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Background Secukinumab, a fully human immunoglobulin G1-kappa monoclonal antibody that directly inhibits interleukin (IL)-17A, has been shown to have robust efficacy in the treatment of moderate-to-severe psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) demonstrating a rapid onset of action and sustained long-term clinical responses with a consistently favorable safety profile in multiple Phase 2 and 3 trials. Here, we report longer-term pooled safety and tolerability data for secukinumab across three indications (up to 5 years of treatment in PsO and PsA; up to 4 years in AS). Methods The integrated clinical trial safety dataset included data pooled from 21 randomized controlled clinical trials of secukinumab 300 or 150 or 75 mg in PsO (14 Phase 3 trials and 1 Phase 4 trial), PsA (3 Phase 3 trials), and AS (3 Phase 3 trials), along with post-marketing safety surveillance data with a cut-off date of June 25, 2017. Adverse events (AEs) were reported as exposure-adjusted incident rates (EAIRs) per 100 patient-years. Analyses included all patients who received ≥ 1 dose of secukinumab. Results A total of 5181, 1380, and 794 patients from PsO, PsA, and AS clinical trials representing secukinumab exposures of 10,416.9, 3866.9, and 1943.1 patient-years, respectively, and post-marketing data from patients with a cumulative exposure to secukinumab of ~ 96,054 patient-years were included in the analysis. The most frequent AE was upper respiratory tract infection. EAIRs across PsO, PsA, and AS indications were generally low for serious infections (1.4, 1.9, and 1.2, respectively), Candida infections (2.2, 1.5, and 0.7, respectively), inflammatory bowel disease (0.01, 0.05, and 0.1, respectively), and major adverse cardiac events (0.3, 0.4, and 0.6, respectively). No cases of tuberculosis reactivation were reported. The incidence of treatment-emergent anti-drug antibodies was low with secukinumab across all studies, with no discernible loss of efficacy, unexpected alterations in pharmacokinetics, or association with immunogenicity-related AEs. Conclusions Secukinumab demonstrated a favorable safety profile over long-term treatment in patients with PsO, PsA, and AS. This comprehensive assessment demonstrated that the safety profile of secukinumab was consistent with previous reports in patients with PsO, PsA, and AS, supporting its long-term use in these chronic conditions.

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.

Background:Pooled safety data have been reported for secukinumab (SEC) administration in patients with psoriasis (PsO), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).[1,2]Objectives:Here, we report safety profile of SEC after extensive patient exposure in clinical trials from a larger pool of patients and including more studies than previously published.[3]Methods:The pooled safety analysis included 47 Phase II/III/IV clinical trials (PsO: 30; PsA: 9; axSpA [including ankylosing spondylitis {AS} and non-radiographic axial spondyloarthritis {nr-axSpA}]: 8 trials) with patients who had received ≥1 dose of subcutaneous SEC 150 mg and/or 300 mg for ≥16 weeks (cut-off: June 2022). Adverse events (AEs) were reported as exposure-adjusted incidence rates (EAIRs)/100 patient-years (PYs).Results:A total of 15,644 patients (PsO [N=9561], PsA [N=3880] and axSpA [N=2203]) were included in the analysis. The most frequent AEs reported across all indications were nasopharyngitis (EAIR [95% confidence interval {CI}]: PsO, 19.44 [18.66, 20.24]; PsA, 11.36 [10.54, 12.23]; axSpA, 12.91 [11.76, 14.14]) and upper respiratory tract infection (EAIR [95% CI]: PsO, 6.14 [5.75, 6.56]; PsA, 8.10 [7.42, 8.82]; axSpA, 8.28 [7.41, 9.22]). EAIRs/100 PYs for inflammatory bowel disease, malignancies and major adverse cardiovascular events remained low across all indications. The EAIRs/100 PYs for AEs of special interest are reported in Table 1.Conclusion:This pooled safety data analysis of 47 Phase II/III/IV clinical trials demonstrates that secukinumab is well tolerated in patients with PsO, PsA and axSpA, and shows no new signals with longer-term follow-up compared to published studies.1,2REFERENCES:[1] Deodhar A, et al. Arthritis Res Ther. 2019;21:111.