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THU0437 Secukinumab for The Treatment of Psoriatic Arthritis: Comparative Effectiveness Results versus Licensed Biologics and Apremilast from A Network Meta-Analysis

Background Secukinumab (SEC) is approved for the treatment of active PsA in adults who have responded inadequately to DMARD therapy. The FUTURE 1 and 2 RCTs which included biologic-naïve and biologic-experienced patients, demonstrated superiority of SEC 150 mg and 300 mg over placebo. As no direct trial comparisons are yet available there is a need for comparative effectiveness assessment. Objectives Comparative assessment of SEC via network meta-analysis (NMA) vs. licensed biologics and apremilast in adults with active PsA who had failed conventional DMARD therapy. Methods A systematic review of the literature (November 2015) identified 20 relevant RCTs. NMAs were conducted following health technology assessment guidance using Bayesian fixed-effects models. PASI and ACR responses and their credible intervals (CrIs), which can be interpreted similarly to CIs, were modelled using a conditional binomial likelihood NMA with probit link function. The results of pairwise comparisons are presented for SEC using relative risks (RRs) [95%CrI]. Non-responder imputation data were used for all comparators except golimumab QM (GOL) and infliximab 5 mg/kg Q2M (INF) for which only last observation carried forward data were available. Analyses were performed in biologic-naïve, biologic-experienced, and mixed populations at week 16 for ACR and at weeks 12–16 for PASI. Results At week 16 in the biologic-naïve population, ACR20 responses were statistically significantly higher for SEC 150 mg (61%) and 300 mg (58%) than for ustekinumab QM (UST) 45 mg (RR 1.95 [1.29–2.86] and RR 1.84 [1.21–2.74], respectively), and for SEC 150 mg vs UST 90 mg (RR 1.52 [1.03–2.16]). ACR20 responses were statistically significantly higher for SEC 150 and 300 mg vs. apremilast BID (APR) 20 mg (RR 2.51 [1.52–4.29] and RR 2.37 [1.39–4.12] respectively), and for SEC 150 mg vs. APR 30 mg (RR 1.72 [1.09–2.71]). Comparisons between SEC and anti-TNFs did not show statisticall significance. For ACR50 and 70, both SEC doses showed the same pattern of significance as for ACR20. Sensitivity analyses using the mixed population were in general agreement with these observations. For PASI50, 75, and 90 at weeks 12–16 in the biologic-naïve population, only a small evidence network with SEC, GOL 50/100mg, adalimumab 40 mg (ADA) and INF was available and there were no statistically significant differences between SEC and these comparators. In the mixed population, SEC was statistically significantly superior to ADA, APR 20/30 mg, certolizumab pegol (CZP) 200/400 mg, etanercept (ETN) 25/50 mg BIW and 50 mg QW, and (SEC 300 mg only) GOL 50 mg. Conclusions SEC shows statistically significantly higher results vs. UST and APR in ACR20, 50 and 70, with at least comparable response rates across all ACR and PASI endpoints vs. all therapies included in this NMA. For PASI50, 75, and 90 responses, SEC had high response rates with statistically significant results vs. ADA, APR, CZP, ETN, and (SEC 300 mg only) GOL 50 mg. Disclosure of Interest I. McInnes Consultant for: Novartis, Janssen, Abbvie, Pfizer and UCB, P. Nash Grant/research support from: Novartis, Consultant for: Novartis, C. Ritchlin Grant/research support from: Abbvie, Amgen, UCB, Consultant for: Amgen, Abbvie, Jannsen, Novartis, Sun Pharma, Sanofi, UCB, Boeringer Ingelheim, H. Thom Consultant for: Novartis Pharma AG and for a short time in 2015 for Eli Lilly, S. Kanters Consultant for: Novartis, E. Palaka Employee of: Novartis employee, K. Gandhi Shareholder of: Novartis, Employee of: Novartis, S. Mpofu Shareholder of: Novartis, Employee of: Novartis, S. Jugl Shareholder of: Novartis, Employee of: Novartis

