June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
A post hoc analysis of intravitreal aflibercept–treated patients from ARIES & ALTAIR applying treatment regimen criteria from TENAYA & LUCERNE
Author Affiliations & Notes
  • Michael Stewart
    Department of Ophthalmology, Mayo Clinic College of Medicine, Mayo Clinic, Jacksonville, Florida, United States
  • Amelie Pielen
    Maximilians-Augenklinik, Nürnberg, Germany
    University Eye Hospital, Hannover Medical School, Hannover, Germany
  • Annabelle A. Okada
    Kyorin University School of Medicine, Tokyo, Japan
  • Paula Scholz
    Bayer Vital GmbH, Leverkusen, Nordrhein-Westfalen, Germany
  • Xin Zhang
    Bayer Consumer Care AG, Basel, Basel-Stadt, Switzerland
  • Tobias Machewitz
    Bayer AG, Berlin, Germany
  • Scott Fitzpatrick
    Bayer Consumer Care AG, Toronto, Ontario, Canada
  • Footnotes
    Commercial Relationships   Michael Stewart Alkahest, Bayer, Code C (Consultant/Contractor), Allergan, Kanghong, Regeneron Pharmaceuticals, Inc., Code F (Financial Support); Amelie Pielen Roche National Study Committee, Code C (Consultant/Contractor), Bayer, Novartis, Roche, Code F (Financial Support), ABF Campus, Allergan, Bayer, Novartis, Roche, Code R (Recipient); Annabelle Okada Bayer Yakuhin Ltd. (Japan), Novartis Pharma KK (Japan), Santen Pharmaceutical Co., Ltd., Code F (Financial Support), AbbVie Japan, Inc., Allergan Japan, Astellas Japan, Bayer Healthcare AG, Bayer Yakuhin Ltd. (Japan), Chugai Pharmaceutical Co., Ltd., Daiichi-Sankyo, Kowa Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Novartis Pharma KK (Japan), Otsuka Pharmaceutical Co., Ltd., Santen Pharmaceutical Co., Ltd., Senju Pharmaceutical Co., Ltd., Code R (Recipient); Paula Scholz Bayer Vital GmbH, Code E (Employment); Xin Zhang Bayer Consumer Care AG, Code E (Employment); Tobias Machewitz Bayer AG, Code E (Employment); Scott Fitzpatrick Bayer Consumer Care AG, Code E (Employment)
  • Footnotes
    Support  The authors would like to thank the authors of both the ARIES and ALTAIR studies. This study was sponsored by Bayer AG, Germany. Medical writing support, under the direction of the authors, was provided by ApotheCom and funded by Bayer Consumer Care AG, Basel, Switzerland, in accordance with Good Publication Practice (GPP3) guidance (Ann Intern Med. 2015;163:461–464).
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2223. doi:
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      Michael Stewart, Amelie Pielen, Annabelle A. Okada, Paula Scholz, Xin Zhang, Tobias Machewitz, Scott Fitzpatrick; A post hoc analysis of intravitreal aflibercept–treated patients from ARIES & ALTAIR applying treatment regimen criteria from TENAYA & LUCERNE. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2223.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : ARIES & ALTAIR (A&A) were Phase 3b–4 trials in patients with neovascular age-related macular degeneration (nAMD) randomized to receive individualized, flexible, proactive treat-and-extend (T&E) regimens of intravitreal aflibercept (IVT-AFL) following 3 initial monthly injections. Treatment intervals were shortened/maintained/extended based on prespecified criteria reassessed continuously throughout the study at all visits. TENAYA & LUCERNE (T&L) were Phase 3 trials in patients with nAMD evaluating noninferiority of faricimab vs IVT-AFL. In T&L, the faricimab group received 4 initial monthly injections, then were assigned different fixed treatment intervals until Week (W) 48 based on a disease activity assessment (DAA) at W20 (8 weeks after the loading phase) and W24. If failing the first DAA at W20, patients were assigned to 8-week (q8) intervals. If failing the second DAA at W24, 12 weeks after their final initial monthly injection, patients were maintained on q12 intervals (despite disease activity at this interval). If passing both DAAs, patients were assigned to q16 intervals. 77.8–79.7% of faricimab-treated patients had treatment intervals of ≥q12. This analysis evaluated the proportion of A&A patients that would hypothetically be assigned to fixed ≥q12 treatment intervals using DAA criteria from T&L, and how this compared to their actual T&E intervals at W52.

Methods : A DAA was applied to IVT-AFL–treated patients from A&A using similar criteria from T&L, including performing the DAA 8 weeks after the loading phase (at W16, after 3 initial monthly injections).

Results : In ARIES, 73.1% (98/134) patients in the early-start T&E arm passed the DAA at W16 and thus would be assigned to ≥q12 intervals. In ALTAIR, 79.3% (195/246) patients in the full analysis set passed the DAA at W16 and thus would be assigned to ≥q12 intervals. Continuous assessment of patients on T&E regimens in A&A led to a real last treatment interval of ≥q12 for 37.8–52.8% of patients at W52.

Conclusions : Applying the DAA criteria from TENAYA & LUCERNE would have resulted in more patients treated on intervals of ≥q12, but the validity of this model is limited by cross-comparing trials, and differences in patient populations and inclusion criteria. A prospective, direct comparison trial using a T&E strategy would provide more information.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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