Albert Roy: Clinically Significant Phase 2 Data Evaluates Deucravacitinib for SLE Treatment

Rheumatology Network interviewed Albert Roy to discuss the recent phase 2 trial data, presented at the European Alliance of Associations for Rheumatology (EULAR) 2022 conference, that evaluated deucravacitinib compared with placebo in patients with moderate-to-severe systemic lupus erythematosus. Roy is the Executive Director of Lupus Research Alliance’s clinical trial arm at Lupus Therapeutics. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the first selective TYK2 inhibitor to be studied across multiple immune-mediated diseases.

The PAISLEY study (NCT03252587), was 1-year, randomized, double-blind, placebo-controlled phase 2 trial in which patients were randomized to receive deucravacitinib 3 mg twice daily (BID), 6 mg BID, 12 mg once daily (QD), or placebo BID. Ultimately, a significantly greater percentage of patients receiving either deucravacitinib 3 mg BID and 6 mg BID achieved SRI(4) at week 32 when compared with placebo (deucravacitinib 3 mg BID: 58.2%, P=0.0006; deucravacitinib 6 mg BID: 49.5%, P=0.0210; placebo: 34.4%).

Rheumatology Network: Why are these positive phase 2 results so important for patients living with systemic lupus erythematosus (SLE)?

Albert Roy: There's still a paucity of therapeutic options for patients available; there are only 2 drugs currently approved for SLE. Because of the type of disease that lupus is, you need an arsenal of new therapies. It would be virtually impossible to have 1 or 2 therapies ultimately cure lupus because it manifests itself differently in different people. Heterogeneity is extreme in lupus. So, having another one, if it's successful, would obviously be very exciting.

I think the other interesting thing about deucravacitinib is its route of administration. It’s a small molecule, therefore it's given orally. This potentially could be very attractive to people living with lupus because it would be the first of its kind as an oral medicine. Its mechanism of action is quite novel in that's very selective and, even though it's a single agent, it hits multiple pathways, or immune mediators, that are very relevant and critical to the pathophysiology of lupus.

RN: What are the next steps for your team?

AR: Lupus Therapeutics worked with Bristol-Myers Squibb in 2018 to partner with them and bring deucravacitinib into the phase 2 SLE study. We at Lupus Therapeutics have a large clinical trial network called the Lupus Clinical Investigators Network (LuCIN), which is a network of academic medical centers in the US and Canada that are experts in conducting lupus clinical trials. We partnered with Bristol-Myers Squibb in their phase 2 PAISLEY program, for which deucravacitinib wasn't named yet. So, we had 21 clinical trials sites from our network that participated in the phase 2 study, and they did exceedingly well with respect to identifying patients who were ultimately included in the trial. We’re really excited to see these results and it’s very encouraging to us. Where we’re going from here is to essentially partner with them again in the phase 3 trial.

I hope this data generates enthusiasm in the lupus community and I hope patients think about talking to their physician when it is available in phase 3 to see if they are good candidates to participate in the clinical trial.