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Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial

  • Clinical Investigation
  • Published:
Japanese Journal of Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

To evaluate efficacy, durability, and safety of faricimab in Japanese patients with diabetic macular edema (DME).

Study design

Subgroup analysis of 2 global, multicenter, randomized, double-masked, active-comparator–controlled, phase 3 trials (YOSEMITE, NCT03622580; RHINE, NCT03622593).

Methods

Patients with DME were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg per personalized treatment interval (PTI), or aflibercept 2.0 mg Q8W through week 100. Primary endpoint was best-corrected visual acuity (BCVA) change from baseline at 1 year, averaged over weeks 48, 52, and 56. This is the first time 1-year outcomes between Japanese patients (only enrolled into YOSEMITE) and the pooled YOSEMITE/RHINE cohort (N = 1891) have been compared.

Results

The YOSEMITE Japan subgroup included 60 patients randomized to faricimab Q8W (n = 21), faricimab PTI (n = 19), or aflibercept Q8W (n = 20). Consistent with global results, the adjusted mean (95.04% confidence interval) BCVA change at 1 year in the Japan subgroup was comparable with faricimab Q8W (+11.1 [7.6–14.6] letters), faricimab PTI (+8.1 [4.4–11.7] letters), and aflibercept Q8W (+6.9 [3.3–10.5] letters). At week 52, 13 (72%) patients in the faricimab PTI arm achieved ≥ Q12W dosing, including 7 (39%) patients receiving Q16W dosing. Anatomic improvements with faricimab were generally consistent between the Japan subgroup and pooled YOSEMITE/RHINE cohort. Faricimab was well tolerated; no new or unexpected safety signals were identified.

Conclusion

Consistent with global results, faricimab up to Q16W offered durable vision gains and improved anatomic and disease-specific outcomes among Japanese patients with DME.

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Data sharing statement

For eligible studies, qualified researchers may request access to individual patient-level clinical data through a data request platform. At the time of writing, this request platform is Vivli (https://vivli.org/ourmember/roche/). For up-to-date details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://go.roche.com/data_sharing). Anonymized records for individual patients across more than 1 data source external to Roche cannot, and should not, be linked due to a potential increase in risk of patient re-identification.

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Acknowledgments

F. Hoffmann-La Roche Ltd. (Basel, Switzerland); Genentech, Inc. (South San Francisco, California, USA); and Chugai Pharmaceutical Co., Ltd. (Tokyo, Japan) provided financial support for the study. Funding was provided by Chugai Pharmaceutical Co., Ltd. for third-party writing assistance, which was provided by Karina D. Hamilton-Peel, PhD, CMPP, of Envision Pharma Group.

