Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1)

被引:80
作者
Strand, Vibeke [1 ]
Mease, Philip [2 ]
Gossec, Laure [3 ]
Elkayam, Ori [4 ]
van den Bosch, Filip [5 ]
Zuazo, James [6 ]
Pricop, Luminita [7 ]
Mpofu, Shephard [6 ]
机构
[1] Stanford Univ, Sch Med, Div Immunol Rheumatol, Palo Alto, CA 94034 USA
[2] Univ Washington, Swedish Med Ctr, Seattle, WA 98195 USA
[3] UPMC Univ Paris 06, Pitie Salpetriere Hosp,GRC UPMC EEMOIS 08, AP HP,Dept Rheumatol,Sorbonne Univ, Inst Pierre Louis Epidemiol & Sante Publ, Paris, France
[4] Tel Aviv Univ, Sackler Fac Med, Tel Aviv Med Ctr, Dept Rheumatol, Tel Aviv, Israel
[5] Univ Ghent, Dept Rheumatol, Ghent, Belgium
[6] Novartis Pharma AG, Basel, Switzerland
[7] Novartis Pharmaceut, E Hanover, NJ USA
关键词
QUALITY-OF-LIFE; RHEUMATOID-ARTHRITIS; ANKYLOSING-SPONDYLITIS; PERSPECTIVE; CRITERIA; FATIGUE;
D O I
10.1136/annrheumdis-2015-209055
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
Objective To evaluate the effect of secukinumab on patient-reported outcomes (PROs) in subjects with active psoriatic arthritis (PsA) in the FUTURE 1 study. Methods Subjects were randomised 1:1:1 to receive intravenous (i.v.) secukinumab 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous secukinumab 150 or 75 mg every 4 weeks or matching placebo until week 24. Results At week 24, subjects receiving secukinumab i.v. -> 1 50 mg or i.v. -> 75 mg reported greater least squares mean changes from baseline than those receiving placebo in patient global assessment of disease activity (-20.6 and -20.0 vs -7.4, respectively), patient assessment of pain (-20.8 and -20.4 vs -6.7), psoriatic arthritis quality of life (-3.5 and -3.2 vs -0.4), Dermatology Life Quality Index (-8.8 and -7.9 vs 0.7); p<0.0001 vs placebo for both secukinumab groups for above PROs and Functional Assessment of Chronic Illness Therapy-Fatigue (6.74 (p<0.05 vs placebo) and 6.03 vs 4.00); all of which well exceeded minimum clinically important differences. Conclusions In subjects with PsA, secukinumab treatment resulted in clinically meaningful improvements in global disease activity, pain, generic and disease-specific measures of health-related quality of life and fatigue.
引用
收藏
页码:203 / 207
页数:5
相关论文
共 22 条
[1]
The Selective Anti-IL17A Monoclonal Antibody Secukinumab ( AIN457) Attenuates IL17A-Induced Levels of IL6 in Human Astrocytes [J].
Elain, Gaelle ;
Jeanneau, Karine ;
Rutkowska, Aleksandra ;
Mir, Anis K. ;
Dev, Kumlesh K. .
GLIA, 2014, 62 (05) :725-735
[2]
Gladman DD, 2007, J RHEUMATOL, V34, P1159
[3]
Guidelines of care for the management of psoriasis and psoriatic arthritis - Section 2. Psoriatic arthritis: Overview and guidelines of care for treatment with an emphasis on the biologics [J].
Gottlieb, Alice ;
Korman, Neil J. ;
Gordon, Kenneth B. ;
Feldman, Steven R. ;
Lebwohl, Mark ;
Koo, John Y. M. ;
Van Voorhees, Abby S. ;
Elmets, Craig A. K. ;
Leonardi, Craig L. ;
Beutner, Karl R. ;
Bhushan, Reva ;
Menter, Alan .
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2008, 58 (05) :851-864
[4]
Effects of AIN457, a Fully Human Antibody to Interleukin-17A, on Psoriasis, Rheumatoid Arthritis, and Uveitis [J].
Hueber, Wolfgang ;
Patel, Dhavalkumar D. ;
Dryja, Thaddeus ;
Wright, Andrew M. ;
Koroleva, Irina ;
Bruin, Gerard ;
Antoni, Christian ;
Draelos, Zoe ;
Gold, Michael H. ;
Durez, Patrick ;
Tak, Paul P. ;
Gomez-Reino, Juan J. ;
Foster, C. Stephen ;
Kim, Rosa Y. ;
Samson, C. Michael ;
Falk, Naomi S. ;
Chu, David S. ;
Callanan, David ;
Quan Dong Nguyen ;
Rose, Kristine ;
Haider, Asifa ;
Di Padova, Franco .
SCIENCE TRANSLATIONAL MEDICINE, 2010, 2 (52)
[5]
Husted JA, 2001, ARTHRIT RHEUM-ARTHR, V45, P151
[6]
Husted JA, 1997, J RHEUMATOL, V24, P511
[7]
Secukinumab in Plaque Psoriasis - Results of Two Phase 3 Trials [J].
Langley, Richard G. ;
Elewski, Boni E. ;
Lebwohl, Mark ;
Reich, Kristian ;
Griffiths, Christopher E. M. ;
Papp, Kim ;
Puig, Lluis ;
Nakagawa, Hidemi ;
Spelman, Lynda ;
Sigurgeirsson, Bardur ;
Rivas, Enrique ;
Tsai, Tsen-Fang ;
Wasel, Norman ;
Tyring, Stephen ;
Salko, Thomas ;
Hampele, Isabelle ;
Notter, Marianne ;
Karpov, Alexander ;
Helou, Silvia ;
Papavassilis, Charis .
NEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (04) :326-338
[8]
Lee Seina, 2010, P T, V35, P680
[9]
Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis [J].
Mease, Philip J. ;
McInnes, Iain B. ;
Kirkham, Bruce ;
Kavanaugh, Arthur ;
Rahman, Proton ;
van der Heijde, Desiree ;
Landewe, Robert ;
Nash, Peter ;
Pricop, Luminita ;
Yuan, Jiacheng ;
Richards, Hanno B. ;
Mpofu, Shephard .
NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (14) :1329-1339