Cost-effectiveness analysis of secukinumab for the treatment of active psoriatic arthritis: a Canadian perspective

Abstract Objective: The study evaluates the cost-effectiveness of secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, vs currently licensed biologic treatments in patients with active psoriatic arthritis (PsA) from a Canadian healthcare system perspective. Methods: A decision analytic semi-Markov model evaluated the cost-effectiveness of secukinumab 150 mg and 300 mg compared to subcutaneous biologics adalimumab, certolizumab pegol, etanercept, golimumab, and ustekinumab, and intravenous biologics infliximab and infliximab biosimilar in biologic-naive and biologic-experienced patients over a lifetime horizon. The response to treatments was evaluated after 12 weeks by PsA Response Criteria (PsARC) response rates. Non-responders or patients discontinuing initial-line of biologic treatment were allowed to switch to subsequent-line biologics. Model input parameters (Psoriasis Area Severity Index [PASI], Health Assessment Questionnaire [HAQ], withdrawal rates, costs, and resource use) were collected from clinical trials, published literature, and other Canadian sources. Benefits were expressed as quality-adjusted life years (QALYs). An annual discount rate of 5% was applied to costs and benefits. The robustness of the study findings were evaluated via sensitivity analyses. Results: Biologic-naive patients treated with secukinumab achieved the highest number of QALYs (8.54) at the lowest cost (CAD 925,387) over a lifetime horizon vs all comparators. Secukinumab dominated all treatments, except for infliximab and its biosimilar, which achieved minimally more QALYs (8.58). However, infliximab and its biosimilar incurred more costs than secukinumab (infliximab: CAD 1,015,437; infliximab biosimilar: CAD 941,004), resulting in higher cost-effectiveness estimates relative to secukinumab. In the biologic-experienced population, secukinumab dominated all treatments as it generated more QALYs (8.89) at lower costs (CAD 954,692). Deterministic sensitivity analyses indicated the results were most sensitive to variation in PsARC response rates, change in HAQ, and utility values in both populations. Conclusions: Secukinumab is either dominant or cost-effective vs all licensed biologics for the treatment of active PsA in biologic-naive and biologic-experienced populations in Canada.

Ankylosing spondylitis causes high burden to patients and the healthcare system: results from a German claims database analysis

To compare healthcare resource utilization and costs between ankylosing spondylitis (AS) patients and a matched sample from the general population without AS covered by the German Statutory Health Insurance (SHI) system, a non-interventional retrospectively matched cohort analysis was conducted using anonymized SHI claims data. Data from January 1st, 2011 through December 31st, 2014 were analyzed. Individuals with a coded diagnosis of AS during the enrollment period comprising the full year of 2013 were directly matched (1:5) to individuals without AS diagnosis in the whole study period by age, gender, hospitalizations, and comorbidities. All-cause healthcare resource utilization and direct costs were analyzed for the year 2013. Statistical tests were applied to compare the differences between the two sampled populations. In 2013, 10,208 AS patients were identified and matched to a sample of 51,040 patients without AS from the general population. Healthcare resource utilization was significantly higher in all healthcare sectors (inpatient, outpatient, pharmaceuticals, remedies, devices and aids, and sick leave) in the AS cohort. Mean all-cause healthcare costs per patient were about €2475 higher in the AS cohort compared to the general population. Most important cost drivers were hospitalizations and pharmaceuticals in terms of bDMARDs prescribed in 10% of the patients. Real-world data from this German claims database analysis showed that AS is associated with a substantial incremental economic burden to the healthcare system.

