皮下注射司库奇尤单抗在根据既往肿瘤坏死因子抑制剂使用情况分层的活动性银屑病关节炎患者中的疗效：随机安慰剂对照FUTURE 2研究结果

Efficacy of Subcutaneous Secukinumab in Patients with Active Psoriatic Arthritis Stratified by Prior Tumor Necrosis Factor Inhibitor Use: Results from the Randomized Placebo-controlled FUTURE 2 Study.

作者信息

Kavanaugh Arthur, McInnes Iain B, Mease Philip J, Hall Stephen, Chinoy Hector, Kivitz Alan J, Wang Zailong, Mpofu Shephard

机构信息

From the University of California-San Diego, School of Medicine, LaJolla, California, USA; Immunology, Infection and Inflammation, University of Glasgow, Glasgow, UK; Swedish Medical Centre, and University of Washington School of Medicine, Seattle, Washington, USA; Monash University, Melbourne, Australia; UK National Institute for Health Research (NIHR) Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospitals National Health Service NHS Foundation Trust, University of Manchester, UK; Altoona Center for Clinical Research, Duncansville, Pennsylvania; Novartis Pharmaceuticals Corp., East Hanover, New Jersey, USA; Novartis Pharma AG, Basel, Switzerland.A. Kavanaugh, MD, Professor of Clinical Medicine, Director of Center for Innovative Therapy, University of California-San Diego, School of Medicine; I.B. McInnes, MD, PhD, Professor of Experimental Medicine (Immunology), Muirhead Chair of Medicine and Director of Institute (School of Medicine), Immunology, Infection and Inflammation, University of Glasgow; P.J. Mease, MD, Clinical Professor, University of Washington School of Medicine, Director of the Rheumatology Clinical Research Division of Swedish Medical Center; S. Hall, MBBS, Professor, Director-Emeritus Research, Monash University; H. Chinoy, PhD, Senior Lecturer, Rheumatology, NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester University Hospitals NHS Foundation Trust, University of Manchester; A.J. Kivitz, MD, CPI, President, Altoona Center for Clinical Research; Z. Wang, PhD, Associate Director, Biometrician, Novartis; S. Mpofu, MD, Senior Global Program Medical Director, Novartis.

出版信息

J Rheumatol. 2016 Sep;43(9):1713-7. doi: 10.3899/jrheum.160275. Epub 2016 Jun 15.

DOI:10.3899/jrheum.160275

PMID:27307536

Abstract

OBJECTIVE

To determine the effect of prior tumor necrosis factor inhibitor (TNFi) therapy on secukinumab efficacy in psoriatic arthritis (PsA).

METHODS

Patients were randomized to secukinumab 300 mg, 150 mg, 75 mg, or placebo.

RESULTS

American College of Rheumatology 20 responses at Week 24 with secukinumab 300 mg, 150 mg, 75 mg, and placebo were 58.2%, 63.5%, 36.9%, and 15.9% in TNFi-naive (n = 258), and 45.5%, 29.7%, 14.7%, and 14.3% in TNFi-exposed patients (n = 139), respectively. Week 52 responses with secukinumab 300 mg, 150 mg, and 75 mg were 68.7%, 79.4%, and 58.5% in TNFi-naive, and 54.5%, 37.8%, and 35.3% in TNFi-exposed patients, respectively.

CONCLUSION

Secukinumab was efficacious in TNFi-naive and TNFi-exposed patients with PsA, with greatest improvements in TNFi-naive patients.

摘要

目的

确定既往使用肿瘤坏死因子抑制剂（TNFi）治疗对司库奇尤单抗治疗银屑病关节炎（PsA）疗效的影响。

方法

将患者随机分为接受300mg、150mg、75mg司库奇尤单抗或安慰剂治疗组。

结果

在未使用过TNFi的患者（n = 258）中，第24周时接受300mg、150mg、75mg司库奇尤单抗和安慰剂治疗达到美国风湿病学会20改善标准的比例分别为58.2%、63.5%、36.9%和15.9%；在曾使用过TNFi的患者（n = 139）中，上述比例分别为45.5%、29.7%、14.7%和14.3%。在第52周时，未使用过TNFi的患者接受300mg、150mg和75mg司库奇尤单抗治疗达到改善标准的比例分别为68.7%、79.4%和58.5%，曾使用过TNFi的患者中上述比例分别为54.5%、37.8%和35.3%。