Lupus Research Alliance Response to Janssen’s Ustekinumab Lupus Trial Discontinuation

June 26, 2020

The Lupus Research Alliance is disappointed at news from Janssen Pharmaceutical Companies of Johnson & Johnson that it has decided to discontinue the Phase 3 LOTUS study of ustekinumab (Stelara®) in Systemic Lupus Erythematosus (SLE).

A Phase 3 trial presents data the U.S. Food and Drug Administration uses to decide whether or not a potential medicine is safe and effective. Although the data affirmed previous safety results, ustekinumab did not demonstrate effectiveness in treating lupus according to the standard measurement tool SRI-4 (Systemic Lupus Responder Index). Under the brand name Stelara,® ustekinumab, a human IL-12 and IL-23 antagonist, is approved by the FDA for certain other autoimmune diseases.

Lupus Research Alliance President & CEO Kenneth M. Farber commented, “This setback underscores the extreme complexity of lupus and the urgent need for accelerated research discovery to find effective treatment options. However, this remains a time of hope for people with lupus with three other promising compounds in Phase 3 and several Phase 2 trials underway in lupus. We appreciate Janssen’s continued commitment to the lupus community and look ahead to better news in the future.”

Janssen announced this news in a press release expressing their intention to share the data with the scientific community to help inform lupus research as well as their continued commitment to research and development of novel therapies for lupus.