A study of Otezla® in patients with plaque psoriasis under routine conditions
Study Details
The objective of this NIS is the collection of data on the utilization of Apremilast under routine conditions in Germany. Patients’ quality-of-life and treatment satisfaction on treatment with Apremilast in daily practice will be documented. Moreover, physician’s and patient’s assessments of the effectiveness and safety of Apremilast will be recorded. FPI was 3rd August 2015, LPO was 14th of June 2018. A total of 391 patients have been enrolled.
Protocol Summary
Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline
Timeframe: Approximately 4 months
Change from Baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at all other visits from baseline.
Timeframe: Up to approximately 52 weeks
Change in the Physician Global Assessment (PGA) Score
Timeframe: Up to approximately 52 weeks
Percent Change in Percent of Affected Body Surface Area (BSA)
Timeframe: Up to approximately 52 weeks
Percent Change in the Psoriasis Area Severity Index (PASI) Score
Timeframe: Up to approximately 52 weeks
Change in the Patient’s Global Assessment (PaGA)
Timeframe: Up to approximately 52 weeks
Patient Preference Questionnaire (PPQ)
Timeframe: Approximately 4 months
Patient Satisfaction (Systemic Therapy Adherence Questionnaire, STAQ)
Timeframe: Approximately 13 months
Change in Pain (Visual Analogue Scale; VAS)
Timeframe: Up to approximately 52 weeks
Adverse Events (AEs)
Timeframe: Up to approximately 52 weeks
Change in Itch (Pruritus) (Visual Analogue Scale; VAS)
Timeframe: Up to approximately 52 weeks
Change in Scalp Involvement -Physician’s Global Assessment (PGA)
Timeframe: Up to approximately 52 weeks
Change in Scalp Involvement - Patient’s Global Assessment (PaGA)
Timeframe: Up to approximately 52 weeks
Change in Nail Involvement - Target Nail Psoriasis Severity Index (NAPSI)
Timeframe: Up to approximately 52 weeks
Change in Nail Involvement Fingernail - Patient’s Global Assessment (PaGA)
Timeframe: Up to approximately 52 weeks
Change in Palmoplantar involvement - Palmoplantar physician’s global assessment (PGA)
Timeframe: Up to approximately 52 weeks
Change in Palmoplantar involvement - Palmoplantar patient’s global assessment (PaGA)
Timeframe: Up to approximately 52 weeks