Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study

To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in prior ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD) enrolled in the LUMINOUS™ study. LUMINOUS, a 5-year, prospective, multicenter, observational study, recruited 30,138 adul...

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Veröffentlicht in:	PloS one 2020-12, Vol.15 (12), p.e0244183
Hauptverfasser:	Holz, Frank G, Minnella, Angelo M, Tuli, Raman, Yoganathan, Pradeepa, Parikh, Soumil, Hamilton, Robin
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Sprache:	eng
Schlagworte:	Acuity Age Age related diseases Aged Aged, 80 and over Angiogenesis Inhibitors - administration & dosage Angiogenesis Inhibitors - adverse effects Angiogenesis Inhibitors - therapeutic use Biology and Life Sciences Diabetic retinopathy Drug Administration Schedule Drug therapy Eye diseases Female Heart attacks Humans Immunotherapy Long Term Adverse Effects - epidemiology Macular degeneration Macular Degeneration - drug therapy Male Medicine and Health Sciences Monoclonal antibodies Older people Patient outcomes Patients Ranibizumab - administration & dosage Ranibizumab - adverse effects Ranibizumab - therapeutic use Retina Safety Social Sciences Visual Acuity
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description	To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in prior ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD) enrolled in the LUMINOUS™ study. LUMINOUS, a 5-year, prospective, multicenter, observational study, recruited 30,138 adult patients (treatment-naïve or prior ranibizumab-treated or other ocular treatments) across all approved indications for ranibizumab. Patients were treated as per local ranibizumab label of participating countries. Here we report the mean change in visual acuity (VA) at Year 1, treatment exposure, overall incidence of ocular, non-ocular adverse events (AEs) and serious AEs (SAEs) in prior ranibizumab-treated nAMD patients (n = 16,167). At baseline, the mean (standard deviation [SD]) age of patients was 78.4 (9.0) years, 59.0% were female, and 80.0% were Caucasian. At Year 1 (n = 10,168), the mean (SD) VA change was -1.6 (12.6) letters (baseline VA: 58.3 [19.0] letters) with a mean (SD) of 4.7 (3.1) ranibizumab injections. Stratified by duration of prior ranibizumab treatment of
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LUMINOUS, a 5-year, prospective, multicenter, observational study, recruited 30,138 adult patients (treatment-naïve or prior ranibizumab-treated or other ocular treatments) across all approved indications for ranibizumab. Patients were treated as per local ranibizumab label of participating countries. Here we report the mean change in visual acuity (VA) at Year 1, treatment exposure, overall incidence of ocular, non-ocular adverse events (AEs) and serious AEs (SAEs) in prior ranibizumab-treated nAMD patients (n = 16,167). At baseline, the mean (standard deviation [SD]) age of patients was 78.4 (9.0) years, 59.0% were female, and 80.0% were Caucasian. At Year 1 (n = 10,168), the mean (SD) VA change was -1.6 (12.6) letters (baseline VA: 58.3 [19.0] letters) with a mean (SD) of 4.7 (3.1) ranibizumab injections. Stratified by duration of prior ranibizumab treatment of <1 (n = 4,112), 1 to <2 (n = 2,095), 2 to <3 (n = 1,506), 3 to <4 (n = 1,123), 4 to <5 (n = 689), and ≥5 (n = 256) years, the mean (SD) VA change at Year 1 were -1.2 (13.5), -2.0 (12.3), -2.0 (11.3), -1.9 (11.8), -2.5 (10.9), and 0.0 (11.2) letters, respectively. Mean (SD) VA change in patients who received ≤6 and >6 injections over 1 year was -1.8 (13.8) and +0.5 (12.5) letters, respectively. The rate of ocular/non-ocular AEs and SAEs across all prior ranibizumab-treated patients over 5 years were 13.29%/23.02% and 0.84%/13.66%, respectively. Overall, regardless of the prior ranibizumab-treatment duration, VA was maintained in these patients at Year 1, and those receiving ≥6 injections showed a trend towards gaining letters. There were no new safety signals. These results may help inform routine clinical practice to appropriately treat nAMD patients with ranibizumab to achieve optimal visual outcomes.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0244183</identifier><identifier>PMID: 33378369</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acuity ; Age ; Age related diseases ; Aged ; Aged, 80 and over ; Angiogenesis Inhibitors - administration & dosage ; Angiogenesis Inhibitors - adverse effects ; Angiogenesis Inhibitors - therapeutic use ; Biology and Life Sciences ; Diabetic retinopathy ; Drug Administration Schedule ; Drug therapy ; Eye diseases ; Female ; Heart attacks ; Humans ; Immunotherapy ; Long Term Adverse Effects - epidemiology ; Macular degeneration ; Macular Degeneration - drug therapy ; Male ; Medicine and Health Sciences ; Monoclonal antibodies ; Older people ; Patient outcomes ; Patients ; Ranibizumab - administration & dosage ; Ranibizumab - adverse effects ; Ranibizumab - therapeutic use ; Retina ; Safety ; Social Sciences ; Visual Acuity</subject><ispartof>PloS one, 2020-12, Vol.15 (12), p.e0244183</ispartof><rights>COPYRIGHT 2020 Public Library of Science</rights><rights>2020 Holz et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2020 Holz et al 2020 Holz et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-5c5ca43dfecc38efe31e81711445f3afb44e16b9096e477ebde5aa2a3371186f3</citedby><cites>FETCH-LOGICAL-c692t-5c5ca43dfecc38efe31e81711445f3afb44e16b9096e477ebde5aa2a3371186f3</cites><orcidid>0000-0003-2861-8761 ; 0000-0001-5896-5313</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7773197/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7773197/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2100,2919,23857,27915,27916,53782,53784,79361,79362</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33378369$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Vavvas, Demetrios G.