Phase III ECLIPSE study of Tremfya demonstrates superiority to Cosentyx in plaque psoriasis.- Janssen.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the ECLIPSE study demonstrating that Tremfya (guselkumab) was superior to Cosentyx (secukinumab) in treating adults with moderate to severe plaque psoriasis for the primary endpoint assessed at week 48. Data from the multi-center, randomized, double-blind head-to-head Phase III study demonstrated that 84.5 percent of patients treated with Tremfya achieved at least 90 percent improvement in their baseline Psoriasis Area Severity Index (PASI) score at week 48, compared with 70.0 percent of patients treated with Cosentyx. Tremfya demonstrated non-inferiority to Cosentyx in the first major secondary endpoint, with 84.6 percent of patients on Tremfya achieving a PASI 75 response at both weeks 12 and 48 vs. 80.2 percent of those on Cosentyx, however, it did not demonstrate superiority.

Because superiority was not demonstrated for the first major secondary endpoint, p-values for all the subsequent major secondary endpoints were considered nominal. Three of the remaining major secondary endpoints evaluated efficacy at week 48, including achievement of a PASI 100 response and Investigator's Global Assessment (IGA) scores of 0 (cleared), or 0 or 1 (cleared or minimal disease). At week 48, 58.2 percent of patients receiving Tremfya achieved a PASI 100 response, compared with 48.4 percent of patients receiving Cosentyx; 62.2 percent of patients receiving Tremfya achieved an IGA score of 0 compared to 50.4 percent of patients receiving Cosentyx; and 85.0 percent of patients receiving Tremfya achieved an IGA score of 0 or 1 compared to 74.9 percent of patients receiving Cosentyx.

The remaining major secondary endpoints assessed non-inferiority of Tremfya versus Cosentyx at week 12. The percentage of patients achieving a PASI 75 response at week 12 was 89.3 percent for Tremfya and 91.6 percent for Cosentyx; the percentage of patients achieving a PASI 90 response at week 12 was 69.1 percent for Tremfya and 76.1 percent for Cosentyx. he safety profiles observed for Tremfya and Cosentyx in ECLIPSE were consistent with the known safety profiles seen in the respective registration trials and current prescribing information. These data will be presented at the 3rd Inflammatory Skin Disease Summit.

Comment: ECLIPSE is Janssen's fourth Tremfya Phase III study in plaque psoriasis and is part of a comprehensive clinical development program that also includes ongoing Phase III studies in psoriatic arthritis and Crohn's disease.