Management of Moderate to Severe Plaque Psoriasis with
Brodalumab in Daily Practice: Real-World Evidence from the
LIBERO Study in the Czech Republic

J 2024

Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic

GKALPAKIOTIS, Spyridon, Martina KOJANOVA, Jorga FIALOVA, Petra CETKOVSKA, Vladimír VAŠKŮ et. al.

Základní údaje

Originální název

Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic

Autoři

GKALPAKIOTIS, Spyridon (203 Česká republika, garant), Martina KOJANOVA (203 Česká republika), Jorga FIALOVA (203 Česká republika), Petra CETKOVSKA (203 Česká republika), Vladimír VAŠKŮ (203 Česká republika, domácí), Yvetta VANTUCHOVA (203 Česká republika), Alena MACHOVCOVA (203 Česká republika), Petra GKALPAKIOTI (203 Česká republika), Pavla HRDA (203 Česká republika) a Petr ARENBERGER (203 Česká republika)

Vydání

DERMATOLOGY AND THERAPY, AUCKLAND, ADIS INT LTD, 2024, 2193-8210

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30216 Dermatology and venereal diseases

Stát vydavatele

Nový Zéland

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.400 v roce 2022

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1007/s13555-023-01066-z

UT WoS

001111465900001

Klíčová slova anglicky

Brodalumab; Biological therapy; LIBERO; Non-interventional study; Plaque psoriasis; Real-world evidence

Štítky

14110125, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 12. 7. 2024 13:40, Mgr. Tereza Miškechová

Anotace

V originále

IntroductionPsoriasis is a chronic, immune-mediated inflammatory skin disease. Despite the availability of several therapies, many patients affected by this disease remain untreated, do not have adequate response, or suffer from treatment-related toxic effects. It has been shown that the interleukin (IL)-17 pathway plays a key role in the immunopathogenesis of psoriasis. Brodalumab, the first human monoclonal IgG2 antibody that selectively binds to subunit A of the human IL-17 receptor, blocking interactions with a number of cytokines of the IL-17 family, has confirmed fast onset of action, high complete clearance rates, and sustained efficacy. Nevertheless, there is only a limited amount of published real-world evidence (RWE) data.MethodsThis was an open-label, multicenter, real-world, prospective, non-interventional, non-controlled (single-arm) observational study (LIBERO-CZ) assessing the management of moderate to severe psoriasis with brodalumab in daily practice for up to 52 weeks of treatment.ResultsFifty-four patients (70.4% male, mean age 46.9 +/- 13.4 years, weight 95.6 +/- 22.7 kg, disease duration 18.6 +/- 12.7 years) were enrolled and included in the final analysis. Forty-nine of the patients completed the study and five discontinued prematurely; 51.8% of all the enrolled patients were biologic-naive. At baseline, 28% patients were classified as severe (psoriasis area severity index (PASI) >= 20). Overall, the mean PASI decreased by 15.6 from 16.1 (+/- 5.0) at baseline to 0.5 (+/- 1.2) at the last visit. The primary endpoint of an absolute PASI <= 3 at week 12 (as observed analysis) was achieved by 95.9% of patients. The static Physician's Global Assessment (sPGA) success (defined as clear = 0 and almost clear = 1) at week 52 was achieved by 92.1% of patients. PASI 75, PASI 90, and PASI 100 were achieved by 98.0%, 87.8%, and 75.5% of patients, respectively, after approximately 52 weeks of treatment. The study also recorded very positive results concerning patient-reported outcomes.ConclusionsLIBERO-CZ confirms the fast onset and high clearance rates of brodalumab in real life in both biologic-naive and biologic-experienced patients.

Citovat

GKALPAKIOTIS, Spyridon, Martina KOJANOVA, Jorga FIALOVA, Petra CETKOVSKA, Vladimír VAŠKŮ, Yvetta VANTUCHOVA, Alena MACHOVCOVA, Petra GKALPAKIOTI, Pavla HRDA a Petr ARENBERGER. Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic. DERMATOLOGY AND THERAPY. AUCKLAND: ADIS INT LTD, 2024, roč. 14, č. 1, s. 115-130. ISSN 2193-8210. Dostupné z: https://dx.doi.org/10.1007/s13555-023-01066-z.

