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Real world experience of brodalumab treatment in patients with moderate-to-severe plaque psoriasis in the Greek population: Results from an interim analysis of the BrIDGE study.
Rigopoulos, Dimitrios; Angelakopoulos, Charalampos; Apalla, Zoi; Georgiou, Sophia; Delli, Florentina; Drosos, Alexandros; Zafiriou, Efterpi; Katsantonis, John; Lazaridou, Elisavet; Panagakis, Pantelis; Papadavid, Evangelia; Papakonstantis, Markos; Roussaki-Schulze, Angeliki-Viktoria; Sotiriou, Elena; Anastasiadis, Georgios; Tampouratzi, Eleftheria; Chasapi, Vasiliki; Sfaelos, Konstantinos; Ioannides, Dimitrios.
Afiliação
  • Rigopoulos D; 1st Department of Dermatology-Venereology, University of Athens, Athens, Greece.
  • Angelakopoulos C; Department of Dermatology, Athens Naval Hospital, Athens, Greece.
  • Apalla Z; 2nd Dermatology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Georgiou S; Department of Dermatology, Medical School, General University Hospital, University of Patras, Patras, Greece.
  • Delli F; State Dermatology Department, Hippokratio General Hospital of Thessaloniki, Thessaloniki, Greece.
  • Drosos A; Department of Dermatology, General Hospital of Xanthi, Xanthi, Greece.
  • Zafiriou E; Department of Dermatology, University General Hospital Larissa, University of Thessaly, Larissa, Greece.
  • Katsantonis J; Dermatological Department, Tzaneio General Hospital, Piraeus, Greece.
  • Lazaridou E; 2nd Dermatology Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
  • Panagakis P; Department of Dermatology and Venereology NHS, Andreas Syggros Hospital, Athens, Greece.
  • Papadavid E; 2nd Department of Dermatology and Venereology, Attikon University Hospital, Athens, Greece.
  • Papakonstantis M; Clinic of Dermatology, 401 General Military Hospital of Athens, Athens, Greece.
  • Roussaki-Schulze AV; Department of Dermatology, University General Hospital Larissa, University of Thessaly, Larissa, Greece.
  • Sotiriou E; 1st Dermatology Department, Aristotle University, Medical School, Thessaloniki, Greece.
  • Anastasiadis G; Department of Dermatology, General Hospital of Athens "Evangelismos", Athens, Greece.
  • Tampouratzi E; Dermatological Department, Tzaneio General Hospital, Piraeus, Greece.
  • Chasapi V; Department of Dermatology and Venereology NHS, Andreas Syggros Hospital, Athens, Greece.
  • Sfaelos K; Department of Dermatology, LEO Pharma Hellas, Kifissia, Greece.
  • Ioannides D; 1st Dermatology Department, Aristotle University, Medical School, Thessaloniki, Greece.
Dermatol Ther ; 35(12): e15886, 2022 12.
Article em En | MEDLINE | ID: mdl-36184757
ABSTRACT
Brodalumab's clinical efficacy and favorable safety profile have been demonstrated during controlled clinical trials, but real-world data remain scarce. BrIDGE, an ongoing 104 week, observational, prospective, multicenter study conducted in Greece, enrolled moderate-to-severe plaque psoriasis patients, with body surface area (BSA) > 10 or psoriasis area severity index score (PASI) > 10 and dermatology life quality index (DLQI) > 10, based on European consensus, initiating brodalumab treatment as per routine clinical practice. This interim analysis includes evaluations 12-16 weeks following treatment initiation. Key efficacy endpoints included proportion of patients achieving static Physician's Global Assessment (sPGA) score of "clear/almost clear" (0/1) and a reduction ≥75%, 90%, 100% from baseline in PASI (PASI75, PASI90, and PASI100) at weeks 12-16. Other endpoints included time to achieve PASI100, changes in self-reported DLQI and psoriasis symptom inventory (PSI) at weeks 12-16. From 200 patients (mean age 51.4 years, 70% male, mean disease duration 13.8 years) enrolled, 72.8% achieved sPGA of 0/1, whereas 70.2%, 47.5%, and 32.0% achieved corresponding PASI75, PASI90, and PASI100 responses following 12-16 weeks of brodalumab treatment, according to the "as-observed" analysis. The mean time to achieve PASI100 was 13.7 ± 1.2 weeks for the 32% who achieved PASI100. Concurrent decreases in mean DLQI and PSI were observed. Furthermore, 90% adherence to brodalumab was noted and nine adverse events were reported. Brodalumab confers substantial clinical improvements short-term as reflected by high levels of skin clearance in moderate-to-severe plaque psoriasis patients within 12-16 weeks of treatment under everyday clinical conditions, followed by improvements in symptoms and quality of life and a favorable safety profile.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Psoríase / Qualidade de Vida Tipo de estudo: Clinical_trials Limite: Female / Humans / Male / Middle aged País como assunto: Europa Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Psoríase / Qualidade de Vida Tipo de estudo: Clinical_trials Limite: Female / Humans / Male / Middle aged País como assunto: Europa Idioma: En Ano de publicação: 2022 Tipo de documento: Article