Effectiveness and safety of secukinumab in Italian patients with psoriasis: an 84 week, multicenter, retrospective real-world study

Abstract

Background: Long term data on the real-life use of secukinumab are scant. The aim of this study was to investigate the real-life effectiveness, safety and treatment persistence of secukinumab in patients with moderate-to-severe psoriasis. Research design and methods: This 84-week, multicenter (n = 7) retrospective study analyzed data from patients who initiated and received at least 6 months of secukinumab treatment between June 2016 and June 2018 in the Campania region of Italy. Patient demographic and treatment characteristics, duration of treatment and reasons for discontinuation as well as Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), and Dermatology Life Quality Index (DLQI) scores were assessed. Results: 324 patients (63% male, mean age 50.2 years) were enrolled and received a mean 11.7 months of secukinumab treatment. Overall, 9.5% discontinued secukinumab, including 5.2% who discontinued due to secondary inefficacy and 1.8% due to adverse events. PASI, BSA and DLQI scores were significantly improved from baseline at every follow-up visit (p < 0.001) and mean PASI decreased from 15.3 ± 6.3 at baseline to 0.5 ± 1.0 at week 84. Secukinumab had comparable effectiveness in biologic naïve and non-naïve patients. Conclusions: This study confirmed the effectiveness and safety of secukinumab in real-world patients with psoriasis.

Secukinumab demonstrates improvements in absolute and relative psoriasis area severity indices in moderate-to-severe plaque psoriasis: results from a European, multicentric, retrospective, real-world study

“…Indeed, in this best-responder patient subcohort, BMI was slightly lower (26.0 vs. kg/m 2 ), disease duration was shorter, arthritis was less observed, age was slightly lower, compared to bioexperienced ( Table 2). This is in line with other reports, showing a greater and faster response to secukinumab in patients bio-naïve, younger, and with lower BMI (11,12,15). Notably, in this study, treatment response in bio-naïve patients was higher compared to bio-experienced patients who showed lower response rates, notwithstanding a higher proportion of patients with baseline PASI score 20.…”

“…Although secukinumab has been shown to be well tolerated and effective in treating patients with plaque psoriasis and PsA in multiple clinical trials (7-9,29-34) with up to 5-year follow up (35), randomized controlled trials are likely to enroll patient populations with more stringent inclusion/exclusion criteria and generally the study design allows a short-term observation compared to the real-world setting. A variety of real-world studies have been recently published: some of them analyzed secukinumab drug survival (36)(37)(38)(39), whereas others assessed its efficacy in psoriasis patient populations with peculiar features, or assessing its effectiveness as improvement of DLQI, BSA, PGA, and PASI scores (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24). Nevertheless, they reported favorable secukinumab safety and effectiveness in terms of mean reduction of PASI value over time, as patient rates achieving PASI 75, PASI 90, and PASI 100 responses at different timepoints, Investigator's Global Assessments or improvements in quality of life measures (11)(12)(13)(14)(15)(16)(17)(18)(19)22).…”

“…First, it is retrospective and can suffer from the effects of bias in the treatment and the rate of patients lost-to-follow up. Second, the observation period was limited to 52 weeks whereas other studies had longer observational periods (14,15). Third, relatively small cohort of patients was included (17,19,23).…”

“…Recently, some real-world studies describing the effectiveness and safety of secukinumab have been published, but only one study included data on the absolute residual PASI score (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24). Indeed, the effectiveness of antipsoriatic treatments is usually reported as the relative 75%, 90%, or 100% improvement from baseline on the Psoriasis Area Severity Index (PASI 75, PASI 90, PASI 100), though there is emerging interest in the evaluation of absolute PASI score reduction as a better benchmark of therapeutic response and the higher clinical relevance of the remaining absolute PASI score as therapeutic target (i.e.…”

Treatment of Psoriasis with Secukinumab in Challenging Patient Scenarios: A Review of the Available Evidence

“…Patients with treated LTBI were not excluded from four phase 2, six phase 3, and two phase 4 secukinumab clinical trials [38], and no cases of TB activation were reported. In a multicenter study of 324 patients with moderate to severe psoriasis treated with secukinumab including ten patients with LTBI treated, secukinumab was effective and safe, with only one case of LTBI reported [39]. In 2044 patients with moderate to severe PsO treated with secukinumab, no cases of TB were observed after 1 year of treatment.…”