{"id":58880,"date":"2026-03-05T17:01:02","date_gmt":"2026-03-05T09:01:02","guid":{"rendered":"https:\/\/flcube.com\/?p=58880"},"modified":"2026-03-05T17:01:03","modified_gmt":"2026-03-05T09:01:03","slug":"abbvies-skyrizi-hits-affirm-study-endpoints-in-crohns-disease-55-clinical-remission-vs-30-placebo-at-week-12","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=58880","title":{"rendered":"AbbVie&#8217;s SKYRIZI Hits AFFIRM Study Endpoints in Crohn&#8217;s Disease \u2013 55% Clinical Remission vs. 30% Placebo at Week 12"},"content":{"rendered":"\n<p><strong>AbbVie Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/ABBV:NYSE\">NYSE: ABBV<\/a>) announced <strong>positive topline results<\/strong> from the <strong>Phase\u202f3 AFFIRM study<\/strong> evaluating <strong>risankizumab (SKYRIZI)<\/strong> subcutaneous induction therapy in adult patients with <strong>moderately to severely active Crohn&#8217;s disease (CD)<\/strong>. The study demonstrated <strong>statistically significant superiority<\/strong> over placebo on both co\u2011primary endpoints, reinforcing SKYRIZI&#8217;s position in the inflammatory bowel disease (IBD) market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-affirm-study-results\">AFFIRM Study Results<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Endpoint<\/th><th>SKYRIZI SC (Week\u202f12)<\/th><th>Placebo (Week\u202f12)<\/th><th>Statistical Significance<\/th><th>Clinical Impact<\/th><\/tr><\/thead><tbody><tr><td><strong>CDAI Clinical Remission<\/strong><\/td><td><strong>55%<\/strong><\/td><td>30%<\/td><td>p&lt;0.0001<\/td><td>25\u202fpercentage\u2011point absolute benefit<\/td><\/tr><tr><td><strong>Endoscopic Response<\/strong><\/td><td><strong>44%<\/strong><\/td><td>14%<\/td><td>p&lt;0.0001<\/td><td>30\u202fpercentage\u2011point absolute benefit<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Maintenance Phase (Week\u202f24):<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Among week\u201112 clinical responders continuing treatment: <strong>67% achieved CDAI clinical remission<\/strong><\/li>\n\n\n\n<li><strong>57% achieved endoscopic response<\/strong> at week\u202f24<\/li>\n<\/ul>\n\n\n\n<p><strong>Study Design:<\/strong> Phase\u202f3, randomized, double\u2011blind, placebo\u2011controlled; subcutaneous induction dosing<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-safety-profile\">Safety Profile<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>Finding<\/th><\/tr><\/thead><tbody><tr><td><strong>Observation Period<\/strong><\/td><td>12\u2011week double\u2011blind placebo\u2011controlled phase<\/td><\/tr><tr><td><strong>Safety Consistency<\/strong><\/td><td>Aligned with established SKYRIZI Crohn&#8217;s disease profile<\/td><\/tr><tr><td><strong>New Safety Risks<\/strong><\/td><td>None identified<\/td><\/tr><tr><td><strong>Discontinuation Rates<\/strong><\/td><td>Comparable to placebo arm<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-profile-amp-market-position\">Product Profile &amp; Market Position<\/h2>\n\n\n\n<p><strong>Mechanism:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IL\u201123 Selective Inhibition:<\/strong> Blocks p19 subunit of interleukin\u201123, a key cytokine in inflammatory signaling<\/li>\n\n\n\n<li><strong>Differentiation:<\/strong> Targeted immunomodulation vs. broad immunosuppression<\/li>\n<\/ul>\n\n\n\n<p><strong>Current Approvals:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Region<\/th><th>Approved Indications<\/th><\/tr><\/thead><tbody><tr><td><strong>U.S. (FDA)<\/strong><\/td><td>Plaque psoriasis, psoriatic arthritis, Crohn&#8217;s disease, ulcerative colitis<\/td><\/tr><tr><td><strong>EU (EMA)<\/strong><\/td><td>Plaque psoriasis, psoriatic arthritis, Crohn&#8217;s disease, ulcerative colitis<\/td><\/tr><tr><td><strong>China (NMPA)<\/strong><\/td><td>Crohn&#8217;s disease, ulcerative colitis<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-commercial-amp-competitive-analysis\">Commercial &amp; Competitive Analysis<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Factor<\/th><th>Strategic Implication<\/th><\/tr><\/thead><tbody><tr><td><strong>Market Expansion<\/strong><\/td><td>AFFIRM data supports potential label expansion for SC maintenance dosing optimization<\/td><\/tr><tr><td><strong>Competitive Positioning<\/strong><\/td><td>Strengthens case vs. ustekinumab (Stelara) and vedolizumab (Entyvio) in bio\u2011na\u00efve and bio\u2011experienced segments<\/td><\/tr><tr><td><strong>Formulation