Efficacy and Safety of a Proposed Ranibizumab Biosimilar
Product vs a Reference Ranibizumab Product for Patients With
Neovascular Age-Related Macular Degeneration A Randomized
Clinical Trial

J 2021

Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration A Randomized Clinical Trial

WOO, Se Joon, Miroslav VEITH, Jan HAMOUZ, Jan ERNEST, Dominik ZALEWSKI et. al.

Basic information

Original name

Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration A Randomized Clinical Trial

Authors

WOO, Se Joon (410 Republic of Korea), Miroslav VEITH (203 Czech Republic), Jan HAMOUZ (203 Czech Republic), Jan ERNEST (203 Czech Republic), Dominik ZALEWSKI (616 Poland), Jan STUDNICKA (203 Czech Republic), Attila VAJAS (348 Hungary), Andras PAPP (348 Hungary), Vogt GABOR (348 Hungary), James LUU (840 United States of America), Veronika MATUŠKOVÁ (203 Czech Republic, belonging to the institution), Young Hee YOON (410 Republic of Korea), Tamas PREGUN (276 Germany), Taehyung KIM (410 Republic of Korea), Donghoon SHIN (410 Republic of Korea) and Neil M. BRESSLER (840 United States of America, guarantor)

Edition

JAMA OPHTHALMOLOGY, CHICAGO, AMER MEDICAL ASSOC, 2021, 2168-6165

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30207 Ophthalmology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 8.253

RIV identification code

RIV/00216224:14110/21:00120886

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1001/jamaophthalmol.2020.5053

UT WoS

000592736300002

Keywords in English

ENDOTHELIAL GROWTH-FACTOR; VERTEPORFIN PHOTODYNAMIC THERAPY

Abstract

V originále

QUESTION Does SB11, a proposed ranibizumab biosimilar product, have equivalent best-corrected visual acuity (BCVA) and optical coherence tomography central subfield thickness (CST) outcomes and a similar safety profile to the reference ranibizumab product in patients with neovascular age-related macular degeneration? FINDINGS This randomized clinical equivalence trial found that SB11 demonstrated equivalence in efficacy for both primary end points: adjusted treatment differences between groups were within predefined equivalence margins for mean changes from baseline in both BCVA at week 8 and CST at week 4. Safety and immunogenicity profiles were similar between SB11 and ranibizumab. MEANING These results indicate that SB11 is similar to its reference product, ranibizumab. This randomized clinical trial compares the efficacy, safety, and immunogenicity of SB11, a ranibizumab biosimilar product, with that of the reference ranibizumab for patients with neovascular age-related macular degeneration (AMD). IMPORTANCE Neovascular age-related macular degeneration is the leading cause of blindness in individuals 50 years or older. The availability of a ranibizumab biosimilar product (SB11) may facilitate access to an effective alternative to this treatment. OBJECTIVE To demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11 compared with the reference ranibizumab. DESIGN, SETTING, AND PARTICIPANTS This randomized, double-masked, parallel-group phase 3 equivalence study was conducted in 75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions. Analysis was performed on an intent-to-treat basis. INTERVENTIONS Intravitreous injection of SB11 or ranibizumab, 0.5 mg, every 4 weeks through week 48. MAIN OUTCOMES AND MEASURES Preplanned interim analysis after all participants completed the week 24 assessment of primary efficacy end points at week 8 for change from baseline in best-corrected visual acuity (BCVA) and week 4 for central subfield thickness (CST), with predefined equivalence margins for adjusted treatment differences of -3 letters to 3 letters for BCVA and -36 mu m to 36 mu m for CST. RESULTS Baseline and disease characteristics among 705 randomized participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years) were comparable between treatment groups (SB11, 351; ranibizumab, 354). Least-squares mean (SE) changes in BCVA from baseline at week 8 were 6.2 (0.5) letters in the SB11 group vs 7.0 (0.5) letters in the ranibizumab group, with an adjusted treatment difference of -0.8 letter (90% CI, -1.8 to 0.2 letters). Least-squares mean (SE) changes in CST from baseline at week 4 were -108 (5) mu m in the SB11 group vs -100 (5) mu m in the ranibizumab group, with an adjusted treatment difference of -8 mu m (95% CI, -19 to 3 mu m). Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups. Immunogenicity was low, with a cumulative incidence of antidrug antibodies up to week 24 of 3.0% (10 of 330) in the SB11 group and 3.1% (10 of 327) in the ranibizumab group. CONCLUSIONS AND RELEVANCE These findings of equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab support the use of SB11 for patients with neovascular age-related macular degeneration.

Citovat

WOO, Se Joon, Miroslav VEITH, Jan HAMOUZ, Jan ERNEST, Dominik ZALEWSKI, Jan STUDNICKA, Attila VAJAS, Andras PAPP, Vogt GABOR, James LUU, Veronika MATUŠKOVÁ, Young Hee YOON, Tamas PREGUN, Taehyung KIM, Donghoon SHIN and Neil M. BRESSLER. Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration A Randomized Clinical Trial. JAMA OPHTHALMOLOGY. CHICAGO: AMER MEDICAL ASSOC, 2021, vol. 139, No 1, p. 68-76. ISSN 2168-6165. Available from: https://dx.doi.org/10.1001/jamaophthalmol.2020.5053.

