两项临床试验中两种糖皮质激素桥接治疗早期类风湿和未分化关节炎的短期疗效和毒性比较

IF 4.6 2区医学 Q1 RHEUMATOLOGY

Seminars in arthritis and rheumatism Pub Date : 2025-05-03 DOI:10.1016/j.semarthrit.2025.152748

J.A. van der Pol , E.G. Brilman , P.H.P. de Jong , A.E.A.M. Weel , L.R. Lard , E.T. Molenaar , T.W.J. Huizinga , S.A. Bergstra , C.F. Allaart

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引用次数: 0

摘要

目的比较早期类风湿或未分化性关节炎患者初始甲氨蝶呤与高剂量或低剂量糖皮质激素（GC）桥接治疗的短期疗效。方法：我们比较了两项试验：一项“高剂量GC”研究，以甲氨蝶呤和强的松60mg /天开始，在7周内逐渐减少到7.5 mg/天（改进试验）；另一项“低剂量GC”研究，以甲氨蝶呤和强的松15mg /天开始，在10周内逐渐减少到零（tREACH试验的C组）。在多次代入后，我们采用线性和逻辑回归模型比较了3 - 4个月后首次随访时DAS和HAQ、DAS缓解率（DAS<1.6）和低疾病活动度（DAS≤2.4），并对基线DAS/HAQ、年龄、性别、症状持续时间、ACPA阳性、BMI和损害进行了调整。结果基线症状持续时间、DAS和HAQ具有可比性，但低剂量gc研究C组中更多的患者符合2010年RA标准。校正混杂因素后，低剂量gc研究组C组患者的DAS显著高于对照组(0.62,95% CI 0.43；0.80)， HAQ高0.28 (95% CI 0.17；与高剂量gc研究的患者相比，第一次随访时的das缓解率（63.4%对28.9%）和低疾病活动性（80.6%对55.7%）更少。在高剂量gc研究中报告的不良事件较少。结论：在早期RA或UA患者中，与使用低剂量糖皮质激素的研究相比，使用高剂量糖皮质激素作为初始治疗的一部分可显著改善早期临床结果，并且早期副作用更少。当比较两个不同的临床试验而不是执行一个试验时，由于存在偏倚风险，这些结果应谨慎解释。

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A comparison of short-term efficacy and toxicity of 2 glucocorticoid bridging strategies in 2 clinical trials in early rheumatoid and undifferentiated arthritis

Objectives

To compare short-term outcomes of initial methotrexate therapy with higher or lower-dose glucocorticoid (GC) bridging in patients with early rheumatoid or undifferentiated arthritis.

Methods

We compared two trials: a ‘higher-dose GC’-study starting with methotrexate and 60 mg/day prednisone, tapered in 7 weeks to 7.5 mg/day (IMPROVED trial) and a ‘lower-dose GC’-study, starting with methotrexate and prednisone 15 mg/day tapered in 10 weeks to nil (arm C of the tREACH trial). After multiple imputation, we compared the DAS and HAQ, rates of DAS-remission (DAS<1.6) and low disease activity (DAS≤2.4) at the first follow-up visit after 3 to 4 months with linear and logistic regression models, adjusted for baseline DAS/HAQ, age, gender, symptom duration, ACPA positivity, BMI and damage.

Results

Baseline symptom duration, DAS and HAQ were comparable, but more patients in the lower-dose GC-study arm C fulfilled the 2010 criteria for RA. After correction for confounders, patients in the lower-dose GC-study arm C had a significantly higher DAS (0.62 higher (95 % CI 0.43; 0.80) and HAQ (0.28 higher (95 % CI 0.17; 0.39) at the first follow-up visit compared to patients in the higher-dose GC-study, and less often DAS-remission (63.4 % versus 28.9 %) and low disease activity (80.6 % versus 55.7 %). Fewer adverse events were reported in the higher-dose GC-study.

Conclusion

In patients with early RA or UA, a study with higher dosed glucocorticoids as part of initial treatment was associated with significantly better early clinical outcomes compared to a study with lower dosed glucocorticoids, and fewer early side effects. These results should be interpreted with caution due to risk of bias when comparing two distinct clinical trials instead of performing one trial.

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来源期刊

Seminars in arthritis and rheumatism 医学-风湿病学

CiteScore

9.20

自引率

4.00%

发文量

176

审稿时长

46 days

期刊介绍： Seminars in Arthritis and Rheumatism provides access to the highest-quality clinical, therapeutic and translational research about arthritis, rheumatology and musculoskeletal disorders that affect the joints and connective tissue. Each bimonthly issue includes articles giving you the latest diagnostic criteria, consensus statements, systematic reviews and meta-analyses as well as clinical and translational research studies. Read this journal for the latest groundbreaking research and to gain insights from scientists and clinicians on the management and treatment of musculoskeletal and autoimmune rheumatologic diseases. The journal is of interest to rheumatologists, orthopedic surgeons, internal medicine physicians, immunologists and specialists in bone and mineral metabolism.