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Published on: December 9, 2015
Disease-modifying agents for multiple sclerosis and the risk for reporting cancer: A disproportionality analysis
Vasileios-Periklis Stamatellos1, Spyridon Siafis1,2, Georgios Papazisis1
1Department of Clinical Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Aim:
While the efficacy of disease-modifying therapies (DMTs) for patients with multiple sclerosis (MS) is established, little is known about their long-term safety. Cancer-risk after DMT use remains unclear. This study aimed to investigate whether the prescription of DMTs for patients with MS increases the risk of reporting cancer.
Methods:
Data from the Food and Drug Administration Adverse Event Reporting System were extracted from 2004 to 2020. After data cleaning, the crude and adjusted reported odds ratios (cROR and aROR) for cancer were calculated for DMTs with Interferon beta-1a as the reference drug. Sensitivity analyses investigated the group of reports with multiple registered DMTs, the effect of indication restriction and the results when using the rest of the DMTs as reference.
Results:
For malignant tumours, aROR (95% confidence interval [CI]) values were Cladribine 0.46 (0.18-0.95), Dimethyl fumarate 0.30 (0.27-0.34), Fingolimod 0.61 (0.53-0.70), Glatiramer 0.50 (0.43-0.58), Alemtuzumab 0.84 (0.64-1.08), Interferon beta-1b 0.49 (0.42-0.56), Natalizumab 0.36 (0.34-0.39), Ocrelizumab 0.48 (0.29-0.74), Peginterferon beta-1a 0.35 (0.26-0.48), Siponimod 0.89 (0.47-1.54) and Teriflunomide 0.25(0.21-0.30) adjusted to age, gender and concomitant medications. In the sensitivity analysis, when the rest of the drugs were used as a reference, Interferon beta-1a and Peginterferon beta-1a had aROR (95% CI) 2.60 (2.47-2.74, P < .001) and Alemtuzumab had aROR 1.47 (1.13-1.88, I = .003).
Conclusions:
No safety signal for increased cancer risk was detected among the approved DMTs. A potential safety signal detected in the sensitivity analysis concerning Interferon beta-1a and Alemtuzumab requires further evaluation with more robust evidence.
Insights
This study found no increased cancer risk with most multiple sclerosis (MS) disease-modifying therapies (DMTs). However, further research is needed for Interferon beta-1a and Alemtuzumab safety regarding cancer risk in MS patients.
Area of Science:
- Neurology
- Pharmacovigilance
- Oncology
Background:
- Efficacy of disease-modifying therapies (DMTs) for multiple sclerosis (MS) is known, but long-term safety, particularly cancer risk, remains unclear.
- Investigating the association between DMT use and cancer incidence is crucial for patient management and therapeutic decision-making in MS.
Purpose of the Study:
- To determine if the use of DMTs in patients with MS is associated with an increased risk of cancer.
- To evaluate the long-term safety profile of various DMTs concerning cancer risk.
Main Methods:
- Utilized data from the Food and Drug Administration Adverse Event Reporting System (FAERS) from 2004 to 2020.
- Calculated crude and adjusted odds ratios (cROR, aROR) for cancer, with Interferon beta-1a as the reference drug.
- Conducted sensitivity analyses, including using other DMTs as reference and analyzing restricted indications.
Main Results:
- Most DMTs showed no increased cancer risk. Adjusted odds ratios (aROR) for malignant tumors were below 1 for Cladribine, Dimethyl fumarate, Fingolimod, Glatiramer, Alemtuzumab, Interferon beta-1b, Natalizumab, Ocrelizumab, Peginterferon beta-1a, and Teriflunomide.
- Sensitivity analyses indicated a potential safety signal for increased cancer risk with Interferon beta-1a (aROR 2.60) and Peginterferon beta-1a (aROR 2.60), and Alemtuzumab (aROR 1.47).
Conclusions:
- No overall safety signal for increased cancer risk was detected among the majority of approved DMTs for MS.
- Potential safety signals for Interferon beta-1a and Alemtuzumab warrant further investigation with more robust evidence to confirm or refute an association with increased cancer risk.
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