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News - Amgen reports positive phase 3 results for subcutaneous TEPEZZA in thyroid eye disease

Image Credit: Amgen.

April 2026 | Jack Overell, Head of Production, SAE Media Group

Earlier this month, Amgen announced positive topline results from a Phase 3 clinical trial evaluating a subcutaneous formulation of TEPEZZA (teprotumumab-trbw) administered via an on-body injector (OBI) in adults with moderate-to-severe active Thyroid Eye Disease (TED).

According to the company, the study met its primary and key secondary endpoints, demonstrating that subcutaneous TEPEZZA achieved comparable efficacy to the intravenous (IV) formulation. TEPEZZA remains the first and only medicine approved for the treatment of TED and has been used in more than 25,000 patients worldwide.

Primary and Secondary Endpoints Achieved

The placebo-controlled Phase 3 trial showed a statistically significant proptosis response rate of 77% over the 24-week study period. Specifically, 76.7% of patients treated with TEPEZZA OBI achieved a proptosis response, compared with 19.6% of patients receiving placebo (p<0.0001).

The study also met a key secondary endpoint, showing a mean reduction in proptosis of greater than 3 mm at Week 24. Patients receiving TEPEZZA OBI experienced a mean reduction of -3.17 mm, compared with -0.80 mm in the placebo group (p<0.0001), a change considered clinically meaningful in the treatment of TED.

“These results extend and support the best-in-class efficacy of TEPEZZA for people living with Thyroid Eye Disease, now with subcutaneous administration delivering IV-level efficacy,” said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. “With a well-understood mechanism and established impact in the clinic, we can evolve how the medicine is delivered to potentially reach even more patients through a more convenient subcutaneous option.”

Additional Clinical Outcomes

Beyond the primary endpoint, the trial demonstrated statistically significant and clinically meaningful improvements across multiple secondary measures. These included overall responder rates, the proportion of patients achieving a Clinical Activity Score (CAS) of 0 or 1, and improvements in diplopia, measured both as response rates and ordinal response categories. Complete diplopia responder rates also favored TEPEZZA OBI.

Patients treated with the subcutaneous formulation additionally showed improvement from baseline at Week 24 in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) appearance subscale. While changes in the GO-QoL visual functioning subscale were not statistically significant, results showed a numerical trend favoring TEPEZZA OBI. Amgen stated that full study results will be presented at a future medical congress.

Safety Profile

Amgen reported that the overall safety findings were generally consistent with the known safety profile of IV TEPEZZA. Mild-to-moderate injection-site reactions were observed in some patients receiving subcutaneous administration; however, these events did not lead to treatment interruption or discontinuation.

The most frequently reported adverse events, occurring in at least 10% of patients, included muscle spasms, tinnitus, weight decrease, ear discomfort, nausea, and diarrhea.

Details of the Phase 3 TEPEZZA OBI Trial

The Phase 3 trial was a randomized, double-masked, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of subcutaneous TEPEZZA compared with placebo in patients with active TED. The primary endpoint was the proptosis responder rate, defined as a reduction of at least 2 mm in the study eye without a corresponding increase of 2 mm or more in the fellow eye at Week 24.

Participants received subcutaneous TEPEZZA or placebo every two weeks for a total of 12 injections using an on-body injector. Eligible patients had a diagnosis of moderate-to-severe active TED within the previous 15 months and baseline proptosis of at least 3 mm above pre-disease levels. Patients with baseline hearing impairment, identified by medical history or audiogram, were permitted to participate.

Post-Marketing Study of IV TEPEZZA

Amgen also announced completion of a separate Phase 3b/4 study conducted to meet an FDA post-marketing requirement for IV TEPEZZA. The study evaluated the safety and tolerability of three different treatment durations – four, eight, and 16 infusions – and assessed the potential need for retreatment. The descriptive study found that the observed safety profile was consistent with the established profile of IV TEPEZZA.

Data from the post-marketing study will be submitted to regulators and presented at an upcoming medical meeting.

Editor’s Corner



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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