[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"article-amgen-s-phase-3-tepezza-obi-results-redefining-thyroid-eye-disease-drug-delivery-en":3,"ArticleBody_6sErAxNoHBYTRlgp6QxM9H31dTfYqkM4y3Aqtgdk":140},{"article":4,"relatedArticles":132,"locale":45},{"id":5,"title":6,"slug":7,"content":8,"htmlContent":9,"excerpt":10,"category":11,"tags":12,"metaDescription":10,"wordCount":13,"readingTime":14,"publishedAt":15,"sources":16,"sourceCoverage":37,"transparency":39,"seo":42,"language":45,"featuredImage":46,"featuredImageCredit":47,"isFreeGeneration":51,"niche":52,"geoTakeaways":56,"geoFaq":65,"entities":66},"69da24e65c0f21a12e62c6c7","Amgen’s Phase 3 TEPEZZA OBI Results: Redefining Thyroid Eye Disease Drug Delivery","amgen-s-phase-3-tepezza-obi-results-redefining-thyroid-eye-disease-drug-delivery","## 1. Phase 3 TEPEZZA OBI Trial at a Glance  \n\n[Amgen](https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FAmgen) reported positive topline Phase 3 results for subcutaneous TEPEZZA ([teprotumumab‑trbw](https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FTeprotumumab)) delivered via an [on-body injector](https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FInjector) (OBI) in adults with moderate-to-severe active [Thyroid Eye Disease](https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FGraves'_disease) (TED), suggesting a practical alternative to the current intravenous (IV) regimen.[2][3]  \n\n**Trial design:**[2][5]  \n- Randomized, double-masked, placebo-controlled, parallel-group, multicenter  \n- Adults with active, moderate-to-severe TED; baseline proptosis ≥3 mm  \n- TEPEZZA or placebo given subcutaneously via OBI every 2 weeks for 24 weeks (12 doses)  \n\n**Comparison to approved IV TEPEZZA:**[1][5]  \n- IV: 8 infusions every 3 weeks in infusion centers  \n- OBI: 12 subcutaneous injections every 2 weeks  \n- Key shift: IV to subcutaneous, and clinic-based infusions to device-enabled dosing  \n\n**Endpoints and outcomes:**[2][3][5]  \n- **Primary:** Proptosis responder rate (≥2‑mm reduction at week 24)  \n  - TEPEZZA OBI: 76.7% vs placebo: 19.6% (p \u003C 0.0001)  \n- **Key secondary:** Mean proptosis change at week 24  \n  - TEPEZZA OBI: −3.17 mm vs placebo: −0.80 mm (p \u003C 0.0001)  \n\n**Key takeaway:** OBI met its primary and key secondary endpoints, with a proptosis effect size closely mirroring IV TEPEZZA.[2][3]  \n\n## 2. Efficacy, Safety, and Clinical Significance  \n\n**Clinical relevance of proptosis reduction:**[2][4]  \n- ≥2 mm decrease is typically meaningful, associated with:  \n  - Less eye bulging and exposure keratopathy  \n  - Lower need for orbital decompression surgery  \n- The −3.17 mm mean reduction with OBI aligns well with historical IV TEPEZZA data, supporting “IV-level efficacy.”[3][4]  \n\n**Secondary efficacy findings:**[2][3]  \n- Statistically significant, clinically meaningful improvements in:  \n  - Overall response rates  \n  - Proportion achieving Clinical Activity Score (CAS) 0 or 1  \n  - Diplopia measures, addressing a major driver of disability and work impact  \n\n**Patient-reported outcomes (GO‑QoL):**[2][3]  \n- **Appearance subscale:** Significant improvement, indicating reduced psychosocial burden from facial changes  \n- **Visual functioning subscale:** Numerical advantage for OBI but not statistically significant, suggesting potential functional gains needing further evaluation  \n\n**Safety profile:**[2][3][4]  \n- Overall safety consistent with IV TEPEZZA, important for a route change  \n- Mild-to-moderate injection-site reactions; none caused treatment interruption or discontinuation  \n- Most common adverse events (≥10%):  \n  - Muscle spasms  \n  - Tinnitus  \n  - Weight decrease  \n  - Ear discomfort  \n  - Nausea  \n  - Diarrhea  \n- No new safety signals, supporting feasibility of a subcutaneous, device-enabled strategy.