Comparison to the Phase 2 Otezla results from 30 subjects
Secondary: Percentage of Participants Who Achieved a PASI-75 Score at Week 12 [ Time Frame: Baseline to Week 12 ] Hide Outcome Measure 5
Measure Type Secondary Measure Title Percentage of Participants Who Achieved a PASI-75 Score at Week 12 Measure Description PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 12. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. Time Frame Baseline to Week 12
Population Description Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. Safety population consisted of all participants who were enrolled and received at least one dose of study medication. If participant had a missing evaluation for any time point assessments, the last observation carried forward (LOCF) method of imputation was used.
Reporting Groups Description Apremilast 20 mg Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
Measured Values Apremilast 20 mg Participants Analyzed [Units: Participants] 30 Percentage of Participants Who Achieved a PASI-75 Score at Week 12 [Units: Percentage of participants] Number (95% Confidence Interval) 30.00 (14.7 to 49.4)
Look at the number that started treatment and the number than completed treatment and the number who discontinued treatment with Otezla due to adverse side effects of the treatment.
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