Anifrolumab: first biologic approved in the EU not restricted to patients with a high degree of disease activity for the treatment of moderate to severe systemic lupus erythematosus

ABSTRACT

Introduction

Type 1 interferons (IFNs) play a crucial role in the pathogenesis of systemic lupus erythematosus (SLE) and various type I IFNs targeting therapeutic approaches have been developed. Anifrolumab, a monoclonal antibody that binds to the subunit 1 of the type I IFN receptor, has acquired considerable interest and has entered different clinical human trials willing to evaluate its efficacy and safety.

Areas covered

This review summarizes the data obtained in phases 1, 2, and 3 clinical trials of anifrolumab for SLE patients. A focus is made on data of clinical efficacy and safety obtained in MUSE, TULIP-1 and TULIP-2 trials.

Expert opinion/Commentary

Anifrolumab is a promising therapeutic option for patients with SLE, currently authorized for moderate-to-severe SLE. Extensive real-world use is now going to generate data required to gain experience on the type of patients who benefit the most from the drug, and the exact positioning of anifrolumab in the therapeutic plan.

KEYWORDS:

• Anifrolumab
• biologics
• COVID-19
• cutaneous lupus erythematosus
• herpes zoster
• systemic lupus erythematosus
• type I interferons

Article highlights

• Type 1 interferons (IFNs) play a crucial role in the pathogenesis of systemic lupus erythematosus (SLE) and several type I IFNs targeting therapeutic approaches have been developed in the last decade.

• Anifrolumab, a fully human monoclonal antibody that inhibits type I IFN by binding to its common receptor, IFNAR, has been recently approved for the treatment of SLE patients with moderate-to-severe lupus despite standard therapy.

• Demonstration of clinical efficacy came from one phase 2 (MUSE) and two phase 3 (TULIP-1 and TULIP-2) randomized studies.

• In these trials, anifrolumab treatment appeared to be consistently associated with rapid improvement in the mucocutaneous domain and also resulted in greater improvements in the musculoskeletal system. It was also associated with a reduction in total glucocorticoid dosage.

• The benefit – risk profile of anifrolumab for SLE patients appeared favorable in the clinical trials, with the most common adverse events of treatment including herpes zoster reactivations and upper respiratory tract infections.

Declaration of interest

E Lazaro received honoraria from Astra Zeneca and GSK. C Richez received consulting fees from AbbVie, Astra Zeneca, GSK, Novartis, Pfizer, honoraria from AbbVie, Amgen, Astra Zeneca, GSK, Pfizer, Biogen, BMS, Galapagos, Lilly, travel support from Amgen, Celltrion, Galapagos, and receipt of drugs by Biogen and Lilly. CR is listed as an inventor of United States Provisional Patent Application No.: 62/933,672 AND 63/031,848; Type I Interferon Inhibition in active Systemic Lupus Erythematosus. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.