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Williams, Geoff: Calgary Retina Consultants, Calgary, CANADA. Wong, David: Unity Health Toronto, Toronto,CANADA. Sun, Xiaodong: Shanghai First People's Hospital, Shanghai City, CHINA. Dusova, Jaroslava: Fakultní nemocnice Hradec Králové, Oční klinika, Hradec Králové, CZECH REPUBLIC. Ernest, Jan: Axon Clinical, Prague, CZECH REPUBLIC. Farkas, Andrej: Nemocnice Sokolov, Sokolov, CZECH REPUBLIC. Nemcansky, Jan: Fakultní nemocnice Ostrava, Ophthalmology clinic, Ostrava, CZECH REPUBLIC. Veith, Miroslav: Fakultní nemocnice Královské Vinohrady, Ophthalmology clinic, Prague, CZECH REPUBLIC. Larsen, Michael: Rigshospitalet Glostrup, Øjenafdelingen, Glostrup, DENMARK. Laugesen, Caroline: Sjællands Universitetshospital Roskilde, Øjenafdelingen, Roskilde, DENMARK. Vorum, Henrik: Aalborg Universitetshospital, Øjenafdelingen, Aalborg, DENMARK. Buffet, Sylvia: Centre Ophtalmologique d' Imagerie et de Laser, Paris, FRANCE. Razavi, Hessam: Centre Ophtalmologique St Exupéry, Ophtalmologie, Tours, FRANCE. Souied, Eric: CHI de Créteil, Ophtalmologie, Créteil, FRANCE. Agostini, Hansjurgen: Universitätsklinikum Freiburg, Klinik für Augenheilkunde, Freiburg, GERMANY. Kampik, Daniel (Ach, Thomas): Universitätsklinikum Würzburg, Augenklinik und Poliklinik, Würzburg, GERMANY. Lohmann, Chris P: Klinikum rechts der Isar der Technischen Universität München, Augenklinik, München, GERMANY. Priglinger, Siegfried (Wolf, Armin): LMU Klinikum der Universität, Augenklinik, München, GERMANY. Sandner, Dirk: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde, Dresden, GERMANY. Schuart, Claudia (Wecke, Thoalf): Universitätsklinikum Magdeburg AöR, Universitätsaugenklinik, Magdeburg, GERMANY. Seitz, Berthold: Universitätsklinikum des Saarlandes, Klinik für Augenheilkunde, Homburg, GERMANY. Fung, Nicholas (Wong, Ian): Queen Mary Hospital, Department of Ophthalmology, Aberdeen, HONG KONG. Lai, Timothy: Hong Kong Eye Hospital, CUHK Eye Centre, Mong Kok, HONG KONG. Kerenyi, Agnes: Bajcsy-Zsilinszky Hospital, Budapest, HUNGARY. Papp, Andras: Semmelweis Egyetem Szemészeti Vizsgálóhely, Budapest, HUNGARY. Szecsko, Timea: Péterfy Sándor Utcai Kórház-Rendelőintézet és Baleseti Központ, Szemészet KR, Budapest, HUNGARY. Vogt, Gábor: Magyar Honvédség Egészségügyi Központ, Szemészeti Osztály, Budapest, HUNGARY. Lanzetta, Paolo: Azienda Ospedaliero Universitaria S Maria della Misericordia di Udine, Clinica Oculistica, Udine, ITALY. Nardi, Marco: Nuovo Ospedale Santa Chiara, AOUP Presidio Ospedaliero di Cisanello, UO Oculistica Universitaria, Pisa, ITALY. Pertile, Grazia: Ospedale Classificato Equiparato Sacro Cuore Don Calabria, Dipartimento Oculistica, Negrar, ITALY. Ricci, Federico: Fondazione Policlinico Tor Vergata di Roma, UOSD Patologie Renitiche, Roma, ITALY. Virgili, Gianni: Azienda Ospedaliero Universitaria Careggi, SOD Oculistica, Firenze, ITALY. Kang, Se Woong: Samsung Medical Center, Seoul, REPUBLIC OF KOREA. Park, Kyu Hyung: Seoul National University Bundang Hospital, Gyeonggi-do, REPUBLIC OF KOREA. Yoon, Young Hee: Asan Medical Center, Seoul, REPUBLIC OF KOREA. Yu, HyeongGon: Seoul National University Hospital, Seoul, REPUBLIC OF KOREA. Yu, Seung Young: Kyung Hee University Hospital, Seoul, REPUBLIC OF KOREA. Borcz, Emilia: Ośrodek Chirurgii Oka Prof Zagórskiego, Rzeszów, POLAND. Kaluzny, Jakub: Oftalmika, Bydgoszcz, POLAND. Raczynska, Dorota: OPTIMUM Profesorskie Centrum Okulistyki, Gdańsk, POLAND. Romanczak, Dominika: Centrum Zdrowia MDM, Warszawa, POLAND. Romanowska-Dixon, Bożena: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Okulistyki i Onkologii Okulistycznej, Kraków, POLAND. Sikorski, Bartosz: Specjalistyczny Ośrodek Okulistyczny Oculomedica, Bydgoszcz, POLAND. Zaczek Zakrzewska, Karolina: PRYZMAT Poradnia Okulistyczna i Salon Optyczny w Gliwicach, Gliwice, POLAND. Zatorska, Barbara: