Using Patient-Level Data to Develop Meaningful Cross-Trial Comparisons of Visual Impairment in Individuals with Diabetic Macular Edema
Identifieur interne : 001475 ( Main/Exploration ); précédent : 001474; suivant : 001476Using Patient-Level Data to Develop Meaningful Cross-Trial Comparisons of Visual Impairment in Individuals with Diabetic Macular Edema
Auteurs : Sobha Sivaprasad [Royaume-Uni] ; Stephane A. Regnier [Suisse] ; Franck Fajnkuchen [France] ; Jonathan Wright [Royaume-Uni] ; Alan R. Berger [Canada] ; Paul Mitchell [Australie] ; Michael Larsen [Danemark]Source :
- Advances in Therapy [ 0741-238X ] ; 2016.
Descripteurs français
- KwdFr :
- Acuité visuelle, Adulte d'âge moyen, Facteur de croissance endothéliale vasculaire de type A (antagonistes et inhibiteurs), Femelle, Humains, Inhibiteurs de l'angiogenèse (usage thérapeutique), Injections intravitréennes, Modèles statistiques, Mâle, Oedème maculaire (diagnostic), Oedème maculaire (traitement médicamenteux), Oedème maculaire (étiologie), Protéines de fusion recombinantes (usage thérapeutique), Ranibizumab (usage thérapeutique), Récepteurs aux facteurs de croissance endothéliale vasculaire (usage thérapeutique), Rétinopathie diabétique (), Rétinopathie diabétique (anatomopathologie), Sujet âgé, Sélection de patients, Thérapie laser (), Troubles de la vision (diagnostic), Troubles de la vision (étiologie), Évaluation des résultats des patients.
- MESH :
- anatomopathologie : Rétinopathie diabétique.
- antagonistes et inhibiteurs : Facteur de croissance endothéliale vasculaire de type A.
- diagnostic : Oedème maculaire, Troubles de la vision.
- traitement médicamenteux : Oedème maculaire.
- usage thérapeutique : Inhibiteurs de l'angiogenèse, Protéines de fusion recombinantes, Ranibizumab, Récepteurs aux facteurs de croissance endothéliale vasculaire.
- étiologie : Oedème maculaire, Troubles de la vision.
- Acuité visuelle, Adulte d'âge moyen, Femelle, Humains, Injections intravitréennes, Modèles statistiques, Mâle, Rétinopathie diabétique, Sujet âgé, Sélection de patients, Thérapie laser, Évaluation des résultats des patients.
English descriptors
- KwdEn :
- Aged, Angiogenesis Inhibitors (therapeutic use), Diabetic Retinopathy (complications), Diabetic Retinopathy (pathology), Female, Humans, Intravitreal Injections, Laser Therapy (methods), Macular Edema (diagnosis), Macular Edema (drug therapy), Macular Edema (etiology), Male, Middle Aged, Models, Statistical, Patient Outcome Assessment, Patient Selection, Ranibizumab (therapeutic use), Receptors, Vascular Endothelial Growth Factor (therapeutic use), Recombinant Fusion Proteins (therapeutic use), Vascular Endothelial Growth Factor A (antagonists & inhibitors), Vision Disorders (diagnosis), Vision Disorders (etiology), Visual Acuity.
- MESH :
- chemical , antagonists & inhibitors : Vascular Endothelial Growth Factor A.
- chemical , therapeutic use : Angiogenesis Inhibitors, Ranibizumab, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins.
- complications : Diabetic Retinopathy.
- diagnosis : Macular Edema, Vision Disorders.
- drug therapy : Macular Edema.
- etiology : Macular Edema, Vision Disorders.
- methods : Laser Therapy.
- pathology : Diabetic Retinopathy.
- Aged, Female, Humans, Intravitreal Injections, Male, Middle Aged, Models, Statistical, Patient Outcome Assessment, Patient Selection, Visual Acuity.
Abstract
The aim of this study was to assess the impact of baseline characteristics on visual outcome of patients with diabetic macular edema and compare the results of clinical trials with different patient populations.
