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07-12-2018 | Psoriatic arthritis | Article

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

Journal: Arthritis Research & Therapy

Authors: L. C. Coates, D. D. Gladman, P. Nash, O. FitzGerald, A. Kavanaugh, T. K. Kvien, L. Gossec, V. Strand, L. Rasouliyan, L. Pricop, K. Ding, S. M. Jugl, C. Gaillez, on behalf of the FUTURE 2 study group

Publisher: BioMed Central

Abstract

Background

Secukinumab has demonstrated sustained improvement in the signs and symptoms of psoriatic arthritis (PsA) over 2 years 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 2 years among patients with PsA in the FUTURE 2 study.

Methods

PASDAS (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]-naïve 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 150 mg) are reported. PASDAS scores and core components were reported as observed, and PROs were analysed using mixed models for repeated measures.

Results

In the overall population, PASDAS remission and LDA were achieved in 15.6% and 22.9%, respectively, of patients treated with secukinumab 300 mg and in 15.2% and 19.2%, respectively, in the secukinumab 150 mg group versus 2.3% and 13.8%, respectively, with placebo at week 16. In the TNFi-naïve group, a higher proportion of patients achieved remission + LDA at week 16 with secukinumab 300 and 150 mg (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 2 years. Patients achieving remission/LDA reported greater improvements in PROs than patients in HDA through 2 years.

Conclusions

Secukinumab-treated patients achieved higher PASDAS-defined remissions or LDA compared with placebo at week 16, which were sustained through 2 years. Remission/LDA was achieved by both TNFi-naïve and TNFi-experienced patients treated with secukinumab, with higher rates in TNFi-naïve 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 registration

