MITIGATE trial<\/strong>, the first randomized, double-blind, placebo-controlled study in this disease, which showed UPLIZNA\u2019s ability to lower disease activity by reducing flares, while maintaining its known safety and efficacy.<\/p>\n\n\n\n<p>This marks the second FDA-approved use for UPLIZNA, which was previously authorized in June 2020 for treating adults with AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD). The drug has also been granted Orphan Drug Designation for generalized myasthenia gravis (gMG), with regulatory submissions for this indication expected to conclude in the first half of 2025. In 2024, Amgen generated <strong>USD 379 million<\/strong> in revenue from UPLIZNA\u2019s use in NMOSD alone. The recent approval for IgG4-RD significantly expands its market potential, as the new indication targets a patient population roughly twice the size of that for NMOSD.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.delveinsight.com\/sample-request\/igg4-related-disease-market\"><img decoding=\"async\" width=\"1024\" height=\"394\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123124\/IgG4-Related-Disease-Market-At-a-Glance-1024x394.png\" alt=\"IgG4-Related-Disease-Market-At-a-Glance\" class=\"wp-image-32478\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123124\/IgG4-Related-Disease-Market-At-a-Glance-1024x394.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123124\/IgG4-Related-Disease-Market-At-a-Glance-300x115.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123124\/IgG4-Related-Disease-Market-At-a-Glance-150x58.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123124\/IgG4-Related-Disease-Market-At-a-Glance-768x295.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123124\/IgG4-Related-Disease-Market-At-a-Glance-1536x591.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123124\/IgG4-Related-Disease-Market-At-a-Glance-2048x788.png 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-igg4-rd-treatment-pipeline-highlights-obexelimab-and-rilzabrutinib\"><span class=\"ez-toc-section\" id=\"IgG4-RD_Treatment_Pipeline_Highlights_Obexelimab_and_Rilzabrutinib\"><\/span><strong>IgG4-RD Treatment Pipeline Highlights: Obexelimab and Rilzabrutinib<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <a href=\"https:\/\/www.delveinsight.com\/report-store\/igg4-related-disease-pipeline-insight\">IgG4-RD treatment pipeline<\/a> possesses some drugs in mid- and late-stage development to be approved in the near future. The emerging IgG4-RD treatment landscape holds a diverse range of therapeutic alternatives for treatment, including <strong>obexelimab (XmAb5871)<\/strong> (Zenas BioPharma and Bristol Myers Squibb) and <strong>rilzabrutinib <\/strong>(Sanofi). Among these emerging therapies, <strong>obexelimab <\/strong>has a promising potential to compete with UPLIZNA.<\/p>\n\n\n\n<p><strong>Obexelimab (XmAb5871)<\/strong> is a dual-function monoclonal antibody that targets both CD19 and Fc\u03b3RIIb, markers commonly found on B cells. Its mechanism allows it to suppress B-cell activity, key drivers in numerous autoimmune disorders, without depleting these cells. The therapy\u2019s novel action and self-administered subcutaneous (SC) dosing approach offer promising potential for effectively managing chronic autoimmune diseases driven by B-cell dysregulation.<\/p>\n\n\n\n<p>In <strong>November 2024<\/strong>, <strong>Zenas BioPharma<\/strong> announced that it had completed targeted enrollment for its <strong>Phase III<\/strong> <strong>INDIGO trial<\/strong>, evaluating obexelimab in patients with IgG4-RD. The company expects to release <strong>topline results<\/strong> from the study by <strong>the end of 2025<\/strong>.<\/p>\n\n\n\n<p><strong>Rilzabrutinib<\/strong> is an oral, reversible, covalent inhibitor of Bruton\u2019s tyrosine kinase (BTK). It is being developed as a potential first- or best-in-class therapy for a range of immune-mediated conditions. BTK is a key signaling molecule in B cells, mast cells, and other innate immune cells, playing a vital role in driving inflammatory and autoimmune responses.<\/p>\n\n\n\n<p>In its Q4 2024 update, Sanofi reported that the Phase II trial of rilzabrutinib demonstrated significant efficacy in reducing disease flares and minimizing the need for glucocorticoids. Previously, in September 2020, Sanofi completed the acquisition of Principia Biopharma for <strong>USD 100 per share in cash<\/strong>, strengthening its immunology pipeline with rilzabrutinib and other assets.<\/p>\n\n\n\n<p>The expected launch of these IgG4-RD therapies shall further create a positive impact on the IgG4-RD treatment market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-recent-developments-in-igg4-rd-treatment-space\"><span class=\"ez-toc-section\" id=\"Recent_Developments_in_IgG4-RD_Treatment_Space\"><\/span><strong>Recent Developments in IgG4-RD Treatment Space<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul class=\"wp-block-list\">\n<li>In <strong>April 2025, Amgen<\/strong> announced that the FDA had approved UPLIZNA as the first and only treatment for adults living with IgG4-RD.<\/li>\n\n\n\n<li>In <strong>March 2025, Zenas BioPharma<\/strong> announced that the company anticipates reporting topline results for the INDIGO trial by the end of 2025.<\/li>\n\n\n\n<li>In <strong>November 2024, Amgen<\/strong> presented new data at the annual American College of Rheumatology (ACR) Convergence 2024, demonstrating a significant reduction in disease activity in patients with IgG4-RD following treatment with UPLIZNA.<\/li>\n\n\n\n<li>In <strong>August 2024, Amgen<\/strong> announced that the US FDA had granted Breakthrough Therapy Designation (BTD) to UPLIZNA for the treatment of IgG4-RD based on data from the MITIGATE study.