Korotaeva T V, Loginova E Yu, Getiya T S, Nasonov E L
V.A. Nasonova Scientific and Research Institute of Rheumatology, Department of Psoriatic arthritis, Moscow, Russia.
I.M. Sechenov First Moscow State Medical University, Department of Rheumatology, Moscow, Russia.
Ter Arkh. 2018 May 11;90(5):22-29. doi: 10.26442/terarkh201890522-29.
To study efficacy of treat-to-target (T2T) strategy in early peripheral psoriatic arthritis (EPsA) after one year of treatment.
44 (M/F - 18/26) DMARD-naїve patients (pts) with active EPsA, according to the CASPAR criteria, mean age 37.5±11.3 years, PsA duration 7 [4; 24] months, psoriasis duration 36 [12; 84] months, disease activity index (DAS) 3.78 [3.18; 4.67], DAS28 4.33 [3.67; 4.8] study were included. At the baseline and every other 3 months for total 12 months of therapy all pts underwent standard clinical examination, tender joint count (TJC), swollen joint count (SJC), patient pain VAS, patient/physician´s global disease activity VAS, enthesitis by Leeds Enthesial Index (LEI)+Plantar Fascia (PF), dactylitis, Psoriasis Area Severity Index (PASI), body surface area (BSA), Health Assessment Questionnaire (HAQ), DAS, DAS28-C-RP, C-RP (mg/l). The dose of MTX s/c was escalated by 5 mg every 2 weeks from 10 mg/wk to appropriate dose 20-25 mg/wk according to the drug intolerance. If pts does not achieve the lower disease activity (LDA), MDA or remission after 3 months of MTX subcutaneous (s/c) mono-therapy, then combination therapy of MTX+Adalimumab (ADA) by standard regime was continued up to one year. At 12 months of therapy the proportion of pts who attained LDA by DAS/DAS28 or remission by DAS<1.6/DAS28-C-RP<2.6 or MDA, ACR20/50/70, PASI75 and dynamics of HAQ, LEI+PF, dactylitis were calculated. Mean±SD, Me [Q25; Q75], %, Friedman (Fr.) ANOVA, U-test, Wilcoxon test were performed. All p<0.05 were considered to indicate statistical significance.
At one year of treatment according to T2T strategy significant improvements disease activity and physical health function related to quality of life was seen. By 12 months of therapy remission by DAS and MDA was reached 61.4%/65.9% of pts accordingly. By 12 months of therapy ACR20/50/70 was seen in 88%/77%/59% of pts. In pts with BSA≥3% (n=16) at baseline psoriasis improvements by PASI75 was seen in 88% of pts. In 55% of active EPsA pts MTX (s/c) mono-therapy was an effective treatment.
One-year treatment according to T2T strategy significantly improves all PsA clinical domains - arthritis, dactylitis, enthesitis, skin psoriasis and quality of life despite of type of treatment. It seems that T2T is a useful strategy in EPsA but additional research concerning its implementation in real practice are needed.
研究达标治疗(T2T)策略在早期外周型银屑病关节炎(EPsA)治疗一年后的疗效。
纳入44例(男/女 = 18/26)未使用过改善病情抗风湿药(DMARDs)的活动性EPsA患者,符合CASPAR标准,平均年龄37.5±11.3岁,银屑病关节炎病程7[4;24]个月,银屑病病程36[12;84]个月,疾病活动指数(DAS)3.78[3.18;4.67],DAS28为4.33[3.67;4.8]。在基线期以及治疗的12个月期间,每3个月对所有患者进行一次标准临床检查,包括压痛关节计数(TJC)、肿胀关节计数(SJC)、患者疼痛视觉模拟评分(VAS)、患者/医生的整体疾病活动视觉模拟评分、利兹附着点炎指数(LEI)加足底筋膜(PF)评估附着点炎、指(趾)炎、银屑病面积和严重程度指数(PASI)、体表面积(BSA)、健康评估问卷(HAQ)、DAS、DAS28-C-反应蛋白(CRP)、C反应蛋白(mg/l)。根据药物耐受性,甲氨蝶呤(MTX)皮下注射剂量每2周增加5mg,从10mg/周增至合适剂量20 - 25mg/周。如果患者在MTX皮下单药治疗3个月后未达到低疾病活动度(LDA)、最小疾病活动度(MDA)或缓解,则按照标准方案继续MTX联合阿达木单抗(ADA)治疗直至1年。在治疗12个月时,计算达到DAS/DAS28定义的LDA、DAS<1.6/DAS28-C-RP<2.6定义的缓解或MDA、美国风湿病学会(ACR)20/50/70、PASI改善75%的患者比例,以及HAQ、LEI + PF、指(趾)炎的变化情况。采用均数±标准差、中位数[四分位数间距]、百分比、Friedman(Fr.)方差分析、U检验、Wilcoxon检验进行统计分析。所有p<0.05被认为具有统计学意义。
根据T2T策略治疗1年后,疾病活动度及与生活质量相关的身体健康功能均有显著改善。治疗12个月时,分别有61.4%/65.9%的患者达到DAS和MDA缓解。治疗12个月时,88%/77%/59%的患者达到ACR20/50/70。基线时体表面积(BSA)≥3%的患者(n = 16)中,88%的患者PASI改善75%。55%的活动性EPsA患者MTX皮下单药治疗有效。
根据T2T策略进行的一年治疗显著改善了银屑病关节炎的所有临床方面——关节炎、指(趾)炎、附着点炎、皮肤银屑病及生活质量,无论治疗类型如何。T-2-T似乎是EPsA治疗中的一种有用策略,但需要进一步研究其在实际临床中的应用情况。