XP-828L in the Treatment of Mild-to-Moderate Psoriasis: A ...

Alternative Medicine Review Volume 12, Number 4 2007Psoriasis StudyEfficacy AssessmentsEfficacy was basedprimarily on the Physician’sGlobal Assessment(PGA), an assessment ofoverall lesion severity comprisingsix categories, rangingfrom none (category 0)to very severe (category 5),based on plaque elevation,scaling, and erythema. 9,10Other efficacy assessmentsincluded the Psoriasis Areaand Severity Index (PASI),body surface area (BSA)covered with psoriasis, anditch severity (0=no itch and3=severe, bothersome withdifficulty in performingdaily activities and causingsleep disturbances).The PASI is a physicianassessedoutcome based onthe extent of involved skinFigure 1. Patient DispositionDay 1 - 56Double-blindPlacebo-controlledDay 56 - 112Double-blindDose comparisonsurface and severity of erythema, desquamation, andplaque induration, with a score ranging from 0 to 72. 9,10Efficacy assessments were done at day 1 (baseline), day56, and day 112. If a value was missing, the last availableobservation was carried forward for analysis.Safety AssessmentSafety was assessed by evaluating adverseevents at each visit. Blood samples for hematology andchemistry analysis and urine samples were collected beforerandomization and at days 4, 7, 28, 56, 59, 62, 84,and 112 and were analyzed by a central laboratory.Statistical AnalysisPGA and PASI scores for patients who receivedXP-828L were compared with those from patientsunder placebo at days 56 and 112 for each testeddose. Gender, age, and baseline PASI score were includedas covariables when appropriate.Continuous end-point variables were analyzedusing mixed-model analyses of variance or analyses ofGroup A42 received XP-828 5 g/day38 completed day 564 discontinued1 Patient’s request1 Disease progression2 OtherGroup A38 received XP-828 5 g/day35 completed day 1123 discontinued1 Patient’s request2 OtherRandomized (n=84)Group B42 received placebo38 completed day 564 discontinued2 Adverse events1 Patient’s request1 OtherGroup B38 received XP-828 10 g/day34 completed day 1124 discontinued2 Patient’s request1 Disease progression1 Othercovariance, controlling for baseline values. Score changesover time were analyzed using two-tailed Student’sunpaired t-tests. Dichotomous end points and safetyparameters were analyzed using chi-square tests. Allstatistical analyses were performed on an intent-to-treatand on a per protocol basis (completers with ≥80%compliance). In all cases, a p value