Immunotherapies in phase II and III trials for the treatment of systemic lupus erythematosus

ABSTRACT

Introduction: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by highly heterogeneous clinical manifestations and a multi systemic involvement. SLE is prone to relapses and remissions, which makes the management challenging. Moreover, conventional therapies may have considerable side-effects, which highlights the demand for new therapeutic strategies. The progress towards a better understanding of the underlying pathogenesis has led to the development of biological therapies targeted directly against crucial molecular mediators of SLE.

Areas covered: In this review we analyzed available biological therapies, phase II and III trials and upcoming new therapies that are currently under development for SLE treatment.

Expert opinion: The complex pathogenesis of SLE is far from being fully understood. Evidence towards a better understanding of the pathogenic pathways, the cellular and molecular mediators involved in SLE are emerging. Henceforth, new biological therapeutic options targeting crucial molecular mediators involved in the pathogenesis of SLE are being developed. In the future, the management of SLE could profit from the use of biological therapies that are tailored towards the individual patient’s specific clinical manifestations, taking into account their genetic background and pathogenic fingerprint.

KEYWORDS:

• Systemic lupus erythematosus
• biological
• therapy
• autoimmunity

Article highlights

• SLE management is still challenging, because of adverse effects related to the conventional therapies and occurrence of refractory disease, making biological therapies highly needed.

• The approval of belimumab by the FDA in 2011 was a cornerstone for SLE treatment.

• Promising results from recent trials and ongoing studies such as those on tabalumab further support the important role of targeting B-cells therapies, as well of the many open label studies of the ‘off label’ use of rituximab.

• SLE pathogenesis is yet to be fully understood and new biological therapeutic options are being developed as evidence progresses towards a better understanding of SLE pathogenetic pathways, cellular and molecular mediators involved.

• Assessment studies are necessary for all novel drugs in order to evaluate the efficacy, safety and immunogenicity profile.

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Declaration of interest

The authors have no 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.

Additional information

Funding

This paper was not funded.