CaminoMed, Tarnowskie Góry, POLAND. Figueira, Joao: Association for Innovation and Biomedical Research on Light, Coimbra, PORTUGAL. Gomes, Nuno: Hospital de Braga, Servico de Oftalmologia, Braga, PORTUGAL. Silva, Rufino: Espaço Médico de Coimbra, Coimbra, PORTUGAL. Vaz-Pereira, Sara: Hospital de Santa Maria, Servico de Oftalmologia, Lisboa, PORTUGAL. Abdulaeva, Elmira: Kuzlyar Ltd, Kazan, RUSSIAN FEDERATION. Bratko, Galina: Intersec Research and Technology Complex, Eye Microsurgery n a SN Fyodorov, Novosibirsk, RUSSIAN FEDERATION. Pozdeyeva, Nadezhda: Intersec Research and Technology Complex, Eye Microsurgery n a SN Fyodorov, Cheboksary, RUSSIAN FEDERATION. Yurieva, Tatiana: Intersec Research and Technology Complex, Eye Microsurgery n a SN Fyodorov, Irkutsk, RUSSIAN FEDERATION. Chee, Caroline: National University Hospital, Ophthalmology Department, Singapore, SINGAPORE. Rajagopalan, Rajesh: Tan Tock Seng Hospital, Ophthalmology Department, Singapore, SINGAPORE. Tan, Gavin: Singapore Eye Research Institute, Singapore, SINGAPORE. Aliseda, Daniel: Complejo Hospitalario de Navarra, Servicio de Oftalmología, Pamplona, SPAIN. Arias, Luis: Hospital Universitari de Bellvitge, Servicio de Oftalmología, L'Hospitalet de Llobregat, SPAIN. Desco, Carmen: FISABIO-Oftalmología Médica, Servicio de Oftalmología, Valencia, SPAIN. Escobar, Joan Josep: Hospital Dos de Maig, Pharmacy Service, Barcelona, SPAIN. Fernandez Vega, Alvaro: Instituto Oftalmológico Fernández-Vega, Servicio de Oftalmología, Oviedo, SPAIN. Figueroa, Marta: VISSUM Madrid, Servicio de Oftalmología, Madrid, SPAIN. Gallego-Pinazo, Roberto: Oftalvist Valencia, Valencia, SPAIN. Montero, Javier: Hospital Universitario Rio Hortega, Servicio de Oftalmología, Valladolid, SPAIN. Sararols, Laura: Hospital General de Catalunya, Servicio de Oftalmología, Sant Cugat del Vallès, SPAIN. Hatz, Katja: Vista Klinik Binningen, Binningen, SWITZERLAND. Chen, Shih-Jen: Taipei Veterans General Hospital, Ophthalmology, Taipei City, TAIWAN. Lai, Chi-Chun: Chang Gung Medical Foundation, Ophthalmology, Taoyuan, TAIWAN. Yang, Chang-Hao: National Taiwan University Hospital, Ophthalmology, Taipei City, TAIWAN. Chaikitmongkol, Voraporn: Maharaj Nakorn Chiang Mai Hospital, Ophthalmology Department, Chiang Mai, THAILAND. Pongsachareonnont, Pear: King Chulalongkorn Memorial Hospital, Ophthalmology Department, Bangkok, THAILAND. Ruamviboonsuk, Paisan: Rajavithi Hospital, Ophthalmology Department, Bangkok, THAILAND. Karabas, Levent: Kocaeli Üniversitesi Tıp Fakültesi, Department of Ophthalmology, Kocaeli, TURKEY. Ozcalışkan, Sehnaz (Perente, Irfan): Beyoğlu Göz Training and Research Hospital; Department of Ophthalmology, Istanbul, TURKEY. Sermet, Figen: Ankara Üniversitesi Tıp Fakültesi, Department of Ophthalmology, Ankara, TURKEY. Yilmaz, Gursel: Başkent Üniversitesi Tıp Fakültesi, Department of Ophthalmology, Ankara, TURKEY. Asaria, Riaz: Royal Free Hospital, London, UNITED KINGDOM. Burton, Ben: James Paget University Hospitals NHS Foundation Trust, Norfolk, UNITED KINGDOM. Cheong-Leen, Richard (George, Sheen): Hillingdon Hospital, Uxbridge, UNITED KINGDOM. Esposti, Simona: Moorfields Eye Hospital NHS Foundation Trust, London, UNITED KINGDOM. Ghanchi, Faruque: Bradford Royal Infirmary, Bradford, UNITED KINGDOM. Harris, Martin (Mehta, Hemal): Barnet Hospital, Royal Free London NHS Foundation Trust, Barnet, UNITED KINGDOM. Jackson, Tim: Kings College Hospital, London, UNITED KINGDOM. Jafree, Afsar: East Kent Hospitals University NHS Foundation Trust, Canterbury, UNITED KINGDOM. Lotery, Andrew: University Hospital Southampton NHS Foundation Trust, Southampton Eye Unit, Southampton, UNITED KINGDOM. McKibbin, Martin: St James University Hospital, Leeds, UNITED KINGDOM. Menon, Geeta: Frimley Park Hospital, Frimley, UNITED KINGDOM. Mohamed, Quresh: Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UNITED