Methotrexate (MTX) Plus Hydroxychloroquine versus MTX Plus Leflunomide in Patients with MTX-Resistant Active Rheumatoid Arthritis: A 2-Year Cohort Study in Real World
Le Zhang,1,2,* Fangfang Chen,2,* Shikai Geng,2,* Xiaodong Wang,2 Liyang Gu,2 Yitian Lang,1 Ting Li,2 Shuang Ye2 1Department of Pharmacy, Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of China; 2Department of Rheumatology, Ren Ji Hospital, Sha...
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2020
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oai:doaj.org-article:11127d7c1f3147f9a2d41825654e3df02021-12-02T13:34:08ZMethotrexate (MTX) Plus Hydroxychloroquine versus MTX Plus Leflunomide in Patients with MTX-Resistant Active Rheumatoid Arthritis: A 2-Year Cohort Study in Real World1178-7031https://doaj.org/article/11127d7c1f3147f9a2d41825654e3df02020-12-01T00:00:00Zhttps://www.dovepress.com/methotrexate-mtx-plus-hydroxychloroquine-versus-mtx-plus-leflunomide-i-peer-reviewed-article-JIRhttps://doaj.org/toc/1178-7031Le Zhang,1,2,* Fangfang Chen,2,* Shikai Geng,2,* Xiaodong Wang,2 Liyang Gu,2 Yitian Lang,1 Ting Li,2 Shuang Ye2 1Department of Pharmacy, Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of China; 2Department of Rheumatology, Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of China*These authors contributed equally to this workCorrespondence: Shuang Ye; Ting LiDepartment of Rheumatology, Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of ChinaTel +86-2134506393Fax +86-2163363475Email ye_shuang2000@163.com; leeting007@163.comPurpose: To compare the efficacy, safety, and cost-effectiveness of methotrexate (MTX) plus hydroxychloroquine (HCQ) vs MTX plus leflunomide (LEF) in established rheumatoid arthritis (RA) with inadequate response to MTX monotherapy in a real-world Chinese cohort.Patients and Methods: A prospective RA cohort (n=549) was screened with eligible patients who had inadequate response (disease activity score in 28 joints using erythrocyte sedimentation rate, DAS28-ESR> 3.2) to initial MTX monotherapy and subsequently received either MTX+HCQ or MTX+LEF. Propensity score matching (PSM) was applied to adjust the possible baseline confounders between two groups. The primary outcome was the proportion of patients achieving first remission (DAS28-ESR< 2.6) during follow-up by log rank test. Secondary outcomes were changes of DAS28, glucocorticoids (GCs) exposure, safety, cost-effectiveness, sustained remission, and low disease activity (LDA) rate after 24-month follow-up.Results: Overall, 222 eligible patients were subjected to the aforementioned two treatment protocols (MTX+HCQ, n=102; MTX+LEF, n=120). After PSM adjustment, 97 patients in each group were analyzed. A higher remission rate was observed in the MTX+HCQ group than in the MTX+LEF group (70.1% vs 56.7%, P=0.048). The median time to remission was 11 and 16 months in the two groups, respectively. At the endpoint, more patients achieved remission (46.8% vs 32.5%, P=0.063) and maintained sustained LDA in the HCQ group (53.2% vs 38.6%, P=0.062) and also more patients withdrew GCs in this group (32% vs 16.7%, P=0.053) than those in the LEF group. Safety profiles were non-alarming, with no significant difference between the two groups. The incremental cost-effectiveness ratio yielded by MTX+HCQ over MTX+LEF was $1,111.8 per quality-adjusted life-year (QALY), within the cost-effective threshold set as the per capita gross domestic product (GDP) of China.Conclusion: The MTX+HCQ combination was seemingly superior to MTX+LEF in a real-world cohort of Chinese RA patients with inadequate response to methotrexate monotherapy in respect of the efficacy and cost-effectiveness.Keywords: hydroxychloroquine, leflunomide, methotrexate-resistant, rheumatoid arthritis, efficacy, cost-effectivenessZhang LChen FGeng SWang XGu LLang YLi TYe SDove Medical Pressarticlehydroxychloroquineleflunomidemethotrexate-resistantrheumatoid arthritisefficacycost-effectivenessPathologyRB1-214Therapeutics. PharmacologyRM1-950ENJournal of Inflammation Research, Vol Volume 13, Pp 1141-1150 (2020) |
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DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
hydroxychloroquine leflunomide methotrexate-resistant rheumatoid arthritis efficacy cost-effectiveness Pathology RB1-214 Therapeutics. Pharmacology RM1-950 |
| spellingShingle |