Cost effectiveness of secukinumab for the treatment of active ankylosing spondylitis in the UK

ObjectiveTo determine the cost effectiveness of secukinumab, a fully human interleukin-17A inhibitor, for adults in the UK with active ankylosing spondylitis (AS) who have not responded adequately to previous treatment with conventional care (CC; biologic-naïve population) or previous biologic therapy (biologic-experienced population).Perspective and SettingUK National Health Service (NHS).MethodsThe model was structured as a 3-month decision tree leading into a Markov model. Comparators were licensed tumour necrosis factor inhibitors (including available biosimilars) and CC in the biologic-naïve and biologic-experienced populations, respectively. Clinical parameters captured treatment response, short-term disease activity and patient functioning, as well as long-term structural disease progression. Utilities were derived from secukinumab trial data. List prices were used for all drugs. The cost year was 2017 and costs and outcomes were discounted at 3.5%.ResultsIn the biologic-naïve population, secukinumab dominated adalimumab and certolizumab pegol. Incremental cost-effectiveness ratios (ICERs) versus other comparators were either below £10,000 per quality-adjusted life-year (QALY) gained or south-west ICERs that implied cost effectiveness of secukinumab. In biologic-experienced patients, the ICER for secukinumab versus CC was £4927 per QALY gained. Treatment response rates, short-term treatment effects, long-term radiographic progression and biologic acquisition costs were key model drivers. Scenario analysis found results to be robust to changes in model structural assumptions. Probabilistic analysis identified greater uncertainty in results in the biologic-naïve population.ConclusionsEven at list price, secukinumab appears to represent a cost-effective use of NHS resources for biologic-naïve and biologic-experienced patients with active AS. Further research on long-term radiographic progression outcomes would be valuable for future cost-effectiveness analyses in AS.

Budget impact model of secukinumab for the treatment of moderate-to-severe psoriasis, psoriatic arthritis, and ankylosing spondylitis in Italy: a cross-indication initiative

Objective Secukinumab, a fully human monoclonal IgG1 antibody that selectively neutralizes the proinflammatory cytokine IL-17A, has been approved in Europe in 2015 for the treatment of adult patients with moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), and ankylosing spondylitis (AS). This analysis assessed the budget impact of introduction of secukinumab to the Italian market for all three indications from the perspective of the Italian National Health Service. Materials and methods A cross-indication budget impact model was developed and included biologic-treated adult patients diagnosed with psoriasis, PsA, and AS. The analyses were conducted over a 3-year time horizon and included direct costs (drug therapy costs, administration costs, diseases-related costs, and adverse events costs). Model input parameters (epidemiology, market share projections, resource use, and costs) were obtained from the published literature and other Italian sources. The robustness of the results was tested via one-way sensitivity analyses: secukinumab cost, secukinumab market share, intravenous administration costs, and adverse events costs were varied by ±10%. Results The total patient population for secukinumab over the 3-year timeframe was projected to be 6,648 in the first year, increasing to 12,001 in the third year, for all three indications combined (psoriasis, PsA, and AS). Compared to a scenario without secukinumab in the market, the introduction of secukinumab in the market for the treatment of psoriasis, PsA, and AS showed a cumulative 3-year incremental budget impact of −5%, corresponding to savings of €66.1 million and per patient savings of about €1,855. The majority of the cost savings came from the adoption of secukinumab in AS (58%), followed by PsA (29%) and psoriasis (13%). Sensitivity analyses confirmed the robustness of the results. Conclusion Results from this cross-indication budget impact model show that secukinumab is a cost-saving option for the treatment of PsA, AS, and psoriasis patients in Italy.

Minimal Disease Activity Among Active Psoriatic Arthritis Patients Treated With Secukinumab: 2‐Year Results From a Multicenter, Randomized, Double‐Blind, Parallel‐Group, Placebo‐Controlled Phase III Study