ClinicalTrials.gov, NCT01752634. Registered on December 19, 2012.
EUDRACT, 2012-004439-22. Registered on December 12, 2012.
Literature
1.
Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(Suppl 2):ii14–7.PubMedPubMedCentral
2.
Rosen CF, Mussani F, Chandran V, Eder L, Thavaneswaran A, Gladman DD. Patients with psoriatic arthritis have worse quality of life than those with psoriasis alone. Rheumatology (Oxford). 2012;51:571–6.CrossRef
3.
Her M, Kavanaugh A. A review of disease activity measures for psoriatic arthritis: what is the best approach? Expert Rev Clin Immunol. 2014;10:1241–54.CrossRefPubMed
4.
Lubrano E, Perrotta FM, Kavanaugh A. An overview of low disease activity and remission in psoriatic arthritis. Clin Exp Rheumatol. 2015;33(5 Suppl 93):S51–4.PubMed
5.
Smolen JS, Schöls M, Braun J, Dougados M, FitzGerald O, Gladman DD, et al. Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force. Ann Rheum Dis. 2018;77(1):3–17.CrossRefPubMed
6.
Coates LC, Kavanaugh A, Mease PJ, Soriano ER, Laura Acosta-Felquer M, Armstrong AW, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015 treatment recommendations for psoriatic arthritis. Arthritis Rheumatol. 2016;68:1060–71.PubMed
7.
Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016;75:499–510.CrossRefPubMed
8.
Chandran V, Maharaj AB. Assessing disease activity in psoriasis and psoriatic arthritis: impact on management and therapy. Expert Rev Clin Immunol. 2016;12:573–82.CrossRefPubMed
9.
Smolen JS, Schoels M, Aletaha D. Disease activity and response assessment in psoriatic arthritis using the Disease Activity index for Psoriatic Arthritis (DAPSA): a brief review. Clin Exp Rheumatol. 2015;33(5 Suppl 93):S48–50.PubMed
10.
Helliwell PS, FitzGerald O, Fransen J, Gladman DD, Kreuger GG, Callis-Duffin K, et al. The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project). Ann Rheum Dis. 2013;72:986–91.CrossRefPubMed
11.
Coates LC, Helliwell PS. Defining low disease activity states in psoriatic arthritis using novel composite disease instruments. J Rheumatol. 2016;43:371–5.CrossRefPubMed
12.
Helliwell PS, Waxman R. Modification of the Psoriatic Arthritis Disease Activity Score (PASDAS). Ann Rheum Dis. 2018;77:467–8.CrossRefPubMed
13.
Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, et al. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014;371:326–38.CrossRefPubMed
14.
Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, et al. Secukinumab inhibition of interleukin-17a in patients with psoriatic arthritis. N Engl J Med. 2015;373(14):1329–39.CrossRefPubMed
15.
McInnes IB, Mease PJ, Kirkham B, Kavanaugh A, Ritchlin CT, Rahman P, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386:1137–46.CrossRefPubMed
16.
McInnes IB, Mease PJ, Ritchlin CT, Rahman P, Gottlieb AB, Kirkham B, et al. Secukinumab sustains improvement in signs and symptoms of psoriatic arthritis: 2 year results from the phase 3 FUTURE 2 study. Rheumatology (Oxford). 2017;56:1993–2003.CrossRef
17.
Nash P, Mease PJ, McInnes IB, Rahman P, Ritchlin CT, Blanco R, et al. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20:47.CrossRefPubMedPubMedCentral
18.
Baeten D, Sieper J, Braun J, Baraliakos X, Dougados M, Emery P, et al. Secukinumab, an interleukin-17a inhibitor, in ankylosing spondylitis. N Engl J Med. 2015;373:2534–48.CrossRefPubMed
19.
Baraliakos X, Kivitz AJ, Deodhar AA, Braun J, Wei JC, Delicha EM, et al. Long-term effects of interleukin-17A inhibition with secukinumab in active ankylosing spondylitis: 3-year efficacy and safety results from an extension of the phase 3 MEASURE 1 trial. Clin Exp Rheumatol. 2018;36:50–5.PubMed
20.
Helliwell PS, Kavanaugh A. Comparison of composite measures of disease activity in psoriatic arthritis using data from an interventional study with golimumab. Arthritis Care Res (Hoboken). 2014;66:749–56.CrossRef
21.
Helliwell P, Mease PJ, Nurminen T, FitzGerald O. Further analysis of Psoriatic Arthritis Disease Activity Score (PASDAS) and Composite Psoriatic Disease Activity Index (CPDAI) using data from a placebo-controlled trial of certolizumab pegol in psoriatic arthritis. Ann Rheum Dis. 2014;73:740.
22.
Coates LC, Husni ME, Lespessailles E, Kerr L, Gallo G. Ixekizumab makes very low disease activity and remission with psoriatic arthritis disease activity score possible in active psoriatic arthritis patients for up to 1 year: SPIRIT-P1 AND SPIRIT-P2 trials. Ann Rheum Dis. 2018;77:375.
23.
Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, et al. Secukinumab provides sustained improvements in the signs and symptoms of active psoriatic arthritis through 3 years: efficacy and safety results from a phase 3 trial [abstract 961]. Arthritis Rheumatol. 2016;68(suppl 10).
24.
Coates LC, Mease PJ, Gossec L, Kirkham B, Sherif B, Gaillez C, et al. Minimal Disease Activity among Active Psoriatic Arthritis Patients Treated with Secukinumab: 2-year Results from the FUTURE 2 Study. Arthritis Care Res (Hoboken). 2018;70:1529–35.CrossRef
25.
Coates LC, Nash P, Kvien T, Gossec L, Mease PJ, Rasouliyan L, et al. Secukinumab Provides Sustained Minimal Disease Activity (MDA) and Remission Related to Disease Activity Index for Psoriatic Arthritis (DAPSA): 2-Year Results from a Phase 3 Study [abstract 622]. Arthritis Rheumatol. 2017;69(suppl 10).
26.
Lubrano E, De Socio A, Perrotta FM. Comparison of composite indices tailored for psoriatic arthritis treated with csDMARD and bDMARD: a cross-sectional analysis of a longitudinal cohort. J Rheumatol. 2017;44:1159–64.CrossRefPubMed