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Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy

Although corticosteroids are currently the first-choice drug for thyroid eye disease (TED), in 20–30% of cases, patients show poor or non-existent responses, and when the drug is withdrawn, 10–20% of patients relapse. Thus, in this study, we aimed to investigate the efficacy of the combined use of m...

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Autores principales: Rajabi, Mohammad Taher, Rafizadeh, Seyed Mohsen, Mohammadi, Abbas, Eshraghi, Bahram, Mohammadi, Nader, Hosseini, Seyedeh Simindokht, Rajabi, Mohammad Bagher, Keshmirshekan, Mohammad Mohsen, Shahriari, Mansoor, Poursayed Lazarjani, Seyedeh Zahra, Parandin, Mohammad Mehdi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8873183/
https://www.ncbi.nlm.nih.gov/pubmed/35223896
http://dx.doi.org/10.3389/fmed.2022.788228
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author Rajabi, Mohammad Taher
Rafizadeh, Seyed Mohsen
Mohammadi, Abbas
Eshraghi, Bahram
Mohammadi, Nader
Hosseini, Seyedeh Simindokht
Rajabi, Mohammad Bagher
Keshmirshekan, Mohammad Mohsen
Shahriari, Mansoor
Poursayed Lazarjani, Seyedeh Zahra
Parandin, Mohammad Mehdi
author_facet Rajabi, Mohammad Taher
Rafizadeh, Seyed Mohsen
Mohammadi, Abbas
Eshraghi, Bahram
Mohammadi, Nader
Hosseini, Seyedeh Simindokht
Rajabi, Mohammad Bagher
Keshmirshekan, Mohammad Mohsen
Shahriari, Mansoor
Poursayed Lazarjani, Seyedeh Zahra
Parandin, Mohammad Mehdi
author_sort Rajabi, Mohammad Taher
collection PubMed
description Although corticosteroids are currently the first-choice drug for thyroid eye disease (TED), in 20–30% of cases, patients show poor or non-existent responses, and when the drug is withdrawn, 10–20% of patients relapse. Thus, in this study, we aimed to investigate the efficacy of the combined use of mycophenolate mofetil (CellCept®) and low dose oral prednisolone in patients with moderate to severe Graves' orbitopathy (GO). For the first time, we investigated the relationship between TED-related parameters and proptosis reduction. In a prospective, non-randomized, interventional case series, 242 patients with moderate-to-severe GO were, assigned to receive oral prednisolone (5 mg/ d) and mycophenolate mofetil (CellCept®) (one 500 mg tablet twice per day according to the therapeutic response). The patients were monitored regularly during the 3rd, 6th, 12th, and 18th month of treatment. The main outcome measures were the clinical activity score (CAS), intraocular pressure (IOP), diplopia, proptosis and visual acuity. We also assessed the relationship between the main outcomes with proptosis changes and time to improvement (months). Adverse effects were recorded during each visit. The clinical response rate increased from 67.7% on the third month to 89.2% on the sixth month, and 94.2% on the 12th month. This therapeutic response continued until the 18th month of follow-up. The CAS responses [disease inactivation (CAS <3)] improved during our study: 70.6% on the third month, 90.0% on the sixth month, and 92.5% at 12th month. These conditions continued until the 18th month of follow-up. Proptosis improvement was 52% on the third month, 71% on the sixth month, 83% on the 12th month, and 87.1% on the 18th month. Changes in IOP and visual acuity were not significant (P = 0.568 and 0.668, respectively). The patient showed significant improvement in the Gorman score. A Shorter duration of treatment was seen in patients with earlier onset of intervention, younger age, and lack of all extraocular muscle (EOM) enlargement on computed tomography (CT) scan (p < 0.05). In addition, a better response (more reduction) in proptosis was related to: younger age at disease, earlier treatment intervention (less interval from the time the diagnosis of moderate-to-severe GO was made until medication initiation), shorter treatment time (less time to improvement), less IOP, lack of EOM enlargement on CT scan, and lack of diplopia (P < 0.05). Adverse events occurred in six patients. Findings show that mycophenolate mofetil (CellCept®) plus low-dose prednisolone can be introduced as a new optimal dosing regimen in GO due to its better effect on chronic complications such as proptosis and diplopia.