Objective: To evaluate minimal disease activity (MDA) among psoriatic arthritis (PsA) patients receiving secukinumab through 2 years in the FUTURE 2 study (NCT01752634). Methods: Patients with active PsA were randomized to receive subcutaneous secukinumab 300, 150, or 75 mg or placebo. MDA was assessed in the overall population (anti-tumor necrosis factor [TNF]-naïve and inadequate responders [antiTNF-IR]) and in patients stratified by prior anti-TNF exposure and by time since diagnosis at Weeks 16, 24, 52, and 104. Function, patient-reported outcomes (PROs) including health-related quality of life (QoL), and work productivity were assessed in MDA responders versus non-responders. Results: Overall, 28% (27/98) and 23% (23/100) of patients achieved MDA at Week 16 with secukinumab 300 and 150 mg, respectively, versus 10% (9/94) with placebo. In the anti–TNF-naïve cohort, a higher proportion of patients achieved MDA at Week A cc ep te d A rt ic le This article is protected by copyright. All rights reserved. 16 with secukinumab 300 and 150 mg (34% and 32%, respectively) versus placebo (13%). The corresponding value in the anti-TNF-IR cohort was 15% and 8% with secukinumab 300 and 150 mg, respectively, versus placebo (3%). At Week 16, 27.1% (16/59) of MDA responders achieved a very low disease activity (VLDA) response, with the percentage being numerically greater with secukinumab 300 and 150 mg (30% [8/27] and 26% [6/23], respectively) versus placebo (22% [2/9]). The MDA and VLDA responses with secukinumab 300 and 150 mg were sustained through 2 years. MDA responders showed greater improvements in QoL outcomes compared to non-responders through 2 years. Conclusion: A greater proportion of patients achieved MDA with secukinumab versus placebo at Week 16, with response rates sustained through 2 years. MDA was associated with improved PROs, including QoL, through 2 years.To evaluate minimal disease activity (MDA) among psoriatic arthritis (PsA) patients receiving secukinumab through 2 years in the FUTURE 2 study.

AB0685 Secukinumab provides sustained improvements in work productivity and health related quality of life in patients with ankylosing spondylitis: long-term results from measure 1 and measure 2

Background Patients (pts) with ankylosing spondylitis (AS) experience significant restrictions in work productivity and health-related quality of life (HRQoL). Secukinumab (SEC) demonstrated rapid improvements in signs, symptoms and physical functioning in pts with AS.1 Objectives To assess whether the beneficial effects of SEC on AS signs and symptoms were reflected in improvements in work productivity and HRQoL in the overall population and in TNF inhibitor (TNF)-naïve pts and pts with an inadequate response or intolerance to TNF inhibitors (TNF-IR) for up to 52 weeks (wks) in MEASURE 2 and 104 wks in MEASURE 1. Methods 371 and 219 pts were randomized to SEC or placebo (PBO) in MEASURE 1 (10 mg/kg IV followed by 150 or 75 mg SC) and MEASURE 2 (150 or 75 mg SC), respectively. At Wk 16, PBO pts were re-randomized to