Guselkumab, which was subcutaneously injected in the participating patients, was assessed for its efficacy and safety in the DISCOVER 1 and 2 trials compared to placebo. Janssen said that the safety profiles observed for the interleukin (IL)-23-targeted biologic therapy in the two late-stage studies were on par with its previous studies and also its current prescribing information.
The Janssen drug has approvals in both the US and Europe for the treatment of adults with moderate to severe plaque psoriasis.
The two randomized, double-blind, multicentre Discover 1 and Discover 2 trials also assessed multiple secondary endpoints such as ACR50/70, disease activity (DAS-28 CRP), resolution of soft tissue inflammation (enthesitis and dactylitis), quality of life (SF-36 PCS and MCS), skin clearance (IGA), and improvement in physical function (HAQ-DI).
Additionally, the DISCOVER-2 trial studied the effect on structural damage (vdH-S) as an important secondary endpoint.
The DISCOVER-1 study featured 381 patients who were subjected in the past to biologic anti-TNF biologics. Janssen said that the phase 3 study will go on for a total of 52 weeks.
The DISCOVER-2 trial, which had enrolled 739 bio-naive patients, will be continued through 100 weeks, said the Johnson & Johnson subsidiary.
Janssen, in a statement, said: “Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for later this year.”
The company is also evaluating guselkumab in a phase 2b programme in Crohn’s disease, and in two Phase 2 programmes, one for the treatment of hidradenitis suppurativa, and the other for the treatment of ulcerative colitis.
In December 2018, the IL-23 inhibitor was demonstrated to be superior to Cosentyx (secukinumab) for the primary endpoint evaluated at week 48 of a phase 3 ECLIPSE trial in adults with moderate to severe plaque psoriasis. The primary endpoint of the late-stage trial was the proportion of patients registering a Psoriasis Area Severity Index (PASI 90) response at week 48.