Abstract
Introduction
Neurological immune-related adverse events are a rare but potentially deadly complication after immune checkpoint inhibitor (ICI) treatment. As multiple sclerosis (MS) is an immune-mediated disease, it is unknown how ICI treatment may affect outcomes.
Methods
We analyzed the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database for pembrolizumab, atezolizumab, nivolumab, ipilimumab, avelumab, and durvalumab 2 years prior their FDA approval until December 31, 2017, to include all cases with confirmed diagnosis/relapse of MS. We also included cases reported in the literature and a patient from our institution.
Results
We identified 14 cases of MS with median age of presentation of 52 years. Indications for ICI included melanoma in 7 (36.36%) cases, non-small cell lung carcinoma in 2 (18.18%) cases, 1 case (9.09%) each of pleural mesothelioma, renal cell carcinoma, and colorectal cancer, and unreported in 2 (18.18%) cases. History of MS was confirmed in 8 (57.1%) cases. Median time to beginning of symptoms was 29 days with rapid disease progression; two patients died due to their relapse. Median time for symptom resolution was 8 weeks. Outcomes did not vary by comparing CTLA-4 and PD-1/PD-L1 inhibitors.
Conclusions
Reported MS relapses after ICI are rare, but the adverse events described include rapid neurologic progression and death. Larger and prospective studies are warranted to assess disability and long-term outcomes and outweigh the risks of starting immunotherapy in patients with MS.
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Funding
Ms. Jayswal was supported by the Biostatistics and Bioinformatics Shared Resource of the University of Kentucky Markey Cancer Center (P30CA177558).
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CG: methodology, conceptualization, investigation, data curation, writing—original draft, and writing—review and editing. RJ: formal analysis, writing—review and editing. VA: conceptualization, writing—review and editing. LA: conceptualization, writing—review and editing. JV: methodology, conceptualization, writing— review and editing.
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The authors have no conflicts of interest.
Ethical statement
Patient consent was not obtained from our institutional case, since the patient passed away many years prior to preparation of this manuscript. Data are de-identified in FAERS and patient consent is not applicable. Our study does not include any studies with animals performed by any of the authors.
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Garcia, C.R., Jayswal, R., Adams, V. et al. Multiple sclerosis outcomes after cancer immunotherapy. Clin Transl Oncol 21, 1336–1342 (2019). https://doi.org/10.1007/s12094-019-02060-8
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DOI: https://doi.org/10.1007/s12094-019-02060-8