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Original Article

Risk of Neuroinflammatory Diseases Among New Recipients of Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drugs

Maximilian Casey

Maximilian Casey

Medical College of Wisconsin, Milwaukee

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Sonia Pannu

Sonia Pannu

University School of Milwaukee, River Hills, Wisconsin

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Saffia Bajwa

Saffia Bajwa

Medical College of Wisconsin, Milwaukee

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Alí Duarte-García

Alí Duarte-García

Mayo Clinic, Rochester, Minnesota

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Michael Putman

Corresponding Author

Michael Putman

Medical College of Wisconsin, Milwaukee

Address correspondence via email to Michael Putman, MD, MSci, at [email protected].

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First published: 03 April 2024

Additional supplementary information cited in this article can be found online in the Supporting Information section (https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.25340).

Author disclosures are available at https://onlinelibrary.wiley.com/doi/10.1002/acr.25340.

Abstract

Objective

Neuroinflammatory adverse events have been observed among new users of tumor necrosis factor (TNF) inhibitors. No studies to date have compared the real-world risk of TNFs with other new users of biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). The objective of this study is to describe the risk of neuroinflammatory disease after initiation b/tsDMARDs.

Methods

This new user comparative effectiveness cohort study used a large US-based electronic health records database to describe the unadjusted incidence of neuroinflammatory adverse events over a 3-year period. The cohort included patients with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis initiating treatment with a TNF inhibitor (n = 93,661) or other b/tsDMARD (n = 38,354).

Results

Among 132,015 patients included in the analysis, the most common first biologic agent was a TNF inhibitor; the unadjusted incidence of neuroinflammatory events was numerically lower among new users of TNF inhibitors (incidence 1.34 per 1,000 patient-years) as compared with the combined non-TNF group (1.69 per 1,000 patient-years). There was no significant association between TNF exposure and neuroinflammatory events as compared with the combined non-TNF b/tsDMARDs overall (hazard ratio 1.01; 95% confidence interval 0.75–1.36) and within each disease group.

Conclusion

The overall risk of neuroinflammatory events among new users of TNF inhibitors did not differ substantially as compared with new users of other b/tsDMARDs. Meta-analyses of randomized trials should be conducted to corroborate these findings, which may be affected by channeling bias.