This year’s Annual Congress of the European League against Rheumatism (EULAR) showcased multiple efforts of small and large pharmaceutical companies to rejoin the systemic lupus erythematosus (SLE) and lupus nephritis (LN) pipeline. The high number of clinical trials in this disease area reflects the invigorated enthusiasm to overcome past clinical development setbacks.

Pharmaceutical developers and attending rheumatologists attributed Aurinia’s Phase IIb study of voclosporin as a predominant driver of the renewed optimism in the development for drugs in SLE and LN. Aurinia’s Phase IIb study has implemented the most aggressive steroid-tapering programme ever attempted in lupus patients. Rheumatologists were astonished by the low levels of steroid requirements to control the disease activity in lupus nephritis patients in the placebo arm, and expressed optimism that current developers are implementing similar steroid-tapering protocols. The administration of steroids in lupus trials has been associated with an efficacy diluting effect, where the application of high-dose steroids on their own were sufficient to control disease activity, thereby masking any potential efficacy of the investigative drug.

EULAR’s session on new treatment options for SLE and LN kicked off with an oral abstract session where Professors Wallace and Dorbronravov presented clinical efficacy and safety data from GSK’s Benlysta (belimumab) and Aurinia’s voclosporin, respectively. Wallace presented new data concerning Benlysta’s ten-year open label extension study, highlighting its excellent safety profile, whereas Dorbronravov demonstrated efficacy data from voclosporin’s recent Phase IIb study. While attending physicians acknowledged Benlysta’s efficacy in only a select patient population, voclosporin’s safety concerns resulting from an increased number of deaths in the treatment arm continued to concern some physicians. However, the majority of physicians seem to accept that these deaths were not treatment-related, but the result of limited access to health care resources.

The oral session was followed by an encouraging number of poster presentations from AstraZeneca, BMS, Celgene, and GSK. GSK presented their newest data from their SC formulation of Benlysta, Celgene highlighted their Phase IIa data on its cereblon modulator CC-220, BMS showcased their Phase I study of the tyrosine kinase-2 inhibitor BMS-986165, and AstraZeneca emphasised results from their Phase IIb study of anifrolumab. In particular, BMS’ advance of the bruton kinase inhibitor BMS-986165 was welcomed, as it potentially opens the door for other developers such as Celgene, Acerta, Merck KGaA, Eli Lilly, Principia, and Takeda; as all these developers are currently exploring bruton kinase inhibitors in rheumatoid arthritis (RA).

Drug development in SLE and LN has historically been hampered by poor trial design, heterogeneous patient populations, and the excessive use of steroids. The reemerging presence of Big Pharma in the lupus pipeline raises the hope that new treatment options will be available for patients suffering from these devastating auto-immune diseases.