[2] Deodhar A, et al. Ann Rheum Dis. 2020;79:722.[3] Gottlieb AB, et al. Acta Derm Venereol. 2022;102:adv00698.Acknowledgements:Medical writing assistance was provided by Ishita Guha Thakurta and Divya Chandrashekhar (Novartis Healthcare Pvt Ltd, Hyderabad) which was funded by Novartis Pharma AG, Basel, Switzerland in accordance with the Good Publication Practice (GPP4) guidelines (http://www.ismpp.org/gpp-2022).Disclosure of Interests:Atul Deodhar Received speaker honoraria from AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Received honoraria for consulting from AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Received research grants from AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Iain B. Mc‎ Innes Received speaker honoraria from AbbVie, Amgen, Bristol Myers Squibb, Cabaletta, Celgene, Compugen, Janssen, Lilly, Moonlake, Novartis, Pfizer, and UCB, Received consultation fees from AbbVie, Amgen, Bristol Myers Squibb, Cabaletta, Celgene, Compugen, Janssen, Lilly, Moonlake, Novartis, Pfizer, and UCB. Board member: Evelo, Received research grant from AbbVie, Amgen, Bristol Myers Squibb, Cabaletta, Celgene, Compugen, Janssen, Lilly, Moonlake, Novartis, Pfizer, and UCB, Xenofon Baraliakos Speaker’s bureau: AbbVie, Bristol Myers Squibb, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB, Consultant for AbbVie, Bristol Myers Squibb, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB, Received research grant from AbbVie, Bristol Myers Squibb, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB, Alice B Gottlieb Honoraria as an advisory board member and consultant for Amgen, Anaptyps Bio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dice Therapeutics, Eli Lilly, Highlights Therapeutics, Janssen, Novartis, Sanofi, UCB, and Xbiotech, Received research or educational grants from Anaptyps Bio, Highlights Therapeutics, Moonlake Immunotherapeutics AG, Novartis, Bristol Myers Squibb, and UCB Pharma, (all paid to Mount Sinai School of Medicine), Uta Kiltz Received speaker honoraria from AbbVie, Biocad, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Received consultancy honoraria from AbbVie, Biocad, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Received unrestricted grant for research from Abbvie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, and Pfizer, Stefan Schreiber Received consultation fees from AbbVie, Arena, Bristol Myers Squibb, Biogen, Celltrion, Celgene, Falk, Fresenius, Gilead, IMAB, Janssen, MSD, Mylan, Pfizer, Protagonist, Provention Bio, Takeda, and Theravance, Braja Gopal Sahoo Employee of Novartis, Weibin Bao Owns stocks of Novartis, Employee of Novartis, Luminita Pricop Owns stocks of Novartis, Employee of Novartis, Corine Gaillez Owns shares of Novartis and Bristol Myers Squibb, Employee of Novartis, Victor Dong Owns stocks of Novartis, Employee of Novartis, Philip J. Mease Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen, Eli Lilly, Merck, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen, Eli Lilly, Merck, Novartis, Pfizer, and UCB, Received Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen, Eli Lilly, Merck, Novartis, Pfizer and UCB.