A model was created with patient-level data from the RESPOND/RESTORE trials to estimate the impact of baseline characteristics on increases in best-corrected visual acuity (BCVA) with anti-vascular endothelial growth factor therapies, measured by letters gained on the Early Treatment Diabetic Retinopathy Study scale from baseline to month 12. Mean BCVA gains with ranibizumab 0.5 mg pro re nata or laser photocoagulation monotherapy were predicted, assuming baseline characteristics equivalent to those in the VIVID-DME/VISTA-DME trials. These results were compared with the gain with aflibercept 2.0 mg every 8 weeks in VIVID-DME/VISTA-DME. Sensitivity analyses assessed outcome robustness.
Baseline BCVA and central retinal thickness differed significantly between trials. In unadjusted data, patients in RESPOND/RESTORE receiving ranibizumab gained an additional 6.6 letters [95% confidence interval (CI): 4.5–8.7] compared with patients receiving laser monotherapy. After adjusting data to assume baseline characteristics equivalent to VIVID-DME/VISTA-DME, patients receiving ranibizumab were predicted to gain an additional 9.9 letters (95% CI: 7.3–12.4) compared with those receiving laser monotherapy. These results were similar (0.1-letter difference in favor of aflibercept; 95% CI: −2.9 to 3.2;
After adjusting for baseline characteristics, the difference in letters gained between patients receiving ranibizumab versus aflibercept was non-significant across trials, highlighting the importance of adjusting for baseline characteristics in future comparisons.
Novartis Pharma AG.
The online version of this article (doi:10.1007/s12325-016-0310-0) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1007/s12325-016-0310-0
PubMed: 26951552
PubMed Central: 4846684
Affiliations:
- Australie, Canada, Danemark, France, Royaume-Uni, Suisse
- Angleterre, Grand Londres, Nouvelle-Galles du Sud, Île-de-France
- Bobigny, Londres, Paris, Sydney
- Université de Sydney
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Le document en format XML
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Berger</name><affiliation wicri:level="1"><nlm:aff id="Aff7">St Michael’s Hospital, Toronto, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>St Michael’s Hospital, Toronto</wicri:regionArea><wicri:noRegion>Toronto</wicri:noRegion></affiliation></author><author><name sortKey="Mitchell, Paul" sort="Mitchell, Paul" uniqKey="Mitchell P" first="Paul" last="Mitchell">Paul Mitchell</name><affiliation wicri:level="4"><nlm:aff id="Aff8">University of Sydney, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>University of Sydney, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region><settlement type="city">Sydney</settlement></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Larsen, Michael" sort="Larsen, Michael" uniqKey="Larsen M" first="Michael" last="Larsen">Michael Larsen</name><affiliation wicri:level="1"><nlm:aff id="Aff9">Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Glostrup</wicri:regionArea><wicri:noRegion>Glostrup</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff10">National Eye Clinic, Kennedy Center, Glostrup, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>National Eye Clinic, Kennedy Center, Glostrup</wicri:regionArea><wicri:noRegion>Glostrup</wicri:noRegion></affiliation></author></analytic><series><title level="j">Advances in Therapy</title><idno type="ISSN">0741-238X</idno><idno type="eISSN">1865-8652</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Angiogenesis Inhibitors (therapeutic use)</term><term>Diabetic Retinopathy (complications)</term><term>Diabetic Retinopathy (pathology)</term><term>Female</term><term>Humans</term><term>Intravitreal Injections</term><term>Laser Therapy (methods)</term><term>Macular Edema (diagnosis)</term><term>Macular Edema (drug therapy)</term><term>Macular Edema (etiology)</term><term>Male</term><term>Middle Aged</term><term>Models, Statistical</term><term>Patient Outcome Assessment</term><term>Patient Selection</term><term>Ranibizumab (therapeutic use)</term><term>Receptors, Vascular Endothelial Growth Factor (therapeutic use)</term><term>Recombinant Fusion Proteins (therapeutic use)</term><term>Vascular Endothelial Growth Factor A (antagonists & inhibitors)</term><term>Vision Disorders (diagnosis)</term><term>Vision Disorders (etiology)</term><term>Visual Acuity</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Acuité visuelle</term><term>Adulte d'âge moyen</term><term>Facteur