Immune checkpoint inhibitor related myositis: an observational, retrospective, pharmacovigilance study

ABSTRACT

Background

Immune checkpoint inhibitors (ICIs) show promise in cancer treatment, but recent cases highlight myositis as a serious complication.

Research design and methods

We did a retrospective study on drug safety using FAERS data up to Q3 2022, focusing on immune checkpoint inhibitors (ICIs) and myositis. We used IC and ROR to assess the association. Logistic regression in R 3.2.5 helped identify factors linked to fatal outcomes.

Results

We identified 558 cases of ICIs-associated myositis. Our study found a significant link between ICIs and myositis (ROR 15.54 [14.23–16.96], IC 3.79 [3.66–3.92], see Figure 1). Notably, myositis was more common in patients on ICI combination therapy compared to monotherapy (ROR 1.72 [1.39–2.11], IC 0.63 [0.30–0.93]). Age increased the risk of ICI-associated myositis and was also a factor in fatality (p = 0.011). Common accompanying adverse events included myocarditis (21.33%), severe myasthenia gravis (16.49%), and malignant neoplasm progression (8.06%). Fatal cases were more common when myositis was accompanied by myocarditis, severe myasthenia gravis, or malignant neoplasm progression.

Conclusions

Clinicians must note the risk of ICI-associated myositis, especially dangerous in older patients or when combined with other issues like myocarditis or severe myasthenia gravis.

KEYWORDS:

• Disproportionality analysis
• food and drug administration adverse events reporting system
• immune checkpoint inhibitors
• myositis
• real word study

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author Contributions

H. Yang was responsible for study conceptualization and design, data acquisition, data analysis and interpretation, manuscript preparation, manuscript editing; Z.X. Ding was responsible for data acquisition; Z.L. An was responsible for study design. Y. Zhao and H.Z. Lu were responsible for study conceptualization, design and interpretation.

Ethical statement

Since the FAERS database is accessible to the public and patient records are anonymized and de-identified, Ethical approval and informed consent are not required for this study.

Data availability statement

The datasets presented in this study can be found in the FAERS database https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE- FAERS.html

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2343023.

Additional information

Funding

This paper was not funded.