BackgroundSecukinumab has demonstrated efficacy and safety in patients with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) categories of juvenile idiopathic arthritis (JIA) for up to 2 years.[1] After completion of a 2-year core study (JUNIPERA), a long-term extension (LTE) study was conducted to evaluate the continued efficacy and safety of secukinumab.ObjectivesTo report interim efficacy and safety results of the LTE study of secukinumab in patients with ERA and JPsA.MethodsIn the core study, a total of 86 patients (2 to <18 years of age) received secukinumab up to week 12 in the open-label (OL) period.[1] JIA ACR30 responders at week 12 (n=75) were subsequently randomised to secukinumab (n=37) or placebo (n=38) up to week 100 in study period 2. Those who flared after randomisation (secukinumab, n=10; placebo, n=21) received OL secukinumab up to week 100.[1] A total of 54 out of 61 patients who had completed the core study consented to enter the LTE study and received secukinumab (s.c.) (75/150 mg in patients <50/ ≥50 kg) every 4 weeks up to 4 years. Patients whose signs and symptoms were not fully controlled, as judged by the investigator in the LTE, could have dose escalation of their secukinumab dose from 75 mg to 150 mg or 150 mg to 300 mg. Median Juvenile Arthritis Disease Activity Scores (JADAS)-27 were presented up to week 156 for efficacy, and adverse events (AEs) and serious AEs were presented for the entire treatment period up to the cut-off date (maximum up to week 232).ResultsJADAS-27 in the core study and in the LTE are presented in the Figure 1. A total of 19 patients had dose escalation in the LTE: 8 patients from 75 mg to 150 mg and 11 patients from 150 mg to 300 mg. The overall exposure-adjusted incidence rate per 100 patient-years (PY) of treatment-emergent AEs was 98.4 PY in the entire JIA population. The most commonly reported AEs (preferred term, safety set 5% cut off) were nasopharyngitis (n=9, 16.7%) and arthralgia (n=8, 14.8%). One major adverse cardiovascular event, not related to the study drug, and 2 cases of uveitis were reported. No cases of Crohn’s disease or deaths were reported, and no patient discontinued treatment due to an AE.ConclusionWith secukinumab treatment, the JADAS-27 inactive disease status was sustained from week 104 to week 156 in patients with JIA who had completed the 2-year core study and enrolled in the LTE study. Safety data were consistent with adult and paediatric indications, with no new or unexpected safety signals.Reference[1]Brunner HI, et al. Ann Rheum Dis. 2023;82(1):154-160.AcknowledgementsThe trial was designed jointly by the PRINTO and PRCSG study groups, and Novartis Pharma AG.Disclosure of InterestsNicolino Ruperto Speakers bureau: Ablynx, AstraZeneca-Medimmune, Bayer, Biogen, Boehringer, Bristol Myers and Squibb, Celgene, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sinergie, Sobi and UCB, Consultant of: Ablynx, AstraZeneca-Medimmune, Bayer, Biogen, Boehringer, Bristol Myers and Squibb, Celgene, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sinergie, Sobi and UCB, Grant/research support from: BMS, Eli-Lilly, GlaxoSmithKline, F Hoffmann-La Roche, Janssen, Novartis, Pfizer, Sobi, Ivan Foeldvari Consultant of: Novartis, BMF, Bayer, Genentech, Sanofi, Abbvie, Chugai, Medac, BMS, Pfizer, Ekaterina Alexeeva Speakers bureau: Novartis, Pfizer, Sanofi, MSD, Amgen, Eli Lilly, Roche, Grant/research support from: Novartis, Pfizer, Sanofi, MSD, Amgen, Eli Lilly, Roche, NURAY AKTAY AYAZ: None declared, Grant Schulert Consultant of: Novartis, Grant/research support from: Novartis, Seza Özen: None declared, Artem Popov: None declared, Athimalaipet Ramanan Speakers bureau: Roche, Sobi, Eli Lilly, UCB, Novartis, Christiaan Scott: None declared, Betul Sozeri: None declared, Elena Zholobova Speakers bureau: Abbvie, Pfizer, Roche, Novartis, Grant/research support from: Pfizer, Novartis, Sudhanshu Chakraborty Shareholder of: IQVIA, Employee of: IQVIA, Xuan Zhu Shareholder of: Novartis, Employee of: Novartis, Ruvie Martin Shareholder of: Novartis, Employee of: Novartis, sarah whelan Shareholder of: Novartis, Employee of: Novartis, Sharonjeet Kaur Shareholder of: Novartis, Employee of: Novartis, Luminita Pricop Shareholder of: Novartis, Employee of: Novartis, Daniel J Lovell Speakers bureau: Abbott, Novartis, Consultant of: AstraZeneca, Wyeth, Amgen, Abbott, Pfizer, Hoffmann-La Roche, Novartis, UBC, Janssen, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Bristol Myers Squibb, AbbVie, Alberto Martini Speakers bureau: Eli Lilly, EMD Serono, Janssen, Novartis, Pfizer, Abbvie, Consultant of: Eli Lilly, EMD Serono, Janssen, Novartis, Pfizer, Abbvie, Hermine Brunner Speakers bureau: Pfizer, Roche and GlaxoSmithKline, Consultant of: Aurinia, Abbvie, AstraZeneca-Medimmune, Biogen, Boehringer, Bristol-Myers Squibb, Celgene, Eli Lilly, EMD Serono, GlaxoSmithKline, F. Hoffmann-La Roche, Merck, Novartis, R-Pharm, Sanofi, Pfizer, Grant/research support from: Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, F. Hoffmann-La Roche, Janssen, Novartis, and Pfizer.