de croissance endothéliale vasculaire de type A (antagonistes et inhibiteurs)</term><term>Femelle</term><term>Humains</term><term>Inhibiteurs de l'angiogenèse (usage thérapeutique)</term><term>Injections intravitréennes</term><term>Modèles statistiques</term><term>Mâle</term><term>Oedème maculaire (diagnostic)</term><term>Oedème maculaire (traitement médicamenteux)</term><term>Oedème maculaire (étiologie)</term><term>Protéines de fusion recombinantes (usage thérapeutique)</term><term>Ranibizumab (usage thérapeutique)</term><term>Récepteurs aux facteurs de croissance endothéliale vasculaire (usage thérapeutique)</term><term>Rétinopathie diabétique ()</term><term>Rétinopathie diabétique (anatomopathologie)</term><term>Sujet âgé</term><term>Sélection de patients</term><term>Thérapie laser ()</term><term>Troubles de la vision (diagnostic)</term><term>Troubles de la vision (étiologie)</term><term>Évaluation des résultats des patients</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Vascular Endothelial Growth Factor A</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Angiogenesis Inhibitors</term><term>Ranibizumab</term><term>Receptors, Vascular Endothelial Growth Factor</term><term>Recombinant Fusion Proteins</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Rétinopathie diabétique</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Facteur de croissance endothéliale vasculaire de type A</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Diabetic Retinopathy</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Macular Edema</term><term>Vision Disorders</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Oedème maculaire</term><term>Troubles de la vision</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Macular Edema</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Macular Edema</term><term>Vision Disorders</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Laser Therapy</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Diabetic Retinopathy</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Oedème maculaire</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Inhibiteurs de l'angiogenèse</term><term>Protéines de fusion recombinantes</term><term>Ranibizumab</term><term>Récepteurs aux facteurs de croissance endothéliale vasculaire</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Oedème maculaire</term><term>Troubles de la vision</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Female</term><term>Humans</term><term>Intravitreal Injections</term><term>Male</term><term>Middle Aged</term><term>Models, Statistical</term><term>Patient Outcome Assessment</term><term>Patient Selection</term><term>Visual Acuity</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Acuité visuelle</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Injections intravitréennes</term><term>Modèles statistiques</term><term>Mâle</term><term>Rétinopathie diabétique</term><term>Sujet âgé</term><term>Sélection de patients</term><term>Thérapie laser</term><term>Évaluation des résultats des patients</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Introduction</title><p>The aim of this study was to assess the impact of baseline characteristics on visual outcome of patients with diabetic macular edema and compare the results of clinical trials with different patient populations.</p></sec><sec><title>Methods</title><p>A model was created with patient-level data from the RESPOND/RESTORE trials to estimate the impact of baseline characteristics on increases in best-corrected visual acuity (BCVA) with anti-vascular endothelial growth factor therapies, measured by letters gained on the Early Treatment Diabetic Retinopathy Study scale from baseline to month 12. Mean BCVA gains with ranibizumab 0.5 mg pro re nata or laser photocoagulation monotherapy were predicted, assuming baseline characteristics equivalent to those in the VIVID-DME/VISTA-DME trials. These results were compared with the gain with aflibercept 2.0 mg every 8 weeks in VIVID-DME/VISTA-DME. Sensitivity analyses assessed outcome robustness.