Mete Kara, Gülay Alp, Mete Pekdiker, Sertaç Ketenci, Annamaria Porreca, Haluk Cinakli
{"title":"评价来氟米特和甲氨蝶呤联合治疗与单药治疗类风湿和银屑病关节炎的疗效。","authors":"Mete Kara, Gülay Alp, Mete Pekdiker, Sertaç Ketenci, Annamaria Porreca, Haluk Cinakli","doi":"10.55730/1300-0144.6010","DOIUrl":null,"url":null,"abstract":"<p><strong>Background/aim: </strong>Methotrexate (MTX) and leflunomide (LEF) are conventional synthetic disease-modifying antirheumatic drugs (DMARDs) commonly used for treating rheumatoid arthritis (RA) and psoriatic arthritis (PsA), either as monotherapies or in combination. This study aimed to compare the adverse effects (AEs) and efficacy of combined use of MTX plus LEF with monotherapy in RA and PsA patients.</p><p><strong>Materials and methods: </strong>This study included 528 patients (385 RA and 143 PsA) with at least 6 months of follow-up. Disease activity was assessed using DAS-28 CRP and DAPSA, and treatment-related AEs were classified based on specific MedDRA categories.</p><p><strong>Results: </strong>The cumulative incidence of AEs in patients with RA treated with MTX, LEF, and MTX plus LEF was 23.8%, 28.2%, and 19.2%, respectively; in PsA patients, 18.1%, 30%, and 23.3%, respectively. None of the groups were superior to each other in terms of general AEs between monotherapy and in combination. LEF monotherapy in RA was associated with more neurological AEs and hypertension. Compared to monotherapy, MTX plus LEF demonstrated greater reductions in disease activity, a more substantial decrease in glucocorticoid doses, and lower utilization of biological/targeted DMARDs (b/tsDMARDs) in both RA and PsA. In univariate analysis, MTX dosage, initial DAS28 CRP, and b/tsDMARD initiation were predictors of low disease activity (LDA) in RA. In multivariate analysis, MTX dosage (95% CI 1.02-1.59, OR = 1.27, p = 0.031) and initial DAS28-CRP (95% CI 2.14-10.90, OR = 4.38, p < 0.001) were found to be independently associated with LDA in RA. In PsA, the factors associated with LDA were initial DAPSA and disease duration in univariate analysis. Only disease duration was found to be an independent predictor in multivariate analysis (95% CI, 1.02-1.38, OR = 1.17 p = 0.039).</p><p><strong>Conclusion: </strong>Adding LEF to MTX or vice versa may serve as a valuable, safe, and effective alternative in situations where b/tsDMARD therapy is challenging.</p>","PeriodicalId":23361,"journal":{"name":"Turkish Journal of Medical Sciences","volume":"55 3","pages":"632-643"},"PeriodicalIF":1.0000,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12270322/pdf/","citationCount":"0","resultStr":"{\"title\":\"Evaluating leflunomide and methotrexate combination vs. monotherapy in rheumatoid and psoriatic arthritis.\",\"authors\":\"Mete Kara, Gülay Alp, Mete Pekdiker, Sertaç Ketenci, Annamaria Porreca, Haluk Cinakli\",\"doi\":\"10.55730/1300-0144.6010\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background/aim: </strong>Methotrexate (MTX) and leflunomide (LEF) are conventional synthetic disease-modifying antirheumatic drugs (DMARDs) commonly used for treating rheumatoid arthritis (RA) and psoriatic arthritis (PsA), either as monotherapies or in combination. This study aimed to compare the adverse effects (AEs) and efficacy of combined use of MTX plus LEF with monotherapy in RA and PsA patients.</p><p><strong>Materials and methods: </strong>This study included 528 patients (385 RA and 143 PsA) with at least 6 months of follow-up. Disease activity was assessed using DAS-28 CRP and DAPSA, and treatment-related AEs were classified based on specific MedDRA categories.