{"analyses":[{"ciLowerLimit":"-8.18","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"-3.81","groupDescription":"The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.","paramType":"Adjusted Mean Treatment Differences","paramValue":"-6.00","statisticalComment":"ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-9.05","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"-4.62","groupDescription":"The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.","paramType":"Ajusted Mean Treatment Differences","paramValue":"-6.84","statisticalComment":"ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.","statisticalMethod":"ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.80","value":"-3.3"},{"groupId":"OG001","spread":"0.58","value":"-9.3"},{"groupId":"OG002","spread":"0.60","value":"-10.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"95"},{"groupId":"OG002","value":"88"}],"units":"Participants"}],"description":"The DLQI is a subject-reported questionnaire designed for use in adult participants with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than of equal to (\\>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=\\<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).","dispersionType":"Standard Error","groups":[{"description":"Placebo sc injection Q2W.\n\nTreatment received from Week 16 - 48 was based on initial treatment and response to treatment:\n\n* PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.\n* PASI75 responders at Week 16 continued to receive Placebo.\n* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.\n* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.\n\nParticipants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.\n\nParticipants formed the Randomized Set (RS).","id":"OG000","title":"Placebo Q2W (RS)"},{"description":"CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.\n\nTreatment received from Week 16 - 48 was based on initial treatment and response to treatment:\n\n* PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.\n* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.\n* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.\n\nParticipants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.\n\nWeek 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.\n\nDepending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.\n\nParticipants formed the RS.","id":"OG001","title":"CZP 200 mg Q2W (RS)"},{"description":"CZP 400 mg Q2W through Week 14.\n\nTreatment received from Week 16 - 48 was based on initial treatment and response to treatment:\n\n* PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.\n* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.\n* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.\n\nParticipants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.\n\nParticipants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.\n\nParticipants formed the RS.","id":"OG002","title":"CZP 400 mg Q2W (RS)"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"The Randomized Set included all participants randomized into the study. Missing data were handled using the last observation carried forward (LOCF) method for the DLQI.","reportingStatus":"POSTED","timeFrame":"At Week 16","title":"Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}