Review and comparison of methodologies for indirect comparison of clinical trial results: an illustration with ranibizumab and aflibercept.

Abstract:

AIM: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

Regnier SA,Alsop J,Wright J,Nixon R,Staines H,Fajnkuchen F

doi

10.1586/14737167.2016.1165609

subject

Has Abstract

pub_date

2016-12-01 00:00:00

pages

793-801

issue

6

eissn

1473-7167

issn

1744-8379

journal_volume

16

pub_type

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