Multicenter, open-label, single-arm, phase II, pilot study. The screening period was up to 4 weeks and treatment took place over 20 weeks per patient. Five visits per patient were performed including: Visit 1 at week -4 to -1 (screening), Visit 2 at week 0 (baseline), Visit 3 at week 4, Visit 4 at week 12, and Visit 5 at week 20 (end of study). There was no follow-up period.
This was a multicenter, open-label, single-arm, phase II, pilot study to evaluate the efficacy and safety of apremilast involving 21 patients with PPP. The screening period was up to 4 weeks and treatment took place over 20 weeks per patient. No follow up period took place. No extension was done. Recruitment period was 4 months; hence study duration from first patient in to last patient out was approximately 9 months. About 4-6 patients per center were recruited, assuming enrolment of both genders with distribution according to prevalence of condition. Patient recruitment took place at 5 centers in Germany. The investigators had relevant expertise in diagnosing and treating PPP or were specialized in dermatology. Patients were enrolled until approximately 20 patients were included into the study. One drop-out was replaced during the recruitment phase. Five visits per patient were performed including: * Visit 1 at week -4 to -1 (screening) * Visit 2 at week 0 (baseline) * Visit 3 at week 4 * Visit 4 at week 12 * Visit 5 at week 20 (end of study) After the end of study participation the investigator ensured that the patient received a suitable therapy appropriate to patient's condition.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Apremilast was taken orally twice daily (except Day 1). Patients received tablets in blister/bottles sufficient for one month. To mitigate potential gastrointestinal side effects (primarily mild-to-moderate nausea and diarrhoea), dose titration was implemented in this study in accordance with the Summary of Product Characteristics (SmPC). A titration pack included tablets of 10, 20 and 30 mg for a period of one month. During the first 5 days, the dosage was up-titrated. The initial dose on day 1 was 10 mg in the morning; this was increased to 10 mg in the morning and evening on day 2. The evening dose was further increased by 10 mg (to 20 mg) on day 3. On day 4, the morning dose was increased to 20 mg, so that 20 mg was taken twice daily, and on day 5 the evening dose was increased to 30 mg. From Day 6 onwards, patients received the 30 mg dose twice a day. Subsequent packs included only tablets of 30 mg strength.
University Hospital Bonn
Bonn, Germany
Universitätsmedizin Göttingen / Georg-August-Universität Department for Dermatology, Venereology and Allergology
Göttingen, Germany
SCIderm GmbH
Harburg, Germany
Universitätsklinik Schleswig-Holstein, Campus Kiel, PSORIASIS-ZENTRUM KIEL, Klinik für Dermatologie, Venerologie und Allergologie
Kiel, Germany
Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) at Week 20 Compared With Baseline
The PPPASI assess palms of hands and soles of feet for psoriasis involvement. The PPPASI score range from 0-72, with higher scores indicating more severe disease.
Time frame: PPPASI Score at baseline and Week 20.
Number of Participants With PPPASI 50 Response
PPPASI 50 response defined as a 50% decrease in PPPASI from baseline.
Time frame: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 20).
Number of Participants With PPPASI 75 Response
PPPASI 75 response defined as a 75% decrease in PPPASI from baseline.
Time frame: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 20).
Dermatology Life Quality Index (DLQI)
The DLQI is a dermatology-specific quality of life instrument designed to assess the impact of a disease on the patient's daily life which is also validated for PPP. It is a 10-item questionnaire and can be used to assess 6 different aspects: symptoms and feelings, leisure, daily activities, work or school performance, personal relationship and treatment. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired. Meaning of DLQI scores: * 0 to 1 = No effect at all on patient's life * 2 to 5 = Small effect on patient's life * 6 to 10 = Moderate effect on patient's life * 11 to 20 = Very large effect on patient's life * 21 to 30 = Extremely large effect on patient's life
Time frame: At Visit 2 (Baseline), Visit 4 (Week 12) and Visit 5 (Week 20).
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Universitätsklinikum Münster Klinik für Hautkrankheiten
Münster, Germany