In a long-term extension study of the TULIP trials, assessing the safety and tolerability of the type I interferon receptor antagonist anifrolumab in patients with systemic lupus erythematosus, the benefit-to-risk profile of anifrolumab remained favourable after 3 years of treatment. The exposure-adjusted incidence rate (EAIR) of serious adverse events was comparable between the anifrolumab group and placebo group (8.5 versus 11.2), as were the EAIRs of non-opportunistic serious infections, malignancy and major acute cardiovascular events. The exposure-adjusted event rate of COVID-19-related adverse events was higher in the anifrolumab group than in the placebo group (15.5 versus 9.8), but no COVID-19-related adverse events occurred in fully vaccinated individuals.
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Kalunian, K. C. et al. A randomized, placebo-controlled phase III extension of anifrolumab in active systemic lupus erythematosus. Arthritis Rheumatol. https://doi.org/10.1002/art.42392 (2022)
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McHugh, J. Long-term anifrolumab safe in SLE. Nat Rev Rheumatol 19, 64 (2023). https://doi.org/10.1038/s41584-022-00902-4
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DOI: https://doi.org/10.1038/s41584-022-00902-4