SEC 150 or 75 mg SC (PBO pts with ASAS20 response at Wk 16 were switched to SEC at Wk 24 in MEASURE 1). Productivity was measured using the Work Productivity and Activity Impairment-General Health (WPAI-GH) questionnaire, which includes questions to assess absenteeism, presenteeism and overall work productivity impairment in employed pts, and general activity impairment in all pts during the preceding 7 days (0–100%). HRQoL was assessed with the ASQoL questionnaire (0–18 points). Across both studies, approximately 69% of pts were TNF-naïve and 31% were TNF-IR. Observed data are presented from the full analysis set and in subgroups stratified by prior TNF exposure. Only data with the approved dose (SEC 150 mg) are shown. Results At baseline (BL), 77 of 125 and 45 of 72 randomized pts were employed and working in the SEC groups in MEASURE 1 and 2, respectively. Improvements in all WPAI domains were observed with SEC in the overall, TNF-naïve and TNF-IR populations at Wk 16 in both studies, and effects were generally sustained through Wks 52 and 104 (Table). In MEASURE 1, activity impairment in the total group improved by 49% and overall work productivity in those employed improved by 45% from BL at Wk 104. Improvements were 51%/49% in TNF-naïve and 42%/19% in TNF-IR pts, respectively. In MEASURE 2, activity impairment and work productivity improved by 43% and 40% vs BL, respectively at Wk 52; improvements in activity impairment/work productivity in TNF-naïve and TNF-IR pts were 49%/54% and 32%/16%, respectively. Similar responses were seen in the other WPAI scores across both studies. Early improvements in ASQoL were sustained through Wk 104 in MEASURE 1 and Wk 52 in MEASURE 2. At Wk 104 of MEASURE 1, ASQoL scores had improved by 48% vs. BL with SEC; improvements were 50% and 39% in TNF-naïve and TNF-IR pts, respectively. Conclusions SEC provides sustained improvements in work productivity and ASQoL for up to 104 wks among AS pts, regardless of prior TNF exposure. References Baeten. NEJM 2015;373:2534–48. Disclosure of Interest A. Deodhar Grant/research support from: Amgen, Abbvie, GSK, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Eli Lilly, Janssen, Novartis, Pfizer, UCB, P. Conaghan Consultant for: Abbvie, BMS, Lilly, Novartis, Pfizer, Roche, Speakers bureau: Abbvie, BMS, Lilly, Novartis, Pfizer, Roche, V. Strand Consultant for: AbbVie, Amgen, BMS, Celgene, Celltrion, CORRONA, Genentech/Roche, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sanofi, and UCB, A. Boonen Grant/research support from: Merck, Pfizer, Abbvie and Amgen, Speakers bureau: Sandoz, Janssen, Lilly, G. Ferraccioli Grant/research support from: BMS, Roche, MSD, Speakers bureau: AbbVie, Pfizer, UCB.Roche, MSD, Eli Lilly, GSK, Novartis, F. Van den Bosch Consultant for: Abbvie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB, V. Bhosekar Employee of: Novartis, B. Porter Shareholder of: Novartis, Employee of: Novartis, K. Gandhi Shareholder of: Novartis, Employee of: Novartis, S. Jugl Shareholder of: Novartis, Employee of: Novartis