</contributor><creatorcontrib>Holz, Frank G</creatorcontrib><creatorcontrib>Minnella, Angelo M</creatorcontrib><creatorcontrib>Tuli, Raman</creatorcontrib><creatorcontrib>Yoganathan, Pradeepa</creatorcontrib><creatorcontrib>Parikh, Soumil</creatorcontrib><creatorcontrib>Hamilton, Robin</creatorcontrib><creatorcontrib>LUMINOUS™ study group</creatorcontrib><creatorcontrib>on behalf of the LUMINOUS™ study group</creatorcontrib><title>Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in prior ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD) enrolled in the LUMINOUS™ study. LUMINOUS, a 5-year, prospective, multicenter, observational study, recruited 30,138 adult patients (treatment-naïve or prior ranibizumab-treated or other ocular treatments) across all approved indications for ranibizumab. Patients were treated as per local ranibizumab label of participating countries. Here we report the mean change in visual acuity (VA) at Year 1, treatment exposure, overall incidence of ocular, non-ocular adverse events (AEs) and serious AEs (SAEs) in prior ranibizumab-treated nAMD patients (n = 16,167). At baseline, the mean (standard deviation [SD]) age of patients was 78.4 (9.0) years, 59.0% were female, and 80.0% were Caucasian. At Year 1 (n = 10,168), the mean (SD) VA change was -1.6 (12.6) letters (baseline VA: 58.3 [19.0] letters) with a mean (SD) of 4.7 (3.1) ranibizumab injections. 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These results may help inform routine clinical practice to appropriately treat nAMD patients with ranibizumab to achieve optimal visual outcomes.</description><subject>Acuity</subject><subject>Age</subject><subject>Age related diseases</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Angiogenesis Inhibitors - administration & dosage</subject><subject>Angiogenesis Inhibitors - adverse effects</subject><subject>Angiogenesis Inhibitors - therapeutic use</subject><subject>Biology and Life Sciences</subject><subject>Diabetic retinopathy</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Eye diseases</subject><subject>Female</subject><subject>Heart attacks</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Long Term Adverse Effects - epidemiology</subject><subject>Macular degeneration</subject><subject>Macular Degeneration - drug therapy</subject><subject>Male</subject><subject>Medicine and Health Sciences</subject><subject>Monoclonal antibodies</subject><subject>Older people</subject><subject>Patient outcomes</subject><subject>Patients</subject><subject>Ranibizumab - 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LUMINOUS, a 5-year, prospective, multicenter, observational study, recruited 30,138 adult patients (treatment-naïve or prior ranibizumab-treated or other ocular treatments) across all approved indications for ranibizumab. Patients were treated as per local ranibizumab label of participating countries. Here we report the mean change in visual acuity (VA) at Year 1, treatment exposure, overall incidence of ocular, non-ocular adverse events (AEs) and serious AEs (SAEs) in prior ranibizumab-treated nAMD patients (n = 16,167). At baseline, the mean (standard deviation [SD]) age of patients was 78.4 (9.0) years, 59.0% were female, and 80.0% were Caucasian. At Year 1 (n = 10,168), the mean (SD) VA change was -1.6 (12.6) letters (baseline VA: 58.3 [19.0] letters) with a mean (SD) of 4.7 (3.1) ranibizumab injections. Stratified by duration of prior ranibizumab treatment of <1 (n = 4,112), 1 to <2 (n = 2,095), 2 to <3 (n = 1,506), 3 to <4 (n = 1,123), 4 to <5 (n = 689), and ≥5 (n = 256) years, the mean (SD) VA change at Year 1 were -1.2 (13.5), -2.0 (12.3), -2.0 (11.3), -1.9 (11.8), -2.5 (10.9), and 0.0 (11.2) letters, respectively. Mean (SD) VA change in patients who received ≤6 and >6 injections over 1 year was -1.8 (13.8) and +0.5 (12.5) letters, respectively. The rate of ocular/non-ocular AEs and SAEs across all prior ranibizumab-treated patients over 5 years were 13.29%/23.02% and 0.84%/13.66%, respectively. Overall, regardless of the prior ranibizumab-treatment duration, VA was maintained in these patients at Year 1, and those receiving ≥6 injections showed a trend towards gaining letters. There were no new safety signals. These results may help inform routine clinical practice to appropriately treat nAMD patients with ranibizumab to achieve optimal visual outcomes.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>33378369</pmid><doi>10.1371/journal.pone.0244183</doi><tpages>e0244183</tpages><orcidid>https://orcid.org/0000-0003-2861-8761</orcidid><orcidid>https://orcid.org/0000-0001-5896-5313</orcidid><oa>free_for_read</oa></addata></record>
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identifier	ISSN: 1932-6203
ispartof	PloS one, 2020-12, Vol.15 (12), p.e0244183
issn	1932-6203 1932-6203
language	eng
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source	MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central; Free Full-Text Journals in Chemistry
subjects	Acuity Age Age related diseases Aged Aged, 80 and over Angiogenesis Inhibitors - administration & dosage Angiogenesis Inhibitors - adverse effects Angiogenesis Inhibitors - therapeutic use Biology and Life Sciences Diabetic retinopathy Drug Administration Schedule Drug therapy Eye diseases Female Heart attacks Humans Immunotherapy Long Term Adverse Effects - epidemiology Macular degeneration Macular Degeneration - drug therapy Male Medicine and Health Sciences Monoclonal antibodies Older people Patient outcomes Patients Ranibizumab - administration & dosage Ranibizumab - adverse effects Ranibizumab - therapeutic use Retina Safety Social Sciences Visual Acuity
title	Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study
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