US FDA approves anifrolumab for systemic lupus erythematosus
Anifrolumab, a monoclonal antibody type I interferon receptor antagonist, has been approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe systemic lupus erythematosus (SLE).
Anifrolumab is the first type I interferon receptor antagonist to receive FDA approval.
In randomised placebo-controlled phase 3 trials, anifrolumab reduced oral corticosteroid dose and severity of skin disease, and improved disease response at 52 weeks, in patients with moderate to severe SLE.
Systemic lupus erythematosus (SLE) is a generalised disorder that can affect any system.
Symptoms and signs may accumulate over time.
The diagnosis is made using 2019 criteria recommended by the American College of Rheumatology and the European League Against Rheumatology.
Treatments for mild to moderate serositis or arthritis include hydroxychloroquine, non-steroidal anti-inflammatory drugs, or corticosteroids.
Treatments for more severe disease may include azathioprine, belimumab, cyclophosphamide, methotrexate, mycophenolate, rituximab, or tacrolimus.
SLE is a chronic multisystem disorder that most commonly affects women during their reproductive years. It is characterised by the presence of antinuclear antibodies. In addition to constitutional symptoms, it most frequently involves the skin and joints, although serositis, nephritis, haematological cytopenias, and neurological manifestations may occur during the course of the disease.
Earlier diagnosis and better management have resulted in a lower prevalence of life-threatening disease.
History and exam
Key diagnostic factors
- malar (butterfly) rash
- photosensitive rash
- discoid rash
Other diagnostic factors
- weight loss
- oral ulcers
- Raynaud's phenomenon
- chest pain and shortness of breath
- venous or arterial thrombosis
- signs of nephrosis (e.g., oedema)
- abdominal pain, vomiting, or diarrhoea
- nose ulcers
- poorly localised proximal limb inflammatory pain with weakness
- dysrhythmias (e.g., tachycardia), conduction defects, or unexplained cardiomegaly
- CNS signs: seizures, cranial nerve abnormalities, cognitive defects, psychosis
- female sex
- age >30 years
- African descent in Europe and US
- sun exposure
- family history of SLE
- tobacco smoking
1st investigations to order
- full blood count and differential
- activated partial thromboplastin time
- urea and electrolytes
- erythrocyte sedimentation rate and C-reactive protein
- antinuclear antibodies, double-stranded (ds)DNA, Smith antigen
- chest x-ray
Investigations to consider
- blood and urine cultures
- antiphospholipid antibodies
- Coombs test
- 24-hour urine collection for protein or spot urine for protein/creatinine ratio
- complement levels
- creatine phosphokinase
- plain x-rays of affected joint(s)
- renal ultrasound
- chest computed tomography
- pulmonary function tests
- pleural aspiration
- brain magnetic resonance imaging
- skin biopsy
- renal biopsy
- thyroid-stimulating hormone
joint symptoms and serositis
Meng May Chee, MBChB, MRCP
Queen Elizabeth University Hospital
MMC was sponsored by Abbvie to attend the European League Against Rheumatism 2020 online conference.
Rajan Madhok, MD, FRCP(Glasg)
Consultant Physician and Rheumatologist
Department of Rheumatology
Glasgow Royal Infirmary
RM holds shares in GSK to the value less than £12,000.
Dr Meng May Chee and Dr Rajan Madhok would like to gratefully acknowledge Dr Gayle McKellar, a previous contributor to this topic.
GM declares that she has no competing interests.
James C. Oates, MD
Medical University of South Carolina
JCO declares that he has no competing interests.
Nancy J. Olsen, MD, PhD
Professor of Medicine
University of Texas Southwestern Medical Center
NJO declares that she has no competing interests.
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