@article{2368008,
   author = {Gkalpakiotis, Spyridon and Kojanova, Martina and Fialova, Jorga and Cetkovska, Petra and Vašků, Vladimír and Vantuchova, Yvetta and Machovcova, Alena and Gkalpakioti, Petra and Hrda, Pavla and Arenberger, Petr},
   article_location = {AUCKLAND},
   article_number = {1},
   doi = {http://dx.doi.org/10.1007/s13555-023-01066-z},
   keywords = {Brodalumab; Biological therapy; LIBERO; Non-interventional study; Plaque psoriasis; Real-world evidence},
   language = {eng},
   issn = {2193-8210},
   journal = {DERMATOLOGY AND THERAPY},
   title = {Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic},
   url = {https://link.springer.com/article/10.1007/s13555-023-01066-z},
   volume = {14},
   year = {2024}
}

TY  - JOUR
ID  - 2368008
AU  - Gkalpakiotis, Spyridon - Kojanova, Martina - Fialova, Jorga - Cetkovska, Petra - Vašků, Vladimír - Vantuchova, Yvetta - Machovcova, Alena - Gkalpakioti, Petra - Hrda, Pavla - Arenberger, Petr
PY  - 2024
TI  - Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic
JF  - DERMATOLOGY AND THERAPY
VL  - 14
IS  - 1
SP  - 115-130
EP  - 115-130
PB  - ADIS INT LTD
SN  - 21938210
KW  - Brodalumab
KW  - Biological therapy
KW  - LIBERO
KW  - Non-interventional study
KW  - Plaque psoriasis
KW  - Real-world evidence
UR  - https://link.springer.com/article/10.1007/s13555-023-01066-z
N2  - IntroductionPsoriasis is a chronic, immune-mediated inflammatory skin disease. Despite the availability of several therapies, many patients affected by this disease remain untreated, do not have adequate response, or suffer from treatment-related toxic effects. It has been shown that the interleukin (IL)-17 pathway plays a key role in the immunopathogenesis of psoriasis. Brodalumab, the first human monoclonal IgG2 antibody that selectively binds to subunit A of the human IL-17 receptor, blocking interactions with a number of cytokines of the IL-17 family, has confirmed fast onset of action, high complete clearance rates, and sustained efficacy. Nevertheless, there is only a limited amount of published real-world evidence (RWE) data.MethodsThis was an open-label, multicenter, real-world, prospective, non-interventional, non-controlled (single-arm) observational study (LIBERO-CZ) assessing the management of moderate to severe psoriasis with brodalumab in daily practice for up to 52 weeks of treatment.ResultsFifty-four patients (70.4% male, mean age 46.9 +/- 13.4 years, weight 95.6 +/- 22.7 kg, disease duration 18.6 +/- 12.7 years) were enrolled and included in the final analysis. Forty-nine of the patients completed the study and five discontinued prematurely; 51.8% of all the enrolled patients were biologic-naive. At baseline, 28% patients were classified as severe (psoriasis area severity index (PASI) >= 20). Overall, the mean PASI decreased by 15.6 from 16.1 (+/- 5.0) at baseline to 0.5 (+/- 1.2) at the last visit. The primary endpoint of an absolute PASI <= 3 at week 12 (as observed analysis) was achieved by 95.9% of patients. The static Physician's Global Assessment (sPGA) success (defined as clear = 0 and almost clear = 1) at week 52 was achieved by 92.1% of patients. PASI 75, PASI 90, and PASI 100 were achieved by 98.0%, 87.8%, and 75.5% of patients, respectively, after approximately 52 weeks of treatment. The study also recorded very positive results concerning patient-reported outcomes.ConclusionsLIBERO-CZ confirms the fast onset and high clearance rates of brodalumab in real life in both biologic-naive and biologic-experienced patients.
ER  -

GKALPAKIOTIS, Spyridon, Martina KOJANOVA, Jorga FIALOVA, Petra CETKOVSKA, Vladimír VAŠKŮ, Yvetta VANTUCHOVA, Alena MACHOVCOVA, Petra GKALPAKIOTI, Pavla HRDA a Petr ARENBERGER. Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic. \textit{DERMATOLOGY AND THERAPY}. AUCKLAND: ADIS INT LTD, 2024, roč.~14, č.~1, s.~115-130. ISSN~2193-8210. Dostupné z: https://dx.doi.org/10.1007/s13555-023-01066-z.

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