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New Hope for Patients with Lupus!! Anifrolumab
Dr. Zahi Touma
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June 10 2016 11:29 AM ET — via RheumReports 
The safety and efficacy of anifrolumab (a type I interferon (IFN) receptor antagonist) was evaluated in a Phase IIB randomized controlled trial of adult SLE patients with moderate to severe disease activity.
Patients were stratified by IFN gene signature (low or high), dose of glucocorticoids (<10 mg/day or > 10 mg/day) and SLE Disease Activity Index 2000 (SLEDAI-2K) score (<10 or >10).
Patients received IV infusions of anifrolumab (300 mg [n=99] or 1000 mg [n=104]) or placebo [n=102] Q4W. The efficacy of anifrolumab was determined based on the SLE Responder Index (SRI-4). All patients also received oral glucocorticoids.
The majority of the patients had activity in the musculoskeletal and/or mucocutaneous systems at baseline. The analysis was based on modified intention-to-treat (mITT).
SRI-4 was achieved in: 34.3% of the patients receiving anifrolumab 300 mg, in 28.8% of anifrolumab 1000 mg and 17.6% of placebo patients. There was a significant improvement in musculoskeletal and mucocutaneous symptoms in patients on anifrolumab vs. placebo.
In patients with immunological activity at baseline, a significantly greater improvement was observed with anifrolumab vs. placebo. A trend for improvement was also observed in cardiorespiratory, vascular, hematological and constitutional systems.
Anifrolumab was well tolerated with no safety signals. A dose related increase in reactivation of Herpes Zoster was observed in the 1000 vs.300 mg group.
In conclusion, anifrolumab resulted in a greater improvement than placebo, and anifrolumab 300 mg showed a more favourable risk-benefit profile.
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About the Author
Dr. Zahi Touma
Dr. Touma is a clinical epidemiologist and an Assistant Professor of Medicine in the Division of Rheumatology at the University of Toronto, and Staff Physician and Clinician Scientist in the Division of Rheumatology, Toronto Western Hospital and Mount Sinai Hospital. In 2012 he completed his PhD in Clinical Epidemiology and subsequently completed one year of post-doctoral work in Measurement in Clinical Research.
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