A Study of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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The objective of this NIS (according to section 4(23) of the German Medicinal Products Act) is the documentation of data on the effectiveness and tolerability of an Apremilast treatment under routine clinical conditions in German patients with plaque psoriasis. This NIS is intended to reflect the apremilast treatment of patients with plaque psoriasis who have received at least one prior conventional, systemic therapy or, if a contraindication is present, did not receive a systemic therapy so far, and who were diagnosed by their treating physicians to be eligible for an apremilast treatment. The treatment of Apremilast will be documented for a period of approximately 52 weeks.

Official Title
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Long-term Documentation of the Utilization of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions (LAPIS-Pso)

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The decision for a therapy with Apremilast was made before enrolment and independent of this study. Patient ≥ 18 years of age Diagnosis of moderate to severe plaque psoriasis Inadequate response or intolerance to a previous systemic treatment, or contraindication for systemic therapies. Written informed consent by the patient for data recording, statistical analysis, filing and forwarding of the data Exclusion Criteria: Pregnancy Hypersensitivity to apremilast or any of the excipients of the film-coated tablet Other criteria according to the Summary of product characteristics (SmPC).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with ≤ 1 conventional, systemic pre-treatment<br>After failure (inadequate response/intolerance) to or contraindication for ≤ 1 conventional, systemic pre-treatment | |
| Patients with > 1 conventional, systemic pre-treatment<br>After failure (inadequate response/intolerance) to or contraindication for > 1 conventional, systemic pre-treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline | DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. | Approximately 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at all other visits from baseline. | DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. | Up to approximately 52 weeks | 
| Change in the Physician Global Assessment (PGA) Score | The PGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the Plaque-Psoriasis. | Up to approximately 52 weeks | 
| Percent Change in Percent of Affected Body Surface Area (BSA) | BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmer surface or handprint excluding DIPs), which equates to approximately 1% of total body surface area. | Up to approximately 52 weeks | 
| Percent Change in the Psoriasis Area Severity Index (PASI) Score | Psoriasis Area Severity Index (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 the 4 anatomic regions is 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) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. | Up to approximately 52 weeks | 
| Change in the Patient's Global Assessment (PaGA) | The PaGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the Plaque-Psoriasis by the patient. | Up to approximately 52 weeks | 
| Patient Preference Questionnaire (PPQ) | PPQ is a questionnaire consisting of 5 questions. PPQ asks the patient for his preference of the actual therapy versus the previous systemic therapy. | Approximately 4 months | 
| Patient Satisfaction (Systemic Therapy Adherence Questionnaire, STAQ) | STAQ; patient questionnaire on patient benefit, communication physician/patient, patient knowledge, and treatment satisfaction with the current systemic treatment (38 questions). | Approximately 13 months | 
| Change in Pain (Visual Analogue Scale; VAS) | The Pain Visual Analog Scores (VAS) is used to measure the amount of pain a participant experiences. Participants are asked: How much pain do you actually experience? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. | Up to approximately 52 weeks | 
| Adverse Events (AEs) | All Serious Adverse Events (SAEs), irrespective of relationship to Apremilast, and all non-serious AEs considered at least possibly related to Apremilast administration [non-serious adverse drug reactions (NS ADRs)], must be recorded within 24 hours of the physician's knowledge to the Sponsors' Drug Safety Department. AEs will be reported by the sponsor as required to Regulatory Authorities and Ethics Committees as applicable, in accordance with the national requirements for marketing authorization holders. | Up to approximately 52 weeks | 
| Change in Itch (Pruritus) (Visual Analogue Scale; VAS) | The Itch Visual Analog Scores (VAS) is used to measure the amount of itch a participant experiences. Participants are asked: How much itch do you actually experience? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. | Up to approximately 52 weeks | 
| Change in Scalp Involvement -Physician's Global Assessment (PGA) | PGA: 5-point scale for the physician's global assessment of the severity of scalp psoriasis. | Up to approximately 52 weeks | 
| Change in Scalp Involvement - Patient's Global Assessment (PaGA) | PaGA: 5-point scale for the patient's global assessment of the severity of scalp psoriasis. | Up to approximately 52 weeks | 
| Change in Nail Involvement - Target Nail Psoriasis Severity Index (NAPSI) | NAPSI: Assessment of target fingernail for nail bed and nail matrix involvement, each can be scored 0-4. Total score ranges from 0-8. | Up to approximately 52 weeks | 
| Change in Nail Involvement Fingernail - Patient's Global Assessment (PaGA) | Fingernail Patient Global Assessment ; 5-point scale on the patient's global assessment of the fingernail involvement, substituted with a 0-100 Visual analog scale (VAS) for the assessment of the impairment caused by this nail involvement. | Up to approximately 52 weeks | 
| Change in Palmoplantar involvement - Palmoplantar physician's global assessment (PGA) | PGA: 5-point scale for the physician's global assessment of the severity of palmoplantar involvement. | Up to approximately 52 weeks | 
| Change in Palmoplantar involvement - Palmoplantar patient's global assessment (PaGA) | PaGA: 5-point scale for the patient's global assessment of the severity of palmoplantar involvement. | Up to approximately 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque psoriasis, Apremilast, Otezla®, LAPIS-Pso, Observational, CC-10004, non-interventional, Germany