Background:Secukinumab (SEC) 150 and 300 mg doses are approved for the treatment of psoriatic arthritis (PsA). SEC 300 mg is the recommended dose for patients (pts) with concomitant moderate-to-severe plaque psoriasis or who are anti-tumour necrosis factor (TNF) inadequate responders. An increase from 150 mg to 300 mg has been reported to be beneficial in some patients with a suboptimal response to SEC 150 mg.1 Here, we present a post hoc analysis in anti-TNF naïve pts who escalated from SEC 150 to 300 mg dose in two Phase 3 studies, FUTURE 4 (NCT02294227) and FUTURE 5 (NCT02404350).Objectives:To evaluate the clinical efficacy on joints following dose escalation from SEC 150 to 300 mg on ACR responses in anti-TNF naïve pts with PsA.Methods:Study design, patient inclusion and exclusion criteria of the FUTURE 4 and FUTURE 5 studies have been reported previously.1–3 In FUTURE 4, 341 pts were randomised in a 1:1:1 ratio to SEC 150 mg with loading dose (LD), SEC 150 mg without LD, or placebo. In FUTURE 5, 996 pts were randomised in a 2:2:2:3 ratio to SEC 300 mg with LD, SEC 150 mg with LD, SEC 150 mg without LD or placebo. Following a protocol amendment, pts were allowed to escalate from 150 mg to the 300 mg dose, in the event of suboptimal response based on investigator’s judgment, starting at Week 36 in FUTURE 4 and at Week 52 in FUTURE 5. ACR responses in anti-TNF naïve pts were evaluated pre- and up to 32 and 40 weeks post-escalation, in FUTURE 4 and FUTURE 5, respectively: pts were grouped into four ranges based on their response: no (< 20); low (≥ 20 to < 50); moderate (≥ 50 to < 70); high (≥ 70) ACR responses. Data presented are as observed in the Sankey-style overlay plot.Results:Dose escalation from SEC 150 to 300 mg occurred in 136 pts in FUTURE 4 and in 236 pts in FUTURE 5. The proportion of ACR responders increased and the proportion of non-responders decreased in anti-TNF naïve pts who escalated from SEC 150 to 300 mg in the two studies. The proportion of anti-TNF naïve pts with a response ≥ACR50 increased from 20% to 41% in FUTURE 4 and 28% to 46% in FUTURE 5, post dose escalation. The ACR responses in anti-TNF naïve pts up to 40 weeks after escalation from SEC 150 to 300 mg are presented in the Sankey-style overlay (Figure).Figure. ACR Response bar chart with Sankey-style overlays up to 40 weeks, after dose escalation from SEC 150 mg to 300 mg, in anti-TNF naïve pts in FUTURE 4 and 5Conclusion:The proportion of ACR responders increased within 12-16 weeks and was sustained up to 40 weeks following dose escalation in anti-TNF naïve pts with PsA. These results suggest that dose escalation from SEC 150 to 300 mg may be beneficial in anti-TNF naïve pts with a suboptimal response on SEC 150 mg.References:[1]Kivitz AJ, et al. Rheumatol Ther. 2019;6(3):393–407;[2]Mease PJ, et al. Ann Rheum Dis. 2018;77:890–7;[3]Mease, P.J., et al. ACR Open Rheumatology. 2019 [ePub ahead of print] doi:10.1002/acr2.11097.Disclosure of Interests:Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor), Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Laura C Coates: None declared, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Erhard Quebe-Fehling Shareholder of: Novartis, Employee of: Novartis, Pascale Pellet Shareholder of: Novartis, Employee of: Novartis, Luminita Pricop Shareholder of: Novartis, Employee of: Novartis, Corine Gaillez Shareholder of: Novartis, Employee of: Novartis, Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB

