Guselkumab: Phase III data
Top-line data from the double-blind, international Phase III VOYAGE 1 trial in 837 patients with moderate to severe plaque psoriasis showed that 100 mg subcutaneous guselkumab at weeks 0 and 4 and then every 8 weeks met the co-primary endpoints of a greater proportion of patients with an IGA score of 0 or 1 point (85.1% vs. 6.9%, p<0.001) and of improving PASI 90 response rate (73.3% vs. 2.9%, p<0.001) at week 16 vs. placebo. Guselkumab also met the secondary endpoints of a greater proportion of patients with an IGA score of 0 or 1 point at weeks 16 (85.1% vs. 65.9%), 24 and 48 vs. Humira adalimumab and of improving PASI 90 response rates at weeks 16 (73.3% vs. 49.7%), 24 (80.2% vs. 53%) and 48 vs. Humira adalimumab (p<0.001 for all). Additionally, guselkumab led to a DLQI score of 0 or 1 point in 60.9% of patients at week 24 and 62.5% of patients at week 48 vs. 39.5% and 38.9% of patients receiving Humira at weeks 24 and 48, respectively. Patients in the placebo arm crossed over to receive guselkumab at weeks 16 and 20 followed by guselkumab every 8 weeks. Data were presented at the European Academy of Dermatology and Venereology meeting in Vienna. ...