利妥昔单抗用于治疗活动性类风湿性关节炎。在本研究中,我们检查了利妥昔单抗减少剂量的长期发作风险和安全性.
这是一个前景,观察,以标准剂量(SD)开始使用利妥昔单抗的患者的单中心研究。患者改用低剂量(LD)(每6个月1克),根据治疗风湿病学家在获得持续临床反应后的决定,而其余患者继续使用标准剂量(SD)。在60个月期间,我们评估了(Kaplan-Meier生存分析)低剂量组的复发率(DAS28-ESR增加≥1.2,持续≥6个月)和因治疗失败而停药,我们比较了LD组和SD组之间严重不良事件(SAEs)的发生率。
在361名患者中[女性占83.4%,平均年龄61.9(10.6)岁,血清阳性50.3%,中位数总合并症计数4],81例患者(22.4%)进入LD的中位时间为24个月(95%CI18-30个月)。血清阳性(或1.823),超过2个以前的bDMARD故障(或0.428),6个月时DAS28<4.88(OR2.329)预测了进入LD的几率(全部p<0.05)。在60个月的随访中,只有7.5%的LD患者复发。与SD组相比,LD组患者的SAE和全因住院率明显较低(均p<0.05)。线性回归分析显示,既往住院期间服用bDMARDs(p<0.0001),使用泼尼松龙>5毫克/天,而利妥昔单抗(p<0.0001),既往有≥2次csDMARDs(p=0.041)的病史可预测严重不良事件的风险。
在一组已确诊的RA和显著的合并症患者中,在最初的疾病活动改善后逐渐减少利妥昔单抗,与SD相比,复发率较低,SAE的发生风险较低.血清阳性,以前使用的BDMARDs数量较少,6个月时较低的DAS28预测了进入LD方案的可能性。
Rituximab is used for the treatment of active rheumatoid arthritis. In the present
study, we examined the long-term flare risk and safety of reduced doses of rituximab.
This was a prospective, observational, single-center
study of patients starting rituximab on standard dose (SD). Patients were switched to low dose (LD) (1 g every 6 months), based on the treating rheumatologist\'s decision after having achieved sustained clinical responses, while the rest of the patients continued on standard dose (SD). During a 60-month period, we assessed (Kaplan-Meier survival analysis) the relapse rate (increase ≥ 1.2 in DAS28-ESR for ≥ 6 months) and discontinuations due to treatment failure in the low dose group, and we compared the incidence of serious adverse events (SAEs) between LD and SD groups.
Out of 361 patients [females 83.4%, mean age 61.9 (10.6) years, seropositive 50.3%, median total comorbidities count 4], 81 patients (22.4%) entered LD in a median time of 24 months (95% CI 18-30 months). Seropositivity (OR 1.823), more than 2 previous bDMARDs failures (OR 0.428), and DAS28 < 4.88 at 6 months (OR 2.329) predicted the odds of entering LD (p < 0.05 for all). During 60 months of follow-up, only 7.5% of patients on LD relapsed. Patients on LD had significantly less SAEs and all-cause hospitalizations as compared to the SD group (p < 0.05 for all). Linear regression analysis showed that previous hospitalization while on bDMARDs (p < 0.0001), use of prednisolone > 5 mg/day while on rituximab (p < 0.0001), and a history of ≥ 2 previous csDMARDs (p = 0.041) predicted the risk of SAEs.
In a cohort of patients with established RA and significant comorbidities who
taper rituximab after substantial initial disease activity improvement, a low rate of relapses and lower risk of SAEs compared to SD were recorded. Seropositivity, a lower number of previous bDMARDs use, and lower DAS28 at 6 months predicted the probability of entering the LD regimen.