FRI0494 Secukinumab provides rapid and sustained pain relief in psoriatic arthritis: 2-year results from the future 2 study

Background Pain remains a major clinical challenge in the treatment of psoriatic arthritis (PsA). Secukinumab (SEC) has demonstrated significant efficacy in PsA patients (pts), across a range of quality of life related outcome measures.1,2 Objectives This post-hoc analysis evaluated change in pain scores from baseline (BL) to Week (Wk) 104 in PsA pts receiving SEC in the FUTURE 2 study. Methods FUTURE 2 study design has been reported.2 Mean change from BL in pain VAS and SF-36 bodily pain domain scores were evaluated using mixed-effect model for repeated measures (MMRM) through Wk 16 and as observed through Wk 104. Proportion of pts reporting improvements ≥clinically meaningful differences in pain VAS (mean change from BL ≥20%) was assessed. Results are reported for SEC 300 and 150mg in overall population and stratified by prior use of TNF inhibitor (TNFi; TNFi-naïve vs. inadequate responder/intolerant [TNFi-IR]). EQ–5D-3L pain item scores (no-, moderate- or extreme-pain/discomfort) were assessed as proportions. Results Mean changes from BL in pain VAS were greater with SEC vs. placebo (PBO) by Wk 3 (least squares mean [LSM]: -16.9, -12.6 with SEC 300 and 150mg, respectively vs. -5.75 with PBO; P<0.05), and Wk 16 (LSM: -24.0 and -23.0 for SEC 300 and 150mg, respectively vs. -8.41 with PBO; P<0.05). Mean changes were sustained through Wk 104 (-26.1 and -25.9 with SEC 300 and 150mg, respectively). In both SEC groups, >50% pts reported improvements of ≥20% by Wk 3 and this increased through Wk 104. Similarly, SF-36 bodily pain domain scores improved from BL by Wk 4 and 16 with SEC vs. PBO, exceeding minimum clinically important differences of 5.0 (Wk 4: LSM: 16.2 and 16.3 for SEC 300 and 150mg, respectively vs. 5.9 with PBO; P<0.05 and Wk 16: LSM: 21.1 and 22.0 for SEC 300 and 150mg, respectively vs. 6.9 with PBO; P<0.05). Improvements in pain were consistent in TNFi-naïve and TNFi-IR pts; and of greater magnitude in the naïve subgroup (table). Based on the EQ–5D-3L pain/discomfort item, 99% pts reported moderate to extreme pain or discomfort at BL. At Wk 4, the proportion of pts with no pain or discomfort was greater for the SEC 300mg (15%) and 150mg (10%) vs. PBO (5%) and increased through Wk 104 to 28% and 16% with SEC 300 and 150mg, respectively.Table 1. Summary of results by TNFi status at baseline TNFi-naïve TNFi-IR SEC 300mg SEC 150mg PBO SEC 300mg SEC 150mg PBO N 67 63 63 33 37 35 Pain VAS  Wk 16 -27.8* -25.1† -11.3 -18.2‡ -21.1§ -4.4  Wk 104 -29.6 -28.3 – -19.3 -20.4 – SF-36 bodily pain  Wk 16 23.8* 25.4* 8.6 18.3§ 17.9§ 5.2  Wk 104 24.2 22.2 – 24.5 14.0¶ – *P<0.0001; †P<0.001; §P<0.01; ‡P<0.05 vs. PBO. P-values and LS mean change at Wk 16 from MMRM analysis. Mean change at Wk 104 from observed data in n=57 (300mg) and 53 (150mg) for TNFi-naïve and n=29 (300mg) and 24 (150mg) for TNFi-IR; ¶n=26. Conclusions SEC provides rapid and sustained pain relief through 104 wks in pts with PsA as assessed by multiple clinically relevant patient-reported measures of pain. Improvements were reported by pts regardless of their prior TNFi therapy status. References Strand V, et al. Ann Rheum Dis 2017;76:203–7. McInnes IB, et al. Lancet 2015;386:1137–46. Disclosure of Interest I. McInnes Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, P. Mease Grant/research support from: Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, Consultant for: Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB, Speakers bureau: Abbvie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB, G. Schett: None declared, B. Kirkham Grant/research support from: AbbVie, Eli Lilly, Novartis, Roche and UCB, Consultant for: Abbott, Eli Lilly and Novartis, Speakers bureau: Abbott, Janssen, Novartis and Pfizer, V. Strand Consultant for: AbbVie, Amgen, BMS, Celgene, Celltrion, Corrona, Genentech/Roche, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi and UCB, N. Williams Consultant for: Novartis through employment at RTI, Employee of: RTI Health Solutions, T. Fox Shareholder of: Novartis, Employee of: Novartis, L. Pricop Shareholder of: Novartis, Employee of: Novartis, S. Jugl Shareholder of: Novartis, Employee of: Novartis, K. Gandhi Shareholder of: Novartis, Employee of: Novartis

THU0393 Secukinumab provides sustained reduction in fatigue in patients with ankylosing spondylitis through 3 years: long-term results of two randomised double-blind placebo-controlled phase 3 studies