</p><p><strong>Results: </strong>The cumulative incidence of AEs in patients with RA treated with MTX, LEF, and MTX plus LEF was 23.8%, 28.2%, and 19.2%, respectively; in PsA patients, 18.1%, 30%, and 23.3%, respectively. None of the groups were superior to each other in terms of general AEs between monotherapy and in combination. LEF monotherapy in RA was associated with more neurological AEs and hypertension. Compared to monotherapy, MTX plus LEF demonstrated greater reductions in disease activity, a more substantial decrease in glucocorticoid doses, and lower utilization of biological/targeted DMARDs (b/tsDMARDs) in both RA and PsA. In univariate analysis, MTX dosage, initial DAS28 CRP, and b/tsDMARD initiation were predictors of low disease activity (LDA) in RA. In multivariate analysis, MTX dosage (95% CI 1.02-1.59, OR = 1.27, p = 0.031) and initial DAS28-CRP (95% CI 2.14-10.90, OR = 4.38, p < 0.001) were found to be independently associated with LDA in RA. In PsA, the factors associated with LDA were initial DAPSA and disease duration in univariate analysis. 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引用次数: 0
摘要
背景/目的:甲氨蝶呤(MTX)和来氟米特(LEF)是常规的合成疾病缓解抗风湿药物(DMARDs),通常用于治疗类风湿性关节炎(RA)和银屑病关节炎(PsA),无论是单独治疗还是联合治疗。本研究旨在比较甲氨蝶呤联合LEF与单药治疗在RA和PsA患者中的不良反应(ae)和疗效。材料和方法:本研究纳入528例患者(385例RA和143例PsA),随访至少6个月。使用DAS-28 CRP和DAPSA评估疾病活动性,并根据特定的MedDRA分类对治疗相关的ae进行分类。结果:MTX、LEF和MTX + LEF治疗的RA患者ae累积发生率分别为23.8%、28.2%和19.2%;PsA患者分别为18.1%、30%和23.3%。在单一治疗和联合治疗的一般ae方面,没有一个组优于另一个组。LEF单药治疗RA与更多的神经系统不良反应和高血压相关。与单药治疗相比,MTX + LEF在RA和PsA治疗中均表现出更大程度的疾病活动性降低,糖皮质激素剂量降低,生物/靶向DMARDs (b/tsDMARDs)利用率降低。在单因素分析中,MTX剂量、初始DAS28 CRP和b/tsDMARD起始是RA低疾病活度(LDA)的预测因子。在多因素分析中,MTX剂量(95% CI 1.02-1.59, OR = 1.27, p = 0.031)和初始DAS28-CRP (95% CI 2.14-10.90, OR = 4.38, p < 0.001)与RA的LDA独立相关。在PsA中,单因素分析中与LDA相关的因素是初始DAPSA和疾病持续时间。在多变量分析中,只有病程是一个独立的预测因子(95% CI, 1.02-1.38, OR = 1.17 p = 0.039)。结论:在b/tsDMARD治疗具有挑战性的情况下,将LEF加入MTX或反之亦然,可能是一种有价值、安全、有效的替代方案。
Evaluating leflunomide and methotrexate combination vs. monotherapy in rheumatoid and psoriatic arthritis.
Background/aim: Methotrexate (MTX) and leflunomide (LEF) are conventional synthetic disease-modifying antirheumatic drugs (DMARDs) commonly used for treating rheumatoid arthritis (RA) and psoriatic arthritis (PsA), either as monotherapies or in combination. This study aimed to compare the adverse effects (AEs) and efficacy of combined use of MTX plus LEF with monotherapy in RA and PsA patients.
Materials and methods: This study included 528 patients (385 RA and 143 PsA) with at least 6 months of follow-up. Disease activity was assessed using DAS-28 CRP and DAPSA, and treatment-related AEs were classified based on specific MedDRA categories.
Results: The cumulative incidence of AEs in patients with RA treated with MTX, LEF, and MTX plus LEF was 23.8%, 28.2%, and 19.2%, respectively; in PsA patients, 18.1%, 30%, and 23.3%, respectively. None of the groups were superior to each other in terms of general AEs between monotherapy and in combination. LEF monotherapy in RA was associated with more neurological AEs and hypertension. Compared to monotherapy, MTX plus LEF demonstrated greater reductions in disease activity, a more substantial decrease in glucocorticoid doses, and lower utilization of biological/targeted DMARDs (b/tsDMARDs) in both RA and PsA. In univariate analysis, MTX dosage, initial DAS28 CRP, and b/tsDMARD initiation were predictors of low disease activity (LDA) in RA. In multivariate analysis, MTX dosage (95% CI 1.02-1.59, OR = 1.27, p = 0.031) and initial DAS28-CRP (95% CI 2.14-10.90, OR = 4.38, p < 0.001) were found to be independently associated with LDA in RA. In PsA, the factors associated with LDA were initial DAPSA and disease duration in univariate analysis. Only disease duration was found to be an independent predictor in multivariate analysis (95% CI, 1.02-1.38, OR = 1.17 p = 0.039).
Conclusion: Adding LEF to MTX or vice versa may serve as a valuable, safe, and effective alternative in situations where b/tsDMARD therapy is challenging.
期刊介绍:
Turkish Journal of Medical sciences is a peer-reviewed comprehensive resource that provides critical up-to-date information on the broad spectrum of general medical sciences. The Journal intended to publish original medical scientific papers regarding the priority based on the prominence, significance, and timeliness of the findings. However since the audience of the Journal is not limited to any subspeciality in a wide variety of medical disciplines, the papers focusing on the technical details of a given medical subspeciality may not be evaluated for publication.