Effectiveness and safety of apremilast in biologic‐naïve patients with moderate psoriasis treated in routine clinical practice in Greece: the APRAISAL study

Abstract

Background Apremilast is an oral phosphodiesterase-4 inhibitor indicated for patients with moderate-to-severe chronic plaque psoriasis and active psoriatic arthritis.Objectives To examine the effectiveness of apremilast on Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI) and nail, scalp and palmoplantar involvement, when administered prior to biologics.Methods This 52-week real-world study included biologic-naive adults with moderate psoriasis (psoriasis-involved body surface area 10% to <20%, or PASI 10 to <20 and DLQI 10 to <20). Apremilast was initiated ≤7 days before enrolment. Data from the first 100 eligible patients who completed 24 weeks (W24) of observation (or were prematurely withdrawn) are presented in this interim analysis using the last-observation-carried-forward imputation method. Results Eligible patients (mean age: 49.9 years; 71.0% males; median disease duration: 8.0 years) were consecutively enrolled between April and October 2017, by 18 dermatology specialists practising in hospital outpatient settings in Greece. Baseline DLQI (median: 12.0) and PASI (median: 11.7) scores improved (P < 0.001) at all postbaseline timepoints (Weeks 6, 16 and 24; W24 median decreases: 9.0 and 9.4 points respectively). At W24, DLQI ≤5, DLQI 0 or 1, and PASI-75 response rates were 63.0%, 25.0% and 48.0% respectively. The Nail Psoriasis Severity Index score in patients with baseline nail involvement (n = 57) decreased at all postbaseline timepoints (P < 0.001; W24 median decrease: 20.0 points). At W24, 50.0% and 51.7% of patients with baseline scalp (n = 76) and palmoplantar (n = 29) involvement respectively achieved postbaseline Physician's Global Assessment (PGA) score of 0 or 1 if baseline score was ≥3, or 0 if Clinicaltrials.gov number: NCT03059953

Apremilast and biologics: Characteristics of patients treated with apremilast before, during, or after a biological treatment

“…The main reason for apremilast withdrawal was lack of adequate efficacy (58.5%), followed by adverse effects. Other studies also agree finding efficacy the first reason to discontinue 5,8,9,13,15 . In two of our patients apremilast was discontinued after good symptomatic control was achieved and maintained.…”

“…Patient demographic data (sex, age, and comorbidities) were similar to those described in other real‐life apremilast series 4–6 . They also found a high percentage of patients who had received prior systemic treatment.…”

“…Other studies also agree finding efficacy the first reason to discontinue. 5,8,9,13,15 In two of our patients apremilast was discontinued after good symptomatic control was achieved and maintained. Other studies also describe symptom relief as the reason to discontinue treatment in a small percentage of patients (5.4%).…”

“…F I G U R E 1 (A) Kaplan-Meier curve of apremilast survival in patients who received previous biological treatment (mean survival 9.9 months, SD 6.5) and those who did not (mean survival 9.4 months, SD 7.3), log-rank p = 0.92, hazard ratio (HR) 0.97 (IC 95% 0.5-1.9 Patient demographic data (sex, age, and comorbidities) were similar to those described in other real-life apremilast series. [4][5][6] They also found a high percentage of patients who had received prior systemic treatment. However, the proportion of patients who had received prior biological therapy was higher in our series (39%) than those reported in other apremilast real-life series (0%-19.4%), [4][5][6][7][8][9][10] probably due to the inclusion criteria of our study.…”

“…[4][5][6] They also found a high percentage of patients who had received prior systemic treatment. However, the proportion of patients who had received prior biological therapy was higher in our series (39%) than those reported in other apremilast real-life series (0%-19.4%), [4][5][6][7][8][9][10] probably due to the inclusion criteria of our study.…”