[2][3]  \n\n## 3. From IV to On-Body Injector: What Changes for TED Care?  \n\nWith efficacy and safety aligned to the IV formulation, the main differentiator for TEPEZZA OBI is its potential to reshape TED care pathways. An OBI-enabled regimen could allow treatment in more flexible settings, potentially including at-home administration under appropriate supervision, rather than anchoring care to infusion centers.[3][5] For patients with visually disabling TED, this may lessen travel demands and cumulative time in clinic.[2][5]  \n\nIV TEPEZZA, approved in 2020 as the first and only therapy for TED, has now treated more than 25,000 patients worldwide and is supported by Phase 4 and real-world data, including use in chronic or low‑CAS disease and extended treatment courses.[3][5] TEPEZZA OBI builds on this foundation by modernizing delivery rather than altering the molecular target.  \n\nClinicians will need to weigh practical trade-offs:[1][2][5]  \n\n- **IV:**  \n  - 8 infusions every 3 weeks  \n  - Fewer visits, longer chair time  \n  - Dependence on infusion-center infrastructure  \n- **OBI:**  \n  - 12 subcutaneous doses every 2 weeks  \n  - More frequent but shorter, more flexible encounters  \n  - Potential integration into community or home-based care  \n\nThese differences will influence clinic operations, patient time burden, and adherence. The OBI regimen remains investigational pending regulatory review.[3][5]  \n\nThe diagram below summarizes the divergent care pathways and their convergence on similar clinical outcomes.  \n\n```mermaid\nflowchart LR\n    title TEPEZZA IV vs OBI Pathways\n    A[Eligible TED patient] --> B[Select route]\n    B --> C[IV infusions]\n    B --> D[OBI injections]\n    C --> E[Monitor outcomes]\n    D --> E[Monitor outcomes]\n    E --> F[Care setting shift]\n```\n\nFor clinicians and payers, IV-comparable efficacy with a more flexible delivery mode could encourage earlier TEPEZZA use, alter referral patterns between endocrinologists and ophthalmologists, and inform future health economic models once full cost, utilization, and quality-of-life data are available.[2][3]  \n\n## Conclusion  \n\nPhase 3 results indicate that TEPEZZA delivered via an on-body injector can achieve IV-comparable efficacy in moderate-to-severe active TED, with a 76.7% proptosis responder rate, a −3.17 mm mean proptosis reduction, improvements across key secondary endpoints, and a safety profile aligned with IV TEPEZZA.[2][3][4]  \n\nThese findings position subcutaneous TEPEZZA as a potentially important new option for a vision-threatening disease with major functional and psychosocial impact. Stakeholders should monitor full data releases and regulatory decisions and begin planning how an on-body, subcutaneous regimen might fit within evolving TED treatment pathways and multidisciplinary guidelines.[2][3]","\u003Ch2>1. Phase 3 TEPEZZA OBI Trial at a Glance\u003C\u002Fh2>\n\u003Cp>\u003Ca href=\"https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FAmgen\" class=\"wiki-link\" target=\"_blank\" rel=\"noopener\">Amgen\u003C\u002Fa> reported positive topline Phase 3 results for subcutaneous TEPEZZA (\u003Ca href=\"https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FTeprotumumab\" class=\"wiki-link\" target=\"_blank\" rel=\"noopener\">teprotumumab‑trbw\u003C\u002Fa>) delivered via an \u003Ca href=\"https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FInjector\" class=\"wiki-link\" target=\"_blank\" rel=\"noopener\">on-body injector\u003C\u002Fa> (OBI) in adults with moderate-to-severe active \u003Ca href=\"https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FGraves'_disease\" class=\"wiki-link\" target=\"_blank\" rel=\"noopener\">Thyroid Eye Disease\u003C\u002Fa> (TED), suggesting a practical alternative to the current intravenous (IV) regimen.