A Study of Treatment With APRemilast in Moderate psoriAsI... | NCT03059953

NCT03059953

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Celgene	INDUSTRY

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	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)	at 24 weeks post-treatment onset

Eligibility Module

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34036627	Result	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.