Despite brodalumad demonstrated efficacy in clinical trials, real‐world data reflecting clinical benefits in unselected patient populations treated in routine clinical practice are limited. Thus, we performed a longitudinal, retrospective, real‐world analysis assessing the long‐term clinical benefits of patients with moderate‐to‐severe psoriasis treated with brodalumab in Greece in the long term (up to 24 months). Main efficacy assessments included changes from baseline in the psoriasis area and severity index (PASI) and proportions of patients achieving at least 50%, 75%, 90% and 100% reduction from baseline in PASI scores (PASI50, PASI75, PASI90 and PASI100) at different timepoints up to 24 months. Other endpoints included changes in the dermatology life quality index (DLQI) and body surface area (BSA) involvement. Data from medical records of 180 patients with moderate‐to‐severe psoriasis treated with brodalumab for up to 24 months were assessed. Following treatment, mean [standard deviation (SD)] PASI scores were decreased across all visits compared to baseline (p < 0.001). The proportion of patients achieving PASI50, PASI75, PASI90 or PASI100 were high as early as at month 1 and consistently tended to increase over time, mainly during the first 6 months. Improvements on disease severity were further reflected by reductions from baseline on BSA scores across all visits (p < 0.001). Concurrent improvements on DLQI scores were observed across all visits (p < 0.001). This retrospective analysis provides real‐world evidence supporting the long‐term efficacy profile of brodalumab in Greek patients with moderate‐to‐severe psoriasis treated in standard clinical practice, which is characterized by a rapid onset of action generally sustained over time.

Background Real‐world data in patients with moderate psoriasis treated with apremilast is limited. Objectives To evaluate the effectiveness and safety of apremilast in bio‐naïve patients with moderate psoriasis in real‐world clinical settings. Methods This was a 52‐week multicenter, observational, prospective study of adult outpatients with moderate psoriasis {[10% < body surface area < 20% or 10 < psoriasis area severity index (PASI) < 20] and 10 < dermatology quality of life index (DLQI) < 20} initiated on apremilast ≤7 days before enrollment. Missing data were imputed using the last observation carried forward method. Results A total of 287 eligible patients (median age: 54.2 years; median psoriasis duration: 9.8 years) were consecutively enrolled. At baseline, the median DLQI and PASI scores were 12.0 and 11.8, respectively. The 52‐week DLQI ≤ 5 and PASI75 response rates were 68.3% and 61.0%. At 52 weeks, 70.8% and 72.7% of the patients shifted from moderate/severe/very severe to clear/minimal scalp and palmoplantar psoriasis involvement, respectively; the pruritus severity state improved in 67.2%. The 52‐week Kaplan–Meier estimated drug continuation rate was 85.3%. The adverse drug reaction rate was 19.9%. Conclusions Apremilast is a safe and effective treatment for bio‐naïve patients with moderate psoriasis and specific psoriasis manifestations.

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

Brodalumab's clinical efficacy and favorable safety profile have been demonstrated during controlled clinical trials, but real‐world data remain scarce. BrIDGE, an ongoing 104 week, observational, prospective, multicenter study conducted in Greece, enrolled moderate‐to‐severe plaque psoriasis patients, with body surface area (BSA) > 10 or psoriasis area severity index score (PASI) > 10 and dermatology life quality index (DLQI) > 10, based on European consensus, initiating brodalumab treatment as per routine clinical practice. This interim analysis includes evaluations 12–16 weeks following treatment initiation. Key efficacy endpoints included proportion of patients achieving static Physician's Global Assessment (sPGA) score of “clear/almost clear” (0/1) and a reduction ≥75%, 90%, 100% from baseline in PASI (PASI75, PASI90, and PASI100) at weeks 12–16. Other endpoints included time to achieve PASI100, changes in self‐reported DLQI and psoriasis symptom inventory (PSI) at weeks 12–16. From 200 patients (mean age 51.4 years, 70% male, mean disease duration 13.8 years) enrolled, 72.8% achieved sPGA of 0/1, whereas 70.2%, 47.5%, and 32.0% achieved corresponding PASI75, PASI90, and PASI100 responses following 12–16 weeks of brodalumab treatment, according to the “as‐observed” analysis. The mean time to achieve PASI100 was 13.7 ± 1.2 weeks for the 32% who achieved PASI100. Concurrent decreases in mean DLQI and PSI were observed. Furthermore, 90% adherence to brodalumab was noted and nine adverse events were reported. Brodalumab confers substantial clinical improvements short‐term as reflected by high levels of skin clearance in moderate‐to‐severe plaque psoriasis patients within 12–16 weeks of treatment under everyday clinical conditions, followed by improvements in symptoms and quality of life and a favorable safety profile.

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