Christopher Collins MD

 Safety and Efficacy of Sifalimumab, an Anti IFN-Alpha Monoclonal Antibody, in a Phase 2b Study of Moderate to Severe Systemic Lupus Erythematosus (SLE).

The cytokine family of type I interferons (IFNs), and especially the IFNÎ± subtypes, have been implicated in systemic lupus erythematosus (SLE) pathogenesis.  It is observed that 

IFNÎ± treatment is sometimes associated with lupus-like syndromes

 as well as the development of autoantibodies.

In patients with SLE, increased type I interferons levels are associated with greater disease activity, and genetic polymorphisms of several components of the IFN signaling pathway have been associated with an increased risk of lupus. Therefore, 

IFNÎ± has been identified as a potential target for drug development in SLE.

(SLE Responder Index – 4 point SLEDAI component improvement) greater than that in the placebo (standard of care) group was 

The ability to achieve a pre-defined primary endpoint in any lupus clinical trial is a feat which 

 to date. This particular agent was able to demonstrate statistically and clinically meaningful improvement not only the primary endpoint of the SRI-4, but across several individual lupus disease manifestations as well as various degrees of disease severity.

This bodes well for not only for sifalimumab as it moves on to phase 3 testing, but keeps the hope alive that

 additional therapeutics are potentially on the horizon 

Also, despite the failure of several high-profile drugs being tested in lupus which used the SRI as a primary endpoint, this study would suggest that, at least for now, the 

SRI remains a viable and meaningful tool for assessing disease improvement 

Articles

(ACR2014) Another Rheumatology Network Editorial Board member weighs in: Christopher Collins MD saw reason for great encouragement in a report about an interferon-α blocker for systemic lupus erythematosus. 

Author | Christopher Collins MD

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My Favorite Report at ACR2014: Sifalimumab for Lupus