title: Review and comparison of methodologies for indirect comparison of clinical trial results: an illustration with ranibizumab and aflibercept.
abstract: OBJECTIVE
  To review and compare methods for indirect comparison of aflibercept and ranibizumab in patients with diabetic macular edema.
  
  
  METHODS
  Post-stratification, inverse probability weighting based on simulated data, weight optimization, and regression model techniques were used to compare pooled individual patient-level data from the RESTORE and RESPOND (ranibizumab 0.5 mg as needed after 3 initial monthly doses) studies with summary-level data from the VIVID and VISTA (aflibercept 2.0 mg every 8 weeks after 5 initial monthly doses, 2q8) studies. The impact of adjusting for up to two baseline characteristics was assessed.
  
  
  RESULTS
  All methods provided similar results. After adjustment for baseline best-corrected visual acuity and central retinal thickness, no statistically significant difference in average gain in baseline best-corrected visual acuity from baseline at month 12 was found between ranibizumab 0.5 mg and aflibercept 2q8.
  
  
  CONCLUSIONS
  Weight optimization and regression methods are useful options to adjust for more than one baseline characteristic.
authors.affiliation: a Novartis Pharma AG , Basel , Switzerland.
authors.forename: Stephane A
authors.initials: SA
authors.lastname: Regnier
authors.affiliation: b Numerus Ltd , Wokingham , UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Alsop
authors.affiliation: b Numerus Ltd , Wokingham , UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Wright
authors.affiliation: a Novartis Pharma AG , Basel , Switzerland.
authors.forename: Richard
authors.initials: R
authors.lastname: Nixon
authors.affiliation: a Novartis Pharma AG , Basel , Switzerland.
authors.forename: Harry
authors.initials: H
authors.lastname: Staines
authors.affiliation: c Centre Ophtalmologique d'Imagerie et de Laser , Paris , France.|d Hôpital Avicenne , Assistance Publique Hôpitaux de Paris , Bobigny , France.
authors.forename: Franck
authors.initials: F
authors.lastname: Fajnkuchen
mesh_terms: D020533:Angiogenesis Inhibitors / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000379:methods; D003930:Diabetic Retinopathy / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology; D015233:Models, Statistical; D000069579:Ranibizumab / Q000627:therapeutic use*; D040262:Receptors, Vascular Endothelial Growth Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D012044:Regression Analysis; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor; D000069579:Ranibizumab
keywords: Confounders; indirect treatment comparison; inverse probability weighting; regression; stratified sampling