A Real-Life 208 Week Single-Centred, Register-Based Retrospective Study Assessing Secukinumab Survival and Long-Term Efficacy and Safety Among Greek Patients with Moderate to Severe Plaque Psoriasis, Including Difficult-to-Treat Manifestations Such as Genitals and Scalp.

INTRODUCTION: Psoriasis is a chronic inflammatory disease with multiple skin manifestations, and in case of lesions affecting the genital area, sexual health impairment and psychological distress can furthermore impair the patients quality of life. Secukinumab is a fully humanized immunoglobulin G1 kappa antagonist of IL-17A and is indicated for the treatment of moderate-to-severe psoriasis, since it shows a significant efficacy in clinical outcomes, with rapid onset of remission, prolonged treatment response rate, advantageous safety profile and a valuable improvement of the patients quality of life.

OBJECTIVES: This study was conducted in order to gather retrospective real-world data regarding the efficacy of secukinumab in treating patients with moderate-to-severe plaque psoriasis in Greece. To fill the relevant literature gap, we included difficult-to-treat manifestations in our analysis, specifically regarding the efficacy in the genital area and on the skin folds where relevant data are missing both from the drug clinical program as well as from the real-world setting.

METHODS: All adult patients receiving 300 mg secukinumab and attending follow-up visits on a regular basis, according to routine medical practice were included. The timeline of the study was from 2015 to 2020. Primary endpoint of the study was the percentage of patients who achieved a psoriasis area and severity index (PASI) 75 response rate at week 16 and week 52 post baseline. Secondary endpoints were the evaluation at baseline (week 0), week 4 (±1), week 16 (±1), week52 (±1), and week 104 (±1), week 156 (±1), week 208 (±1) of clinical outcomes, incidence of adverse events and potential predictive variables influencing response rate.

RESULTS: Ninety-nine patients were included in the study population, from whom sixty six patients (66.67%) were bio-naive, whereas 33 patients had never received systemic treatment. Regarding difficult-to-treat manifestations, we recorded scalp involvement in 74.74% (74/99) of our patients, genital psoriasis in 27.27% (27/99) and skin folds involvement (psoriasis inversa) in 17% (17/99). At week 16, PASI75/PASI90/PASI100 were observed in 87.5%/69.8%/49%, respectively. At week 4 lesions affecting the genital area and patients with skin fold involvement experienced a rapid regression and 84.1% of patients achieved sPGA 0/1 (Physician Global Assessment). Treatment with secukinumab during the 208 weeks of observation did not reveal any major adverse event or systemic infection and generally it was well tolerated.

CONCLUSIONS: According to our outcomes secukinumab is an effective treatment choice for treating chronic plaque psoriasis, but, additionally, it can be efficacious in the subgroups of patients with difficult-to-treat manifestations, as our patients experienced great improvement starting even 5 weeks after treatment initiation. This real-life study offers information about clinical efficacy, retention and safety profile of secukinumab in patients from everyday clinical practice over a long-term, 4-year, follow-up period in Greece.