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spelling pubmed-88731832022-02-26 Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy Rajabi, Mohammad Taher Rafizadeh, Seyed Mohsen Mohammadi, Abbas Eshraghi, Bahram Mohammadi, Nader Hosseini, Seyedeh Simindokht Rajabi, Mohammad Bagher Keshmirshekan, Mohammad Mohsen Shahriari, Mansoor Poursayed Lazarjani, Seyedeh Zahra Parandin, Mohammad Mehdi Front Med (Lausanne) Medicine Although corticosteroids are currently the first-choice drug for thyroid eye disease (TED), in 20–30% of cases, patients show poor or non-existent responses, and when the drug is withdrawn, 10–20% of patients relapse. Thus, in this study, we aimed to investigate the efficacy of the combined use of mycophenolate mofetil (CellCept®) and low dose oral prednisolone in patients with moderate to severe Graves' orbitopathy (GO). For the first time, we investigated the relationship between TED-related parameters and proptosis reduction. In a prospective, non-randomized, interventional case series, 242 patients with moderate-to-severe GO were, assigned to receive oral prednisolone (5 mg/ d) and mycophenolate mofetil (CellCept®) (one 500 mg tablet twice per day according to the therapeutic response). The patients were monitored regularly during the 3rd, 6th, 12th, and 18th month of treatment. The main outcome measures were the clinical activity score (CAS), intraocular pressure (IOP), diplopia, proptosis and visual acuity. We also assessed the relationship between the main outcomes with proptosis changes and time to improvement (months). Adverse effects were recorded during each visit. The clinical response rate increased from 67.7% on the third month to 89.2% on the sixth month, and 94.2% on the 12th month. This therapeutic response continued until the 18th month of follow-up. The CAS responses [disease inactivation (CAS <3)] improved during our study: 70.6% on the third month, 90.0% on the sixth month, and 92.5% at 12th month. These conditions continued until the 18th month of follow-up. Proptosis improvement was 52% on the third month, 71% on the sixth month, 83% on the 12th month, and 87.1% on the 18th month. Changes in IOP and visual acuity were not significant (P = 0.568 and 0.668, respectively). The patient showed significant improvement in the Gorman score. A Shorter duration of treatment was seen in patients with earlier onset of intervention, younger age, and lack of all extraocular muscle (EOM) enlargement on computed tomography (CT) scan (p < 0.05). In addition, a better response (more reduction) in proptosis was related to: younger age at disease, earlier treatment intervention (less interval from the time the diagnosis of moderate-to-severe GO was made until medication initiation), shorter treatment time (less time to improvement), less IOP, lack of EOM enlargement on CT scan, and lack of diplopia (P < 0.05). Adverse events occurred in six patients. Findings show that mycophenolate mofetil (CellCept®) plus low-dose prednisolone can be introduced as a new optimal dosing regimen in GO due to its better effect on chronic complications such as proptosis and diplopia. Frontiers Media S.A. 2022-02-11 /pmc/articles/PMC8873183/ /pubmed/35223896 http://dx.doi.org/10.3389/fmed.2022.788228 Text en Copyright © 2022 Rajabi, Rafizadeh, Mohammadi, Eshraghi, Mohammadi, Hosseini, Rajabi, Keshmirshekan, Shahriari, Poursayed Lazarjani and Parandin. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Rajabi, Mohammad Taher
Rafizadeh, Seyed Mohsen
Mohammadi, Abbas
Eshraghi, Bahram
Mohammadi, Nader
Hosseini, Seyedeh Simindokht
Rajabi, Mohammad Bagher
Keshmirshekan, Mohammad Mohsen
Shahriari, Mansoor
Poursayed Lazarjani, Seyedeh Zahra
Parandin, Mohammad Mehdi
Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy
title Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy
title_full Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy
title_fullStr Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy
title_full_unstemmed Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy
title_short Mycophenolate Mofetil (CellCept®) in Combination With Low Dose Prednisolone in Moderate to Severe Graves' Orbitopathy
title_sort mycophenolate mofetil (cellcept®) in combination with low dose prednisolone in moderate to severe graves' orbitopathy
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8873183/
https://www.ncbi.nlm.nih.gov/pubmed/35223896
http://dx.doi.org/10.3389/fmed.2022.788228
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