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Anifrolumab – Mechanism, Uses & Side Effects

Anifrolumab is a monoclonal antibody used to treat systemic lupus erythematosus (SLE). It works by blocking the type I interferon receptor, thereby reducing inflammation.

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Things worth knowing about "Anifrolumab"

Anifrolumab is a monoclonal antibody used to treat systemic lupus erythematosus (SLE). It works by blocking the type I interferon receptor, thereby reducing inflammation.

What is Anifrolumab?

Anifrolumab is a monoclonal antibody approved for the treatment of systemic lupus erythematosus (SLE), a chronic autoimmune disease in which the immune system mistakenly attacks the body's own tissues. It is marketed under the brand name Saphnelo and has received approval from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Mechanism of Action

Anifrolumab works by specifically blocking the type I interferon receptor (IFNAR1). Type I interferons – including interferon-alpha and interferon-beta – are signaling proteins that play a key role in promoting inflammation in SLE. In the majority of SLE patients, type I interferon activity is abnormally elevated. By blocking the receptor, anifrolumab prevents these proteins from exerting their pro-inflammatory effects, thereby reducing disease activity and alleviating symptoms.

Indication and Usage

Anifrolumab is approved for adult patients with moderate to severe SLE who do not achieve adequate disease control despite standard therapy (e.g., hydroxychloroquine, corticosteroids, immunosuppressants). It is used as an add-on therapy in combination with existing treatments, not as a standalone treatment.

Administration

Anifrolumab is administered as an intravenous infusion (directly into a vein).
The recommended dose is 300 mg every 4 weeks.
Each infusion takes approximately 30 minutes and is administered in a clinical setting under medical supervision.

Clinical Studies and Efficacy

The approval of anifrolumab is based on the TULIP-1 and TULIP-2 trials, two large, randomized, placebo-controlled Phase III studies. These trials demonstrated that anifrolumab significantly reduced disease activity compared to placebo. Additionally, a proportion of patients were able to reduce their corticosteroid dose, which may help limit the long-term side effects associated with prolonged steroid use.

Side Effects

Like all medications, anifrolumab can cause side effects. The most commonly reported include:

Infusion-related reactions (e.g., headache, dizziness, skin reactions)
Upper respiratory tract infections (e.g., bronchitis, nasopharyngitis)
Herpes infections (e.g., herpes zoster / shingles)
Increased susceptibility to other infections due to immune modulation

Serious side effects are rare but possible. Patients should seek immediate medical attention if they experience signs of a severe infection.

Contraindications and Precautions

Anifrolumab should not be used in patients with active, severe infections.
Live vaccines should not be administered during treatment.
Use during pregnancy and breastfeeding should only be considered after careful assessment of benefits and risks by the treating physician.
Regular medical monitoring is required throughout the entire course of treatment.

References

European Medicines Agency (EMA): Saphnelo (Anifrolumab) – Summary of Product Characteristics. Available at: https://www.ema.europa.eu (accessed 2024).
Morand EF et al. – Trial of Anifrolumab in Active Systemic Lupus Erythematosus (TULIP-2). New England Journal of Medicine, 2020; 382(3):211–221.
Furie RA et al. – Type I Interferon Inhibitor Anifrolumab in Active Systemic Lupus Erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. The Lancet Rheumatology, 2019; 1(4):e208–e219.

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