Methods:In a phase 2 trial,we randomly assigned patients with a GPP flare in a 2:1 ratio to receive a single 900-mg intravenous dose of spesolimab or placebo.Patients in both groups could receive an open-label dose of...Methods:In a phase 2 trial,we randomly assigned patients with a GPP flare in a 2:1 ratio to receive a single 900-mg intravenous dose of spesolimab or placebo.Patients in both groups could receive an open-label dose of spesolimab on day 8,an open-label dose of spesolimab as a rescue medication after day 8,or both and were followed to week 12.The primary end point was a Generalized Pustular Psoriasis Physician Global Assessment(GPPGA)pustulation subscore of 0(range,0[no visible pustules]to 4[severe pustulation])at the end of week 1.The key secondary end point was a GPPGA total score of 0 or 1(clear or almost clear skin)at the end of week 1;scores range from 0 to 4,with higher scores indicating greater disease severity.展开更多
文摘Methods:In a phase 2 trial,we randomly assigned patients with a GPP flare in a 2:1 ratio to receive a single 900-mg intravenous dose of spesolimab or placebo.Patients in both groups could receive an open-label dose of spesolimab on day 8,an open-label dose of spesolimab as a rescue medication after day 8,or both and were followed to week 12.The primary end point was a Generalized Pustular Psoriasis Physician Global Assessment(GPPGA)pustulation subscore of 0(range,0[no visible pustules]to 4[severe pustulation])at the end of week 1.The key secondary end point was a GPPGA total score of 0 or 1(clear or almost clear skin)at the end of week 1;scores range from 0 to 4,with higher scores indicating greater disease severity.