\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cp>\u003Cstrong>Trial design:\u003C\u002Fstrong>\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-5\" class=\"citation-link\" title=\"View source [5]\">[5]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cul>\n\u003Cli>Randomized, double-masked, placebo-controlled, parallel-group, multicenter\u003C\u002Fli>\n\u003Cli>Adults with active, moderate-to-severe TED; baseline proptosis ≥3 mm\u003C\u002Fli>\n\u003Cli>TEPEZZA or placebo given subcutaneously via OBI every 2 weeks for 24 weeks (12 doses)\u003C\u002Fli>\n\u003C\u002Ful>\n\u003Cp>\u003Cstrong>Comparison to approved IV TEPEZZA:\u003C\u002Fstrong>\u003Ca href=\"#source-1\" class=\"citation-link\" title=\"View source [1]\">[1]\u003C\u002Fa>\u003Ca href=\"#source-5\" class=\"citation-link\" title=\"View source [5]\">[5]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cul>\n\u003Cli>IV: 8 infusions every 3 weeks in infusion centers\u003C\u002Fli>\n\u003Cli>OBI: 12 subcutaneous injections every 2 weeks\u003C\u002Fli>\n\u003Cli>Key shift: IV to subcutaneous, and clinic-based infusions to device-enabled dosing\u003C\u002Fli>\n\u003C\u002Ful>\n\u003Cp>\u003Cstrong>Endpoints and outcomes:\u003C\u002Fstrong>\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003Ca href=\"#source-5\" class=\"citation-link\" title=\"View source [5]\">[5]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cul>\n\u003Cli>\u003Cstrong>Primary:\u003C\u002Fstrong> Proptosis responder rate (≥2‑mm reduction at week 24)\n\u003Cul>\n\u003Cli>TEPEZZA OBI: 76.7% vs placebo: 19.6% (p < 0.0001)\u003C\u002Fli>\n\u003C\u002Ful>\n\u003C\u002Fli>\n\u003Cli>\u003Cstrong>Key secondary:\u003C\u002Fstrong> Mean proptosis change at week 24\n\u003Cul>\n\u003Cli>TEPEZZA OBI: −3.17 mm vs placebo: −0.80 mm (p < 0.0001)\u003C\u002Fli>\n\u003C\u002Ful>\n\u003C\u002Fli>\n\u003C\u002Ful>\n\u003Cp>\u003Cstrong>Key takeaway:\u003C\u002Fstrong> OBI met its primary and key secondary endpoints, with a proptosis effect size closely mirroring IV TEPEZZA.\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003C\u002Fp>\n\u003Ch2>2. Efficacy, Safety, and Clinical Significance\u003C\u002Fh2>\n\u003Cp>\u003Cstrong>Clinical relevance of proptosis reduction:\u003C\u002Fstrong>\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-4\" class=\"citation-link\" title=\"View source [4]\">[4]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cul>\n\u003Cli>≥2 mm decrease is typically meaningful, associated with:\n\u003Cul>\n\u003Cli>Less eye bulging and exposure keratopathy\u003C\u002Fli>\n\u003Cli>Lower need for orbital decompression surgery\u003C\u002Fli>\n\u003C\u002Ful>\n\u003C\u002Fli>\n\u003Cli>The −3.17 mm mean reduction with OBI aligns well with historical IV TEPEZZA data, supporting “IV-level efficacy.”