Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe

Abstract

Introduction The broad and sustained efficacy of apremilast for psoriasis has been demonstrated in randomized and real-world observational studies. Data from Central and Eastern Europe (CEE) are lacking. Moreover, apremilast use in this region is limited by country-specific reimbursement criteria. This is the first study to report data on the real-world use of apremilast in the region. Methods APPRECIATE (NCT02740218) was an observational, retrospective, cross-sectional study assessing psoriasis patients 6 (± 1) months after apremilast treatment initiation. The study aimed to describe the characteristics of patients with psoriasis receiving apremilast, estimate treatment outcomes, including Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), and Dermatology Life Quality Index (DLQI), and assess dermatologists' and patients' perspectives on treatment using questionnaires including the Patient Benefit Index (PBI). Adverse event reports were taken from the medical records. Results Fifty patients (Croatia: 25; Czech Republic: 20; Slovenia: 5) were enrolled. In patients continuing apremilast at 6 (± 1) months, mean (± SD) PASI score was reduced from 16.2 ± 8.7 points at treatment initiation to 3.1 ± 5.2 at 6 (± 1) months; BSA from 11.9% ± 10.3% to 0.8% ± 0.9%; DLQI from 13.7 ± 7.4 points to 1.6 ± 3.2. PASI 75 was reached by 81% of patients. Physicians reported that the overall treatment success fulfilled their expectations in more than two thirds of patients (68%). At least three-quarters of patients reported apremilast had a quite or very high benefit on the needs they identified as being most important. Apremilast was well tolerated; no serious or fatal adverse events were identified. Conclusion Apremilast was effective in reducing skin involvement and improving quality of life in CEE patients having severe disease. Treatment satisfaction among physicians and patients was very high. These data add to the growing body of evidence showing consistent effectiveness of apremilast across the continuum of psoriasis disease severity and manifestations. Trial registration ClinicalTrials.gov identifier, NCT02740218. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02468-3.

Real-World Apremilast Use for Treatment of Plaque Psoriasis in Italy: Patient Perspective, Characteristics, and Clinical Outcomes from the DARWIN Study

“…It is widely reported that patient-perceived burden can be unrelated to the severity and extent of psoriasis [ 7 , 8 , 32 ]. Previous real-world studies with apremilast have reported similarly high disease burden among patients with moderate skin involvement and clinically relevant improvements following apremilast treatment [ 17 , 18 , 21 , 23 , 36 , 37 ]. LAPIS-PSO, a real-world study focused on QoL, reported that patients with moderate-to-severe plaque psoriasis benefited from apremilast treatment up to approximately 13 months of observation [ 27 ].…”

“…Placebo-controlled randomized clinical trials demonstrated the efficacy and tolerability of apremilast in patients with moderate-to-severe plaque psoriasis previously treated with or naïve to biologics [ 14 – 16 ]. The retrospective, cross-sectional APPRECIATE study has reported the characteristics of patients with psoriasis treated with apremilast in routine clinical practice across nine European countries, and treatment needs and outcomes from the perspectives of both physicians and patients [ 17 , 18 ]. APPRECIATE used validated disease severity scores, including PASI and BSA, and patient-reported outcomes such as the Dermatology Life Quality Index (DLQI), the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9), and the Patient Benefit Index (PBI).…”