The Needs of Patients with Psoriasis and Benefits of Apremilast in French Clinical Practice: Results from the Observational REALIZE Study.

INTRODUCTION: Real-world data on the needs of patients with psoriasis and patient-perceived benefits of apremilast are limited. We report such data from France.

METHODS: The multicenter, observational REALIZE study was conducted in real-life clinical practice in France and enrolled patients with moderate-to-severe plaque psoriasis who had initiated apremilast per French reimbursement criteria in the 4 weeks preceding enrollment (September 2018-June 2020). Physician assessments and patient-reported outcomes (PROs) were collected at enrollment, 6 months, and 12 months. PROs included the Patient Benefit Index for skin diseases (PBI-S), Dermatology Life Quality Index (DLQI), and 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). The primary outcome was PBI-S ≥ 1 (minimum clinically relevant benefit) at month 6.

RESULTS: Of 379 enrolled patients who received ≥ 1 dose of apremilast, most [n = 270 (71.2%)] remained on apremilast at 6 months and over half [n = 200 (52.8%)] persisted at 12 months. Patients reported the following treatment goals as most important (≥ 70% reported goal as "very important" in the Patient Needs Questionnaire): get better skin quickly, regain disease control, be healed of skin alterations, and have confidence in the therapy. Most patients persisting on apremilast achieved a PBI-S ≥ 1 at months 6 and 12 (91.6% and 93.8%, respectively). Mean (SD) DLQI decreased from 11.75 (6.69) at enrollment to 5.17 (5.35) and 4.18 (4.39) at months 6 and 12, respectively. Most patients (72.3%) reported moderate-to-severe pruritus at enrollment and no/mild pruritus at months 6 and 12 (78.8% and 85.9%, respectively). Mean (SD) TSQM-9 Global Satisfaction scores were 68.4 (23.3) and 71.7 (21.5) at months 6 and 12, respectively. Apremilast was well tolerated; no new safety signals were identified.

CONCLUSIONS: REALIZE provides insights regarding the needs of patients with psoriasis and the patient-perceived benefits of apremilast. Patients who persisted on apremilast reported improvements in quality of life, high treatment satisfaction, and clinically relevant benefits.

TRIAL REGISTRATION: NCT03757013.