\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003Ca href=\"#source-4\" class=\"citation-link\" title=\"View source [4]\">[4]\u003C\u002Fa>\u003C\u002Fli>\n\u003C\u002Ful>\n\u003Cp>\u003Cstrong>Secondary efficacy findings:\u003C\u002Fstrong>\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cul>\n\u003Cli>Statistically significant, clinically meaningful improvements in:\n\u003Cul>\n\u003Cli>Overall response rates\u003C\u002Fli>\n\u003Cli>Proportion achieving Clinical Activity Score (CAS) 0 or 1\u003C\u002Fli>\n\u003Cli>Diplopia measures, addressing a major driver of disability and work impact\u003C\u002Fli>\n\u003C\u002Ful>\n\u003C\u002Fli>\n\u003C\u002Ful>\n\u003Cp>\u003Cstrong>Patient-reported outcomes (GO‑QoL):\u003C\u002Fstrong>\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cul>\n\u003Cli>\u003Cstrong>Appearance subscale:\u003C\u002Fstrong> Significant improvement, indicating reduced psychosocial burden from facial changes\u003C\u002Fli>\n\u003Cli>\u003Cstrong>Visual functioning subscale:\u003C\u002Fstrong> Numerical advantage for OBI but not statistically significant, suggesting potential functional gains needing further evaluation\u003C\u002Fli>\n\u003C\u002Ful>\n\u003Cp>\u003Cstrong>Safety profile:\u003C\u002Fstrong>\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003Ca href=\"#source-4\" class=\"citation-link\" title=\"View source [4]\">[4]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cul>\n\u003Cli>Overall safety consistent with IV TEPEZZA, important for a route change\u003C\u002Fli>\n\u003Cli>Mild-to-moderate injection-site reactions; none caused treatment interruption or discontinuation\u003C\u002Fli>\n\u003Cli>Most common adverse events (≥10%):\n\u003Cul>\n\u003Cli>Muscle spasms\u003C\u002Fli>\n\u003Cli>Tinnitus\u003C\u002Fli>\n\u003Cli>Weight decrease\u003C\u002Fli>\n\u003Cli>Ear discomfort\u003C\u002Fli>\n\u003Cli>Nausea\u003C\u002Fli>\n\u003Cli>Diarrhea\u003C\u002Fli>\n\u003C\u002Ful>\n\u003C\u002Fli>\n\u003Cli>No new safety signals, supporting feasibility of a subcutaneous, device-enabled strategy.\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003C\u002Fli>\n\u003C\u002Ful>\n\u003Ch2>3. From IV to On-Body Injector: What Changes for TED Care?\u003C\u002Fh2>\n\u003Cp>With efficacy and safety aligned to the IV formulation, the main differentiator for TEPEZZA OBI is its potential to reshape TED care pathways. An OBI-enabled regimen could allow treatment in more flexible settings, potentially including at-home administration under appropriate supervision, rather than anchoring care to infusion centers.\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003Ca href=\"#source-5\" class=\"citation-link\" title=\"View source [5]\">[5]\u003C\u002Fa> For patients with visually disabling TED, this may lessen travel demands and cumulative time in clinic.\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-5\" class=\"citation-link\" title=\"View source [5]\">[5]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cp>IV TEPEZZA, approved in 2020 as the first and only therapy for TED, has now treated more than 25,000 patients worldwide and is supported by Phase 4 and real-world data, including use in chronic or low‑CAS disease and extended treatment courses.\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003Ca href=\"#source-5\" class=\"citation-link\" title=\"View source [5]\">[5]\u003C\u002Fa> TEPEZZA OBI builds on this foundation by modernizing delivery rather than altering the molecular target.