Update on Clinical Trials in Systemic Lupus Erythematosus

Sonali Narain; Richard Furie


Curr Opin Rheumatol. 2016;28(5):477-487. 

In This Article

Abstract and Introduction


Purpose of review With advancement in our understanding of pathogenic mechanisms in systemic lupus erythematosus (SLE), there is tremendous enthusiasm in examining drugs, old and new, to improve outcomes. This review highlights recent trials' successes and impasses that have come to fore.

Recent findings Among B-cell therapies, belimumab continues its run of successes with sustained safety and tolerability documented in a long-term extension as well as the likely approval of a subcutaneous formulation in the near future. With greater antibody-dependent cytotoxicity and less immunogenicity, there is hope for obinituzumab to succeed where its anti-CD 20 predecessors have failed. Drugs targeting type I interferons – sifalimumab and anifrolumab – have been efficacious albeit with an increase in incidence of Herpes zoster infections. There is also renewed interest in evaluating the efficacy of calcineurin inhibitors, specifically tacrolimus in the induction and maintenance of lupus nephritis. Introspection into clinical trial designs have highlighted the effects of entry criteria, end points, background medications and geographical differences on study outcomes.

Summary There are at least 50 drugs and targets being evaluated in SLE. In addition to developing new drugs to treat lupus, future trials have to focus on more effective study designs to improve chances of trial success.


Systemic lupus erythematosus (SLE) has been called a 'disease with a 1000 faces'. As we better understand its pathogenic mechanisms, this phrase rings true. SLE is a complex disease with protean manifestations that is associated with different genetic susceptibility alleles and gene–environment interactions.[1] Given the genotypic and phenotypic heterogeneity, it is a daunting task to find a single drug that will improve disease activity for all. Consequently, it is not surprising that only one drug received Food and Drug Administration (FDA) approval in over 50 years. Despite the enormous challenges, there has been a surge of clinical trials in SLE. In this review, we highlight recent drug development activity in SLE.