Background:Pooled safety data has been reported with secukinumab (SEC) in patients (pts) with Psoriatic arthritis (PsA), Ankylosing Spondylitis (AS) and Psoriasis (PsO).1Objectives:To report longer-term safety data of SEC treatment in PsA, AS, PsO pts up to 5 years.Methods:The integrated clinical trial safety dataset included data pooled from 28 randomised controlled clinical trials of SEC 300 or 150 or 75 mg in PsO (11 Phase 3 and 8 Phase 4 trials), PsA (5 Phase 3 trials), and AS (4 Phase 3 trials), along with post-marketing safety surveillance data with a cut-off date of 25 December 2018. Adverse events (AEs) were reported as exposure-adjusted incident rates (EAIRs) per 100 pt-years. Analyses included all pts who received ≥1 dose of SEC.Results:A total of 12637 pts (8819, 2678 and 1140 pts with PsO, PsA and AS, with an exposure of 15063.1, 5984.6 and 3527.2 pt-years, respectively) were included. The most frequent AE was upper respiratory tract infection and EAIR per 100 pt-years for IBD, malignancies and MACE remained low. The EAIR per 100 pt-years for adverse events (AEs) of special interest are reported in Table 1. The cumulative post-marketing exposure to SEC was estimated to be ~285,811 pt-years across the approved indications. Safety data from post-marketing surveillance are reported in Table 2.Table 1.Selected AEs of interest with SEC across pooled clinical trialsVariablePsOPsAASSECN=8819SECN=2678SECN=1140Exposure (Days), Mean (SD)623.9 (567.7)816.2 (580.7)1130.1 (583.0)Death, n (%)15 (0.2)13 (0.5)10 (0.9)Selected AE’s of interest, EAIR (95% CI)Serious infections11.4 (1.2, 1.6)1.8 (1.5, 2.2)1.2 (0.9, 1.6)Candida infections22.9 (2.7, 3.2)1.5 (1.2, 1.9)0.7 (0.5, 1.1)IBD3Crohn’s disease3Ulcerative colitis30.01 (0.0, 0.05)0.1 (0.05, 0.2)0.1 (0.08, 0.2)0.03 (0.0, 0.1)0.1 (0.04, 0.2)0.1 (0.04, 0.2)0.03 (0.0, 0.2)0.4 (0.24, 0.7)0.2 (0.1, 0.5)MACE40.4 (0.31, 0.5)0.4 (0.3, 0.6)0.7 (0.4, 1.0)Uveitis30.01 (0.0, 0.05)0.1 (0.04, 0.2)1.2 (0.9, 1.7)Malignancy50.9 (0.7, 1.0)1.0 (0.77, 1.3)0.5 (0.3, 0.8)1Rates for system organ class; 2Rates for high level term; 3Rates for preferred term (PT; IBD for unspecified IBD); 4Rates for Novartis MedDRA Query term; 5Rates for standardized MedDRA query term – ‘malignancies and unspecified tumour’; EAIR, exposure adjusted incidence rate per 100 pt-years; N, number of pts in the analysisTable 2.Summary of SEC post-marketing safetyExposure (PTY)PSUR126Dec14 -25Jun15PSUR226 Jun - 25Dec15PSUR326Dec15 -25Jun16PSUR426Jun -25Dec16PSUR526Dec16 -25Dec17PSUR626Dec17 -25Dec18Cumulative18387450168712854993744137325285811                    n (Reporting rate PTY)Serious infections89 (4.8)149 (2.0)232 (1.4)475 (1.7)649 (0.7)1841 (1.3)3980 (1.4)Malignancy2 (0.1)15 (0.2)21 (0.1)50 (0.2)225 (0.2)422 (0.3)788 (0.3)Total IBD4 (0.2)12 (0.2)37(0.2)46 (0.2)185 (0.2)340 (0.3)693 (0.2)MACE6 (0.3)15 (0.2)16 (0.1)39 (0.1)151 (0.2)238 (0.2)504 (0.2)PSUR, periodic safety update report; PTY, pt-treatment