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在用戈利木单抗治疗的初治活动性银屑病关节炎患者中评估皮肤和指甲银屑病的改善情况:GO-VIBRANT研究第52周的结果

Evaluation of Improvement in Skin and Nail Psoriasis in Bio-naïve Patients With Active Psoriatic Arthritis Treated With Golimumab: Results Through Week 52 of the GO-VIBRANT Study.

作者信息

Mease Philip, Elaine Husni M, Chakravarty Soumya D, Kafka Shelly, Parenti Dennis, Kim Lilianne, Hung Lo Kim, Hsia Elizabeth C, Kavanaugh Arthur

机构信息

Swedish Medical Center, Seattle, Washington and University of Washington School of Medicine, Seattle.

Cleveland Clinic, Cleveland, Ohio.

出版信息

ACR Open Rheumatol. 2020 Nov;2(11):640-647. doi: 10.1002/acr2.11180. Epub 2020 Oct 19.

Abstract

OBJECTIVE

To evaluate whether intravenous (IV) golimumab produces improvements in skin and nail symptoms that are concomitant with improvements in quality of life (QoL) and joint symptoms in patients with psoriatic arthritis.

METHODS

Patients were randomized to either IV golimumab 2 mg/kg at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo at weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52. Assessments included Psoriasis Area and Severity Index (PASI), modified Nail Psoriasis Severity Index (mNAPSI), Dermatology Life Quality Index (DLQI), and American College of Rheumatology (ACR) rheumatoid arthritis response criteria.

RESULTS

Through week 24, achievement of PASI 75/90/100 responses (P ≤ .0098) and mean improvements in mNAPSI (-11.4 vs -3.7; P < .0001) and DLQI (-9.8 vs -2.9; P < .0001) were significantly greater with golimumab versus placebo. Responses were maintained in patients treated with golimumab through week 52. In placebo-crossover patients, increases in the proportion of patients achieving PASI 75/90/100 responses were observed from weeks 24 to 52, and mean improvements in mNAPSI (from -3.7 to -12.9) and DLQI (from -2.9 to -7.8) increased from weeks 24 to 52. Simultaneous achievement of PASI and DLQI responses, PASI and ACR responses, and mNAPSI and DLQI responses were also observed. Similar responses were observed for all assessments regardless of concomitant methotrexate use.

CONCLUSION

Improvements in skin and nail psoriasis symptoms with IV golimumab in patients with psoriatic arthritis were concomitant with improvements in QoL and arthritis disease activity through 1 year.

摘要

目的

评估静脉注射戈利木单抗是否能改善银屑病关节炎患者的皮肤和指甲症状,同时改善其生活质量(QoL)和关节症状。

方法

患者被随机分为两组,一组在第0、4周静脉注射戈利木单抗2mg/kg,随后每8周(q8w)注射一次,直至第52周;另一组在第0、4周注射安慰剂,随后q8w注射,在第24、28周交叉至静脉注射戈利木单抗2mg/kg,随后q8w注射,直至第52周。评估指标包括银屑病面积和严重程度指数(PASI)、改良指甲银屑病严重程度指数(mNAPSI)、皮肤病生活质量指数(DLQI)以及美国风湿病学会(ACR)类风湿关节炎反应标准。

结果

至第24周时,与安慰剂相比,戈利木单抗组在达到PASI 75/90/100反应方面(P≤0.0098)以及mNAPSI(-11.4对-3.7;P<0.0001)和DLQI(-9.8对-2.9;P<0.0001)的平均改善情况均显著更优。接受戈利木单抗治疗的患者至第52周时仍维持了这些反应。在安慰剂交叉治疗的患者中,从第24周到52周,达到PASI 75/90/100反应的患者比例有所增加,mNAPSI(从-3.7至-12.9)和DLQI(从-2.9至-7.8)的平均改善情况也从第24周增加至52周。同时还观察到PASI与DLQI反应、PASI与ACR反应以及mNAPSI与DLQI反应的同时达成。无论是否同时使用甲氨蝶呤,所有评估指标均观察到类似的反应。

结论

银屑病关节炎患者静脉注射戈利木单抗后,皮肤和指甲银屑病症状的改善与生活质量和关节炎疾病活动度的改善在1年内同时出现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51f9/7672302/ab20dd6ef316/ACR2-2-640-g001.jpg

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