Background In patients (pts) with ankylosing spondylitis (AS), fatigue is a common symptom negatively affecting health-related quality of life (HRQoL) and social functioning. Secukinumab (SEC), a fully human anti–IL-17A mAb, rapidly improved signs and symptoms, physical functioning, and HRQoL in pts with AS.1,2 Objectives To assess the long-term effects of SEC on fatigue in TNF inhibitor (TNF)-naïve and TNF inhibitor inadequate responder/intolerant (TNF-IR) AS pts in MEASURE 1 and MEASURE 2. Methods 371 and 219 pts were randomized to SEC or placebo (PBO) in MEASURE 1 (10 mg/kg IV followed by 150 or 75 mg SC) and MEASURE 2 (150 or 75 mg SC), respectively. At Week (Wk) 16, non-responder PBO pts were re-randomized to SEC 150 or 75 mg SC (in MEASURE 1, PBO pts achieving ASAS20 response at Wk 16 were switched to SEC at Wk 24). Fatigue was measured at baseline (BL) and Wks 4, 8, 12, 16, 24, 52, 104 and 156 using FACIT-F, which assesses fatigue in the previous 7 days using 13 questions graded on a 0–4 scale (higher scores=less fatigue). An increase from BL in FACIT-F score of ≥4 points (based on MCID) was used to define “response”. Approximately 69% of pts were TNF-naïve and 31% were TNF-IR across both trials. Analyses were based on the full analysis set and subgroups stratified by prior TNF therapy. Correlations between BL characteristics and improvements in fatigue were investigated using a logistical regression model. Only data from the approved dose (SEC 150 mg) are presented. Results FACIT-F was 24.5–25.6 and 22.6–24.3 at BL across groups in MEASURE 1 and 2, respectively. Improvements in FACIT-F with SEC at Wk 16 were sustained through Wk 156 in MEASURE 1 and Wk 104 in MEASURE 2 (Table). Rapid and sustained fatigue responses were also seen in subgroups stratified by prior TNF use. In the overall population, LS mean changes (±SEM) from BL in FACIT-F scores were significantly greater with SEC vs PBO at Wk 16 in both MEASURE 1 (7.60±0.99 vs 3.34±1.00, P=0.002) and MEASURE 2 (8.10±1.09 vs 3.27±1.09, P=0.018); reductions in fatigue were sustained throughout the entire follow up in both trials (MEASURE 1 Wk 156: 9.81±0.95; MEASURE 2 Wk 104: 9.27±1.13). Similar results were reported in both TNF-naïve and TNF-IR pts. Correlational analyses based on pooled data from both trials did not identify any BL factors that consistently predicted improvement in fatigue response at Wks 16, 52, and 104. A one-unit increase in BL BASDAI score (i.e. worsening) was a significant factor for achieving FACIT-F response at Wk 104 (P=0.02). Conclusions SEC provided sustained improvements in fatigue for up to 156 wks in both TNF-naïve and TNF-IR pts with AS. Fatigue response was generally higher in TNF-naïve pts. References Baeten. NEJM 2015;373:2534–48. Kvien. ARD 2016;75(Suppl2):823. Disclosure of Interest T. Kvien Consultant for: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB, Speakers bureau: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB, A. Deodhar Grant/research support from: Eli Lilly, Janssen, Novartis, Pfizer, UCB, Abbvie, Amgen, GSK, L. Gossec Grant/research support from: BMS, Lippy, Pfizer, Consultant for: Abbvie, BMS, Celgene, Janssen, MSD, Novartis, Pfizer, Roche and UCB, P. Conaghan Consultant for: Abbvie, BMS, Lilly, Novartis, Pfizer, Roche, Speakers bureau: Abbvie, BMS, Lilly, Novartis, Pfizer, Roche, V. Strand Consultant for: AbbVie, Amgen, BMS, Celgene, Celltrion, CORRONA, Genentech/Roche, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sanofi, and UCB, M. Østergaard Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merck, Novartis, Orion, Pfizer, Regeneron, Roche, UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merck, Novartis, Orion, Pfizer, Regeneron, Roche, UCB, N. Williams Employee of: RTI Health Solutions, B. Porter Shareholder of: Novartis, Employee of: Novartis, K. Gandhi Shareholder of: Novartis, Employee of: Novartis, S. Jugl Shareholder of: Novartis, Employee of: Novartis

SAT0463 Secukinumab provides sustained reduction in fatigue in patients with active psoriatic arthritis through 3 years: long-term data from the future 1 and future 2 studies

