This article is more than 5 years old. Information may no longer be current.
Study finds more adverse ocular events with intravitreal bevacizumab than with ranibizumab
Greater risk for acute intraocular inflammation may be associated with bevacizumab.
Patients receiving intravitreal bevacizumab may be at greater risk for adverse intraocular events than those receiving intravitreal ranibizumab, according to a study.
“While the event rate is small, clinicians might want to consider using Lucentis [ranibizumab, Genentech] over Avastin [bevacizumab, Genentech] in patients who might be predisposed to inflammation,” Sanjay Sharma, MD, lead study author, told OSN Retina.
Study methods, results
The retrospective, single-center cohort study examined 693 consecutive bevacizumab injections in 173 patients and 891 consecutive ranibizumab injections in 351 patients. All injections were performed by a single surgeon.
Patients were examined primarily for acute intraocular inflammation, infectious endophthalmitis, retinal detachment and vitreous hemorrhage.
Acute intraocular inflammation occurred in nine patients after bevacizumab injection and once after ranibizumab injection. This translates to a twelvefold greater likelihood of developing an adverse ocular event following each injection with bevacizumab, a statistically significant difference, according to Sharma.
Among the nine patients with inflammation, an average of 6.1 lines of visual acuity were lost at the end of follow-up. No other adverse events were reported in either group.
The study was published in the Canadian Journal of Ophthalmology.
Systemic adverse events
The study also found a trend for more systemic adverse events occurring within 1 month of injection in patients receiving bevacizumab than in those receiving ranibizumab, although the study may have been underpowered to detect systemic adverse events, Sharma said.
“Or, there may not truly be a difference in systemic [adverse events] between the two groups,” he said.
To quantify the systemic adverse events, the researchers looked at the emergency department records of both groups of injected patients within a specified area and within a 1-month window after injection. In the bevacizumab group, two patients were seen for myocardial infarction and one for transient ischemic attack; in the ranibizumab group, one patient was seen for transient ischemic attack.
Documentation reporting systemic adverse events could be improved, Sharma said.
“As we abstracted data from clinical records, data entry regarding potential adverse events was not standardized. Records may have been incomplete,” Sharma said, adding that some patients may have reported their adverse events outside the geographic area that was monitored.
Physicians who examine a small number of patients experiencing adverse events can put procedures into place to improve their documentation, Sharma said.
Sharma and colleagues are developing an assay to measure the systemic levels of bevacizumab and ranibizumab.
“While it is very tempting for policy makers to want to turn to Avastin to save the health care system significant dollars, patient safety has to be part of the equation,” Sharma said. “You have to consider both the incremental benefits and the incremental costs. The incremental costs have to include both the humanistic and real costs of adverse events.” – by Ashley Biro
References:
- Sharma S, Johnson D, Abouammoh M, Hollands S, Brissette A. Rate of serious adverse effects in a series of bevacizumab and ranibizumab injections. Can J Ophthalmol. 2012;47(3):275-279.
- The CATT Research Group, Martin DF, Maguire MG, et al. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011;364(20):1897-1908.
For more information:
- Sanjay Sharma, MD, can be reached at Queen’s University, 166 Brock St., Hotel Dieu Hospital, Kingston, Ontario, Canada. K7L 5G2; 613-544-3400, ext. 2227; fax: 613-544-5707; email: sanjay_sharma60@hotmail.com.
- Disclosure: Sharma has acted as a consultant for Health Canada, Ontario Ministry of Health and Longterm Care, the Centers for Disease Control and Prevention, Allergan, Alcon, Bayer, Genentech, Novartis and QLT.
Perspective
Back to Top
The take-home message of the study is one thing, which is that one has to be careful of choosing the proper compounding pharmacy to obtain Avastin. I think there is a danger in a study like this in overreaching, extending and extrapolating the data to where it becomes misleading.
In this study, there are nuances that suggest there may be more adverse effects, more thromboembolic events, in the Avastin population. That is really quite misleading. The numbers are small and they are nowhere close to being statistically significant. Even the CATT-2 was not nearly large enough to have statistical significance in showing any safety difference.
In addition, it is always very dangerous to compare Avastin and Lucentis safety issues because oftentimes the patients who get Avastin are patients who are underserved, patients who are underinsured, or patients who tend to be less healthy because they do not have adequate access to health care.
It is crucial to emphasize that there is a big difference between the safety of the drug and the safety of compounding the drug. Avastin as a drug is absolutely safe. What sometimes may not be safe is the compounding of that drug. You have to make sure you pick the proper responsible, ethical, well-reputed compounding pharmacy, realizing that there are very few regulations in the compounding pharmacy industry.