Statins can inhibit the beneficial effects of rituximab on disease activity in rheumatoid arthritis patients, according to the findings of a study of 187 patients from the Dutch Rheumatoid Arthritis Monitoring registry.

After 6 months of treatment, the mean reduction in disease activity score using 28 joint counts (DAS28) was lower in 23 of 187 RA patients who were treated with both statins and rituximab (RTX) than in 164 patients treated with RTX alone (mean reduction of 0.5 vs. 1.0 point). The difference was of borderline statistical significance after adjustment for age, sex, baseline DAS28 score, and rheumatoid factor positivity, Dr. E.E.A. Arts of Radboud University Nijmegen (the Netherlands) Medical Center and colleagues reported online in the Oct. 18 issue of Annals of the Rheumatic Diseases.

Compared with the RTX-only patients, those exposed to statins also had a shorter effective period following RTX treatment (median of 7 months vs. 9 months), and were more likely to experience a failure event (hazard ratio, 2.3), after adjustment for the same confounders, the investigators said (Ann. Rheum. Dis. 2010 Oct. 18 [doi:10.1136/ard.2010.136093]).

All patients in the DREAM registry were included in the prospective cohort study, and all received 50 mg of prednisone with the first RTX infusion. Patients in both the RTX plus statin and the RTX-only groups had similar DAS28 scores at baseline. The statin group was older (mean age, 66 vs. 58 years) and included a greater proportion of men than the RTX-only group (48% vs. 20%), but the groups were otherwise similar.

Although the study had a small sample size, it was sufficiently powered and showed a clinically relevant difference in DAS28 score changes over the 6-month study period, the investigators noted, adding that lack of randomization was another limitation of little concern, because “confounding by indication is unlikely.”

More studies to replicate these findings and measure the magnitude of the effect are needed, they said.

“Significant interactions of statins with RTX in RA have not previously been shown. A critical review of common practice regarding concomitant use of statins in RTX-treated patients with RA is needed,” they concluded.

The DREAM registry is funded by the Dutch affiliations of Wyeth Pharmaceuticals, Abbott Laboratories, Schering-Plough Corp., Roche Pharmaceuticals, UCB Pharma Inc., and Bristol-Myers Squibb Co.

Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

根据荷兰类风湿关节炎监测(Dutch Rheumatoid Arthritis Monitoring，DREAM)登记处的一项研究发现，他汀类药物会降低利妥昔单抗(rituximab，RTX)改善类风湿关节炎患者疾病活动指数的效果。

 

在荷兰内梅亨大学医学中心的研究人员完成的这项研究中，所有在DREAM登记处登记的患者都被纳入这项前瞻性队列研究，共187例患者，其中他汀+RTX组23例，单用RTX组164例。所有患者在接受第一次RTX输注时均给予了50 mg的泼尼松。两组患者的DAS28评分基线值相似。与单用RTX组相比，他汀+RTX组患者的平均年龄更大一些(58岁对66岁)，并且男性的比例更大(20%对48%)，但其他一般情况相似。

 

研究显示，治疗6个月后，他汀+RTX组患者的28关节疾病活动度指数(DAS28)平均下降值低于单用RTX组(分别为下降0.5和下降1.0分)。校正年龄、性别、基线DAS28评分及类风湿因子阳性情况后，两组的差异具有统计学意义。校正混杂因素后结果显示，与单用RTX组患者比较，使用他汀类药物使RTX治疗有效时间也缩短了(分别为平均7个月和9个月)，而且更有可能出现治疗失败的情况(风险比为2.3)。

 

该研究结果有力地显示，经过6个月的疗程后两组的DAS28评分改变有明显的差异，这一结果还需进行大量研究以得以重现，同时还需要评价他汀类药物对RTX疗效影响的大小。

 

研究者指出，以前以往人们并未注意到使用RTX的类风湿关节炎患者应用他汀类药物后出现的这种显著药物相互作用，今后应对联合使用RTX和他汀类药物的类风湿关节炎患者的临床资料进行认真的回顾分析。

 

DREAM登记处声明曾接受过多家医药公司的经济资助。

 

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