Lupus Update: Findings from the Latest Phase 3 Clinical Trials

This summer, two phase 3 studies were released with promising findings for the treatment of patients with systemic lupus erythematosus (SLE) and those with lupus nephritis.

SLE Disease Activity

Dapirolizumab pegol is a novel, investigational, Fc-free anti-CD40L agent for people living with moderate to severe SLE.¹ The randomized, double-blind, parallel-group PHOENYCS GO trial (N=321) evaluated dapirolizumab pegol as an add-on therapy to standard-of-care treatment compared with placebo combined with standard-of-care treatment in patients with SLE. (Note: Standard-of-care treatment at a stable dose included anti-malarial treatment in combination with corticosteroids and/or immunosuppressants, or as stand-alone treatment if justified; or treatment with corticosteroids and/or immunosuppressants if anti-malarial treatment was not possible.)

Dapirolizumab pegol, with standard-of-care treatment, met the study’s primary end point, demonstrating a greater improvement in disease activity scores at week 48 than placebo, as assessed by the British Isles Lupus Assessment Group (BILAG) based Composite Lupus Assessment (BICLA). BICLA is an established, composite, primary efficacy end point for the measurement of clinical disease activity based on patient medical history, clinical examination and laboratory tests. This finding was statistically significant (P value not reported).

In the study, clinical improvements were observed among key secondary end points measuring disease activity and flares. After these positive results, a second phase 3 trial of dapirolizumab pegol is being initiated this year, PHOENYCS FLY (NCT04294667). Additionally, participants from PHOENYCS GO will continue to be followed in a long-term open-label study.²

Kidney Protection

Obinutuzumab (Gazyva) is a type 2 engineered humanized monoclonal antibody designed to attach to CD20 found on certain types of B cells to reduce inflammation by targeting and depleting these disease-causing B cells. Obinutuzumab aims to further protect the kidneys from damage and prevent or delay the development of end-stage renal disease. The agent was originally approved by the U.S. Food & Drug Administration (FDA) on Nov. 1, 2013, to manage patients with previously untreated chronic lymphocytic leukemia in combination with chlorambucil.³ A subsequent FDA approval added the treatment of different stages of follicular lymphoma.⁴ 

This July, study results from the phase 3 REGENCY trial, which evaluated patients with active lupus nephritis treated with obinutuzumab (n=271), were reported (NCT04221477).⁵ This study was double blind and placebo controlled, and participants had proliferative class 3 or 4 lupus nephritis.