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Meta-analysis compares safety profiles of ranibizumab intravitreal injections
TORONTO — Results of a meta-analysis comparing the safety profiles of intravitreal ranibizumab injections are consistent with the established systemic safety profile of ranibizumab, according to a presenter here.
“Intravitreally, there are concerns about the possibility of systemic adverse events, but we haven’t really been able to calculate accurately because of sample size,” Baruch D. Kuppermann, MD, told colleagues at the American Society of Retina Specialists meeting here.
To overcome that barrier, a pairwise comparison of 14 phase 2/3 randomized clinical trials was undertaken, looking in particular for serious adverse events occurring after intravitreal injection of ranibizumab (Lucentis, Genentech).
The safety meta-analysis included 6,504 patients representing 7,544 patient-years, Kuppermann said. The investigators looked at 0.5-mg and 0.3-mg doses of ranibizumab vs. sham, as well as 0.5 mg ranibizumab vs. 0.3 mg ranibizumab, as treatment for wet age-related macular degeneration, retinal vein occlusion (RVO) and diabetic macular edema (DME).
No imbalances were observed in wet AMD or RVO for any of the prespecified systemic endpoints examined. Although overall event rates were low for DME, numerical imbalances in pairwise comparisons were observed in stroke, death and wound healing complications, according to Kuppermann. The imbalances for death and stroke were observed in the second year and were based on results of the RISE and RIDE studies, in which ranibizumab was administered monthly for 2 years, he said.
Independent of treatment, patients with DME and certain comorbidities, such as prior stroke, were at higher risk for serious adverse events.
The meta-analysis had several limitations, Kuppermann said. Evaluation of infrequent systemic adverse events can be difficult because these events are also seen in the target patient populations. The pooled treatment regimens included patients with different dosing frequencies, and some patients also received photodynamic therapy laser treatment. Additionally, the combined studies varied by design, patient population, control group, duration of treatment, dosing frequency, inclusion and exclusion criteria and region. Risk factors were collected differently between studies, and systemic endpoints were broadly defined such that event rates may be overestimated, he said.
Disclosure: Data in the presentation are proprietary to Novartis and Genentech, and Kuppermann is a consultant for both companies.