The role of concomitant methotrexate dosage and maintenance over time in the therapy of rheumatoid arthritis patients treated with adalimumab or etanercept: retrospective analysis of a local registry
Ennio Giulio Favalli,1 Andrea Becciolini,1 Martina Biggioggero,2 Ilaria Bertoldi,3 Chiara Crotti,2 Maria Gabriella Raimondo,2 Antonio Marchesoni1 1Department of Rheumatology, Gaetano Pini Institute, Milan, Italy; 2Department of Clinical Sciences and Health Community, University of Milan, Division o...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2018-05-01
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| Series: | Drug Design, Development and Therapy |
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| Online Access: | https://www.dovepress.com/the-role-of-concomitant-methotrexate-dosage-and-maintenance-over-time--peer-reviewed-article-DDDT |
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| author | Favalli EG Becciolini A Biggioggero M Bertoldi I Crotti C Raimondo MG Marchesoni A |
| author_facet | Favalli EG Becciolini A Biggioggero M Bertoldi I Crotti C Raimondo MG Marchesoni A |
| author_sort | Favalli EG |
| collection | DOAJ |
| description | Ennio Giulio Favalli,1 Andrea Becciolini,1 Martina Biggioggero,2 Ilaria Bertoldi,3 Chiara Crotti,2 Maria Gabriella Raimondo,2 Antonio Marchesoni1 1Department of Rheumatology, Gaetano Pini Institute, Milan, Italy; 2Department of Clinical Sciences and Health Community, University of Milan, Division of Rheumatology, Gaetano Pini Institute, Milan, Italy; 3Pfizer Innovative Health, I&I Medical Affairs, Rome, Italy Objective: To evaluate the pattern of prescription and maintenance over time of concomitant methotrexate (MTX), and its impact on a 2-year clinical response in a cohort of rheumatoid arthritis (RA) patients treated with a first-line tumor necrosis factor alpha inhibitor (TNFi). Patients and methods: The study population included all RA patients receiving adalimumab or etanercept a as first-line biologic drug, extracted from a local registry. Enrolled patients were stratified into 3 subgroups according to baseline concomitant MTX: no MTX, low-dose MTX (≤10 mg/wk), and high-dose MTX (≥12.5 mg/wk). The 2-year persistence of the initial MTX regimen was computed by the Kaplan–Meier method, and a Cox proportional hazard model was developed to examine potential predictors of MTX withdrawal/change of dosage. European League Against Rheumatism remission and good-to-moderate response were evaluated according to baseline MTX regimen and MTX maintenance over time. Results: A total of 330 patients (163 treated with adalimumab and 167 with etanercept) were included; 141 were prescribed TNFi without MTX and 112 received low-dose and 77 high-dose concomitant MTX. Male sex, younger age, and shorter mean disease duration were predictors of high-dose MTX use. Among MTX users (76.2% parenteral and 23.8% oral), initial MTX dose persisted over time in 79.9% at 1 year and 70.2% at 2 years. Fifty-one patients (27%) underwent MTX dose de-escalation/discontinuation because of intolerance/adverse events. The 2-year EULAR remission rate was higher in the patients receiving and maintaining high-dose MTX than in those receiving low-dose or no MTX (46.2% vs 29.5% and 23.4%, respectively; p=0.009). The same was true for good-to-moderate response rate (71.2% vs 52.6% and 50.4%, respectively; p=0.031). Conclusion: In a real-life setting, about one-third of RA patients treated with TNFis experienced dose reduction/discontinuation of concomitant MTX because of intolerance/adverse events over a 2-year follow-up period. Initial high-dose MTX and its maintenance over time are associated with better 2-year clinical response. Keywords: rheumatoid arthritis, methotrexate, biologic drugs, combination therapy, etanercept, adalimumab |
| first_indexed | 2024-12-10T09:09:38Z |
| format | Article |
| id | doaj.art-40269ea0e95a40338f20c6a1ae3feb07 |
| institution | Directory Open Access Journal |
| issn | 1177-8881 |
| language | English |
| last_indexed | 2024-12-10T09:09:38Z |
| publishDate | 2018-05-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Drug Design, Development and Therapy |