<\/li>\n<\/ul>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-roadblocks-in-igg4-rd-treatment\"><span class=\"ez-toc-section\" id=\"Roadblocks_in_IgG4-RD_Treatment\"><\/span><strong>Roadblocks in IgG4-RD Treatment<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The approval of UPZILNA represents a breakthrough for the IgG4-RD market, becoming the first authorized treatment for this previously neglected disease. This milestone is expected to reshape the therapeutic landscape, boost diagnostic rates, and influence commercial strategies through pricing and physician uptake. Nevertheless, its long-term success will depend on factors like market awareness, real-world evidence, and emerging competition.<\/p>\n\n\n\n<p>Patients may face higher out-of-pocket costs for IV-administered treatments like inebilizumab under Medicare Part B, which covers outpatient services, compared to oral or subcutaneous drugs under Medicare Part D. This could position obexelimab as a more cost-effective option.&nbsp;<\/p>\n\n\n\n<p>Regulatory challenges remain, as there are no well-defined endpoints or precedents for IgG4-RD trials, adding uncertainty to future approvals. Furthermore, payers may hesitate to reimburse expensive biologics, particularly if off-label rituximab continues to offer a cheaper alternative, though this is not a concern in Japan, where rituximab is not approved for IgG4-RD due to insurance limitations.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-future-of-igg4-rd-treatment-looks-promising\"><span class=\"ez-toc-section\" id=\"Future_of_IgG4-RD_Treatment_Looks_Promising\"><\/span><strong>Future of IgG4-RD Treatment Looks Promising<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The future of IgG4-related disease treatment is increasingly optimistic, marked by the first FDA-approved therapy, UPLIZNA, setting a new precedent. This milestone not only validates IgG4-RD as a serious, distinct clinical entity but also opens the door for broader therapeutic innovation. The approval is expected to accelerate disease recognition, refine diagnostic pathways, and encourage earlier intervention, ultimately improving long-term outcomes. Moreover, as more real-world evidence emerges from inebilizumab use, it could guide more personalized and effective treatment regimens.<\/p>\n\n\n\n<p>The total&nbsp; <a href=\"https:\/\/www.delveinsight.com\/report-store\/igg4-related-disease-market\">IgG4-RD market size<\/a> in the 7MM was estimated to be nearly <strong>USD 170 million<\/strong> in 2024, and it is expected to grow positively by 2034. This change is mainly due to the increase in prevalence and the launch of upcoming therapies during the forecast period.<\/p>\n\n\n\n<p>Looking ahead, the treatment landscape is poised for significant evolution. A wave of investigational agents, ranging from other B-cell depleting therapies to novel immune-modulating biologics, is under exploration, promising to expand options beyond corticosteroids and traditional immunosuppressants. Additionally, advances in biomarker discovery and precision medicine may enable better stratification of patients by disease activity, risk of relapse, or organ involvement, ensuring tailored approaches. As research deepens and awareness grows, the future of IgG4-RD care appears increasingly comprehensive and patient-centric.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.delveinsight.com\/report-store\/igg4-related-disease-market\"><img decoding=\"async\" width=\"1024\" height=\"194\" src=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123009\/IgG4-Related-Disease-Market-Outlook--1024x194.png\" alt=\"IgG4-Related Disease Market Outlook \" class=\"wp-image-32477\" srcset=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123009\/IgG4-Related-Disease-Market-Outlook--1024x194.png 1024w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123009\/IgG4-Related-Disease-Market-Outlook--300x57.png 300w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123009\/IgG4-Related-Disease-Market-Outlook--150x28.png 150w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123009\/IgG4-Related-Disease-Market-Outlook--768x145.png 768w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123009\/IgG4-Related-Disease-Market-Outlook--1536x291.png 1536w, https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/06\/16123009\/IgG4-Related-Disease-Market-Outlook-.png 1584w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>IgG4-related disease (IgG4-RD) was first identified as a systemic condition between 2001 and 2003 in a group of Japanese patients. Subsequently, in 2011, Japan\u2019s Ministry of Health, Labor and Welfare introduced the first diagnostic criteria for the disease. Although specific data on the period prevalence of IgG4-RD in the United States is limited, findings from [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":32475,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[22577,22578,22574,22576,22575,22579],"industry":[17225],"therapeutic_areas":[17227],"class_list":["post-32473","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-igg4-rd","tag-igg4-rd-treatment","tag-igg4-related-disease","tag-igg4-related-disease-market","tag-igg4-related-disease-treatment","tag-uplizna","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The Shifting IgG4-Related Disease Treatment Paradigm<\/title>\n<meta name=\"description\" content=\"Future of IgG4-related disease treatment is increasingly optimistic, marked by first FDA-approved therapy, UPLIZNA, setting a new precedent.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/igg4-related-disease-treatment-landscape\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Shifting IgG4-Related Disease Treatment Paradigm\" \/>\n<meta property=\"og:description\" content=\"Future of IgG4-related disease treatment is increasingly optimistic, marked by first FDA-approved therapy, UPLIZNA, setting a new precedent.\" \/>\n<meta property=\"og:url\" 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