Cargando…

Real-world Efficacy and Safety of Apremilast Monotherapy in the Management of Moderate-to-severe Psoriasis

INTRODUCTION: Apremilast is the new oral drug in the management of moderate-to-severe plaque psoriasis with well-established effectiveness and safety in long-term clinical trials and a few real-world studies. However, its effectiveness and safety in Indian setup have not been reported yet. MATERIALS...

Descripción completa

Detalles Bibliográficos
Autores principales: Shah, Bela J., Mistry, Deval, Chaudhary, Navin, Shah, Shikha
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7001393/
https://www.ncbi.nlm.nih.gov/pubmed/32055509
http://dx.doi.org/10.4103/idoj.IDOJ_169_19
_version_ 1783494234895024128
author Shah, Bela J.
Mistry, Deval
Chaudhary, Navin
Shah, Shikha
author_facet Shah, Bela J.
Mistry, Deval
Chaudhary, Navin
Shah, Shikha
author_sort Shah, Bela J.
collection PubMed
description INTRODUCTION: Apremilast is the new oral drug in the management of moderate-to-severe plaque psoriasis with well-established effectiveness and safety in long-term clinical trials and a few real-world studies. However, its effectiveness and safety in Indian setup have not been reported yet. MATERIALS AND METHODS: This was retrospective, single-center, longitudinal, observational cohort study where the total study period was 24 weeks. Effectiveness parameters were the proportion of patients achieving psoriasis area and severity index (PASI) 50, 75, 90, and 100 response at week 16 and 24. Safety was measured as the proportion of patients reporting ≥1 adverse event (AE) during the study period. RESULTS: Data of a total of 70 patients were included in our study. At week 16, 76.92%, 41.53%, 15.38%, and 6.15% patients achieved PASI 50, 75, 90, and 100, respectively. At week 24, 81.53%, 58.46%, 29.23%, and 10.76% patients achieved PASI 50, 75, 90, and 100, respectively. Mean percentage reduction in PASI was 67% at week 24 and DLQI score was reduced significantly to 3.4 from mean baseline DLQI score of 10.8 (P < 0.001). 40% of patients reported ≥1 AE during the study period. 5 out of 70 patients discontinued apremilast due to AE. Nausea was most common AE reported by 21.4% patients followed by diarrhea (18.57%), headache (17.4%), vomiting (8%), weight loss (7.69%), myalgia (6.15%), and gastritis (6.15%). Most of the AEs were of mild-to-moderate severity. CONCLUSION: The results of this study support the long-term use of apremilast monotherapy as an efficacious and safe treatment option for the management of moderate-to-severe plaque psoriasis.
format Online
Article
Text
id pubmed-7001393
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Wolters Kluwer - Medknow
record_format MEDLINE/PubMed
spelling pubmed-70013932020-02-13 Real-world Efficacy and Safety of Apremilast Monotherapy in the Management of Moderate-to-severe Psoriasis Shah, Bela J. Mistry, Deval Chaudhary, Navin Shah, Shikha Indian Dermatol Online J Brief Report INTRODUCTION: Apremilast is the new oral drug in the management of moderate-to-severe plaque psoriasis with well-established effectiveness and safety in long-term clinical trials and a few real-world studies. However, its effectiveness and safety in Indian setup have not been reported yet. MATERIALS AND METHODS: This was retrospective, single-center, longitudinal, observational cohort study where the total study period was 24 weeks. Effectiveness parameters were the proportion of patients achieving psoriasis area and severity index (PASI) 50, 75, 90, and 100 response at week 16 and 24. Safety was measured as the proportion of patients reporting ≥1 adverse event (AE) during the study period. RESULTS: Data of a total of 70 patients were included in our study. At week 16, 76.92%, 41.53%, 15.38%, and 6.15% patients achieved PASI 50, 75, 90, and 100, respectively. At week 24, 81.53%, 58.46%, 29.23%, and 10.76% patients achieved PASI 50, 75, 90, and 100, respectively. Mean percentage reduction in PASI was 67% at week 24 and DLQI score was reduced significantly to 3.4 from mean baseline DLQI score of 10.8 (P < 0.001). 40% of patients reported ≥1 AE during the study period. 5 out of 70 patients discontinued apremilast due to AE. Nausea was most common AE reported by 21.4% patients followed by diarrhea (18.57%), headache (17.4%), vomiting (8%), weight loss (7.69%), myalgia (6.15%), and gastritis (6.15%). Most of the AEs were of mild-to-moderate severity. CONCLUSION: The results of this study support the long-term use of apremilast monotherapy as an efficacious and safe treatment option for the management of moderate-to-severe plaque psoriasis. Wolters Kluwer - Medknow 2020-01-13 /pmc/articles/PMC7001393/ /pubmed/32055509 http://dx.doi.org/10.4103/idoj.IDOJ_169_19 Text en Copyright: © 2020 Indian Dermatology Online Journal http://creativecommons.org/licenses/by-nc-sa/4.0 This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Brief Report
Shah, Bela J.
Mistry, Deval
Chaudhary, Navin
Shah, Shikha
Real-world Efficacy and Safety of Apremilast Monotherapy in the Management of Moderate-to-severe Psoriasis
title Real-world Efficacy and Safety of Apremilast Monotherapy in the Management of Moderate-to-severe Psoriasis
title_full Real-world Efficacy and Safety of Apremilast Monotherapy in the Management of Moderate-to-severe Psoriasis
title_fullStr Real-world Efficacy and Safety of Apremilast Monotherapy in the Management of Moderate-to-severe Psoriasis
title_full_unstemmed Real-world Efficacy and Safety of Apremilast Monotherapy in the Management of Moderate-to-severe Psoriasis
title_short Real-world Efficacy and Safety of Apremilast Monotherapy in the Management of Moderate-to-severe Psoriasis
title_sort real-world efficacy and safety of apremilast monotherapy in the management of moderate-to-severe psoriasis
topic Brief Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7001393/
https://www.ncbi.nlm.nih.gov/pubmed/32055509
http://dx.doi.org/10.4103/idoj.IDOJ_169_19
work_keys_str_mv AT shahbelaj realworldefficacyandsafetyofapremilastmonotherapyinthemanagementofmoderatetoseverepsoriasis
AT mistrydeval realworldefficacyandsafetyofapremilastmonotherapyinthemanagementofmoderatetoseverepsoriasis
AT chaudharynavin realworldefficacyandsafetyofapremilastmonotherapyinthemanagementofmoderatetoseverepsoriasis
AT shahshikha realworldefficacyandsafetyofapremilastmonotherapyinthemanagementofmoderatetoseverepsoriasis