Amgen (AMGN) – Subcutaneous TEPEZZA has demonstrated statistically significant and clinically meaningful results in a pivotal Phase 3 trial, Amgen announced today. The study focused on adults living with moderate-to-severe active Thyroid Eye Disease (TED), evaluating the efficacy, safety, and patient convenience of a new delivery method via an on-body injector (OBI).+1
Groundbreaking Trial Data for Subcutaneous TEPEZZA
The Phase 3 randomized, double-masked, placebo-controlled trial met its primary endpoint with high statistical significance. Patients treated with Subcutaneous TEPEZZA achieved a 77% proptosis response rate at week 24, compared to only 19.6% in the placebo group (p<0.0001). Proptosis, or eye bulging, is a hallmark symptom of TED that can lead to permanent vision loss and significant facial disfigurement.
Key secondary endpoints also showed remarkable improvements. The mean reduction in proptosis for those receiving the treatment was -3.17 mm, while the placebo group saw a reduction of only -0.80 mm. Furthermore, patients experienced significant enhancements in their Clinical Activity Score (CAS) and a reduction in diplopia (double vision), reinforcing the drug’s “best-in-class” status.
Read More: U.S. FDA Approves Amgen’s UPLIZNA® for Generalized Myasthenia Gravis in Adults
The Innovation of Subcutaneous TEPEZZA Delivery
Historically, TEPEZZA has been administered via intravenous (IV) infusion, requiring long clinic visits. The introduction of Subcutaneous TEPEZZA via an automated on-body injector aims to evolve the patient experience. This delivery system allows for a more flexible administration process that could potentially be moved to a home-care setting, significantly reducing the burden on patients and the healthcare system.
These results extend and support the efficacy of TEPEZZA, now with subcutaneous administration delivering IV-level efficacy.
Jay Bradner, M.D., executive vice president of Research and Development at Amgen.
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Phase 3 Trial Data: Subcutaneous TEPEZZA vs. Placebo
| Endpoint | Subcutaneous TEPEZZA (N=XX) | Placebo (N=XX) | P-Value |
| Primary Endpoint: Proptosis Response Rate (Week 24) | 76.7% | 19.6% | $p < 0.0001$ |
| Mean Reduction in Proptosis (Week 24) | -3.17 mm | -0.80 mm | $p < 0.0001$ |
| Overall Responder Rate | Significant Improvement | Minimal Change | Statistically Significant |
| CAS of 0 or 1 (Week 24) | Significant Improvement | Minimal Change | Statistically Significant |
| Diplopia Response Rate | Significant Improvement | Minimal Change | Statistically Significant |
| GO-QoL (Appearance Subscale) | Significant Improvement | Minimal Change | Statistically Significant |
| GO-QoL (Visual Function Subscale) | Favorable Trend | N/A | Non-Significant |
