Anifrolumab promising for patients with moderate to severe lupus: reveals Longest SLE trial
USA: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by multisystem involvement ranging from mild to life-threatening disease.
Researchers have conducted a long-term extension (LTE) study the findings of which support the favourable benefit-risk profile of anifrolumab in patients having Systemic lupus erythematosus of moderate to severe intensity receiving standard therapy.
The study has been published published in Arthritis & Rheumatology.
Type I interferon (IFN) is a powerful immune activator that is present at high levels in the majority of patients with lupus, an autoimmune disease. In the study, Kenneth C. Kalunian, San Diego School of Medicine, La Jolla, California, and colleagues reported positive results from the first placebo-controlled long-term trial of anifrolumab-a human monoclonal antibody that targets the type I IFN receptor-in patients with lupus.
In the long-term extension trial of two earlier phases 3 trials, patients continued anifrolumab 300 mg, switched from anifrolumab 150 mg to 300 mg, or were re-randomized from placebo to either anifrolumab 300 mg or continued placebo, administered every 4 weeks, with all patients also receiving standard therapy. Anifrolumab was administered as an intravenous infusion.
Treatment with anifrolumab was well tolerated and had an acceptable long-term safety profile while sustaining a reduction in lupus disease activity and reducing or eliminating the need for steroid medications.
Key findings include:
- In the LTE study, exposure-adjusted incidence rates (EAIRs) of serious adverse events (SAEs) were 8.5 with anifrolumab compared with 11.2 with placebo; likewise, EAIRs of AEs leading to treatment discontinuation were 2.5 versus 3.2, respectively.
- EAIRs of non-opportunistic serious infections were comparable between groups (3.7 with anifrolumab versus 3.6 with placebo).
- Exposure-adjusted event rates of COVID-related AEs, including asymptomatic infections, were 15.5 with anifrolumab compared with 9.8 with placebo. No COVID-related AEs occurred in fully vaccinated individuals.
- EAIRs of malignancy and major acute cardiovascular events were low and comparable between groups.
- Anifrolumab was associated with lower cumulative glucocorticoid use and greater mean improvement in the SLE Disease Activity Index 2000, compared with placebo.
"Managing systemic lupus erythematosus is challenging, due to the complexity of the disease itself, as well as from treatments like oral corticosteroids that can reduce disease activity, but also place a significant burden on patients when used in high doses long-term," said corresponding author Hussein Al-Mossawi, MD, PhD, of AstraZeneca. "These new data from the TULIP extension trial-the longest placebo-controlled clinical trial performed in lupus to date-support the benefit-risk profile of anifrolumab seen in previous trials, now over four years."
Reference:
Kenneth C. Kalunian, Richard Furie, Eric F. Morand, Ian N. Bruce, Susan Manzi, Yoshiya Tanaka, Kevin Winthrop, Ihor Hupka, Lijin (Jinny) Zhang, Shanti Werther, Gabriel Abreu, Micki Hultquist, Raj Tummala, Catharina Lindholm, Hussein Al-Mossawi First published: 11 November 2022 https://doi.org/10.1002/art.42392
