Apremilast treatment of plaque psoriasis (PsO) after systemic therapy in Spanish clinical practice: Data from the APPROPRIATE study

• Published in: JEADV clinical practice Vol. 2; no. 3; pp. 488 - 501
• Main Authors: Cueva, Pablo, Armesto, Susana, Montesinos, Encarnacion, García, Francisco Javier, Morales, Ana Maria, Rivera‐Díaz, Raquel, Hospital, Mercedes, Mollet, Jordi, Llamas‐Velasco, Mar, Carrascosa, Jose‐Manuel, García, Mercedes, Vázquez, Jimena, Puig, Lluís
• Format: Journal Article
• Language: English
• Published: Madrid John Wiley & Sons, Inc 01-09-2023; Wiley
• Subjects: apremilast; Body mass index; Cardiovascular disease; Clinical medicine; Demographics; Hypothesis testing; Light therapy; Liver diseases; Metabolic disorders; Patients; plaque psoriasis; prospective; Pruritus; Psoriasis; Psoriatic arthritis; Questionnaires; real‐world study; Skin; systemic therapy; Tumors; Variables; Spain
• ISSN: 2768-6566; 2768-6566
• DOI: 10.1002/jvc2.155

Background
Despite the proven efficacy and safety of apremilast to treat plaque psoriasis (PsO), data regarding its real‐world use and patient‐perceived benefits are limited.
Objectives
Describe apremilast use, persistence and tolerability, and its patient‐perceived benefits and effectiveness in patients with PsO in Spanish clinical practice.
Methods
Observational, prospective, multicenter study including patients with moderate‐to‐severe PsO initiating apremilast 3 months (±4 weeks) before enrolment, after at least one conventional systemic therapy and no biologics. Prospective data were collected 3 (at enrolment), 6 and 12 months (±4 weeks) after apremilast initiation. Primary outcome was a Patient Benefit Index (PBI) score ≥1 (minimum clinically relevant benefit) at 6 months.
Results
Of 153 patients enroled, 119 were included in the analysis; mean (standard deviation [SD]) age, 52.8 (15.2) years. At apremilast initiation, mean (SD) Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) were 8.3 (4.9) and 10.5 (6.8), respectively. Most patients (81%) had comorbidities; PsO manifestations included scalp (47% of patients), palmoplantar (26%), nails (24%) and genitals (11%). Over three‐quarters (86%) of patients were continuing apremilast at Month 6, with most (91%) achieving a PBI ≥ 1% and 43% achieving a PBI ≥ 3; two‐thirds (68%) were continuing apremilast at Month 12, with 91% and 42% achieving a PBI ≥ 1 and ≥3, respectively. Mean (SD) pruritus scores decreased from 54.5 (32.1) at apremilast initiation to 23.4 (27.0) at Month 12; 57%, 69% and 69% of patients achieved a DLQI 0‒1, PASI < 3 and BSA < 3, respectively. Adverse events were consistent with the known safety profile.
Conclusions
Patients initiating apremilast after conventional systemic therapy in Spanish clinical practice had moderate PsO at bothersome/visible locations and impaired quality of life. Most patients remained on apremilast for 12 months, with improved patient‐reported outcomes and skin involvement, and almost all patients reported some clinical benefit. Apremilast was well tolerated without new safety signals.