Department of Clinical Immunology and Rheumatology, Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu, 632004, India.
Department of Biostatistics, Christian Medical College, Vellore, India.
Clin Rheumatol. 2021 May;40(5):1871-1879. doi: 10.1007/s10067-020-05433-5. Epub 2020 Oct 14.
Evaluation of response to combination conventional synthetic DMARD (csDMARD) therapy with methotrexate (MTX) and sulfasalazine (SSZ) in active axial spondyloarthritis (axSpA) patients without peripheral arthritis (group 1) as compared to active axSpA with peripheral arthritis (group 2), who are economically constrained for biologicals.
A prospective, observational, single-centre, cohort study on 150 consecutive active axSpA patients who were already initiated on the above mentioned combination csDMARD therapy and satisfying the other pre-defined eligibility criteria, was conducted between July 2016 and July 2017 using ASAS20 response as primary outcome measure at 3 and 6 months post treatment.
ASAS20 response at 3 months was achieved in 31/58 (53.4%) and in 24/36 (66.6%) in groups 1 and 2, respectively (p = 0.2); at 6 months, these figures were 45/76 (59.2%) and 28/44 (63.6%), respectively (p = 0.6). Similarly, there was significant reduction in mean ASAS NSAID index from 29.6 to 14 over 6 months from baseline (p = 0.001), and it was similar in both groups. Using BASDAI ≥ 4 to define active disease, a 34% reduction in requirement of biologicals was also observed.
In resource-limited population, treatment with combination of methotrexate and sulphasalazine over a period of 6 months is equally efficacious in patients with active axSpA with and without peripheral arthritis, as evidenced by improved ASAS20 response rates, reduction in NSAID use and fewer patients switching to biologicals. Key Points • Combination of MTX+SSZ was efficacious and safe in active axSpA patients who had economic hardships to use biologicals. • This benefit in axSpA patients was similar between those without any peripheral arthritis and those with. • MTX+SSZ combination therapy also demonstrated NSAID sparing action. • Combination of MTX and SSZ prevented escalation to biological therapy as per a BASDAI score driven policy.
评估无外周关节炎的活动性中轴型脊柱关节炎（axSpA）患者（第 1 组）与有外周关节炎的活动性 axSpA 患者（第 2 组）对甲氨蝶呤（MTX）+柳氮磺胺吡啶（SSZ）联合常规合成改善病情抗风湿药（csDMARD）治疗的反应，第 2 组患者因经济原因无法使用生物制剂。
2016 年 7 月至 2017 年 7 月，我们进行了一项前瞻性、观察性、单中心队列研究，共纳入 150 例已接受上述联合 csDMARD 治疗且符合其他预定义纳入标准的连续活动性 axSpA 患者，主要结局指标为治疗后 3 个月和 6 个月时的 ASAS20 缓解率。
第 1 组和第 2 组患者在治疗后 3 个月时 ASAS20 缓解率分别为 31/58（53.4%）和 24/36（66.6%）（p=0.2），6 个月时分别为 45/76（59.2%）和 28/44（63.6%）（p=0.6）。同样，两组患者的平均 ASAS 非甾体抗炎药（NSAID）指数均从基线时的 29.6 显著降至 14（p=0.001）。使用 BASDAI≥4 定义活动性疾病，生物制剂的需求减少了 34%。
在资源有限的人群中，6 个月时使用 MTX+SSZ 联合治疗对有和无外周关节炎的活动性 axSpA 患者同样有效，这体现在 ASAS20 缓解率提高、NSAID 使用减少和较少患者转为生物制剂。
对经济困难无法使用生物制剂的 axSpA 患者，MTX+SSZ 联合治疗安全有效。
这种疗效在无外周关节炎和有外周关节炎的 axSpA 患者中相似。
MTX+SSZ 联合治疗还具有 NSAID 节约作用。
根据 BASDAI 评分指导的策略，MTX 和 SSZ 的联合治疗防止了生物制剂的升级。
