How lupus clinical trials are evolving

A high magnification micrograph of histomorphologic changes in a lymph node resulting from systemic lupus erythematosus (SLE). Image from Wikipedia.

In the past half-century, scores of investigational drugs for lupus have seemingly failed in clinical trials. GSK’s Benlysta (belimumab) is unique in winning approval from the FDA and European regulatory authorities.

Anifrolumab from AstraZeneca, which would be a first-in-class type I interferon inhibitor, is one of the most promising investigational drugs for treating systemic lupus erythematosus (SLE). SLE is the most common form of lupus. The PDUFA date for anifrolumab is September 30, 2021, according to the Antibody Society.

A fully human monoclonal antibody, anifrolumab binds to subunit 1 of the type I interferon receptor, potentially calming the impact of pro-inflammatory cytokines involved in lupus.

Anifrolumab has shown promise in SLE patie…

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AstraZeneca’s TULIP trials highlight role of interferon in lupus

A recent post hoc analysis from AstraZeneca (LON:AZN) found that the monoclonal antibody anifrolumab (Saphnelo) led to consistent improvements in skin rash and arthritis in patients with systemic lupus erythematosus (SLE), which is the most common lupus type. A pooled analysis of the Phase 3 TULIP-1 and TULIP-2 clinical trials investigating anifrolumab showed the drug led to a sustained reduction in SLE symptoms based on the British Isles Lupus Assessment Group (BILAG)–based Composite Lupus Assessment (BICLA).

Anifrolumab binds to the type I interferon receptor subunit 1 and blocks all type I interferons.

If approved, anifrolumab would be a first-in-class lupus treatment. Researchers have known for decades that inflammation-causing signaling proteins known as interferons were involved in lupus. It was, however, unclear whether inhibiting interferons would provide relief to lupus patients. The TULIP clinical trial series, which draws its name from an acronym of …

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