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Long-term safety and efficacy of anifrolumab in adults with systemic lupus erythematosus: results of a phase 2 open-label extension study


Arthritis Rheumatol. 2020 Nov 22. doi: 10.1002/art.41598. Online ahead of print.

W Winn Chatham 1Richard Furie 2Amit Saxena 3Philip Brohawn 4Erik Schwetje 4Gabriel Abreu 5Raj Tummala 4

Author Information

1 University of Alabama at Birmingham, AL, United States, Birmingham.

2 Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, United States.

3 NYU School of Medicine, New York, NY, United States.

4 AstraZeneca, Gaithersburg, MD, United States.

5 AstraZeneca, Gothenburg, Sweden.


Objective: To investigate long-term safety and tolerability of anifrolumab, a human monoclonal antibody to the type I interferon (IFN) receptor subunit 1, in patients with moderate to severe systemic lupus erythematosus (SLE).

Methods: This 3-year, multinational, open-label extension (OLE) enrolled adult patients who completed treatment (48 weeks anifrolumab or placebo; 12-week follow-up) in the MUSE phase 2b randomized controlled trial (RCT). Patients initially received intravenous anifrolumab 1000 mg every 4 weeks, reduced to 300 mg every 4 weeks based on the benefit/risk profile established in MUSE. Adverse events (AEs) were assessed monthly. Exploratory endpoints included SLE Disease Activity Index 2000 (SLEDAI-2K), SLICC Damage Index (SDI), pharmacodynamics, and health-related quality of life (HRQoL).

Results: Of 246 patients who completed the RCT, 218 (88.6%) enrolled in the OLE; 139/218 (63.8%) completed 3 years of treatment. Approximately 69.7% of patients reported ≥1 AE during the first year of OLE treatment. Frequency and patterns of serious AEs and AEs of special interest over 3 years were consistent with those reported for 1 year of treatment in the RCT. Few patients (6.9%) discontinued treatment because of AEs. No new safety signals were identified. Improvement in SLEDAI-2K was sustained over 3 years. SDI and Short Form 36 Health Survey scores remained stable. Neutralization of type I IFN gene signatures was maintained in the IFN-high population, and C3, C4, and anti-dsDNA showed numeric trends toward sustained improvement.

Conclusion: Long-term anifrolumab treatment demonstrated an acceptable safety profile with sustained improvement in disease activity, HRQoL, and serologies.