The Janssen Pharmaceutical Companies of Johnson & Johnson today 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 multicentre, randomised, double-blind head-to-head Phase 3 study demonstrated that 84.5 percent of patients treated with guselkumab 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 secukinumab (p<0.001).
“Psoriasis is a painful, debilitating and life-long condition, and those who suffer from it are in need of treatments that not only work well, but work well for a long time,” said Dr Jaime Oliver, MD, Janssen Therapeutic Area Lead, Immunology, Europe, Middle East & Africa, Cilag GmbH International. “The evidence supporting guselkumab shows that not only does this treatment offer patients high levels of skin clearance, but our current 3-year data shows a consistent maintenance of efficacy – something we hope to see continue as we gain more data.”
ECLIPSE incorporated six major secondary endpoints that used a fixed statistical sequence procedure to control for multiple comparisons and included both shorter and longer-term analyses. Guselkumab demonstrated non-inferiority to secukinumab in the first major secondary endpoint, with 84.6 percent of patients on guselkumab achieving a PASI 75 response at both weeks 12 and 48 versus 80.2 percent of those on secukinumab (p<0.001), however, it did not demonstrate superiority (p=0.062). 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 guselkumab achieved a PASI 100 response, compared with 48.4 percent of patients receiving secukinumab; 62.2 percent of patients receiving guselkumab achieved an IGA score of 0 compared to 50.4 percent of patients receiving secukinumab and 85.0 percent of patients receiving guselkumab achieved an IGA score of 0 or 1 compared to 74.9 percent of patients receiving secukinumab (all comparisons with nominal p≤0.001).
The remaining major secondary endpoints assessed non-inferiority of guselkumab versus secukinumab at week 12. The percentage of patients achieving a PASI 75 response at week 12 was 89.3 percent for guselkumab and 91.6 percent for secukinumab (p<0.001 for non-inferiority); the percentage of patients achieving a PASI 90 response at week 12 was 69.1 percent for guselkumab and 76.1 percent for secukinumab (p=0.127 for non-inferiority).
The safety profiles observed for guselkumab and secukinumab in ECLIPSE were consistent with the known safety profiles seen in the respective registration trials and current prescribing information. Similar percentages of patients receiving guselkumab (77.9 percent), and secukinumab (81.6 percent) reported at least one adverse event (AE). Serious AEs were reported in 6.2 percent of patients receiving guselkumab and 7.2 percent of patients receiving secukinumab. Serious infections occurred in six patients receiving guselkumab and five patients receiving secukinumab.