Patients/Treatment
Patients who completed week 60 were eligible to enter the long-term extension period if the investigator concluded that the patient had maintained efficacy response with adequate overall safety. Patients could escalate to every 2-week (Q2W) dosing per investigator opinion. Patients included in this intentto- treat subanalysis had baseline involvement in at least one of the three anatomic areas (scalp, fingernail, or palmoplantar locations) and 1) received IXE through week 60, with a 160- mg starting dose 80 mg Q2W through week 12 and every 4 weeks (Q4W) thereafter, 2) achieved a static Physician’s Global Assessment score of 0 or 1 at week 12, and 3) completed week 60 and continued treatment with IXE Q4W or were escalated to Q2W during the long-term extension.15
Outcomes/Evaluation Methods
Methods Efficacy outcomes in UNCOVER-1 and UNCOVER-2 were represented as percent improvement for the following: 1) 90%/100% improvement in Psoriasis Scalp and Severity Index (PSSI 90/100), 2) Nail Psoriasis Severity Index of zero (NAPSI 0), and 3) 90%/100% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 90/100). Improvement in Dermatology Life Quality Index (DLQI) was measured from weeks 60 through 264.
Statistical Methods
Combined long-term data regarding efficacy, health outcomes, and safety through 5 years were analyzed with SAS Version 9.4 (SAS Institute Inc., Cary, NC). Data were recorded at baseline, weeks 1, 2, 4, Q4W through week 60, and every 12 weeks, thereafter, through week 264. The continuous efficacy analyses (PSSI, NAPSI total score, and PPASI) were performed based on patients with the corresponding baseline involvement (e.g. PSSI, PPASI, or NAPSI for patients with baseline scalp, palmoplantar, or fingernail involvement, respectively) and were summarized as the change and percent improvement from baseline using descriptive statistics for observed data and last observation carried forward (LOCF) for missing data. Response rates for the categorical measures (PSSI 90/100, NAPSI 0, PPASI 90/100) were summarized as the percentages of responders at each time point for both observed data and modified non-responder imputation (mNRI) for missing data. Percentages of patients with DLQI total scores of (0,1) who had baseline involvement in each of the three areas (observed and mNRI) were calculated. Categorical safety measures were summarized as percentage rates for each year, from year 1 through year 5, for patients in each of the three burdensome areas.
Patients who completed week 60 were eligible to enter the long-term extension period if the investigator concluded that the patient had maintained efficacy response with adequate overall safety. Patients could escalate to every 2-week (Q2W) dosing per investigator opinion. Patients included in this intentto- treat subanalysis had baseline involvement in at least one of the three anatomic areas (scalp, fingernail, or palmoplantar locations) and 1) received IXE through week 60, with a 160- mg starting dose 80 mg Q2W through week 12 and every 4 weeks (Q4W) thereafter, 2) achieved a static Physician’s Global Assessment score of 0 or 1 at week 12, and 3) completed week 60 and continued treatment with IXE Q4W or were escalated to Q2W during the long-term extension.15
Outcomes/Evaluation Methods
Methods Efficacy outcomes in UNCOVER-1 and UNCOVER-2 were represented as percent improvement for the following: 1) 90%/100% improvement in Psoriasis Scalp and Severity Index (PSSI 90/100), 2) Nail Psoriasis Severity Index of zero (NAPSI 0), and 3) 90%/100% improvement in Palmoplantar Psoriasis Area and Severity Index (PPASI 90/100). Improvement in Dermatology Life Quality Index (DLQI) was measured from weeks 60 through 264.
Statistical Methods
Combined long-term data regarding efficacy, health outcomes, and safety through 5 years were analyzed with SAS Version 9.4 (SAS Institute Inc., Cary, NC). Data were recorded at baseline, weeks 1, 2, 4, Q4W through week 60, and every 12 weeks, thereafter, through week 264. The continuous efficacy analyses (PSSI, NAPSI total score, and PPASI) were performed based on patients with the corresponding baseline involvement (e.g. PSSI, PPASI, or NAPSI for patients with baseline scalp, palmoplantar, or fingernail involvement, respectively) and were summarized as the change and percent improvement from baseline using descriptive statistics for observed data and last observation carried forward (LOCF) for missing data. Response rates for the categorical measures (PSSI 90/100, NAPSI 0, PPASI 90/100) were summarized as the percentages of responders at each time point for both observed data and modified non-responder imputation (mNRI) for missing data. Percentages of patients with DLQI total scores of (0,1) who had baseline involvement in each of the three areas (observed and mNRI) were calculated. Categorical safety measures were summarized as percentage rates for each year, from year 1 through year 5, for patients in each of the three burdensome areas.
RESULTS
Demographics
Patient demographics and clinical characteristics in each of the subcategories are listed in Table 1. In all categories, there were more males than females. A high percentage of patients with nail psoriasis also had concomitant scalp psoriasis (93.5%) and palmoplantar (40.7%) psoriasis. About 87.7% of patients with palmoplantar psoriasis also had nail psoriasis. Otherwise, the baseline demographics and clinical characteristics were similar between subcategories.
Patient demographics and clinical characteristics in each of the subcategories are listed in Table 1. In all categories, there were more males than females. A high percentage of patients with nail psoriasis also had concomitant scalp psoriasis (93.5%) and palmoplantar (40.7%) psoriasis. About 87.7% of patients with palmoplantar psoriasis also had nail psoriasis. Otherwise, the baseline demographics and clinical characteristics were similar between subcategories.