Advantage<\/strong><\/td><td>Subcutaneous delivery offers convenience vs. IV induction alternatives<\/td><\/tr><tr><td><strong>Revenue Contribution<\/strong><\/td><td>SKYRIZI generated <strong>$11.6\u202fbillion global sales<\/strong> in 2024; Crohn&#8217;s indication contributes ~15% of volume with growth trajectory<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pipeline Synergy:<\/strong> Data readout supports ongoing ** ulcerative colitis maintenance studies** and potential <strong>combination therapy<\/strong> investigations with ABBV\u20113373 (anti\u2011TNF\/TL1A bispecific)<\/li>\n\n\n\n<li><strong>Pricing Power:<\/strong> Superior endoscopic response rates (44% vs. competitor range 25\u201335%) support premium positioning in payor negotiations<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory submissions, label expansion, and commercial projections for SKYRIZI in Crohn&#8217;s disease. Actual results may differ due to FDA\/EMA review timelines, competitive market dynamics, and reimbursement decisions.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>AbbVie Inc. (NYSE: ABBV) announced positive topline results from the Phase\u202f3 AFFIRM study evaluating risankizumab&#8230;<\/p>\n","protected":false},"author":1,"featured_media":58881,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[234,17,853],"class_list":["post-58880","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-abbvie","tag-clinical-trial-results","tag-nyse-abbv"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>AbbVie&#039;s SKYRIZI Hits AFFIRM Study Endpoints in Crohn&#039;s Disease \u2013 55% Clinical Remission vs. 30% Placebo at Week 12 - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"AbbVie Inc. (NYSE: ABBV) announced positive topline results from the Phase\u202f3 AFFIRM study evaluating risankizumab (SKYRIZI) subcutaneous induction therapy in adult patients with moderately to severely active Crohn&#039;s disease (CD). The study demonstrated statistically significant superiority over placebo on both co\u2011primary endpoints, reinforcing SKYRIZI&#039;s position in the inflammatory bowel disease (IBD) market.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=58880\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AbbVie&#039;s SKYRIZI Hits AFFIRM Study Endpoints in Crohn&#039;s Disease \u2013 55% Clinical Remission vs. 30% Placebo at Week 12\" \/>\n<meta property=\"og:description\" content=\"AbbVie Inc. (NYSE: ABBV) announced positive topline results from the Phase\u202f3 AFFIRM study evaluating risankizumab (SKYRIZI) subcutaneous induction therapy in adult patients with moderately to severely active Crohn&#039;s disease (CD). 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(NYSE: ABBV) announced positive topline results from the Phase\u202f3 AFFIRM study evaluating risankizumab (SKYRIZI) subcutaneous induction therapy in adult patients with moderately to severely active Crohn's disease (CD). The study demonstrated statistically significant superiority over placebo on both co\u2011primary endpoints, reinforcing SKYRIZI's position in the inflammatory bowel disease (IBD) market.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=58880#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=58880"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=58880#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/0502-1.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/0502-1.webp","width":1080,"height":608,"caption":"AbbVie's SKYRIZI Hits AFFIRM Study Endpoints in Crohn's Disease \u2013 55% Clinical Remission vs. 30% Placebo at Week 12"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=58880#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"AbbVie&#8217;s SKYRIZI Hits AFFIRM Study Endpoints in Crohn&#8217;s Disease \u2013 55% Clinical Remission vs. 30% Placebo at Week 12"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/03\/0502-1.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/58880","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=58880"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/58880\/revisions"}],"predecessor-version":[{"id":58882,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/58880\/revisions\/58882"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/58881"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=58880"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=58880"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=58880"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}