Update on Clinical Trials in Systemic Lupus Erythematosus

Sonali Narain; Richard Furie


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

In This Article

Interleukin-6 Inhibition

No new studies have been performed with tocilizumab. In an initial phase I open-label dose escalation study,[86] the drug was reasonably well tolerated, with patients showing improvement in arthritis, anti-DNA antibodies and urine sediment. IL6 inhibition with sirukumab in nonrenal SLE[87] did not result in significant differences in clinical outcomes and more adverse events were reported in the sirukumab group. A study[88] of sirukumab in patients with class III or intravenous lupus nephritis, reported at EULAR 2014, failed to meet its primary end point of reduction in proteinuria at week 24. Given the lack of benefit and high frequency of serious infections (~50%), further pursuit in lupus nephritis will not occur.

PF-04236921 is a human antibody against IL6. A phase II three-dose study in 183 patients with active SLE[89,90] failed to meet its primary end point of SRI 4 response at week 24. However, there was a BICLA response in the 10 mg dose group as well as a reduction in severe flares in the 10 and 50 mg dose groups. Three of the four deaths in the study occurred at the highest dose of 200 mg, and recruitment into this arm was terminated.