Cargando…

Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe

INTRODUCTION: The broad and sustained efficacy of apremilast for psoriasis has been demonstrated in randomized and real-world observational studies. Data from Central and Eastern Europe (CEE) are lacking. Moreover, apremilast use in this region is limited by country-specific reimbursement criteria....

Descripción completa

Detalles Bibliográficos
Autores principales: Cetkovská, Petra, Dediol, Iva, Šola, Marija, Kojanová, Martina, Trčko, Katarina, Čarija, Antoanela, Čeović, Romana, Ledić-Drvar, Daniela, Kaštelan, Marija, Hrabar, Andina, Missoup, Myriam Cordey, Mamun, Khalid
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9979124/
https://www.ncbi.nlm.nih.gov/pubmed/36862361
http://dx.doi.org/10.1007/s12325-023-02468-3
_version_ 1784899659741790208
author Cetkovská, Petra
Dediol, Iva
Šola, Marija
Kojanová, Martina
Trčko, Katarina
Čarija, Antoanela
Čeović, Romana
Ledić-Drvar, Daniela
Kaštelan, Marija
Hrabar, Andina
Missoup, Myriam Cordey
Mamun, Khalid
author_facet Cetkovská, Petra
Dediol, Iva
Šola, Marija
Kojanová, Martina
Trčko, Katarina
Čarija, Antoanela
Čeović, Romana
Ledić-Drvar, Daniela
Kaštelan, Marija
Hrabar, Andina
Missoup, Myriam Cordey
Mamun, Khalid
author_sort Cetkovská, Petra
collection PubMed
description INTRODUCTION: The broad and sustained efficacy of apremilast for psoriasis has been demonstrated in randomized and real-world observational studies. Data from Central and Eastern Europe (CEE) are lacking. Moreover, apremilast use in this region is limited by country-specific reimbursement criteria. This is the first study to report data on the real-world use of apremilast in the region. METHODS: APPRECIATE (NCT02740218) was an observational, retrospective, cross-sectional study assessing psoriasis patients 6 (± 1) months after apremilast treatment initiation. The study aimed to describe the characteristics of patients with psoriasis receiving apremilast, estimate treatment outcomes, including Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), and Dermatology Life Quality Index (DLQI), and assess dermatologists' and patients' perspectives on treatment using questionnaires including the Patient Benefit Index (PBI). Adverse event reports were taken from the medical records. RESULTS: Fifty patients (Croatia: 25; Czech Republic: 20; Slovenia: 5) were enrolled. In patients continuing apremilast at 6 (± 1) months, mean (± SD) PASI score was reduced from 16.2 ± 8.7 points at treatment initiation to 3.1 ± 5.2 at 6 (± 1) months; BSA from 11.9% ± 10.3% to 0.8% ± 0.9%; DLQI from 13.7 ± 7.4 points to 1.6 ± 3.2. PASI 75 was reached by 81% of patients. Physicians reported that the overall treatment success fulfilled their expectations in more than two thirds of patients (68%). At least three-quarters of patients reported apremilast had a quite or very high benefit on the needs they identified as being most important. Apremilast was well tolerated; no serious or fatal adverse events were identified. CONCLUSION: Apremilast was effective in reducing skin involvement and improving quality of life in CEE patients having severe disease. Treatment satisfaction among physicians and patients was very high. These data add to the growing body of evidence showing consistent effectiveness of apremilast across the continuum of psoriasis disease severity and manifestations. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02740218. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-023-02468-3.
format Online
Article
Text
id pubmed-9979124
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-99791242023-03-02 Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe Cetkovská, Petra Dediol, Iva Šola, Marija Kojanová, Martina Trčko, Katarina Čarija, Antoanela Čeović, Romana Ledić-Drvar, Daniela Kaštelan, Marija Hrabar, Andina Missoup, Myriam Cordey Mamun, Khalid Adv Ther Original Research INTRODUCTION: The broad and sustained efficacy of apremilast for psoriasis has been demonstrated in randomized and real-world observational studies. Data from Central and Eastern Europe (CEE) are lacking. Moreover, apremilast use in this region is limited by country-specific reimbursement criteria. This is the first study to report data on the real-world use of apremilast in the region. METHODS: APPRECIATE (NCT02740218) was an observational, retrospective, cross-sectional study assessing psoriasis patients 6 (± 1) months after apremilast treatment initiation. The study aimed to describe the characteristics of patients with psoriasis receiving apremilast, estimate treatment outcomes, including Psoriasis Area Severity Index (PASI), Body Surface Area (BSA), and Dermatology Life Quality Index (DLQI), and assess dermatologists' and patients' perspectives on treatment using questionnaires including the Patient Benefit Index (PBI). Adverse event reports were taken from the medical records. RESULTS: Fifty patients (Croatia: 25; Czech Republic: 20; Slovenia: 5) were enrolled. In patients continuing apremilast at 6 (± 1) months, mean (± SD) PASI score was reduced from 16.2 ± 8.7 points at treatment initiation to 3.1 ± 5.2 at 6 (± 1) months; BSA from 11.9% ± 10.3% to 0.8% ± 0.9%; DLQI from 13.7 ± 7.4 points to 1.6 ± 3.2. PASI 75 was reached by 81% of patients. Physicians reported that the overall treatment success fulfilled their expectations in more than two thirds of patients (68%). At least three-quarters of patients reported apremilast had a quite or very high benefit on the needs they identified as being most important. Apremilast was well tolerated; no serious or fatal adverse events were identified. CONCLUSION: Apremilast was effective in reducing skin involvement and improving quality of life in CEE patients having severe disease. Treatment satisfaction among physicians and patients was very high. These data add to the growing body of evidence showing consistent effectiveness of apremilast across the continuum of psoriasis disease severity and manifestations. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02740218. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-023-02468-3. Springer Healthcare 2023-03-02 2023 /pmc/articles/PMC9979124/ /pubmed/36862361 http://dx.doi.org/10.1007/s12325-023-02468-3 Text en © The Author(s) 2023 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
Cetkovská, Petra
Dediol, Iva
Šola, Marija
Kojanová, Martina
Trčko, Katarina
Čarija, Antoanela
Čeović, Romana
Ledić-Drvar, Daniela
Kaštelan, Marija
Hrabar, Andina
Missoup, Myriam Cordey
Mamun, Khalid
Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe
title Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe
title_full Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe
title_fullStr Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe
title_full_unstemmed Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe
title_short Apremilast Use in Severe Psoriasis: Real-World Data from Central and Eastern Europe
title_sort apremilast use in severe psoriasis: real-world data from central and eastern europe
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9979124/
https://www.ncbi.nlm.nih.gov/pubmed/36862361
http://dx.doi.org/10.1007/s12325-023-02468-3
work_keys_str_mv AT cetkovskapetra apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT dedioliva apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT solamarija apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT kojanovamartina apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT trckokatarina apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT carijaantoanela apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT ceovicromana apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT ledicdrvardaniela apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT kastelanmarija apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT hrabarandina apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT missoupmyriamcordey apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope
AT mamunkhalid apremilastuseinseverepsoriasisrealworlddatafromcentralandeasterneurope