\u003C\u002Fp>\n\u003Cp>Clinicians will need to weigh practical trade-offs:\u003Ca href=\"#source-1\" class=\"citation-link\" title=\"View source [1]\">[1]\u003C\u002Fa>\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-5\" class=\"citation-link\" title=\"View source [5]\">[5]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cul>\n\u003Cli>\u003Cstrong>IV:\u003C\u002Fstrong>\n\u003Cul>\n\u003Cli>8 infusions every 3 weeks\u003C\u002Fli>\n\u003Cli>Fewer visits, longer chair time\u003C\u002Fli>\n\u003Cli>Dependence on infusion-center infrastructure\u003C\u002Fli>\n\u003C\u002Ful>\n\u003C\u002Fli>\n\u003Cli>\u003Cstrong>OBI:\u003C\u002Fstrong>\n\u003Cul>\n\u003Cli>12 subcutaneous doses every 2 weeks\u003C\u002Fli>\n\u003Cli>More frequent but shorter, more flexible encounters\u003C\u002Fli>\n\u003Cli>Potential integration into community or home-based care\u003C\u002Fli>\n\u003C\u002Ful>\n\u003C\u002Fli>\n\u003C\u002Ful>\n\u003Cp>These differences will influence clinic operations, patient time burden, and adherence. The OBI regimen remains investigational pending regulatory review.\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003Ca href=\"#source-5\" class=\"citation-link\" title=\"View source [5]\">[5]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cp>The diagram below summarizes the divergent care pathways and their convergence on similar clinical outcomes.\u003C\u002Fp>\n\u003Cpre>\u003Ccode class=\"language-mermaid\">flowchart LR\n    title TEPEZZA IV vs OBI Pathways\n    A[Eligible TED patient] --> B[Select route]\n    B --> C[IV infusions]\n    B --> D[OBI injections]\n    C --> E[Monitor outcomes]\n    D --> E[Monitor outcomes]\n    E --> F[Care setting shift]\n\u003C\u002Fcode>\u003C\u002Fpre>\n\u003Cp>For clinicians and payers, IV-comparable efficacy with a more flexible delivery mode could encourage earlier TEPEZZA use, alter referral patterns between endocrinologists and ophthalmologists, and inform future health economic models once full cost, utilization, and quality-of-life data are available.\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003C\u002Fp>\n\u003Ch2>Conclusion\u003C\u002Fh2>\n\u003Cp>Phase 3 results indicate that TEPEZZA delivered via an on-body injector can achieve IV-comparable efficacy in moderate-to-severe active TED, with a 76.7% proptosis responder rate, a −3.17 mm mean proptosis reduction, improvements across key secondary endpoints, and a safety profile aligned with IV TEPEZZA.\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003Ca href=\"#source-4\" class=\"citation-link\" title=\"View source [4]\">[4]\u003C\u002Fa>\u003C\u002Fp>\n\u003Cp>These findings position subcutaneous TEPEZZA as a potentially important new option for a vision-threatening disease with major functional and psychosocial impact. Stakeholders should monitor full data releases and regulatory decisions and begin planning how an on-body, subcutaneous regimen might fit within evolving TED treatment pathways and multidisciplinary guidelines.\u003Ca href=\"#source-2\" class=\"citation-link\" title=\"View source [2]\">[2]\u003C\u002Fa>\u003Ca href=\"#source-3\" class=\"citation-link\" title=\"View source [3]\">[3]\u003C\u002Fa>\u003C\u002Fp>\n","1. Phase 3 TEPEZZA OBI Trial at a Glance  \n\nAmgen reported positive topline Phase 3 results for subcutaneous TEPEZZA (teprotumumab‑trbw) delivered via an on-body injector (OBI) in adults with moderate...","trend-radar",[],744,4,"2026-04-11T10:44:51.750Z",[17,22,26,30,33],{"title":18,"url":19,"summary":20,"type":21},"Amgen has announced positive topline results from a Phase 3 trial of TEPEZZA (TM) delivered via an on-body injector (OBI)","https:\u002F\u002Fwww.facebook.com\u002FGDATF\u002Fposts\u002Famgen-has-announced-positive-topline-results-from-a-phase-3-trial-of-tepezza-tm-\u002F1378524350974027\u002F","Amgen has announced positive topline results from a Phase 3 trial of TEPEZZA (TM) delivered via an on-body injector (OBI). Patients treated with TEPEZZA currently receive eight infusions delivered thr...","kb",{"title":23,"url":24,"summary":25,"type":21},"Amgen releases positive topline results from phase 3 trial of teprotumumab-trbw (TEPEZZA)","https:\u002F\u002Fwww.ophthalmologytimes.com\u002Fview\u002Famgen-releases-positive-topline-results-from-phase-3-trial-of-teprotumumab-trbw-tepezza-","Amgen announced positive topline results from the phase 3 study of subcutaneous TEPEZZA (teprotumumab-trbw) for moderate-to-severe thyroid eye disease (TED).