</p></sec><sec><title>Results</title><p>Baseline BCVA and central retinal thickness differed significantly between trials. In unadjusted data, patients in RESPOND/RESTORE receiving ranibizumab gained an additional 6.6 letters [95% confidence interval (CI): 4.5–8.7] compared with patients receiving laser monotherapy. After adjusting data to assume baseline characteristics equivalent to VIVID-DME/VISTA-DME, patients receiving ranibizumab were predicted to gain an additional 9.9 letters (95% CI: 7.3–12.4) compared with those receiving laser monotherapy. These results were similar (0.1-letter difference in favor of aflibercept; 95% CI: −2.9 to 3.2; <italic>P</italic> = 0.94) to the gain in BCVA in patients receiving aflibercept in VIVID-DME/VISTA-DME compared with those receiving laser monotherapy (10.0 letters, 95% CI: 8.3–11.7).</p></sec><sec><title>Conclusion</title><p>After adjusting for baseline characteristics, the difference in letters gained between patients receiving ranibizumab versus aflibercept was non-significant across trials, highlighting the importance of adjusting for baseline characteristics in future comparisons.</p></sec><sec><title>Funding</title><p>Novartis Pharma AG.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1007/s12325-016-0310-0) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Cheung, N" uniqKey="Cheung N">N Cheung</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ciulla, Ta" uniqKey="Ciulla T">TA Ciulla</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Davidov, E" uniqKey="Davidov E">E Davidov</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Matza, Ls" uniqKey="Matza L">LS Matza</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Bandello, F" uniqKey="Bandello F">F Bandello</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Berger, A" uniqKey="Berger A">A Berger</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Mitchell, P" uniqKey="Mitchell P">P Mitchell</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Korobelnik, Jf" uniqKey="Korobelnik J">JF Korobelnik</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jansen, Jp" uniqKey="Jansen J">JP Jansen</name></author><author><name sortKey="Naci, H" uniqKey="Naci H">H Naci</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nixon, R" uniqKey="Nixon R">R Nixon</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bressler, Sb" uniqKey="Bressler S">SB Bressler</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rayess, N" uniqKey="Rayess N">N Rayess</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bucher, Hc" uniqKey="Bucher H">HC Bucher</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Bressler, Sb" uniqKey="Bressler S">SB Bressler</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Mathew, R" uniqKey="Mathew R">R Mathew</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Korobelnik, Jf" uniqKey="Korobelnik J">JF Korobelnik</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>Danemark</li><li>France</li><li>Royaume-Uni</li><li>Suisse</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Nouvelle-Galles du Sud</li><li>Île-de-France</li></region><settlement><li>Bobigny</li><li>Londres</li><li>Paris</li><li>Sydney</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Sivaprasad, Sobha" sort="Sivaprasad, Sobha" uniqKey="Sivaprasad S" first="Sobha" last="Sivaprasad">Sobha Sivaprasad</name></region><name sortKey="Sivaprasad, Sobha" sort="Sivaprasad, Sobha" uniqKey="Sivaprasad S" first="Sobha" last="Sivaprasad">Sobha Sivaprasad</name><name sortKey="Wright, Jonathan" sort="Wright, Jonathan" uniqKey="Wright J" first="Jonathan" last="Wright">Jonathan Wright</name></country><country name="Suisse"><noRegion><name sortKey="Regnier, Stephane A" sort="Regnier, Stephane A" uniqKey="Regnier S" first="Stephane A." last="Regnier">Stephane A. Regnier</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Fajnkuchen, Franck" sort="Fajnkuchen, Franck" uniqKey="Fajnkuchen F" first="Franck" last="Fajnkuchen">Franck Fajnkuchen</name></region><name sortKey="Fajnkuchen, Franck" sort="Fajnkuchen, Franck" uniqKey="Fajnkuchen F" first="Franck" last="Fajnkuchen">Franck Fajnkuchen</name></country><country name="Canada"><noRegion><name sortKey="Berger, Alan R" sort="Berger, Alan R" uniqKey="Berger A" first="Alan R." last="Berger">Alan R. Berger</name></noRegion></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Mitchell, Paul" sort="Mitchell, Paul" uniqKey="Mitchell P" first="Paul" last="Mitchell">Paul Mitchell</name></region></country><country name="Danemark"><noRegion><name sortKey="Larsen, Michael" sort="Larsen, Michael" uniqKey="Larsen M" first="Michael" last="Larsen">Michael Larsen</name></noRegion><name sortKey="Larsen, Michael" sort="Larsen, Michael" uniqKey="Larsen M" first="Michael" last="Larsen">Michael Larsen</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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