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Incidence of progressive multifocal leukoencephalopathy in patients with rheumatoid arthritis: a national
Elizabeth V Arkema1, Ronald F van Vollenhoven, Johan Askling
1Clinical Epidemiology Unit (T2), Department of Medicine, Karolinska Institutet, Stockholm SE-171 76, Sweden. earkema@post.harvard.edu
Background:
Cases of progressive multifocal leukoencephalopathy (PML), a rare but serious disease, have been reported in patients with rheumatoid arthritis (RA) in association with biological therapy, but little is known about the incidence of PML in patients with RA in the absence of treatment exposure.
Objective:
To estimate the incidence rate of PML in patients with RA compared with the general population, with and without exposure to biological agents.
Methods:
Patients with adult onset RA, exposure to biological agents and a diagnosis of PML from 1999 through 2009 were identified from national registries and linked using each Swedish resident's unique personal identification number. General population comparators matched on age, sex and county were also identified. Crude and age- and sex-standardised incidence rates (cases per 100 000 person-years) were calculated with 95% CI.
Results:
66 278 patients with RA and 286 949 general population comparators were included in the study. The incidence rate of PML in the overall RA population was 1.0 (95% CI 0.3 to 2.5) compared with 0.3 (95% CI 0.1 to 0.6) in the general population. The difference in incidence rate was 0.7 (95% CI -0.3 to 17). Among all patients exposed to biological agents, only one patient was diagnosed with PML.
Conclusion:
Data from this national population-based cohort study suggest that patients with RA may have an increased rate of PML compared with the general population.
Insights
Patients with rheumatoid arthritis (RA) may face a higher risk of progressive multifocal leukoencephalopathy (PML) compared to the general population. This study investigated PML incidence in RA patients, with or without biological agent exposure.
Area of Science:
- Rheumatology
- Neurology
- Epidemiology
Background:
- Progressive multifocal leukoencephalopathy (PML) is a rare but serious disease.
- PML cases have been reported in rheumatoid arthritis (RA) patients on biological therapy.
- Limited data exists on PML incidence in RA patients without biological agent exposure.
Purpose of the Study:
- To estimate the incidence rate of PML in RA patients.
- To compare PML incidence in RA patients versus the general population.
- To assess PML incidence with and without exposure to biological agents.
Main Methods:
- Utilized Swedish national registries from 1999-2009.
- Included adult-onset RA patients diagnosed with PML and biological agent exposure.
- Matched RA patients with general population comparators by age, sex, and county.
- Calculated crude and standardized incidence rates per 100,000 person-years.
Main Results:
- The study included 66,278 RA patients and 286,949 general population comparators.
- PML incidence rate in RA patients was 1.0 (95% CI 0.3 to 2.5) vs. 0.3 (95% CI 0.1 to 0.6) in the general population.
- Only one PML case was identified among patients exposed to biological agents.
Conclusions:
- RA patients may have an increased rate of PML compared to the general population.
- Further research is needed to understand the specific risks and mechanisms involved.
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