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The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis
Apremilast is a novel agent for the treatment of inflammatory based autoimmune disorders. The objective of this study was to assess the pharmacokinetic effects of co administration of apremilast and methotrexate on both agents. This was an open-label, multi-center, 3-treatment period, sequential stu...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BlackWell Publishing Ltd
2014
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4467241/ https://www.ncbi.nlm.nih.gov/pubmed/26097790 http://dx.doi.org/10.1002/cpdd.109 |
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author | Liu, Yong Zhou, Simon Nissel, James Wu, Anfan Lau, Henry Palmisano, Maria |
author_facet | Liu, Yong Zhou, Simon Nissel, James Wu, Anfan Lau, Henry Palmisano, Maria |
author_sort | Liu, Yong |
collection | PubMed |
description | Apremilast is a novel agent for the treatment of inflammatory based autoimmune disorders. The objective of this study was to assess the pharmacokinetic effects of co administration of apremilast and methotrexate on both agents. This was an open-label, multi-center, 3-treatment period, sequential study conducted in otherwise healthy subjects with psoriatic arthritis or rheumatoid arthritis who were receiving a stable oral dose of methotrexate between 7.5 to 20 mg once weekly. Subjects received their dose of methotrexate on Days 1 and 8 of the study in addition to Apremilast 30 mg oral every 12 hours on Days 3–8. Pharmacokinectic profiles of methotrexate and 7-OH methotrexate were characterized after methotrexate alone (Day 1) and after co-administration of methotrexate and Apremilast (on Day 8). The pharmacokinetic profile of Apremilast was characterized after Apremilast alone (on Day 7) and after co-administration of methotrexate and Apremilast (on Day 8). The 90% confidence interval of the ratio of the geometric means for the C(max) and AUC parameters for methotrexate, 7-OH methotrexate, and Apremilast alone and after co-adminstration are all within the FDA acceptance range for equivalency (80–125%). This study showed that methotrexate and apremilast can be co-administered without any effect on the pharmacokinetic exposure of either agent. |
format | Online Article Text |
id | pubmed-4467241 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BlackWell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-44672412015-06-17 The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis Liu, Yong Zhou, Simon Nissel, James Wu, Anfan Lau, Henry Palmisano, Maria Clin Pharmacol Drug Dev Articles Apremilast is a novel agent for the treatment of inflammatory based autoimmune disorders. The objective of this study was to assess the pharmacokinetic effects of co administration of apremilast and methotrexate on both agents. This was an open-label, multi-center, 3-treatment period, sequential study conducted in otherwise healthy subjects with psoriatic arthritis or rheumatoid arthritis who were receiving a stable oral dose of methotrexate between 7.5 to 20 mg once weekly. Subjects received their dose of methotrexate on Days 1 and 8 of the study in addition to Apremilast 30 mg oral every 12 hours on Days 3–8. Pharmacokinectic profiles of methotrexate and 7-OH methotrexate were characterized after methotrexate alone (Day 1) and after co-administration of methotrexate and Apremilast (on Day 8). The pharmacokinetic profile of Apremilast was characterized after Apremilast alone (on Day 7) and after co-administration of methotrexate and Apremilast (on Day 8). The 90% confidence interval of the ratio of the geometric means for the C(max) and AUC parameters for methotrexate, 7-OH methotrexate, and Apremilast alone and after co-adminstration are all within the FDA acceptance range for equivalency (80–125%). This study showed that methotrexate and apremilast can be co-administered without any effect on the pharmacokinetic exposure of either agent. BlackWell Publishing Ltd 2014-11 2014-05-08 /pmc/articles/PMC4467241/ /pubmed/26097790 http://dx.doi.org/10.1002/cpdd.109 Text en © 2014 The Authors. Clinical Pharmacology in Drug Development Published by The American College of Clinical Pharmacology http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. |
spellingShingle | Articles Liu, Yong Zhou, Simon Nissel, James Wu, Anfan Lau, Henry Palmisano, Maria The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis |
title | The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis |
title_full | The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis |
title_fullStr | The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis |
title_full_unstemmed | The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis |
title_short | The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis |
title_sort | pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritis |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4467241/ https://www.ncbi.nlm.nih.gov/pubmed/26097790 http://dx.doi.org/10.1002/cpdd.109 |
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