Secukinumab provides sustained PASDAS-defined remission in psoriatic arthritis and improves health-related quality of life in patients achieving remission: 2-year results from the phase III FUTURE 2 study

被引:31
作者
Coates, L. C. [1 ]
Gladman, D. D. [2 ]
Nash, P. [3 ]
FitzGerald, O. [4 ]
Kavanaugh, A. [5 ,6 ]
Kvien, T. K. [7 ]
Gossec, L. [8 ,9 ]
Strand, V. [10 ]
Rasouliyan, L. [11 ]
Pricop, L. [12 ]
Ding, K. [12 ]
Jugl, S. M. [13 ]
Gaillez, C. [13 ]
机构
[1] Univ Oxford, Botnar Res Ctr, Nuffield Dept Orthopaed Rheumatol & Musculoskele, Windmill Rd, Oxford OX3 7LD, England
[2] Univ Toronto, Toronto Western Hosp, Dept Med, Rheumatol, Toronto, ON, Canada
[3] Univ Queensland, Dept Med, Brisbane, Qld, Australia
[4] St Vincents Univ Hosp, Dept Rheumatol, Dublin, Ireland
[5] Univ Coll Dublin, Conway Inst Biomol Res, Dublin, Ireland
[6] Univ Calif San Diego, Sch Med, La Jolla, CA USA
[7] Diakonhjemmet Hosp, Dept Rheumatol, Oslo, Norway
[8] UPMC Univ Paris 06, Sorbonne Univ, Paris, France
[9] Hop La Pitie Salpetriere, Rheumatol Dept, AP HP, Paris, France
[10] Stanford Univ, Sch Med, Div Immunol Rheumatol, Palo Alto, CA 94304 USA
[11] RTI Hlth Solut, Barcelona, Spain
[12] Novartis Pharmaceut, E Hanover, NJ USA
[13] Novartis Pharma AG, Basel, Switzerland
关键词
Psoriatic arthritis; Secukinumab; PASDAS; Remission; Interleukin-17A; FUTURE; 2; study; LOW DISEASE-ACTIVITY; PLACEBO-CONTROLLED TRIAL; ACTIVITY INDEX; INTERLEUKIN-17A; RECOMMENDATIONS; INHIBITION; MANAGEMENT; EFFICACY; SAFETY;
D O I
10.1186/s13075-018-1773-y
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
BackgroundSecukinumab has demonstrated sustained improvement in the signs and symptoms of psoriatic arthritis (PsA) over 2years in the FUTURE 2 study (NCT01752634). This post hoc analysis assessed the ability of secukinumab to achieve Psoriatic Arthritis Disease Activity Score (PASDAS)-based remission or low disease activity (LDA) through 2years among patients with PsA in the FUTURE 2 study.MethodsPASDAS (cut-off scores: remission 1.9; LDA >1.9 and<3.2; Moderate Disease Activity 3.2 and<5.4; and high disease activity [HDA]5.4) was assessed in the overall population (tumour necrosis factor inhibitor [TNFi]-naive and TNFi-experienced), in patients stratified by prior TNFi use and by disease duration at weeks 16, 52 and 104. The impact of secukinumab on individual PASDAS core components and on the relationship between PASDAS states and patient-reported outcomes (PROs), including physical function, health-related quality of life (HRQoL) and work productivity, were also assessed. Data for the approved doses of secukinumab (300 and 150mg) are reported. PASDAS scores and core components were reported as observed, and PROs were analysed using mixed models for repeated measures.ResultsIn the overall population, PASDAS remission and LDA were achieved in 15.6% and 22.9%, respectively, of patients treated with secukinumab 300mg and in 15.2% and 19.2%, respectively, in the secukinumab 150mg group versus 2.3% and 13.8%, respectively, with placebo at week 16. In the TNFi-naive group, a higher proportion of patients achieved remission+LDA at week 16 with secukinumab 300 and 150mg (46.2% and 42.9%, respectively) versus placebo (17.5%), with corresponding responses in TNFi-experienced patients being 22.6% and 19.4% versus 13.3%. Remission/LDA responses with secukinumab were sustained through 2years. Patients achieving remission/LDA reported greater improvements in PROs than patients in HDA through 2years.ConclusionsSecukinumab-treated patients achieved higher PASDAS-defined remissions or LDA compared with placebo at week 16, which were sustained through 2years. Remission/LDA was achieved by both TNFi-naive and TNFi-experienced patients treated with secukinumab, with higher rates in TNFi-naive patients. Secukinumab-treated patients achieving remission/LDA reported significantly greater improvements in PROs, including physical function and different dimensions of health-related quality of life and work, than patients in HDA.Trial registrationClinicalTrials.gov, NCT01752634. Registered on December 19, 2012.EUDRACT, 2012-004439-22. Registered on December 12, 2012.
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