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Benefit-risk analysis supports as-needed anti-VEGF therapy vs. laser in treatment of DME
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VIENNA — Benefit-risk analysis of phase 3 clinical trial data supports the favorable profile of ranibizumab 0.5 mg as-needed dosing compared with laser therapy for treatment of diabetic macular edema, according to a presentation here.
Comparative benefit-risk assessment was conducted using the Benefit Risk Action Team Software Tool (BRAT), which encompasses a series of steps for selection, summarization, organization and interpretation of data.
Alan Cruess
“The BRAT framework provides the rationale for decision making based on benefit-risk assessment and serves as a tool that may benefit patients, drug developers and decision makers,” Alan Cruess, MD, FRCS(C), said at the American Society of Retina Specialists meeting.
Trials involving ranibizumab 0.5 mg PRN vs. laser were the RESTORE, REVEAL and RESPOND. Benefit measures were a gain of 10 or more letters in best corrected visual acuity, no loss greater than 10 letters, achieving a central retina thickness of less than 275 µm and various Visual Function Questionnaire (VFQ) outcomes. Risk measures included endophthalmitis rate, intraocular inflammation, IOP increase, systemic events and death. The absolute numbers were translated into an incidence risk per 1,000 patients.
Clinically meaningful differences favoring ranibizumab (Lucentis, Genentech) were observed for visual and anatomical outcomes.
“Not a surprise for anyone,” Cruess said.
VFQ scores also showed statistically significant benefits with as-needed ranibizumab treatment.
On the risk side, no difference in incidence rate was observed for endophthalmitis or inflammation, while IOP increase favored laser. Risk of systemic events was almost identical with a slight, nonsignificant higher risk of nonvascular death with ranibizumab treatment.
“These data support ranibizumab as an effective first-line therapy, with superior efficacy and similar safety to laser therapy for this increasingly prevalent disease,” Cruess said. — by Michela Cimberle
Disclosure: Cruess reports he is a consultant to Novartis and Bayer/Regeneron, and has received grant support from Alcon, Allergan and Regeneron.