yearsConclusion:In this long-term analysis across clinical trials and post-marketing surveillance, of pts with PsO, PsA and AS, SEC was well tolerated, with a safety profile consistent with previous reports.1Reference:[1]Deodhar et al. Arthritis Research & Therapy (2019) 21:111.Disclosure of Interests:Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Iain McInnes Grant/research support from: Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, Novartis, Pfizer, and UCB, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Kristian Reich Grant/research support from: Affibody; Almirall; Amgen; Biogen; Boehringer Ingelheim; Celgene; Centocor; Covagen; Eli Lilly; Forward Pharma; Fresenius Medical Care; GlaxoSmithKline; Janssen; Kyowa Kirin; LEO Pharma; Medac; Merck; Novartis; Miltenyi Biotec; Ocean Pharma; Pfizer; Regeneron; Samsung Bioepis; Sanofi Genzyme; Takeda; UCB; Valeant and Xenoport., Consultant of: Affibody; Almirall; Amgen; Biogen; Boehringer Ingelheim; Celgene; Centocor; Covagen; Eli Lilly; Forward Pharma; Fresenius Medical Care; GlaxoSmithKline; Janssen; Kyowa Kirin; LEO Pharma; Medac; Merck; Novartis; Miltenyi Biotec; Ocean Pharma; Pfizer; Regeneron; Samsung Bioepis; Sanofi Genzyme; Takeda; UCB; Valeant and Xenoport., Speakers bureau: Affibody; Almirall; Amgen; Biogen; Boehringer Ingelheim; Celgene; Centocor; Covagen; Eli Lilly; Forward Pharma; Fresenius Medical Care; GlaxoSmithKline; Janssen; Kyowa Kirin; LEO Pharma; Medac; Merck; Novartis; Miltenyi Biotec; Ocean Pharma; Pfizer; Regeneron; Samsung Bioepis; Sanofi Genzyme; Takeda; UCB; Valeant and Xenoport., Alice B Gottlieb Grant/research support from:: Research grants, consultation fees, or speaker honoraria for lectures from: Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB., Consultant of:: Research grants, consultation fees, or speaker honoraria for lectures from: Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB., Speakers bureau:: Research grants, consultation fees, or speaker honoraria for lectures from: Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB., Mark Lebwohl Grant/research support from: AbbVie, Amgen, Arcutis, AstraZeneca, Boehringer Ingelheim, Celgene, Clinuvel, Eli Lilly, Incyte, Janssen Research & Development, LLC, Kadmon Corp., LLC, Leo Pharmaceutucals, Medimmune, Novartis, Ortho Dermatologics, Pfizer, Sciderm, UCB, Inc., and ViDac, Consultant of: Allergan, Almirall, Arcutis, Inc., Avotres Therapeutics, BirchBioMed Inc., Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy’s Laboratories, Theravance, and Verrica, Stefan Schreiber Consultant of: AbbVie, Arena, BMS, Biogen, Celltrion, Celgene, IMAB, Gilead, MSD, Mylan, Pfizer, Fresenius, Janssen, Takeda, Theravance, provention Bio, Protagonist and Falk, Weibin Bao Shareholder of: Novartis, Employee of: Novartis, Kwaku Marfo Shareholder of: Novartis, Employee of: Novartis, Hanno Richards Shareholder of: Novartis, Employee of: Novartis, Luminita Pricop Shareholder of: Novartis, Employee of: Novartis, Abhijit Shete Shareholder of: Novartis, Employee of: Novartis, Jorge Safi Shareholder of: Novartis, Employee of: Novartis, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau

