Delayed onset panuveitis following intravitreal aflibercept injection

Glading, Jodi; Lake, Stewart; Craig, Jamie E; Supramaniam, Devaraj

doi:10.1136/bcr-2013-202515

Cited by 8 publications

(3 citation statements)

References 15 publications

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“…In one published report, 3 20 cases were identified from a single practice with similar characteristics and outcomes to those presented in this report. In another report, 4 2 cases of panuveitis arose more than 4 weeks after aflibercept injection.…”

Section: Discussionmentioning

confidence: 91%

Postmarketing Analysis of Aflibercept-Related Sterile Intraocular Inflammation

et al. 2015

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IMPORTANCE Aflibercept-related sterile inflammation, an event that is poorly understood, has been the subject of ongoing postmarketing reports. OBJECTIVE To analyze cases of aflibercept-related sterile inflammation reported to the American Society of Retina Specialists (ASRS) Therapeutic Surveillance Committee (TSC), an independent task force formed to monitor drug-and device-related safety events. DESIGN, SETTING, AND PARTICIPANTS A retrospective review of 56 cases in 55 patients was performed of all cases of sterile inflammation after aflibercept injection that were voluntarily reported by 12 practices throughout the United States to the ASRS TSC from December 1, 2011, through February 12, 2014. MAIN OUTCOMES AND MEASURES Cases of aflibercept-related sterile inflammation were analyzed for baseline and demographic information, presenting symptoms and findings, visual acuity changes, injection technique, and management details. RESULTS Among 56 reported cases of sterile inflammation, mean time to onset was 3.5 days (median, 2 days; range, 0-30 days). Most cases consisted of initial loss of vision and intraocular inflammation without prominent redness, severe pain, or hypopyon. Thirty-seven cases (66%) were treated with topical corticosteroids and/or observation alone. Mean time to resolution was 28.6 days (median, 28 days; range, 4-84 days). Although final vision was overall unchanged, some patients developed permanent vision loss, which may have resulted from inflammation and/or progression of the underlying disease. Age older than 80 years was associated with worse visual outcomes. No difference in visual outcome was detected in patients with sterile inflammation undergoing topical therapy alone vs invasive procedures (vitreous biopsy and/or intravitreal antibiotic administration and/or vitrectomy). CONCLUSIONS AND RELEVANCE With the largest number of reported cases of aflibercept-related sterile inflammation to our knowledge, this analysis suggests typical findings and an often favorable prognosis of this event. Analysis of real-world, postmarketing data has limitations, and these findings should be considered as hypothesis-generating assessments rather than a definitive reflection of this event or its typical course. Distinguishing sterile inflammation and infectious endophthalmitis at the time of presentation may often be difficult, and cautious evaluation and management of these patients are warranted. The ASRS TSC encourages active postmarketing surveillance by all physicians.

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Section: Discussionmentioning

confidence: 91%

Postmarketing Analysis of Aflibercept-Related Sterile Intraocular Inflammation

et al. 2015

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“…In contrast, bevacizumab showed a signif- Original article icant inverse association with both retinal haemorrhage and uveitis. An Australian case report on uveitis following the use of intravitreal aflibercept also cautions clinicians to be aware of late-onset sterile uveitis and vitritis after aflibercept injection [19]. Conversely, a double-blind randomised controlled trial showed that aflibercept was associated with similar visual and anatomic outcomes as ranibizumab when dosed monthly, as well as similar safety and tolerability [20].…”

Section: Discussionmentioning

confidence: 99%

Pharmacovigilance in ophthalmology in Switzerland: an analysis of the most frequently reported ocular adverse drug reactions within the last 25 years

