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Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-Related Macular Degeneration: A Phase III Randomized Trial
J. Hamouz, A. Nowosielska, A. Święch-Zubilewicz, S. Abengoechea, K. Baumane, A. Vajas, M. Siewierska, M. Veselovsky, M. Veith, Á. Kerényi, S. Mange, K. Baidya, G. Laganovska, I. Jürgens, A. Papp, J. Gosai, J. Štefanickova, M. Han, P. Fryczkowski,...
Language English
Document type Journal Article, Clinical Trial, Phase III, Randomized Controlled Trial, Multicenter Study
- MeSH
- Biosimilar Pharmaceuticals * administration & dosage adverse effects MeSH
- Double-Blind Method MeSH
- Angiogenesis Inhibitors administration & dosage adverse effects MeSH
- Intravitreal Injections MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Tomography, Optical Coherence MeSH
- Ranibizumab * administration & dosage adverse effects MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Vascular Endothelial Growth Factor A antagonists & inhibitors MeSH
- Wet Macular Degeneration * drug therapy diagnosis MeSH
- Treatment Outcome MeSH
- Dose-Response Relationship, Drug MeSH
- Visual Acuity * MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
OBJECTIVE: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD). DESIGN: This was a multicenter, double-masked, randomized, controlled phase III trial. PARTICIPANTS: Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab. METHODS: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every 4 weeks for 48 weeks. MAIN OUTCOME MEASURES: The primary end point was change in best-corrected visual acuity (BCVA) by ETDRS letters at week 8 compared with baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49. RESULTS: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, -2.23 to 0.13) and 95% CI (-2.46 to 0.36) of the difference between the 2 treatment groups (P = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups. CONCLUSIONS: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Clinical Research and Development Centre Qilu Pharmaceutical Jinan China
Department of Ophthalmology Bajcsy Zsilinszky Hospital Budapest Hungary
Department of Ophthalmology Barraquer Ophthalmology Center Barcelona Spain
Department of Ophthalmology Clinical Centre Bikernieki Riga East University Hospital Riga Latvia
Department of Ophthalmology Diagnostic and Microsurgery Center of the Eye LENS Olsztyn Poland
Department of Ophthalmology MJ Western Regional Institute of Ophthalmology Ahmedabad Gujarat India
Department of Ophthalmology Pauls Stradins Clinical University Hospital Riga Latvia
Department of Ophthalmology Retina Ophthalmological Outpatient Clinic and Hospital Warsaw Poland
Department of Ophthalmology Semmelweis University Budapest Hungary
Department of Ophthalmology Shivam Retina Clinic and Eye Hospital Vadodara Gujarat India
Department of Ophthalmology St Rose Hospital Kraków Poland
Department of Ophthalmology Tianjin Eye Hospital Tianjin China
Department of Ophthalmology University Hospital and Policlinic of Zilina Zilina Slovakia
Department of Ophthalmology University Hospital Kralovske Vinohrady Prague Czech Republic
Department of Ophthalmology University of Debrecen Debrecen Hungary
Ophthalmology and Eye Surgery Clinic Warsaw Eye Hospital Warsaw Poland
Retina and Vitreous Department Institut Català de Retina Barcelona Spain
References provided by Crossref.org
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- $a OBJECTIVE: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD). DESIGN: This was a multicenter, double-masked, randomized, controlled phase III trial. PARTICIPANTS: Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab. METHODS: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every 4 weeks for 48 weeks. MAIN OUTCOME MEASURES: The primary end point was change in best-corrected visual acuity (BCVA) by ETDRS letters at week 8 compared with baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49. RESULTS: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, -2.23 to 0.13) and 95% CI (-2.46 to 0.36) of the difference between the 2 treatment groups (P = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups. CONCLUSIONS: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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