热门资讯> 正文
周三，Thomai和Biogen公布了使用360毫克皮下自动注射器Lecanemab治疗早期阿尔茨海默病的研究性维持治疗结果
2025-07-31 16:22
- Clinical trials of lecanemab SC were conducted as a sub-study of the open-label extension (OLE) following the core Phase 3 Clarity AD study in individuals with early AD, to evaluate a range of doses administered by SC vial or autoinjector. Eisai has developed a SC-AI for maintenance therapy at a dose of 360 mg weekly and a500 mg SC-AI is being developed for initiation dosing.
Similar Impact on Clinical Outcomes and Biomarkers with IV and SC Dosing
The pharmacology (PK/PD), clinical (efficacy endpoints such as CDR-SB) and biomarker (amyloid PET and blood biomarkers) relationships established with extensive clinical data supported the FDA approval of IV maintenance therapy after the initial 18 months of treatment and support the investigational SC maintenance dose option.
- Data supports that transitioning to a weekly 360 mg SC AI dose of lecanemab after 18 months of initiation dose (10 mg/kg IV biweekly) maintains clinical and biomarker benefits comparable to continued biweekly IV dosing.
- Clinical and biomarker responses at 48 months with monthly IV maintenance dosing are similar to the responses with ongoing biweekly dosing whether patients are amyloid positive (>30 CL) or negative (<30 CL) at 18 months.
- Data shows the 500 mg SC AI has equivalent exposure as the initial treatment regimen of 10mg/kg IV biweekly up to 18 months for amyloid removal, efficacy, and ARIA-E.
Safety Matters
The safety profile of 360 mg weekly SC maintenance dosing was shown to be consistent with that of IV maintenance therapy, with <1% systemic injection/infusion reactions. Across all SC doses, the rate of systemic injection/infusion reactions is 1% compared to 26% with IV. The 360 mg SC maintenance dose was initiated after 18 months of IV treatment, beyond the high-risk period for ARIA. There were 0 cases of ARIA-E observed out of 49 treated with 360 mg SC weekly maintenance for a mean of 6 months.
Study Participants Successfully Administered SC-AI and Found it Easy to Use
To optimize the safe and effective use of SC autoinjector (SC-AI), additional studies were conducted, including a human factors (HF) study and a tolerability assessment of the device.
The HF Study involved 110 participants (63 early AD patients, 32 care partners, and 15 healthcare professionals: HCPs) to assess the appropriate administration of lecanemab SC-AI. Overall, 95% (104/110) of participants successfully administered the maintenance dose.
The Autoinjector Device Acceptability Study involved 126 participants (25 early AD patients, 50 care partners, and 51 HCPs), to evaluate the device's ease of use, convenience and feasibility of administration. As an interim outcome, over 95% of participants reported that the SC-AI is easy to administer. They were highly satisfied with it and had no concerns about administration, even at home. Furthermore, all patients responded that they welcomed the introduction of SC-AI.
These studies and evaluations of lecanemab SC-AI have demonstrated that the investigational SC-AI offers efficacy and safety comparable to IV administration with the potential to reduce the incidence of infusion site adverse events. From the perspective of patients and care partners, benefits included the ability to use the device at home, shortening treatment time, and to continue treatment without having to worry about visiting an infusion center. From the perspective of HCPs, they reported that the device has the potential to provide a new option for patients who are benefiting from lecanemab to continue the treatment. The SC formulation has the potential to reduce medical preparation and administration time related to IV therapy. These factors suggest that the SC AI may play an important role in continuing treatment for early AD.
推荐文章
风险及免责提示：以上内容仅代表作者的个人立场和观点，不代表华盛的任何立场，华盛亦无法证实上述内容的真实性、准确性和原创性。投资者在做出任何投资决定前，应结合自身情况，考虑投资产品的风险。必要时，请咨询专业投资顾问的意见。华盛不提供任何投资建议，对此亦不做任何承诺和保证。
