SAT0390\u2005GUSELKUMAB WAS MORE EFFECTIVE THAN SECUKINUMAB IN PATIENTS WITH PLAQUE PSORIASIS AND THE SUBSET OF PATIENTS WITH SELF-REPORTED PSORIATIC ARTHRITIS IN THE RANDOMIZED, DOUBLE-BLIND, HEAD-TO-HEAD COMPARISON STUDY ECLIPSE OVER 1 YEAR

Abstract

Background Guselkumab (GUS, an antibody against IL-23) and secukinumab (SEC, an antibody against IL-17A) are both approved for the treatment of psoriasis (PsO). Up to 30% of patients with PsO may have psoriatic arthritis (PsA). Objectives The ECLIPSE study compared efficacy and safety of GUS vs SEC in patients with plaque PsO. Post hoc analyses examined outcomes in the subgroup of patients with self-reported psoriatic arthritis (PsA). Methods ECLIPSE was a randomized, double-blind trial of adults with moderate-to-severe plaque PsO who received GUS 100 mg at Weeks 0, 4, then every 8 weeks, or SEC 300 mg at Weeks 0, 1, 2, 3, and 4, then every 4 weeks, both through Week 44. The primary endpoint was the proportion of patients achieving ≥90% improvement compared to baseline in the Psoriasis Area and Severity Index (PASI) score at Week 48. Cochran-Mantel Haenszel chi-square testing stratified by investigator was used to compare treatment-group responses. Results Overall, treatment groups [GUS (n=534), SEC (n=514)] were comparable at baseline: weight 89kg, 24% body surface area PsO, and Investigator Global Assessment (IGA) moderate (76%) or severe (24%). These characteristics were similar to those of subgroups with self-reported PsA [GUS (n=97), SEC (n=79)]. In the overall population, the primary endpoint of PASI 90 response at Week 48 was achieved by 84.5% of GUS vs 70.0% of SEC patients (treatment difference 14.2 [95% CI=9.6%,18.8%], P<0.001). Among patients with PsA, the primary endpoint of PASI 90 response at Week 48 was achieved by 82.5% of GUS vs 63.3% of SEC patients (treatment difference 19.2% [95% CI=5.0%, 33.4%]). Beyond week 20, in both the overall study population and the PsA subpopulation, GUS-treated patients maintained the PASI 90 response while SEC-treated patients had a reduction in response through week 48 (Figure). In the overall population, results of the first major secondary endpoint (proportion of patients with a PASI 75 response at both Week 12 and 48) showed non-inferiority of GUS vs SEC (GUS-84.6% vs SEC-80.2% of patients, p<0.001), but superiority was not demonstrated (p=0.062). Adverse events observed in the overall population and PsA subgroup were generally consistent with the established safety profiles for GUS and SEC. Conclusion In the subset of patients with self-reported PsA in the ECLIPSE study, GUS demonstrated better maintenance of response and higher efficacy at approximately one year compared with SEC in the treatment of moderate to severe plaque PsO. These findings were consistent with those for the overall study population of patients with plaque PsO. AEs observed were generally consistent with the established safety profiles for GUS and SEC. Disclosure of Interests Joseph F Merola Grant/research support from: Janssen, Shu Li Employee of: Janssen Research & Development, LLC, Ming-Chun Hsu Employee of: Janssen Research & Development, LLC, Chetan Karyekar Shareholder of: J&J, Employee of: Janssen Scientific Affairs, LLC, Abbott, BMS, Novartis, Susan Flavin Employee of: Janssen Research & Development, LLC, Bruce Randazzo Employee of: Janssen Research & Development, LLC, Laura C Coates Grant/research support from: AbbVie, Celgene, Lilly, Novartis and Pfizer, Consultant for: AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead Sciences Inc., Janssen, Lilly, Novartis, Pfizer, Prothena Corp and UCB