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Potential cerebrovascular accident signal for risankizumab: A disproportionality analysis of the FDA Adverse Event
1Levin, Papantonio, Rafferty, Proctor, Buchanan, O'Brien, Barr & Mougey, P.A, Pensacola, Florida, USA.
Aims:
The interleukin-23 (IL-23) inhibitor risankizumab was recently approved for the treatment of moderate-to-severe plaque psoriasis in the United States. Low rates of cerebrovascular accident (CVA) were observed in risankizumab-treated patients during clinical trials. The aim of this study was to determine whether risankizumab may be associated with CVA in a real-world setting.
Methods:
A retrospective disproportionality analysis was conducted utilizing postmarketing adverse event reports submitted to the US Food and Drug Administration Adverse Event Reporting System (FAERS) through the fourth quarter of 2021. A custom query consisting of 22 CVA-related Medical Dictionary for Regulatory Activities (MedDRA) preferred terms previously reported in clinical trials of plaque psoriasis medications was used to identify cases. Disproportionality was measured by calculating reporting odds ratios (ROR) and 95% confidence intervals (CI), whereby the lower limit of a 95% CI >1.0 and ≥ three cases was considered a signal.
Results:
Risankizumab was associated with significantly disproportionate CVA reporting compared to all other drugs in FAERS (ROR 2.48; 95% CI 2.14-2.88) as well as 11 alternative plaque psoriasis therapeutics across five pharmacologic classes. The largest disproportionality signals for risankizumab were identified relative to apremilast (ROR 9.07; 95% CI 7.56-10.89), ixekizumab (ROR 6.75; 95% CI 5.14-8.86), guselkumab (ROR 6.74; 95% CI 4.68-9.71), certolizumab (ROR 5.70; 95% CI 4.74-6.85) and etanercept (ROR 4.91; 95% CI 4.21-5.73).
Conclusion:
This study detected a previously unreported signal of disproportionate CVA reporting with the real-world use of risankizumab. Further long-term observational data will be necessary to better characterize this unconfirmed potential safety signal.
Insights
This study found a potential safety signal for cerebrovascular accident (CVA) associated with risankizumab in real-world psoriasis treatment. Further research is needed to confirm this association.
Area of Science:
- Pharmacovigilance
- Immunodermatology
- Neurology
Background:
- Risankizumab, an interleukin-23 (IL-23) inhibitor, is approved for moderate-to-severe plaque psoriasis.
- Clinical trials noted low rates of cerebrovascular accident (CVA) with risankizumab.
- Real-world safety data is crucial for understanding potential risks.
Purpose of the Study:
- To investigate the association between risankizumab use and CVA in a real-world setting.
- To analyze postmarketing adverse event reports for potential safety signals.
- To compare CVA reporting for risankizumab against other psoriasis treatments.
Main Methods:
- Retrospective disproportionality analysis of US Food and Drug Administration Adverse Event Reporting System (FAERS) data through Q4 2021.
- Utilized a custom query of 22 CVA-related MedDRA terms.
- Calculated reporting odds ratios (ROR) and 95% confidence intervals (CI) to identify safety signals.
Main Results:
- Risankizumab showed significantly disproportionate CVA reporting compared to all other drugs in FAERS (ROR 2.48; 95% CI 2.14-2.88).
- Disproportionality signals were also observed when compared to 11 alternative psoriasis therapeutics.
- Largest signals were noted relative to apremilast, ixekizumab, guselkumab, certolizumab, and etanercept.
Conclusions:
- A previously unreported signal of disproportionate CVA reporting was detected with real-world risankizumab use.
- This finding suggests a potential, unconfirmed safety signal requiring further investigation.
- Long-term observational studies are necessary to characterize this potential risk.
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