Background:Enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) are two ILAR categories of juvenile idiopathic arthritis (JIA) and represent paediatric correlates of axial spondyloarthritis (axSpA) and adult psoriatic arthritis (PsA), respectively.1,2 Secukinumab (SEC) has demonstrated efficacy and safety in adult patients (pts) with PsA, ankylosing spondylitis and non-radiographic axSpA.3-5Objectives:Evaluate efficacy and safety of SEC using a flare prevention design in pts with active ERA and JPsA.Methods:This 2-yr study consisted of an open-label (OL) s.c. SEC (75/150 mg in pts <50/ ≥50 kg) at baseline (BL), and at Weeks (Wk) 1, 2, 3, 4, 8 and 12 in treatment-period (TP) 1. Responder pts who achieved at least JIA ACR 30 response at Wk 12 were randomised into the double-blinded TP2 to continue SEC or placebo (PBO) q4w until a disease flare, or up to Wk 100. Pts (aged 2 to <18 yrs) classified as ERA or JPsA according to ILAR criteria of ≥6 months duration with active disease were included. Primary endpoint was time to flare in TP2 and key secondary endpoints were JIA ACR 30/50/70/90/100, inactive disease, JADAS, enthesitis count and safety. Analysis of time to flare in TP2 included proportion of disease flare, Kaplan-Meier (KM) estimate of median time to flare in days, hazard ratio (95% CI) from Cox model, and P-value for the Stratified log-rank test. KM estimates of the probability to disease flare by treatment groups in TP2 were plotted against days. Observed data were used in all analyses. Post-hoc analyses using non-responder imputation (NRI) were performed for JIA ACR 30/50/70/90/100 responses.Results:86/97 (89%) pts were enrolled in the OL period TP1 (mean age, 13.1 yrs; female, 33.7%; ERA, n=52; JPsA, n=34). At BL, mean JADAS-27 score was 15.1 and enthesitis count was 2.6. At the end of TP1, 90.4% (75/83) of pts achieved JIA ACR 30 and 69.9% (58/83) achieved JIA ACR 70. There were 21 and 10 flares in TP2, respectively in PBO and SEC treated pts with a significantly longer time to flare and 72% risk of flare reduction in SEC treatment vs PBO (HR: 0.28; 95% CI: 0.13–0.63; P<0.001) (Figure 1). JIA ACR responses, disease activity and enthesitis count are reported in Table 1. NRI analyses showed that 87.2%, 83.7%, 67.4%, 38.4% and 24.4% of pts achieved JIA ACR 30/50/70/90/100, respectively. Rates of adverse events (AEs; 91.7% vs 92.1%) and serious AEs (14.6% vs 10.5%) in SEC and PBO groups were comparable in the entire TP. No new safety signals were observed.Table 1.Efficacy of secukinumab in Treatment Periods 1 and 2 (Key secondary endpoints)Efficacy Outcomes, %TP1TP2¥SEC (N=83)^SEC (N=37)PBO (N=37)P-valueJIA ACR 3090.489.264.90.014JIA ACR 5086.778.462.20.152JIA ACR 7069.967.643.20.042JIA ACR 9039.851.440.50.431JIA ACR 10025.343.237.80.745Inactive disease#36.147.237.80.500JADAS-27, mean (SD)15.1 (7.2)14.6 (8.1)13.3 (5.8)NAEnthesitis count, mean change from BL (SD)−1.8 (2.3)−2.1 (2.0)−1.9 (1.2)NAP-values: Cochran-Mantel-Haenszel test, adjusted for analysis factors: JIA category (ERA/ JPsA) and MTX use at BL¥The N numbers are values at the end of TP2^Efficacy outcomes (%) in TP1 calculated in patients with evaluable data at Wk 12 (N=83)#Inactive disease: Definition adapted from JIA ACR