Background Fatigue, a common symptom in patients (pts) with PsA, can negatively impact HRQoL and social functioning. Secukinumab (SEC), a fully human anti–IL-17A mAb, rapidly improved signs and symptoms, physical functioning, HRQoL, and fatigue in pts with PsA.1,2 Objectives To assess the long-term effects of SEC on fatigue in TNF inhibitor (TNF)-naïve PsA pts and those with an inadequate response or intolerance to TNF inhibitor therapy (TNF-IR). Methods 606 and 397 pts were randomized to SEC or placebo (PBO) in FUTURE 1 (10 mg/kg IV followed by 150 or 75 mg SC) and FUTURE 2 (300, 150, or 75 mg SC), respectively. At Wk 16, PBO pts with ≤20% reduction in tender/swollen joint count (non-responders) were re-randomized to SEC 150 or 75 mg SC (FUTURE 1) and SEC 300 or 150 mg SC (FUTURE 2); responders were re-randomized at Wk 24. Pts in FUTURE 1 could enter a LTE study at Wk 104 (NCT01892436). Across both studies, approximately 68% of pts were TNF-naïve and 32% were TNF-IR. Fatigue was assessed at baseline (BL) and Wks 4, 8, 12, 16, 24, 52, 104, and 156 (FUTURE 1 only) using FACIT-F (higher scores = less fatigue). Fatigue response was defined by an increase in FACIT-F score of ≥4 from BL (corresponding to the MCID). Correlations between BL characteristics and improvements in fatigue were investigated using a logistical regression model. Only data with approved doses of SEC (300/150 mg) are shown. Results FACIT-F was 27.8–28.9 and 26.6–29.2 at BL across groups in FUTURE 1 and 2, respectively. Improvements in fatigue seen with all doses of SEC vs. PBO from Wks 4–24 were sustained through 156 wks in FUTURE 1 and 104 wks in FUTURE 2 in both the overall population and subgroups stratified by prior exposure to TNF (Table). The numerically higher responses with SEC 150 vs. 300 mg in this observed analysis were as a result of a higher rate of discontinuation due to lack of efficacy with the lower dose, which inflated the response rate. In the overall population, the LS mean change (±SEM) from BL in FACIT-F was significantly greater with SEC vs. PBO at Wk 16 in both FUTURE 1 (7.25±0.72 vs. 4.07±0.76; P=0.002) and FUTURE 2 (300 mg: 5.89±0.92 vs. 1.86±0.93, P=0.002; 150 mg: 7.40±0.90 vs. 1.86±0.93, P<0.0001); improvements were sustained throughout the entire follow up in both studies (FUTURE 1 Wk 156: 6.14±0.77; FUTURE 2 Wk 104: 300 mg 7.29±1.04, 150 mg 7.02±1.06). Improvements were generally somewhat larger in TNF-naïve pts than in TNF-IR pts. Correlation analyses did not identify any BL factors that consistently predicted change in fatigue score across Wks 16, 52, and 104. Conclusions SEC-treated PsA pts achieved rapid, sustained, and clinically meaningful improvements in fatigue for up to 156 wks, with higher responses in TNF-naïve pts. References McInnes et al. Lancet 2015;386:1137–46. Mease et al. N Engl J Med 2015;373:1329–39. Disclosure of Interest L. Gossec Grant/research support from: BMS, Lippy, Pfizer; Consultant for: Abbvie, BMS, Celgene, Janssen, MSD, Novartis, Pfizer, Roche and UCB, T. Kvien Consultant for: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB, Speakers bureau: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Novartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz and UCB, P. Conaghan Consultant for: Abbvie, BMS, Lilly, Novartis, Pfizer, Roche, Speakers bureau: Abbvie, BMS, Lilly, Novartis, Pfizer, Roche, M. Østergaard Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merck, Novartis, Orion, Pfizer, Regeneron, Roche, UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merck, Novartis, Orion, Pfizer, Regeneron, Roche, UCB, D. Gladman Grant/research support from: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Consultant for: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, P. Mease Grant/research support from: Abbvie, Amgen, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merch, Novartis, Pfizer, SUN, UCB, Consultant for: Abbvie, Amgen, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merch, Novartis, Pfizer, SUN, UCB, Speakers bureau: Abbvie, Amgen, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Janssen, Merch, Novartis, Pfizer, SUN, UCB, L. Rasouliyan Consultant for: Novartis, L. Pricop Shareholder of: Novartis, Employee of: Novartis, C. Gaillez Shareholder of: Novartis and BMS, Employee of: Novartis, S. Jugl Shareholder of: Novartis, Employee of: Novartis