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Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data

BACKGROUND:  The efficacy and safety of secukinumab in patients with psoriasis has been established in randomised clinical trials. However, data on effectiveness and safety of secukinumab in Latin American real-world settings are scarce. OBJECTIVES: To evaluate the effectiveness and safety of secuki...

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Autores principales: Papp, Kim A., Gooderham, Melinda, Dei-Cas, Ignacio, LopezTello, Adriana, Garcia-Rodriguez, Juan C., Taveras, Carmen Yris, Rousselin, Azucena Hernández, Lavieri, Alberto, Maiolino, Mónica, Quintero, Delfina Guadalupe Villanueva, Rihakova, Lenka, Salibe, Mariano, Pertuz, Wilfran
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9823177/
https://www.ncbi.nlm.nih.gov/pubmed/36496547
http://dx.doi.org/10.1007/s13555-022-00849-0
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author Papp, Kim A.
Gooderham, Melinda
Dei-Cas, Ignacio
LopezTello, Adriana
Garcia-Rodriguez, Juan C.
Taveras, Carmen Yris
Rousselin, Azucena Hernández
Lavieri, Alberto
Maiolino, Mónica
Quintero, Delfina Guadalupe Villanueva
Rihakova, Lenka
Salibe, Mariano
Pertuz, Wilfran
author_facet Papp, Kim A.
Gooderham, Melinda
Dei-Cas, Ignacio
LopezTello, Adriana
Garcia-Rodriguez, Juan C.
Taveras, Carmen Yris
Rousselin, Azucena Hernández
Lavieri, Alberto
Maiolino, Mónica
Quintero, Delfina Guadalupe Villanueva
Rihakova, Lenka
Salibe, Mariano
Pertuz, Wilfran
author_sort Papp, Kim A.
collection PubMed
description BACKGROUND:  The efficacy and safety of secukinumab in patients with psoriasis has been established in randomised clinical trials. However, data on effectiveness and safety of secukinumab in Latin American real-world settings are scarce. OBJECTIVES: To evaluate the effectiveness and safety of secukinumab in real-world settings in patients with psoriasis in Latin America. METHODS: PURE is an ongoing multinational, prospective, observational study in patients with moderate-to-severe chronic plaque psoriasis in Canada and Latin America assessing the real-world safety and effectiveness of secukinumab and other approved therapies. The study enrolled (1:1) patients treated with secukinumab versus other approved therapies (other Tx) per local standard of care from 81 community- and hospital-based speciality sites (21 in Latin America). Here, we report effectiveness and safety outcomes with secukinumab and other Tx for plaque psoriasis for up to 12 months in a Latin American population. RESULTS: Overall, 187 patients were included in the analysis, 89 of whom initiated secukinumab treatment and 98 of whom received other Tx. At month 12, 84.4%, 71.1% and 53.3% of patients treated with secukinumab achieved Psoriasis Area and Severity Index (PASI) 75/90/100, respectively, compared with 66.7%, 47.9% and 29.2% of patients who received other Tx. Investigator Global Assessment (IGA) 0/1 responders in secukinumab versus other Tx were 78.3% versus 36.7% at month 3 and 81.8% versus 66.7% at month 12, respectively. Overall, the proportion of patients achieving Dermatology Life Quality Index (DLQI) 0/1 improved from 6.9% at baseline to 76.5% at month 12 in patients treated with secukinumab versus 5.6% at baseline to 54.5% at month 12 in patients on other Tx. No unexpected adverse events were reported during the 12-month observation period. CONCLUSION: Secukinumab demonstrated real-world effectiveness and improved dermatology quality-of-life in chronic plaque psoriasis patients from Latin America. TRIAL REGISTRATION: PURE: NCT02786186. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-022-00849-0.
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spelling pubmed-98231772023-01-08 Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data Papp, Kim A. Gooderham, Melinda Dei-Cas, Ignacio LopezTello, Adriana Garcia-Rodriguez, Juan C. Taveras, Carmen Yris Rousselin, Azucena Hernández Lavieri, Alberto Maiolino, Mónica Quintero, Delfina Guadalupe Villanueva Rihakova, Lenka Salibe, Mariano Pertuz, Wilfran Dermatol Ther (Heidelb) Original Research BACKGROUND:  The efficacy and safety of secukinumab in patients with psoriasis has been established in randomised clinical trials. However, data on effectiveness and safety of secukinumab in Latin American real-world settings are scarce. OBJECTIVES: To evaluate the effectiveness and safety of secukinumab in real-world settings in patients with psoriasis in Latin America. METHODS: PURE is an ongoing multinational, prospective, observational study in patients with moderate-to-severe chronic plaque psoriasis in Canada and Latin America assessing the real-world safety and effectiveness of secukinumab and other approved therapies. The study enrolled (1:1) patients treated with secukinumab versus other approved therapies (other Tx) per local standard of care from 81 community- and hospital-based speciality sites (21 in Latin America). Here, we report effectiveness and safety outcomes with secukinumab and other Tx for plaque psoriasis for up to 12 months in a Latin American population. RESULTS: Overall, 187 patients were included in the analysis, 89 of whom initiated secukinumab treatment and 98 of whom received other Tx. At month 12, 84.4%, 71.1% and 53.3% of patients treated with secukinumab achieved Psoriasis Area and Severity Index (PASI) 75/90/100, respectively, compared with 66.7%, 47.9% and 29.2% of patients who received other Tx. Investigator Global Assessment (IGA) 0/1 responders in secukinumab versus other Tx were 78.3% versus 36.7% at month 3 and 81.8% versus 66.7% at month 12, respectively. Overall, the proportion of patients achieving Dermatology Life Quality Index (DLQI) 0/1 improved from 6.9% at baseline to 76.5% at month 12 in patients treated with secukinumab versus 5.6% at baseline to 54.5% at month 12 in patients on other Tx. No unexpected adverse events were reported during the 12-month observation period. CONCLUSION: Secukinumab demonstrated real-world effectiveness and improved dermatology quality-of-life in chronic plaque psoriasis patients from Latin America. TRIAL REGISTRATION: PURE: NCT02786186. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-022-00849-0. Springer Healthcare 2022-12-10 /pmc/articles/PMC9823177/ /pubmed/36496547 http://dx.doi.org/10.1007/s13555-022-00849-0 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Papp, Kim A.
Gooderham, Melinda
Dei-Cas, Ignacio
LopezTello, Adriana
Garcia-Rodriguez, Juan C.
Taveras, Carmen Yris
Rousselin, Azucena Hernández
Lavieri, Alberto
Maiolino, Mónica
Quintero, Delfina Guadalupe Villanueva
Rihakova, Lenka
Salibe, Mariano
Pertuz, Wilfran
Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data
title Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data
title_full Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data
title_fullStr Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data
title_full_unstemmed Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data
title_short Effectiveness and Safety of Secukinumab in Latin American Patients with Moderate to Severe Plaque Psoriasis: PURE Registry 12-Month Data
title_sort effectiveness and safety of secukinumab in latin american patients with moderate to severe plaque psoriasis: pure registry 12-month data
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9823177/
https://www.ncbi.nlm.nih.gov/pubmed/36496547
http://dx.doi.org/10.1007/s13555-022-00849-0
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