@article{1713457,
   author = {Woo, Se Joon and Veith, Miroslav and Hamouz, Jan and Ernest, Jan and Zalewski, Dominik and Studnicka, Jan and Vajas, Attila and Papp, Andras and Gabor, Vogt and Luu, James and Matušková, Veronika and Yoon, Young Hee and Pregun, Tamas and Kim, Taehyung and Shin, Donghoon and Bressler, Neil M.},
   article_location = {CHICAGO},
   article_number = {1},
   doi = {http://dx.doi.org/10.1001/jamaophthalmol.2020.5053},
   keywords = {ENDOTHELIAL GROWTH-FACTOR; VERTEPORFIN PHOTODYNAMIC THERAPY},
   language = {eng},
   issn = {2168-6165},
   journal = {JAMA OPHTHALMOLOGY},
   title = {Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration A Randomized Clinical Trial},
   url = {https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2772987?utm_campaign=articlePDF&utm_medium=articlePDFlink&utm_source=articlePDF&utm_content=jamaophthalmol.2020.5053},
   volume = {139},
   year = {2021}
}

TY  - JOUR
ID  - 1713457
AU  - Woo, Se Joon - Veith, Miroslav - Hamouz, Jan - Ernest, Jan - Zalewski, Dominik - Studnicka, Jan - Vajas, Attila - Papp, Andras - Gabor, Vogt - Luu, James - Matušková, Veronika - Yoon, Young Hee - Pregun, Tamas - Kim, Taehyung - Shin, Donghoon - Bressler, Neil M.
PY  - 2021
TI  - Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration A Randomized Clinical Trial
JF  - JAMA OPHTHALMOLOGY
VL  - 139
IS  - 1
SP  - 68-76
EP  - 68-76
PB  - AMER MEDICAL ASSOC
SN  - 21686165
KW  - ENDOTHELIAL GROWTH-FACTOR
KW  - VERTEPORFIN PHOTODYNAMIC THERAPY
UR  - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2772987?utm_campaign=articlePDF&utm_medium=articlePDFlink&utm_source=articlePDF&utm_content=jamaophthalmol.2020.5053
L2  - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2772987?utm_campaign=articlePDF&utm_medium=articlePDFlink&utm_source=articlePDF&utm_content=jamaophthalmol.2020.5053
N2  - QUESTION Does SB11, a proposed ranibizumab biosimilar product, have equivalent best-corrected visual acuity (BCVA) and optical coherence tomography central subfield thickness (CST) outcomes and a similar safety profile to the reference ranibizumab product in patients with neovascular age-related macular degeneration? FINDINGS This randomized clinical equivalence trial found that SB11 demonstrated equivalence in efficacy for both primary end points: adjusted treatment differences between groups were within predefined equivalence margins for mean changes from baseline in both BCVA at week 8 and CST at week 4. Safety and immunogenicity profiles were similar between SB11 and ranibizumab. MEANING These results indicate that SB11 is similar to its reference product, ranibizumab. This randomized clinical trial compares the efficacy, safety, and immunogenicity of SB11, a ranibizumab biosimilar product, with that of the reference ranibizumab for patients with neovascular age-related macular degeneration (AMD). IMPORTANCE Neovascular age-related macular degeneration is the leading cause of blindness in individuals 50 years or older. The availability of a ranibizumab biosimilar product (SB11) may facilitate access to an effective alternative to this treatment. OBJECTIVE To demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11 compared with the reference ranibizumab. DESIGN, SETTING, AND PARTICIPANTS This randomized, double-masked, parallel-group phase 3 equivalence study was conducted in 75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions. Analysis was performed on an intent-to-treat basis. INTERVENTIONS Intravitreous injection of SB11 or ranibizumab, 0.5 mg, every 4 weeks through week 48. MAIN OUTCOMES AND MEASURES Preplanned interim analysis after all participants completed the week 24 assessment of primary efficacy end points at week 8 for change from baseline in best-corrected visual acuity (BCVA) and week 4 for central subfield thickness (CST), with predefined equivalence margins for adjusted treatment differences of -3 letters to 3 letters for BCVA and -36 mu m to 36 mu m for CST. RESULTS Baseline and disease characteristics among 705 randomized participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years) were comparable between treatment groups (SB11, 351; ranibizumab, 354). Least-squares mean (SE) changes in BCVA from baseline at week 8 were 6.2 (0.5) letters in the SB11 group vs 7.0 (0.5) letters in the ranibizumab group, with an adjusted treatment difference of -0.8 letter (90% CI, -1.8 to 0.2 letters). Least-squares mean (SE) changes in CST from baseline at week 4 were -108 (5) mu m in the SB11 group vs -100 (5) mu m in the ranibizumab group, with an adjusted treatment difference of -8 mu m (95% CI, -19 to 3 mu m). Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups. Immunogenicity was low, with a cumulative incidence of antidrug antibodies up to week 24 of 3.0% (10 of 330) in the SB11 group and 3.1% (10 of 327) in the ranibizumab group. CONCLUSIONS AND RELEVANCE These findings of equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab support the use of SB11 for patients with neovascular age-related macular degeneration.
ER  -

WOO, Se Joon, Miroslav VEITH, Jan HAMOUZ, Jan ERNEST, Dominik ZALEWSKI, Jan STUDNICKA, Attila VAJAS, Andras PAPP, Vogt GABOR, James LUU, Veronika MATUŠKOVÁ, Young Hee YOON, Tamas PREGUN, Taehyung KIM, Donghoon SHIN and Neil M. BRESSLER. Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration A Randomized Clinical Trial. \textit{JAMA OPHTHALMOLOGY}. CHICAGO: AMER MEDICAL ASSOC, 2021, vol.~139, No~1, p.~68-76. ISSN~2168-6165. Available from: https://dx.doi.org/10.1001/jamaophthalmol.2020.5053.

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