Real‐World, Prospective, Multicenter Outcomes to Brodalumab Treatment in Patients With Moderate‐to‐Severe Psoriasis in Greece (The RESOLVE Study)

ABSTRACT Background Prospective, multicenter, real‐world studies on brodalumab's effectiveness and safety in patients with moderate‐to‐severe psoriasis are lacking. Objectives The RESOLVE study was an observational, prospective, multicenter, real‐world study in moderate‐to severe plaque psoriasis patients treated with brodalumab in Greece. The primary objective was to assess the proportion of patients achieving absolute Psoriasis Area and Severity Index (PASI) ≤ 3 after 12 weeks (W12) of treatment and, in those who continued brodalumab after W12, the percentage achieving static Physician's Global Assessment (sPGA) success (“clear/almost clear”) after 52 weeks (W52). Secondary objectives included patients' profile, Patient Reported Outcomes and adverse events' frequency/severity. Methods Analyses were conducted using the as‐observed data. Two imputation methods were applied for the missing data: “last observation carried forward” and “worst‐case” scenario. Continuous variables were reported using summary statistics, whereas for categorical variables frequency tables were used. Results One hundred and forty‐five patients who initiated treatment with or switched to brodalumab were enrolled. Based on the “as‐observed data,” 76.4% of patients achieved absolute PASI ≤ 3 at W12, 97.9% continued brodalumab after W12% and 96.1% achieved sPGA success [“clear” or “almost clear” skin (i.e. 0 or 1)] at W52. At W12 i) 78.5%, 68.1% and 53.5% achieved PASI75/90/100, respectively and ii) 71.5% and 54.2% of patients achieved sPGA0/1 and sPGA 0, respectively. The median time [(95% confidence interval (CI)] to achieve PASI ≤ 3 was 13.1 (13.0, 13.6) weeks. From baseline to W12 and W52 (i) mean DLQI scores decreased by 9.3 ± 6.0 and 12.6 ± 6.2, (ii) 52.6% and 81.9% of patients reported being “free of symptoms” and (iii) 57.4% and 82.7% of patients, responded being “extremely satisfied with treatment,” respectively. Conclusions Brodalumab treatment demonstrated clinically relevant short‐ and long‐term effectiveness in real‐world patients with moderate‐to‐severe psoriasis and improvement in quality of life.