A global non-interventional study investigating real-world proactive dosing regimens with intravitreal aflibercept in patients with neovascular age-related macular degeneration: Interim analysis of first 12-month completers from XTEND

Thème:
Rétine
Quoi:
Paper Presentation | Présentation d'article
Quand:
4:02 PM, samedi 11 juin 2022 (7 minutes)
Comment:

Authors: Varun Chaudhary, Jean-François Korobelnik, Paul Mitchell, Se Woong Kang, Ramin Tadayoni, Helmut Allmeier, JinKyung Lee, Tobias Machewitz, Kristian T. Johnson, Clare Bailey. 
Author Disclosure Block: V. Chaudhary: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Novartis, Bayer. Any direct financial payments including receipt of honoraria; Description of relationship(s); Speaker fees. Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Novartis, Bayer, Roche, Alcon Inc.. Membership on advisory boards or speakers’ bureaus; Description of relationship(s); Advisory board. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Novartis, Bayer. Funded grants or clinical trials; Description of relationship(s); Grants and clinical trials. J. Korobelnik: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Allergan-Abbvie, Apellis, Bayer, Iveric, Janssen, KangHong, Thea. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Carl Zeiss Meditec, Appelis, Iveric, Roche. Funded grants or clinical trials; Description of relationship(s); Grant, Clinical trials. P. Mitchell: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Allergan, Bayer and Novartis. Any direct financial payments including receipt of honoraria; Description of relationship(s); Consulting fees received. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Name of for-profit or not-for-profit organization(s); Bayer. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Description of relationship(s); Steering committee member. S. Kang: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Novartis, Bayer, and Samchundang. Membership on advisory boards or speakers’ bureaus; Description of relationship(s); Advisory boards or speakers’ bureaus. R. Tadayoni: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Alcon, Alimera, Allergan, Bausch & Lomb, Bayer, FCI and Novartis. Membership on advisory boards or speakers’ bureaus; Description of relationship(s); Board Member. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Name of for-profit or not-for-profit organization(s); Alcon, Allergan, Bausch & Lomb, Novartis, Roche, Genetech and Zeiss. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Description of relationship(s); Consultant. H. Allmeier: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Bayer. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee. J. Lee: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Bayer. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee. T. Machewitz: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Bayer AG, Berlin, Germany. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee. K.T. Johnson: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Bayer. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee. C. Bailey: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Bayer, Roche, Novartis, Boehringer Ingelheim, Alimera Sciences. Any direct financial payments including receipt of honoraria; Description of relationship(s); Advisory board work, Occasional speaker fees and travel support. Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Bayer, Roche, Novartis, Boehringer Ingelheim, Alimera sciences, Janssen. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Bayer, Roche, Novartis, Allergan Boehringer Ingelheim, Alimera Sciences. Funded grants or clinical trials; Description of relationship(s); Bristol Eye Hospital clinical research unit has undertaken clinical trials/studies in the last 2 years with these pharmaceutical companies.

Purpose: The ongoing XTEND study examines the outcomes of real-world proactive intravitreal aflibercept (IVT-AFL) treatment regimens, with the primary objective of describing the effectiveness of such regimens during routine clinical practice in patients with neovascular age-related macular degeneration (nAMD). This prespecified interim analysis was conducted after ≥500 patients had a Month 12 (M12) visual acuity assessment (data cut-off date: February 4, 2021). 

Study Design: XTEND (NCT03939767; ethics approved) is a 36-month, observational study recruiting patients from sites in the Asia-Pacific region, Europe, Latin America, and North America. XTEND enrolled treatment-naïve patients aged ≥50 years with nAMD for whom IVT-AFL was planned to be initiated in flexible proactive regimens (fixed dosing or treat-and-extend [T&E]) by label regimen, with minimum treatment intervals following three initial monthly injections of 8 weeks (w; European Medicines Agency [EMA]-aligned label), or 4w (without EMA-aligned label), in Year 1. Enrollment was planned to include ≥1200 patients from countries reflecting the EMA-aligned IVT-AFL labels and ≥250 patients from countries without EMA-aligned labels (Australia, Canada, and Switzerland). The prespecified interim analysis was to include ≥300 patients from countries with the EMA-aligned label. 

Methods: Following three initial monthly injections, treatment intervals could be extended in 2- or 4-w increments up to a maximum of 12w or 16w according to the local label. The primary endpoint was mean change in best-corrected visual acuity (BCVA; Early Treatment Diabetes Retinopathy Study [ETDRS] letters) from baseline (BL) at M12. Statistics are descriptive. 

Results: Of the 1563 patients enrolled in the XTEND study, 742 (mean age 79 years; 63% female; enrolled May 2019-March 2020) were included in the interim analysis. Most patients (90%) were scheduled to be treated according to a T&E dosing regimen; however, because of the COVID-19 pandemic (beginning after study initiation), planned treatment interval extensions were not performed in all countries. From BL to M12, mean±SD change in BCVA was +5.1±16.5 letters (BL: 55.6±18.6) and mean change in central retinal thickness (CRT) was ‒109±128 μm (BL: 373±123), with similar improvements observed with both IVT-AFL label types. By M12, mean number of IVT-AFL injections was 7.8±2.1, and the last completed injection interval was ≥8w in 73% of patients (44% ≥10w; 24% ≥12w; 8% ≥16w). No new safety concerns were identified; two cases each of endophthalmitis and intraocular inflammation were reported. 

Conclusions: Despite the impact of the COVID-19 pandemic, treatment-naïve patients with nAMD proactively treated with IVT-AFL achieved robust vision gains over the first year. Similar improvements in BCVA and CRT were observed with both IVT-AFL label types, as assumed in the study design. The safety profile of IVT-AFL in XTEND was consistent with previous studies. Follow-up in XTEND is ongoing, and presentation of the primary endpoint evaluation in the full analysis population is planned for 2022.

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