KINGDOM. Pearce, Ian: Royal Liverpool University Hospital, St Paul's Clinical Eye Research Centre, Liverpool, UNITED KINGDOM. Peto, Tunde: Belfast Health and Social Care Trust, Royal Victoria Hospital, Belfast, UNITED KINGDOM. Ross, Adam: University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital, Bristol, UNITED KINGDOM. Stone, Amy (Mahmood, Sajjad): Manchester Royal Eye Hospital, Manchester, UNITED KINGDOM. Talks, James: Royal Victoria Infirmary, Newcastle upon Tyne, UNITED KINGDOM. Varma, Deepali: Sunderland Eye Infirmary, Sunderland, UNITED KINGDOM. Adams, Serrhel: Northwest Arkansas Retina Associates, Springdale, AR, UNITED STATES. Adrean, Sean: Retina Consultants of Orange County, Fullerton, CA, UNITED STATES. Alfaro, Virgil: Charleston Neuroscience Institute, Ladson, SC, UNITED STATES. Awh, Carl C: Tennessee Retina PC, Nashville, TN, UNITED STATES. Barakat, Mark (Dugel, Pravin): Retinal Research Institute LLC, Phoenix, AZ, UNITED STATES. Baumal, Caroline: Tufts Medical Center Ophthalmology, Boston, MA, UNITED STATES. Bergstrom, Chris: Retina Consultants Of Carolina, Greenville, SC, UNITED STATES. Boyer, David: Retina-Vitreous Associates Medical Group, Beverly Hills, CA, UNITED STATES. Brown, David M: Retina Consultants of Houston, Houston, TX, UNITED STATES. Burgess, Stuart: Fort Lauderdale Eye Institute, Plantation, FL, UNITED STATES. Castellarin, Alessandro: California Retina Consultants, Santa Barbara, CA, UNITED STATES. Chaudhry, Nauman: Retina Group of New England, Waterford, CT, UNITED STATES. Chiang, Allen (Ho, Allen): Mid Atlantic Retina, Wills Eye Hospital, Philadelphia, PA, UNITED STATES. Connolly, Brian: Retina Associates of Western New York, Rochester, NY, UNITED STATES. Eichenbaum, David: Retina Vitreous Associates of Florida, Saint Petersburg, FL, UNITED STATES. Engstrom, Robert: The Retina Partners, Encino, CA, UNITED STATES. Falk, Naomi: The Retina Consultants, Slingerlands, NY, UNITED STATES. Fortun, Jorge: Bascom Palmer Eye Institute, Palm Beach Gardens, FL, UNITED STATES. Goldberg, Roger: Bay Area Retina Associates, Walnut Creek, CA, UNITED STATES. Hershberger, Vrinda: Florida Eye Associates, Melbourne, FL, UNITED STATES. Higgins, Patrick: Retina Center of New Jersey, Bloomfield, NJ, UNITED STATES. Khurana, Rahul: Northern California Retina Vitreous Associates, Mountain View, CA, UNITED STATES. Kuriyan, Ajay: University of Rochester Flaum Eye Institute, Rochester, NY, UNITED STATES. Kwong, Henry (Klein-Mascia, Kendra): Associated Retina Consultants, Phoenix, AZ, UNITED STATES. Liu, Judy (Thach, Allen): Retina Consultants of Nevada, Henderson, NV, UNITED STATES. Marcus, Dennis: Southeast Retina Center, Augusta, GA, UNITED STATES. Margherio, Alan: Associated Retinal Consultants, Grand Rapids, MI, UNITED STATES. Modi, Yasha: New York University, New York, NY, UNITED STATES. Oliver, Scott: University of Colorado, Department of Ophthalmology, Aurora, CO, UNITED STATES. Pearlman, Joel: Retinal Consultants Medical Group, Sacramento, CA, UNITED STATES. Perkins, Stephen: Southeastern Retina Associates, Knoxville, TN, UNITED STATES. Pieramici, Dante: California Retina Consultants, Santa Maria, CA UNITED STATES. Qureshi, Jawad: Retina Center of Texas, Grapevine, TX, UNITED STATES. Raskauskas, Paul: National Ophthalmic Research Institute, Fort Myers, FL, UNITED STATES. Rosenblatt, Brett: Long Island Vitreoretinal Consultants, Hauppauge, NY, UNITED STATES. Shah, Ankur: Prairie Retina Center, Springfield, IL, UNITED STATES. Shah, Rohan: Southeastern Retina Associates, Chattanooga, TN, UNITED STATES. Sharma, Sumit (Singh, Rishi): Cleveland Clinic Foundation, Cole Eye Institute, Cleveland, OH, UNITED STATES. Sheth, Veeral: University Retina and Macula Associates PC, Oak Forest, IL, UNITED STATES. 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Author information

