Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study

被引:32
作者
Kiltz, Uta [1 ,2 ]
Sfikakis, Petros P. [3 ]
Gaffney, Karl [4 ]
Sator, Paul-Gunther [5 ]
von Kiedrowski, Ralph [6 ]
Bounas, Andreas [7 ]
Gullick, Nicola [8 ]
Conrad, Curdin [9 ]
Rigopoulos, Dimitris [10 ]
Lespessailles, Eric [11 ,12 ]
Romanelli, Marco [13 ]
Ghislain, Pierre-Dominique [14 ]
Brandt-Juergens, Jan [15 ]
Rashkov, Rasho [16 ]
Aassi, Maher [17 ]
Orsenigo, Roberto [18 ]
Perella, Chiara [17 ]
Pournara, Effie [17 ]
Gathmann, Sven [17 ]
Jagiello, Piotr [17 ]
Veit, Justyna [19 ]
Augustin, Matthias [20 ]
机构
[1] Rheumazentrum Ruhrgebiet, Herne, Germany
[2] Ruhr Univ Bochum, Bochum, Germany
[3] Natl & Kapodistrian Univ Athens, Joint Rheumatol Programme, Med Sch, Athens, Greece
[4] Norfolk & Norwich Univ Hosp NHS Fdn Trust, Norwich, Norfolk, England
[5] Municipal Hosp Hietzing, Dept Dermatol, Vienna, Austria
[6] Co Med Study & Serv Selters CMS3 GmbH, Selters, Germany
[7] Olymp Therapeutir, Patras, Greece
[8] Univ Hosp Coventry & Warwickshire NHS Trust, Coventry, W Midlands, England
[9] CHU Vaudois, Lausanne, Switzerland
[10] Natl & Kapodistrian Univ Athens, Med Sch, Dermatol & Venerol, Athens, Greece
[11] Reg Hosp, Orleans, France
[12] Univ Orleans, Orleans, France
[13] Univ Pisa, Dermatol Dept, Lungarno Antonio Pacinotti 43, Pisa 56126, PI, Italy
[14] Catholic Univ Louvain, Clin St Luc, Dermatol, Brussels, Belgium
[15] Rheumatol Schwerpunktpraxis, Berlin, Germany
[16] Med Univ, Dept Internal Med, Sofia, Bulgaria
[17] Novartis Pharma AG, Basel, Switzerland
[18] Novartis Farma SpA, Origgio, Italy
[19] Novartis Pharma GmbH, Nurnberg, Germany
[20] Univ Med Ctr Hamburg, Inst Hlth Serv Res Dermatol & Nursing, Hamburg, Germany
关键词
Ankylosing spondylitis; Biologics; Observational; Psoriasis; Psoriatic arthritis; Real-world; Rheumatology; Safety; Secukinumab; QUALITY-OF-LIFE; ANTI-INTERLEUKIN-17A MONOCLONAL-ANTIBODY; RANDOMIZED CONTROLLED-TRIAL; SEVERE PLAQUE PSORIASIS; VISUAL ANALOG SCALE; DISEASE-ACTIVITY; EXTRAARTICULAR MANIFESTATIONS; NAIL PSORIASIS; DOUBLE-BLIND; INDEX DLQI;
D O I
10.1007/s12325-020-01352-8
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Introduction Secukinumab, 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. Methods SERENA 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. Results Overall 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/m(2)) 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. Conclusion Baseline 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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页码:2865 / 2883
页数:19
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