IL-6R Inhibitors and Gastrointestinal Perforations: A Study
Author Information
Author(s): Zou Shupeng, Ouyang Mengling, Cheng Qian, Shi Xuan, Zhao Yazheng, Sun Minghui
Primary Institution: Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Hypothesis
What is the relationship between IL-6R inhibitors and gastrointestinal perforations?
Conclusion
IL-6R inhibitors may increase the risk of gastrointestinal perforations, particularly in certain patient demographics and with specific medications.
Supporting Evidence
- 994 cases of gastrointestinal perforations associated with IL-6R inhibitors were identified.
- Tocilizumab showed a reporting odds ratio of 6.86 for gastrointestinal perforations.
- 71% of gastrointestinal perforation cases occurred within the first six months after starting tocilizumab treatment.
- Independent risk factors for gastrointestinal perforations included female sex and age 40 years or older.
- The risk prediction model demonstrated good discrimination with an AUC of 0.73 in the training set and 0.75 in the validation set.
Takeaway
Some medicines can cause holes in your stomach, especially if you're a woman or over 40 years old. Doctors need to be careful when giving these medicines.
Methodology
A disproportionate analysis was used to quantify the signals of gastrointestinal perforations caused by IL-6R inhibitors using two algorithms, and logistic regression analysis was conducted.
Potential Biases
The study included a significantly higher number of women than men, which may introduce a gender bias.
Limitations
The study relied on a public self-reporting system, which may include missing, duplicated, or inaccurate data, potentially leading to biases.
Participant Demographics
71.63% of the cases were female, with a median age of 54 years.
Statistical Information
P-Value
p<0.001
Confidence Interval
95%CI 6.43–7.31 for tocilizumab; 95%CI 2.83–5.73 for sarilumab
Statistical Significance
p<0.001
Digital Object Identifier (DOI)
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