Authors and Affiliations

  1. Tokyo Medical University Hachioji Medical Center, 1163, Tatemachi, Hachioji-shi, Tokyo, 193-0998, Japan

    Masahiko Shimura

  2. Tokyo Women’s Medical University Hospital, Tokyo, Japan

    Shigehiko Kitano

  3. Nara Medical University Hospital, Nara, Japan

    Nahoko Ogata

  4. Tokushima University Graduate School, Tokushima, Japan

    Yoshinori Mitamura

  5. Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan

    Hideyasu Oh

  6. Chugai Pharmaceutical Co., Ltd., Tokyo, Japan

    Haruka Ochi & Shino Ohsawa

  7. Kyorin University School of Medicine, Tokyo, Japan

    Akito Hirakata

Authors
  1. Masahiko Shimura
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  2. Shigehiko Kitano
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  3. Nahoko Ogata
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  4. Yoshinori Mitamura
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  5. Hideyasu Oh
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  6. Haruka Ochi
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  7. Shino Ohsawa
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  8. Akito Hirakata
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  • , Gursel Yilmaz
  • , Riaz Asaria
  • , Ben Burton
  • , Richard (George, Sheen) Cheong-Leen
  • , Simona Esposti
  • , Faruque Ghanchi
  • , Martin (Mehta, Hemal) Harris
  • , Tim Jackson
  • , Afsar Jafree
  • , Andrew Lotery
  • , Martin McKibbin
  • , Geeta Menon
  • , Quresh Mohamed
  • , Ian Pearce
  • , Tunde Peto
  • , Adam Ross
  • , Amy (Mahmood, Sajjad) Stone
  • , James Talks
  • , Deepali Varma
  • , Serrhel Adams
  • , Sean Adrean
  • , Virgil Alfaro
  • , Carl C Awh
  • , Mark (Dugel, Pravin) Barakat
  • , Caroline Baumal
  • , Chris Bergstrom
  • , David Boyer
  • , David M Brown
  • , Stuart Burgess
  • , Alessandro Castellarin
  • , Nauman Chaudhry
  • , Allen (Ho, Allen) Chiang
  • , Brian Connolly
  • , David Eichenbaum
  • , Robert Engstrom
  • , Naomi Falk
  • , Jorge Fortun
  • , Roger Goldberg
  • , Vrinda Hershberger
  • , Patrick Higgins
  • , Rahul Khurana
  • , Ajay Kuriyan
  • , Henry (Klein-Mascia, Kendra) Kwong
  • , Judy (Thach, Allen) Liu
  • , Dennis Marcus
  • , Alan Margherio
  • , Yasha Modi
  • , Scott Oliver
  • , Joel Pearlman
  • , Stephen Perkins
  • , Dante Pieramici
  • , Jawad Qureshi
  • , Paul Raskauskas
  • , Brett Rosenblatt
  • , Ankur Shah
  • , Rohan Shah
  • , Sumit (Singh, Rishi) Sharma
  • , Veeral Sheth
  • , David J Spinak
  • , Nathan Steinle
  • , Glenn Stoller
  • , Ali Tabassian
  • , Stanford (Chittum, Mark) Taylor
  • , John Thompson
  • , Eduardo Uchiyama
  • , John A Wells
  • , Robert Wong
  • , Paul Yates
  •  & Jeffrey Zheutlin

Corresponding author

Correspondence to Masahiko Shimura.

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Conflicts of interest

M. Shimura, Consulting fees (Chugai, Roche), Lecture fees (Chugai); S. Kitano, Consulting fees (Chugai), Speaker fees (Bayer, Novartis); N. Ogata, None; Y. Mitamura, Grants (Santen), Speaker fee (Bayer, Chugai, Novartis, Santen); H. Oh, Grants (Chugai), Lecture fees (Alcon, Bayer, Kowa, Novartis, Santen); H. Ochi, Employee (Chugai); S. Ohsawa, Employee (Chugai); A. Hirakata, None.

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Corresponding Author: Masahiko Shimura

Study group investigators: The YOSEMITE and RHINE investigators and study sites are listed in acknowledgements section.

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Shimura, M., Kitano, S., Ogata, N. et al. Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial. Jpn J Ophthalmol 67, 264–279 (2023). https://doi.org/10.1007/s10384-023-00979-8

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