\n\nThe phase 3 TEPEZZA trial was a randomize...",{"title":27,"url":28,"summary":29,"type":21},"AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR SUBCUTANEOUS TEPEZZA® IN ADULTS LIVING WITH MODERATE-TO-SEVERE ACTIVE THYROID EYE DISEASE","https:\u002F\u002Fwww.amgen.com\u002Fnewsroom\u002Fpress-releases\u002F2026\u002F04\u002Famgen-announces-positive-topline-phase-3-results-for-subcutaneous-tepezza-in-adults-living-with-moderate-to-severe-active-thyroid-eye-disease","Amgen (NASDAQ: AMGN) today announced positive topline results from a Phase 3 trial of TEPEZZA (teprotumumab-trbw) administered by subcutaneous injection via an on-body injector (OBI) in participants w...",{"title":27,"url":31,"summary":32,"type":21},"https:\u002F\u002Fwww.prnewswire.com\u002Fnews-releases\u002Famgen-announces-positive-topline-phase-3-results-for-subcutaneous-tepezza-in-adults-living-with-moderate-to-severe-active-thyroid-eye-disease-302734375.html","Amgen today announced positive topline results from a Phase 3 trial of TEPEZZA (teprotumumab-trbw) administered by subcutaneous injection via an on-body injector (OBI) in participants with moderate-to...",{"title":34,"url":35,"summary":36,"type":21},"TEPEZZA on-body injector demonstrates positive phase 3 performance for TED","https:\u002F\u002Fglance.eyesoneyecare.com\u002Fstories\u002F2026-04-08\u002Ftepezza-on-body-injector-demonstrates-positive-phase-3-performance-for-ted\u002F","This is editorially independent content\n\nApr 08, 2026\n\n5 min read\n\n148 views\n\nAmgen released positive topline findings from a phase 3 clinical trial evaluating TEPEZZA (teprotumamb-trbw) administered ...",{"totalSources":38},5,{"generationDuration":40,"kbQueriesCount":38,"confidenceScore":41,"sourcesCount":38},55152,100,{"metaTitle":43,"metaDescription":44},"Amgen Phase 3 TEPEZZA OBI Data: TED Delivery Shift","Amgen’s Phase 3 TEPEZZA OBI trial shows IV‑level efficacy with subcutaneous delivery in TED. Learn trial design, key results, and what this shift means next.","en","https:\u002F\u002Fimages.unsplash.com\u002Fphoto-1508361727343-ca787442dcd7?ixid=M3w4OTczNDl8MHwxfHNlYXJjaHwxfHxtb2Rlcm4lMjB0ZWNobm9sb2d5fGVufDF8MHx8fDE3NzU5MDM5NzN8MA&ixlib=rb-4.1.0&w=1200&h=630&fit=crop&crop=entropy&auto=format,compress&q=60",{"photographerName":48,"photographerUrl":49,"unsplashUrl":50},"Tom Parkes","https:\u002F\u002Funsplash.com\u002F@tomparkes?utm_source=coreprose&utm_medium=referral","https:\u002F\u002Funsplash.com\u002Fphotos\u002Fman-walking-through-pathway-Ns-BIiW_cNU?utm_source=coreprose&utm_medium=referral",true,{"key":53,"name":54,"nameEn":55},"actualites","Actualités & News","News & Current Events",[57,59,61,63],{"text":58},"Phase 3 TEPEZZA OBI met primary and key secondary endpoints with a 76.7% proptosis responder rate (≥2 mm reduction) versus 19.6% for placebo (p \u003C 0.0001) and a mean proptosis change of −3.17 mm versus −0.80 mm (p \u003C 0.0001).",{"text":60},"Efficacy with the on‑body injector closely mirrors historical IV TEPEZZA outcomes, supporting “IV‑level” clinical benefit for moderate‑to‑severe active TED.",{"text":62},"Safety was consistent with IV TEPEZZA: no new safety signals, common adverse events ≥10% included muscle spasms, tinnitus, weight decrease, ear discomfort, nausea, and diarrhea; injection‑site