Chandramohan Parvathypriya, Jain Avinash, Antony Glindow, Krishnan Narayanan, Shenoy Padmanabha
Centre for Arthritis and Rheumatism Excellence (CARE), Kochi.
Division of Clinical Immunology and Rheumatology, Sawai Mansingh Medical College and Hospital, Jaipur, India.
Rheumatol Adv Pract. 2021 Jan 7;5(1):rkaa077. doi: 10.1093/rap/rkaa077. eCollection 2021.
A significant proportion of RA patients, particularly those associated with poor prognostic factors, fail on conventional DMARDs (cDMARDs). Although rituximab (RTX) has been effective in these patients, the cost of therapy makes it unaffordable, particularly in poor and developing countries. Numerous, albeit small, studies using lower doses have shown contradictory results. We aimed to analyse the effectiveness of a low-dose RTX protocol based on clinical outcomes in RA patients.
Seropositive RA patients with moderate to high disease activity (DAS28-ESR > 3.2) despite combination cDMARDs, treated with RTX, were included in retrospective analysis. All patients were treated according to a predefined protocol, using 500 mg RTX with ongoing cDMARDs at baseline and repeat dosing at 6 weeks or beyond, on lack of moderate to good EULAR response. The B cell count was assessed at baseline, 2 and 24 weeks.
At 12 weeks, 93% of 166 patients [mean (s.d.) age, 51.5 (11.96) years, 25 men and 141 women, with a disease duration of 10.4 (6.29) years] achieved moderate to good EULAR response. At 24 weeks, 90.8% of patients achieved moderate to good EULAR response, 19.8% achieved low disease activity and 29.5% achieved remission, with a mean change in DAS28-ESR from baseline of 2.9 (1.3). RTX failure and relapse were seen in 5.4% and 3.6%, respectively. The response was maintained for 12.3 (7.2) months with a mean RTX dose 521.1 (100.8) mg. Adverse events were seen in 9.6%. When compared with the standard dosing regimen with the originator molecule, a cost reduction of 90% was achieved.
A low-dose RTX regimen achieved reasonably good clinical outcomes at the end of 6 months, with a significantly lower cost.
相当一部分类风湿关节炎（RA）患者，尤其是那些伴有不良预后因素的患者，使用传统改善病情抗风湿药（cDMARDs）治疗失败。尽管利妥昔单抗（RTX）对这些患者有效，但治疗费用使其难以承受，尤其是在贫穷和发展中国家。众多规模较小的研究使用较低剂量RTX，结果相互矛盾。我们旨在根据临床结果分析低剂量RTX方案对RA患者的有效性。
对血清学阳性、尽管联合使用cDMARDs但疾病活动度仍为中度至高度（DAS28-ESR＞3.2）且接受RTX治疗的RA患者进行回顾性分析。所有患者均按照预定义方案治疗，基线时使用500mg RTX联合持续使用的cDMARDs，若未达到欧洲抗风湿病联盟（EULAR）中度至良好反应，则在6周或更晚时间重复给药。在基线、2周和24周时评估B细胞计数。
12周时，166例患者[平均（标准差）年龄51.5（11.96）岁，男性25例，女性141例，病程10.4（6.29）年]中有93%达到EULAR中度至良好反应。24周时，90.8%的患者达到EULAR中度至良好反应，19.8%达到低疾病活动度，29.5%达到缓解，DAS28-ESR较基线平均变化2.9（1.3）。RTX治疗失败和复发率分别为5.4%和3.6%。平均RTX剂量521.1（100.8）mg时，反应维持了12.3（7.2）个月。不良事件发生率为9.6%。与原研药的标准给药方案相比，成本降低了90%。
低剂量RTX方案在6个月末取得了相当不错的临床效果，且成本显著降低。
