Siliq / Kyntheum real world study in Greece

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This study was an observational, prospective, multicentre, real-world study in moderate-to severe plaque psoriasis patients treated with Siliq / Kyntheum (brodalumab) in Greece.

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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.

Source: onlinelibrary.wiley.com

*Funding: LEO Pharmaceutical Hellas S.A

Kyntheum / Siliq (brodalumab)