hydroxychloroquine leflunomide methotrexate-resistant rheumatoid arthritis efficacy cost-effectiveness Pathology RB1-214 Therapeutics. Pharmacology RM1-950 Zhang L Chen F Geng S Wang X Gu L Lang Y Li T Ye S Methotrexate (MTX) Plus Hydroxychloroquine versus MTX Plus Leflunomide in Patients with MTX-Resistant Active Rheumatoid Arthritis: A 2-Year Cohort Study in Real World |
| description |
Le Zhang,1,2,* Fangfang Chen,2,* Shikai Geng,2,* Xiaodong Wang,2 Liyang Gu,2 Yitian Lang,1 Ting Li,2 Shuang Ye2 1Department of Pharmacy, Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of China; 2Department of Rheumatology, Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of China*These authors contributed equally to this workCorrespondence: Shuang Ye; Ting LiDepartment of Rheumatology, Ren Ji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, People’s Republic of ChinaTel +86-2134506393Fax +86-2163363475Email ye_shuang2000@163.com; leeting007@163.comPurpose: To compare the efficacy, safety, and cost-effectiveness of methotrexate (MTX) plus hydroxychloroquine (HCQ) vs MTX plus leflunomide (LEF) in established rheumatoid arthritis (RA) with inadequate response to MTX monotherapy in a real-world Chinese cohort.Patients and Methods: A prospective RA cohort (n=549) was screened with eligible patients who had inadequate response (disease activity score in 28 joints using erythrocyte sedimentation rate, DAS28-ESR> 3.2) to initial MTX monotherapy and subsequently received either MTX+HCQ or MTX+LEF. Propensity score matching (PSM) was applied to adjust the possible baseline confounders between two groups. The primary outcome was the proportion of patients achieving first remission (DAS28-ESR< 2.6) during follow-up by log rank test. Secondary outcomes were changes of DAS28, glucocorticoids (GCs) exposure, safety, cost-effectiveness, sustained remission, and low disease activity (LDA) rate after 24-month follow-up.Results: Overall, 222 eligible patients were subjected to the aforementioned two treatment protocols (MTX+HCQ, n=102; MTX+LEF, n=120). After PSM adjustment, 97 patients in each group were analyzed. A higher remission rate was observed in the MTX+HCQ group than in the MTX+LEF group (70.1% vs 56.7%, P=0.048). The median time to remission was 11 and 16 months in the two groups, respectively. At the endpoint, more patients achieved remission (46.8% vs 32.5%, P=0.063) and maintained sustained LDA in the HCQ group (53.2% vs 38.6%, P=0.062) and also more patients withdrew GCs in this group (32% vs 16.7%, P=0.053) than those in the LEF group. Safety profiles were non-alarming, with no significant difference between the two groups. The incremental cost-effectiveness ratio yielded by MTX+HCQ over MTX+LEF was $1,111.8 per quality-adjusted life-year (QALY), within the cost-effective threshold set as the per capita gross domestic product (GDP) of China.Conclusion: The MTX+HCQ combination was seemingly superior to MTX+LEF in a real-world cohort of Chinese RA patients with inadequate response to methotrexate monotherapy in respect of the efficacy and cost-effectiveness.Keywords: hydroxychloroquine, leflunomide, methotrexate-resistant, rheumatoid arthritis, efficacy, cost-effectiveness |
| format |
article |
| author |
Zhang L Chen F Geng S Wang X Gu L Lang Y Li T Ye S |
| author_facet |
Zhang L Chen F Geng S Wang X Gu L Lang Y Li T Ye S |
| author_sort |
Zhang L |
| title |
Methotrexate (MTX) Plus Hydroxychloroquine versus MTX Plus Leflunomide in Patients with MTX-Resistant Active Rheumatoid Arthritis: A 2-Year Cohort Study in Real World |
| title_short |
Methotrexate (MTX) Plus Hydroxychloroquine versus MTX Plus Leflunomide in Patients with MTX-Resistant Active Rheumatoid Arthritis: A 2-Year Cohort Study in Real World |
| title_full |
Methotrexate (MTX) Plus Hydroxychloroquine versus MTX Plus Leflunomide in Patients with MTX-Resistant Active Rheumatoid Arthritis: A 2-Year Cohort Study in Real World |
| title_fullStr |
Methotrexate (MTX) Plus Hydroxychloroquine versus MTX Plus Leflunomide in Patients with MTX-Resistant Active Rheumatoid Arthritis: A 2-Year Cohort Study in Real World |
| title_full_unstemmed |
Methotrexate (MTX) Plus Hydroxychloroquine versus MTX Plus Leflunomide in Patients with MTX-Resistant Active Rheumatoid Arthritis: A 2-Year Cohort Study in Real World |
| title_sort |
methotrexate (mtx) plus hydroxychloroquine versus mtx plus leflunomide in patients with mtx-resistant active rheumatoid arthritis: a 2-year cohort study in real world |
| publisher |
Dove Medical Press |
| publishDate |
2020 |
| url |
https://doaj.org/article/11127d7c1f3147f9a2d41825654e3df0 |
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