Clinical trial NCT03059953: A Study of Treatment With APRemilast in Moderate psoriAsIS in Real Life clinicAL Practice (The 'APRAISAL' Study)
Official title: A Non-interventional, Prospective, Observational Study of Treatment With APRemilast in Moderate psoriAsIS in Real Life clinicAL Practice (The 'APRAISAL' Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate Plaque Psoriasis
Lead sponsor: Genesis Pharma S.A.
Sponsor class: INDUSTRY
Collaborators: name: Celgene
First posted: 2017-02-23
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients ≥ 18 years of age, diagnosed with moderate chronic plaque psoriasis \[(10\<BSA\<20 or 10\<PASI\<20) and 10\<DLQI\<20\], who failed to respond to or who have a contraindication to, or are intolerant to other classical systemic therapy and naïve to biologic treatments

Brief summary: For patients with moderate plaque psoriasis who are intolerable to, have a contraindication to or have failed classical systemic treatments, the current commonly employed management strategy encompasses treatment with biologic agents. The direct and indirect costs of biologic treatment, accruing, among others, from the high drug acquisition and administration costs, the required baseline safety screening and subsequent routine monitoring as well as the potential loss of patients' working hours constitute a significant financial burden on the public healthcare system. In light of the above evidence, it appears that in routine care apremilast may fulfill an important gap in the treatment armamentarium of psoriasis by providing a promising treatment option to be employed prior to biologics, which has demonstrated efficacy even in hard-to-treat areas such as the scalp, nails, palms and soles, and has a limited manageable safety profile, while being more convenient and cost-effective than biologics.

In view of the scarcity of real-world evidence regarding the impact of apremilast on the patients' health-related quality of life (HRQoL) and extent and severity of the disease, and under the consideration that the moderate psoriasis patient {defined as \[10\<body surface area (BSA)\<20 or 10\<psoriasis area severity index (PASI)\<20\] and 10\<dermatology quality of life index (DLQI)\<20}, naïve to biologic treatment was likely underrepresented in the pivotal ESTEEM trials since approximately 30% of the enrolled patients had been previously treated with biologic therapy, 28-30% had a baseline PASI score \>20, and 48-52% had a BSA \>20%, this study represents an attempt to examine the impact of apremilast in routine clinical practice settings in Greece on the patient with moderate plaque psoriasis when this therapeutic strategy precedes biologics in the treatment algorithm.

Specifically, the present study aims to generate novel real-world evidence on the effect of apremilast treatment in biologic treatment naïve patients with moderate plaque psoriasis in terms of the patients' HRQoL, patient-perceived benefits of therapy, treatment response rate, and impact on nail, scalp and palmoplantar psoriatic involvement and severity of pruritus, while concurrently assessing apremilast survival rate and cost per PASI-75 responder in the routine clinical practice of Greece.


Eligibility criteria: Inclusion Criteria:

Patients eligible for inclusion in this study have to meet all of the following criteria:

* Male and female patients ≥ 18 years of age at the time of informed consent;
* Patients diagnosed with moderate chronic plaque psoriasis \[(10\<BSA\<20 or 10\<PASI\<20) and 10\<DLQI\<20\], who failed to respond to or who have a contraindication to, or are intolerant to other classical systemic therapy;
* Patients naïve to biologic treatments;
* Patients for whom the decision to prescribe therapy with apremilast (Otezla®) according to the locally approved summary of product characteristics (SmPC) has already been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study;
* Patients with available BSA, PASI and DLQI scores at the start of apremilast treatment;
* Patients must be able to read, understand and complete the study specific questionnaires;
* Patients must provide a written Informed Consent prior to inclusion to the study;
* Patients must be able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from participation in this study:

* Patients who have initiated treatment with apremilast more than 7 days before enrollment into the study;
* Patients that meet any of the contraindications to the administration of the apremilast as outlined in the latest version of the locally approved SmPC;
* Patients currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with apremilast;
* Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.

Primary outcomes:
measure: Quality of Life - Percentage of patients with moderate plaque psoriasis treated with apremilast who will achieve a DLQI total score ≤ 5 (i.e., no or small effect of their skin problem on HRQoL)
timeFrame: at 24 weeks post-treatment onset
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 401 General Military Hospital
Study officials:
References:
citation: Ioannides D, Antonakopoulos N, Georgiou S, Chasapi V, Katsantonis I, Drosos A, Rigopoulos D, Antoniou C, Anastasiadis G, Bassukas I, Ioannidou D, Protopapa A, Neofotistou O, Krasagakis K, Aronis P, Papageorgiou M, Lazaridou E, Patsatsi A, Lefaki I, Roussaki-Schulze AV, Satra F, Anagnostopoulos Z, Papakonstantis M. Effectiveness and safety of apremilast in biologic-naive patients with moderate psoriasis treated in routine clinical practice in Greece: the APRAISAL study. J Eur Acad Dermatol Venereol. 2021 Sep;35(9):1838-1848. doi: 10.1111/jdv.17392. Epub 2021 Jul 13.