et al. 2019

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AIMS OF THE STUDY: Although systemic drugs can exert local effects on the eye, ophthalmology is a medical specialty with perhaps the fewest assessed adverse drug reactions (ADRs), representing a particular challenge in pharmacovigilance. Our aim was to quantify ADRs in ophthalmology in Switzerland, with a focus on angiogenesis inhibitors.METHODS: Individual case safety reports (ICSRs) on suspected ADRs reported in Switzerland from January 1991 to June 2016 were extracted from the WHO Global ICSR database, VigiBase™. ICSRs were analysed in relation to treatment duration, patient age, route of administration, patient sex and reported symptoms. RESULTS: A total of 80,515 ICSRs were reported in Switzerland during the reference period. Reactions linked to eye disorders accounted for 2793 (3.5%) cases. The main Anatomic Therapeutic Chemical / Defined Daily Dose drug classes associated with eye disorders were drugs acting on the nervous system (27.7%) followed by drugs "acting on sensory organs" (20.2%) and antineoplastic agents (18.0%). Most cases involved adult patients (70.6%). Patients over 60 years accounted for 815 (29.2%) ICSRs, and reactions in children were significantly less frequent (8.2%). Older patients were exposed to a higher number of drugs, and the majority of serious reactions involved children and older patients. A significant positive correlation between polypharmacy and seriousness of reported reactions was observed. The reported drugs were categorised as "suspected" in 51.1%, "concomitant" in 43.3% and "interacting" in 2.6% of cases. "Visual impairment" was the most commonly reported adverse reaction, experienced by 635 (22.7%) of patients (7.2% of all reported eye-related symptoms). The majority of reactions were transient, as 4173 (47.1%) completely resolved. Severe reactions included fatal outcome in 18 patients (0.6%) and blindness in 78 patients (2.6%). Since 2000, the intravitreous vascular endothelial growth factor (VEGF) inhibitors bevacizumab, aflibercept and ranibizumab accounted for 99 ICSRs. Retinal haemorrhage (reporting odds ratio [ROR] 10.36, 95% confidence interval [95% CI] 2.65-40.50; p <0.001), blindness (ROR 3.73,; p = 0.04) and uveitis (ROR 6.91,; p = 0.01) were significantly more frequently reported for aflibercept than for bevacizumab and ranibizumab.CONCLUSIONS: ADRs that affect the eye represented 3.5% of all pharmacovigilance reports during the reporting period. Whereas retinal haemorrhage and uveitis are known adverse reactions to angiogenesis inhibitors, the reported cases of blindness and death should heighten awareness of potential safety issues associated with VEGF inhibitors for the treatment of proliferative eye disorders.

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“…Sterile inflammation following the intravitreal aflibercept injection is previously reported but its cause is still unknown [5–10]. The American Society of Retina Specialists' therapeutic surveillance subcommittee first reported 15 cases of aflibercept related sterile inflammation [6] and later expanded this series to 56 cases from the practices throughout the United States between December 2011 and February 2014 [10].…”

Section: Discussionmentioning

confidence: 99%

Bilateral Severe Sterile Inflammation with Hypopyon after Simultaneous Intravitreal Triamcinolone Acetonide and Aflibercept Injection in a Patient with Bilateral Marked Rubeosis Associated with Ocular Ischemic Syndrome

Engin

Ayhan

Men

et al. 2017

Case Reports in Ophthalmological Medicine

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We report the clinical course of a diabetic patient with bilateral cataract and rubeosis in association with ocular ischemic syndrome and initially treated him with simultaneous intravitreal 2 mg aflibercept and 2 mg triamcinolone acetonide injection at the same setting prior to planned cataract surgery and further photocoagulation. However, sterile anterior segment inflammation characterized by hypopyon occurred four days apart in OU. Right eye developed the sterile inflammation at the third postinjection day and the left eye developed the sterile inflammation at the seventh postinjection day (two days after the uneventful cataract surgery with intraocular lens implantation) without any pain or significant redness. Vitreous biopsy taken during the right phacovitrectomy was negative for any microbial contamination. Both eyes were treated successfully with intensive topical prednisolone acetate with a relatively good visual outcome. It is likely that underlying ocular ischemic syndrome might have facilitated the formation of sterile inflammation as blood-aqueous barrier disruption and flare have already been present.

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Delayed onset panuveitis following intravitreal aflibercept injection

Cited by 8 publications

References 15 publications

Postmarketing Analysis of Aflibercept-Related Sterile Intraocular Inflammation

Postmarketing Analysis of Aflibercept-Related Sterile Intraocular Inflammation

Pharmacovigilance in ophthalmology in Switzerland: an analysis of the most frequently reported ocular adverse drug reactions within the last 25 years

Bilateral Severe Sterile Inflammation with Hypopyon after Simultaneous Intravitreal Triamcinolone Acetonide and Aflibercept Injection in a Patient with Bilateral Marked Rubeosis Associated with Ocular Ischemic Syndrome

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