reactions were mild\u002Fmoderate and did not cause discontinuation.",{"text":64},"Delivery shifts from 8 IV infusions (every 3 weeks) to 12 subcutaneous OBI doses (every 2 weeks), potentially enabling clinic‑flexible or supervised at‑home administration and altering care pathways and resource use.",[],[67,73,77,81,85,89,93,96,100,105,109,115,120,125,129],{"id":68,"name":69,"type":70,"confidence":71,"wikipediaUrl":72},"69da26484eea09eba3e2b6d2","proptosis responder rate","concept",0.95,null,{"id":74,"name":75,"type":70,"confidence":76,"wikipediaUrl":72},"69da26494eea09eba3e2b6d4","Clinical Activity Score",0.93,{"id":78,"name":79,"type":70,"confidence":80,"wikipediaUrl":72},"69da26494eea09eba3e2b6d8","weight decrease",0.9,{"id":82,"name":83,"type":70,"confidence":80,"wikipediaUrl":84},"69da26494eea09eba3e2b6d9","nausea","https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FNausea",{"id":86,"name":87,"type":70,"confidence":80,"wikipediaUrl":88},"69da26494eea09eba3e2b6d6","muscle spasms","https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FSpasm",{"id":90,"name":91,"type":70,"confidence":80,"wikipediaUrl":92},"69da26494eea09eba3e2b6da","diarrhea","https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FDiarrhea",{"id":94,"name":95,"type":70,"confidence":71,"wikipediaUrl":72},"69da26494eea09eba3e2b6d3","mean proptosis change",{"id":97,"name":98,"type":70,"confidence":99,"wikipediaUrl":72},"69da26494eea09eba3e2b6d5","GO‑QoL",0.92,{"id":101,"name":102,"type":70,"confidence":103,"wikipediaUrl":104},"69da26484eea09eba3e2b6cf","Thyroid Eye Disease",0.99,"https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FGraves'_disease",{"id":106,"name":107,"type":70,"confidence":80,"wikipediaUrl":108},"69da26494eea09eba3e2b6d7","tinnitus","https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FTinnitus",{"id":110,"name":111,"type":112,"confidence":113,"wikipediaUrl":114},"69da264a4eea09eba3e2b6dc","2020 approval","event",0.88,"https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FUnited_States_presidential_approval_rating",{"id":116,"name":117,"type":112,"confidence":118,"wikipediaUrl":119},"69da26484eea09eba3e2b6d0","Phase 3 trial",0.98,"https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FPhases_of_clinical_research",{"id":121,"name":122,"type":123,"confidence":103,"wikipediaUrl":124},"69da26474eea09eba3e2b6ca","Amgen","organization","https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FAmgen",{"id":126,"name":127,"type":128,"confidence":71,"wikipediaUrl":72},"69da26484eea09eba3e2b6d1","placebo","other",{"id":130,"name":131,"type":128,"confidence":80,"wikipediaUrl":72},"69da26494eea09eba3e2b6db","infusion center",[133],{"id":134,"title":135,"slug":136,"excerpt":137,"category":11,"featuredImage":138,"publishedAt":139},"69cf4eba82224607917b048f","CPAC 2026 in Grapevine: How GOP Messaging Sets the Tone for 2026 and 2028","cpac-2026-in-grapevine-how-gop-messaging-sets-the-tone-for-2026-and-2028","1. Framing CPAC 2026 in Grapevine: stakes, scene, and structure\n\nCPAC 2026 in Grapevine, Texas will be more than a rally; it will test how Republicans talk about culture, the economy, and institutions...","https:\u002F\u002Fimages.unsplash.com\u002Fphoto-1619772602509-c526dd4da14b?ixid=M3w4OTczNDl8MHwxfHNlYXJjaHwxfHxhdXRvbW9iaWxlJTIwdGVjaG5vbG9neXxlbnwxfDB8fHwxNzc1MTkzNzg2fDA&ixlib=rb-4.1.0&w=1200&h=630&fit=crop&crop=entropy&auto=format,compress","2026-04-03T05:24:42.353Z",["Island",141],{"key":142,"params":143,"result":145},"ArticleBody_6sErAxNoHBYTRlgp6QxM9H31dTfYqkM4y3Aqtgdk",{"props":144},"{\"articleId\":\"69da24e65c0f21a12e62c6c7\"}",{"head":146},{}]