Rheumatology Unit, ASL3 - Regione Liguria, Genoa, Italy.
Rheumatology Unit, Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Clin Exp Rheumatol. 2019 Nov-Dec;37(6):1003-1009. Epub 2019 Jun 6.
The MARI study investigated the prescription patterns of methotrexate (MTX) in patients presenting with rheumatoid arthritis (RA) in Italy. The primary aims of this cross-sectional analysis from the MARI study were to investigate the effect of gender on the prescription patterns and safety of MTX therapy.
The study enrolled 1336 patients with RA. Retrospective data included patients' clinical history, previous treatment with MTX and other DMARDs, and MTX modifications in the previous 12-month period. Cross-sectional data included information about current treatment with MTX (dose and route of administration, and adverse events), concomitant medications, disease activity, and modifications of MTX treatment at study entry. The prescription patterns of MTX, rates and causes of MTX modifications were analysed according to gender.
There were no significant differences related to gender in the prescription patterns of MTX, either at 6 months after starting MTX or at the time of study entry. In the 12 months prior to study entry, women (4%) were more likely to undergo MTX modifications (dose or route of administration) compared to men (2%, p=0.032), due to subjective intolerance, but this difference was no longer significant after controlling for confounders. At study entry, a higher proportion of women (27%) reported tolerability issues (nausea and weakness) related to MTX compared to men (14%, p=0.001). Although a similar percentage of males and females changed dose or route of administration of MTX at the time of study entry, the reasons for such modifications were dissimilar between genders. Particularly, a higher proportion of women underwent MTX modification due to intolerance (women 6% vs. men 1%, p=0.002).
In Italy, prescription patterns of MTX do not differ between genders. However, women seem to be at higher risk of adverse events leading to MTX modifications.
MARI 研究调查了意大利类风湿关节炎(RA)患者甲氨蝶呤(MTX)的处方模式。本 MARI 研究的横断面分析的主要目的是研究性别对 MTX 治疗的处方模式和安全性的影响。
该研究纳入了 1336 例 RA 患者。回顾性数据包括患者的临床病史、既往 MTX 和其他 DMARD 治疗情况,以及过去 12 个月内 MTX 的调整情况。横断面数据包括当前 MTX(剂量和给药途径,以及不良反应)、伴随药物、疾病活动度和研究入组时 MTX 治疗调整的信息。根据性别分析 MTX 的处方模式、MTX 调整的发生率和原因。
在开始 MTX 后 6 个月或研究入组时,MTX 的处方模式与性别无关。在研究入组前的 12 个月内,女性(4%)比男性(2%)更有可能进行 MTX 调整(剂量或给药途径),这与主观不耐受有关,但在控制混杂因素后,这一差异不再显著。在研究入组时,更多的女性(27%)报告与 MTX 相关的耐受性问题(恶心和乏力),而男性为 14%(p=0.001)。尽管男性和女性在研究入组时改变 MTX 剂量或给药途径的比例相似,但改变的原因在性别之间存在差异。特别是,更多的女性因不耐受而进行 MTX 调整(女性 6%,男性 1%,p=0.002)。
在意大利,MTX 的处方模式在性别之间没有差异。然而,女性似乎更有可能因不良反应而导致 MTX 调整。