June 1, 2022
The Lupus Research Alliance (LRA) and its clinical trial arm Lupus Therapeutics congratulate Bristol Myers Squibb (BMS) on new positive results from a Phase 2 trial of its investigational agent deucravacitinib for the treatment of systemic lupus erythematosus (SLE). Deucravacitinib is a potentially first-in-class inhibitor of Tyrosine kinase 2 (TYK2), which regulates the levels of Type I interferons, molecules in the immune system that contribute to tissue damage and lupus symptoms.
Data showed that the primary endpoint at week 32 evaluating the effectiveness of deucravacitinib was met; a significantly greater percentage of patients treated with the study drug met the required reduction of symptoms as evaluated by the SLE Responder Index-4 (SRI-4), a composite measurement of disease activity (58.2% of patients taking deucravacitinib versus 34.4% on placebo). At 48 weeks, those patients given deucravacitinib at an oral dose of 3 mg twice daily showed statistically significant reduction in symptoms according to four objective measurements of BICLA, LLDAS, CLASI 50, and change in active joint counts. Safety was demonstrated with similar rates of side effects between those patients given deucravacitinib compared with those receiving placebo.
These late-breaking data were presented by Professor Eric Morand, Head of the School of Clinical Sciences at Monash University in Australia and Lupus Research Alliance Distinguished Innovator Award recipient, at the European Alliance of Associations for Rheumatology (EULAR) 2022 Annual Congress, June 1-4, Copenhagen.
Albert Roy, Executive Director of Lupus Therapeutics commented, “These are very encouraging results for patients with SLE. We are honored to have played a role in this exciting work by helping to conduct this clinical trial through our Lupus Clinical Investigators Network (LuCIN) of renowned North American academic centers. We thank BMS, all the investigators, and all the patients for their participation in this study evaluating what could serve as a much-needed treatment option.”
“The lupus community owes tremendous gratitude to the patients who took part in this study. Lupus is a highly heterogeneous autoimmune disease which differs from person to person, so many new treatments are needed. We urge every person with lupus to talk to their healthcare professionals about participating in clinical research as an opportunity for high-quality care while helping improve the future for all those living with lupus,” Roy added.
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90 percent of people with lupus are women; lupus is most often diagnosed during the childbearing years of 15-45. African Americans, Latinx, Asians and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.
About the Lupus Research Alliance
The Lupus Research Alliance, the largest nongovernmental, nonprofit research organization dedicated to lupus research worldwide, aims to transform treatment while advancing toward a cure by funding the most innovative lupus research in the world. The organization’s stringent peer review grant process fosters diverse scientific talent who are driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance’s Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.
About Lupus Therapeutics
Lupus Therapeutics, an affiliate of the Lupus Research Alliance, aims to accelerate drug discovery and diagnostic innovation for all patients living with lupus. Lupus Therapeutics collaborates with biotechnology and pharmaceutical partners through its unprecedented Lupus Clinical Investigators Network (LuCIN) to drive rapid and meaningful progress in the treatment of lupus patients. The organization aims to place the patient voice and community stakeholders at the center of the clinical research process with the most innovative and renowned experts throughout North America.