| spelling | doaj.art-40269ea0e95a40338f20c6a1ae3feb072022-12-22T01:55:04ZengDove Medical PressDrug Design, Development and Therapy1177-88812018-05-01Volume 121421142938508The role of concomitant methotrexate dosage and maintenance over time in the therapy of rheumatoid arthritis patients treated with adalimumab or etanercept: retrospective analysis of a local registryFavalli EGBecciolini ABiggioggero MBertoldi ICrotti CRaimondo MGMarchesoni AEnnio Giulio Favalli,1 Andrea Becciolini,1 Martina Biggioggero,2 Ilaria Bertoldi,3 Chiara Crotti,2 Maria Gabriella Raimondo,2 Antonio Marchesoni1 1Department of Rheumatology, Gaetano Pini Institute, Milan, Italy; 2Department of Clinical Sciences and Health Community, University of Milan, Division of Rheumatology, Gaetano Pini Institute, Milan, Italy; 3Pfizer Innovative Health, I&I Medical Affairs, Rome, Italy Objective: To evaluate the pattern of prescription and maintenance over time of concomitant methotrexate (MTX), and its impact on a 2-year clinical response in a cohort of rheumatoid arthritis (RA) patients treated with a first-line tumor necrosis factor alpha inhibitor (TNFi). Patients and methods: The study population included all RA patients receiving adalimumab or etanercept a as first-line biologic drug, extracted from a local registry. Enrolled patients were stratified into 3 subgroups according to baseline concomitant MTX: no MTX, low-dose MTX (≤10 mg/wk), and high-dose MTX (≥12.5 mg/wk). The 2-year persistence of the initial MTX regimen was computed by the Kaplan–Meier method, and a Cox proportional hazard model was developed to examine potential predictors of MTX withdrawal/change of dosage. European League Against Rheumatism remission and good-to-moderate response were evaluated according to baseline MTX regimen and MTX maintenance over time. Results: A total of 330 patients (163 treated with adalimumab and 167 with etanercept) were included; 141 were prescribed TNFi without MTX and 112 received low-dose and 77 high-dose concomitant MTX. Male sex, younger age, and shorter mean disease duration were predictors of high-dose MTX use. Among MTX users (76.2% parenteral and 23.8% oral), initial MTX dose persisted over time in 79.9% at 1 year and 70.2% at 2 years. Fifty-one patients (27%) underwent MTX dose de-escalation/discontinuation because of intolerance/adverse events. The 2-year EULAR remission rate was higher in the patients receiving and maintaining high-dose MTX than in those receiving low-dose or no MTX (46.2% vs 29.5% and 23.4%, respectively; p=0.009). The same was true for good-to-moderate response rate (71.2% vs 52.6% and 50.4%, respectively; p=0.031). Conclusion: In a real-life setting, about one-third of RA patients treated with TNFis experienced dose reduction/discontinuation of concomitant MTX because of intolerance/adverse events over a 2-year follow-up period. Initial high-dose MTX and its maintenance over time are associated with better 2-year clinical response. Keywords: rheumatoid arthritis, methotrexate, biologic drugs, combination therapy, etanercept, adalimumabhttps://www.dovepress.com/the-role-of-concomitant-methotrexate-dosage-and-maintenance-over-time--peer-reviewed-article-DDDTrheumatoid arthritismethotrexatebiologic drugscombination therapyetanerceptadalimumab |
| spellingShingle | Favalli EG Becciolini A Biggioggero M Bertoldi I Crotti C Raimondo MG Marchesoni A The role of concomitant methotrexate dosage and maintenance over time in the therapy of rheumatoid arthritis patients treated with adalimumab or etanercept: retrospective analysis of a local registry Drug Design, Development and Therapy rheumatoid arthritis methotrexate biologic drugs combination therapy etanercept adalimumab |
| title | The role of concomitant methotrexate dosage and maintenance over time in the therapy of rheumatoid arthritis patients treated with adalimumab or etanercept: retrospective analysis of a local registry |
| title_full | The role of concomitant methotrexate dosage and maintenance over time in the therapy of rheumatoid arthritis patients treated with adalimumab or etanercept: retrospective analysis of a local registry |
| title_fullStr | The role of concomitant methotrexate dosage and maintenance over time in the therapy of rheumatoid arthritis patients treated with adalimumab or etanercept: retrospective analysis of a local registry |
| title_full_unstemmed | The role of concomitant methotrexate dosage and maintenance over time in the therapy of rheumatoid arthritis patients treated with adalimumab or etanercept: retrospective analysis of a local registry |
| title_short | The role of concomitant methotrexate dosage and maintenance over time in the therapy of rheumatoid arthritis patients treated with adalimumab or etanercept: retrospective analysis of a local registry |
| title_sort | role of concomitant methotrexate dosage and maintenance over time in the therapy of rheumatoid arthritis patients treated with adalimumab or etanercept retrospective analysis of a local registry |
| topic | rheumatoid arthritis methotrexate biologic drugs combination therapy etanercept adalimumab |
| url | https://www.dovepress.com/the-role-of-concomitant-methotrexate-dosage-and-maintenance-over-time--peer-reviewed-article-DDDT |
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