• Uta Kiltz, Petros P Sfikakis, Karl Gaffney, Paul-Gunther Sator, Ralph von Kiedrowski, Andreas Bounas, Nicola Gullick, Curdin Conrad, Dimitris Rigopoulos, Eric Lespessailles, Marco Romanelli, Pierre-Dominique Ghislain, Jan Brandt-Jürgens, Rasho Rashkov, Maher Aassi, Roberto Orsenigo, Chiara Perella, Effie Pournara, Sven Gathmann, Piotr Jagiello, Justyna Veit, and Matthias Augustin.
• Rheumazentrum Ruhrgebiet, Herne, Germany. Uta.Kiltz@elisabethgruppe.de.
• Adv Ther. 2020 Jun 1; 37 (6): 2865-2883.

IntroductionSecukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications.MethodsSERENA is an ongoing, longitudinal, observational study conducted at 438 sites across Europe in patients with moderate to severe plaque PsO, active PsA or active AS. Patients should have received at least 16 weeks of secukinumab treatment before enrolment in the study.ResultsOverall 2800 patients were included in the safety set; patients with PsA (N = 541) were older than patients with PsO (N = 1799) and patients with AS (N = 460); patients with PsO had a higher mean body weight than patients with PsA and patients with AS; and patients with PsO and patients with AS were predominantly male. Time since diagnosis was longer in patients with PsO compared with patients with PsA and patients with AS, and about 40% of patients were either current or former smokers. The proportion of obese patients (body mass index ≥ 30 kg/m2) was similar across indications. Patients were treated with secukinumab for a mean duration of 1 year prior to enrolment (range 0.89-1.04). The percentages of patients with prior biologics exposure were 31.5% PsO, 59.7% PsA and 55% AS. The percentages of patients prescribed secukinumab monotherapy were 75% (n = 1349) in PsO, 48.2% (n = 261) in PsA and 48.9% (n = 225) in AS groups.ConclusionBaseline demographics of the study population are consistent with existing literature. This large observational study across all secukinumab indications will provide valuable information on the long-term effectiveness and safety of secukinumab in the real-world setting.

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