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
© 2022 Wiley Periodicals LLC..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:35 |
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| Enthalten in: |
Dermatologic therapy - 35(2022), 12 vom: 01. Dez., Seite e15886 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rigopoulos, Dimitrios [VerfasserIn] |
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| Links: |
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| Themen: |
Antibodies, Monoclonal |
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| Anmerkungen: |
Date Completed 20.12.2022 Date Revised 20.03.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/dth.15886 |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Rigopoulos, Dimitrios |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Real world experience of brodalumab treatment in patients with moderate-to-severe plaque psoriasis in the Greek population |b Results from an interim analysis of the BrIDGE study |
| 264 | 1 | |c 2022 | |
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| 520 | |a © 2022 Wiley Periodicals LLC. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a brodalumab | |
| 650 | 4 | |a clinical response | |
| 650 | 4 | |a plaque psoriasis | |
| 650 | 4 | |a quality of life | |
| 650 | 4 | |a real-life | |
| 650 | 4 | |a safety | |
| 650 | 7 | |a Antibodies, Monoclonal |2 NLM | |
| 700 | 1 | |a Angelakopoulos, Charalampos |e verfasserin |4 aut | |
| 700 | 1 | |a Apalla, Zoi |e verfasserin |4 aut | |
| 700 | 1 | |a Georgiou, Sophia |e verfasserin |4 aut | |
| 700 | 1 | |a Delli, Florentina |e verfasserin |4 aut | |
| 700 | 1 | |a Drosos, Alexandros |e verfasserin |4 aut | |
| 700 | 1 | |a Zafiriou, Efterpi |e verfasserin |4 aut | |
| 700 | 1 | |a Katsantonis, John |e verfasserin |4 aut | |
| 700 | 1 | |a Lazaridou, Elisavet |e verfasserin |4 aut | |
| 700 | 1 | |a Panagakis, Pantelis |e verfasserin |4 aut | |
| 700 | 1 | |a Papadavid, Evangelia |e verfasserin |4 aut | |
| 700 | 1 | |a Papakonstantis, Markos |e verfasserin |4 aut | |
| 700 | 1 | |a Roussaki-Schulze, Angeliki-Viktoria |e verfasserin |4 aut | |
| 700 | 1 | |a Sotiriou, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Anastasiadis, Georgios |e verfasserin |4 aut | |
| 700 | 1 | |a Tampouratzi, Eleftheria |e verfasserin |4 aut | |
| 700 | 1 | |a Chasapi, Vasiliki |e verfasserin |4 aut | |
| 700 | 1 | |a Sfaelos, Konstantinos |e verfasserin |4 aut | |
| 700 | 1 | |a Ioannides, Dimitrios |e verfasserin |4 aut | |
| 700 | 0 | |a BrIDGE Study Group |e verfasserin |4 aut | |
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