Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase III Study.

Autor:	Wolf S; Department of Ophthalmology, Inselspital, Bern University Hospital, Bern, Switzerland; Department of BioMedical Research, Bern, Switzerland., Stanga PE; The Retina Clinic London, London, United Kingdom; Institute of Ophthalmology, University College London, London, United Kingdom., Veselovsky M; Faculty hospital with Policlinic Zilina, Ophthalmology Department, Zilina, Slovakia., Veith M; Univerzity Hospital Kralovske Vinohrady, Prague, Czech Republic; 3(rd) Faculty of Medicine, Charles University, Prague, Czech Republic., Papp A; Semmelweis University Department of Ophthalmology, Budapest, Hungary., Mange S; Shivam Retina Clinic and Eye Hospital, Surat, India., Kanta Mondal L; Regional Institute of Ophthalmology, Kolkata, India., Romanczak D; Centrum Zdrowia MDM, Warszawa, Poland., Janco L; II. Ocna Klinika SZU, F.D. Roosevelt Hospital, Banska Bystrica, Slovakia., Chauhan R; Rising Retina Clinic, Ahmedabad, India., Romanowska-Dixon B; University Hospital of Krakow, Jagiellonian University, CM, Krakow, Poland., Eremina A; Novosibirsk Branch of FBSI IRTC, Novosibirsk, Russia., Zavgorodnya N; Medical Center Ltd VISUS, Zaporizhzhia, Ukraine., Dusova J; University Hospital Hradec Králové, Hradec Králové, Czech Republic., Sagong M; Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Republic of Korea., Kim S; Celltrion, Inc., Incheon, Republic of Korea., Ahn K; Celltrion, Inc., Incheon, Republic of Korea., Kim S; Celltrion, Inc., Incheon, Republic of Korea., Bae Y; Celltrion, Inc., Incheon, Republic of Korea., Lee S; Celltrion, Inc., Incheon, Republic of Korea., Kang H; Celltrion, Inc., Incheon, Republic of Korea., Brown DM; Retina Consultants of Texas, Retina Consultants of America, Houston, TX. Electronic address: dmbmd@retinaconsultantstexas.com.
Jazyk:	angličtina
Zdroj:	Ophthalmology. Retina [Ophthalmol Retina] 2024 Jun 26. Date of Electronic Publication: 2024 Jun 26.
DOI:	10.1016/j.oret.2024.06.013
Abstrakt:	Objective: To demonstrate the therapeutic similarity of CT-P42 compared with reference aflibercept (Eylea) in adult patients with diabetic macular edema (DME). Design: Randomized, active-controlled, double-masked, phase III clinical trial PARTICIPANTS: Patients with a diagnosis of either type 1 or 2 diabetes mellitus with DME involving the center of the macula. Methods: Patients were randomized (1:1) to receive either CT-P42 or reference aflibercept (2 mg/0.05 ml) by intravitreal injection every 4 weeks (5 doses), then every 8 weeks (4 doses), in the main study period. Results up to week 24 are reported herein. Main Outcome Measures: The primary end point was mean change from baseline at week 8 in best-corrected visual acuity (BCVA) using the ETDRS chart. Equivalence between CT-P42 and reference aflibercept was to be concluded if the 2-sided 95% confidence interval (CI) (global assumptions) and 2-sided 90% CI (United States Food and Drug Administration [FDA] assumptions) for the treatment difference fell entirely within the equivalence margin of ±3 letters, as assessed in the full analysis set. Results: Overall, 348 patients were randomized (CT-P42: 173; reference aflibercept: 175). Best-corrected visual acuity improved from baseline to week 8 in both groups, with a least squares mean (standard error) improvement of 9.43 (0.798) and 8.85 (0.775) letters in the CT-P42 and reference aflibercept groups, respectively. The estimated between-group treatment difference was 0.58 letters, with the CIs within the predefined equivalence margin of ±3 letters (95% CI, -0.73 to 1.88 [global]; 90% CI, -0.52 to 1.67 [FDA]). Through week 24, other efficacy results for the 2 groups, in terms of change in BCVA and retinal central subfield thickness, as well as ETDRS Diabetic Retinopathy Severity Scale score, supported therapeutic similarity. Pharmacokinetics, usability, safety (including the proportions of patients experiencing ≥1 treatment-emergent adverse event [CT-P42: 50.3%; reference aflibercept: 53.7%]), and immunogenicity were also comparable between groups. Conclusions: This study in patients with DME demonstrated equivalence between CT-P42 and reference aflibercept (2 mg/0.05 ml) in terms of efficacy, with similar pharmacokinetic, usability, safety, and immunogenicity profiles. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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