criteria of Wallace et al., 2011. N=36 for SEC at the end of TP2JADAS, Juvenile Arthritis Disease Activity Score; N, total number of patients in the treatment group; NA, data not availableFigure 1.Time to flare in Treatment Period 2 (Primary Endpoint)[Figure omitted. See PDF]Conclusion:In children and adolescents with ERA and JPsA, efficacy of SEC was demonstrated with a significantly longer time to flare vs PBO with sustained improvement of signs and symptoms up to Wk 104 and a favourable safety profile.References:[1]Colbert RA. Nat Rev Rheumatol. 2010;6:477–85.[2]Martini A, et al. J Rheumatol. 2019;46:190–7.[3]McInnes IB, et al. Lancet. 2015;386:1137–46.[4]Baeten D, et al. N Engl J Med. 2015;373:2534–48.[5]Deodhar A, et al. Arthritis Rheumatol. 2021;73:110–20.Disclosure of Interests:Nicolino Ruperto Consultant of: Ablynx, Astrazeneca-Medimmune, Bayer, Biogen, Boehringer, Bristol Myers and Squibb, Celgene, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sinergie, Sobi and UCB, Grant/research support from: BMS, Eli-Lilly, GlaxoSmithKline, F Hoffmann-La Roche, Janssen, Novartis, Pfizer, Sobi, Speakers bureau: Ablynx, Astrazeneca-Medimmune, Bayer, Biogen, Boehringer, Bristol Myers and Squibb, Celgene, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, Sinergie, Sobi and UCB, Ivan Foeldvari Consultant of: Novartis, Speakers bureau: Novartis, Ekaterina Alexeeva Grant/research support from: Novartis, Pfizer, Sanofi, MSD, AMGEN, Eli Lilly, Roche, Speakers bureau: Novartis, Pfizer, Sanofi, MSD, AMGEN, Eli Lilly, Roche, NURAY AKTAY AYAZ: None declared, Inmaculada Calvo Consultant of: Sobi, Novartis, Abbvie, GlaxoSmithKline, Pfizer, Amgen, Clementia, Speakers bureau: Sobi, Novartis, Abbvie, GlaxoSmithKline, Pfizer, Amgen, Clementia, Ozgur KASAPCOPUR: None declared, Vyacheslav Chasnyk: None declared, Markus Hufnagel Grant/research support from: Astellas, F. Hoffmann-La Roche, Novartis, Zbigniew Żuber: None declared, Grant Schulert Consultant of: Sobi, Novartis, Seza Ozen: None declared, Artem Popov: None declared, Athimalaipet Ramanan Speakers bureau: Roche, Sobi, Eli Lilly, UCB, Novartis, Christiaan Scott: None declared, Betül Sözeri: None declared, Elena Zholobova Grant/research support from: Pfizer, Novartis, Speakers bureau: Abbvie, Pfizer, Roche, Novartis, Xuan Zhu Employee of: Novartis, sarah whelan Employee of: Novartis, Shareholder of: Novartis, Luminita Pricop Employee of: Novartis, Shareholder of: Novartis, Angelo Ravelli Consultant of: Abbvie, Bristol-Myers Squibb, Pfizer, Hoffmann-LaRoche, Novartis, Centocor, Angelini Holding, Reckitt Benckiser, Speakers bureau: Abbvie, Bristol-Myers Squibb, Pfizer, Hoffmann-LaRoche, Novartis, Centocor, Angelini Holding, Reckitt Benckiser, Alberto Martini Consultant of: Eli Lilly, EMD Serono, Janssen, Novartis, Pfizer, Abbvie, Speakers bureau: Eli Lilly, EMD Serono, Janssen, Novartis, Pfizer, Abbvie, Daniel J Lovell Consultant of: AstraZeneca, Wyeth, Amgen, Abbott, Pfizer, Hoffmann-La Roche, Novartis, UBC, Takeda, Janssen, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Bristol Myers Squibb, AbbVie, Forest Research, Speakers bureau: AstraZeneca, Wyeth, Amgen, Abbott, Pfizer, Hoffmann-La Roche, Novartis, UBC, Takeda, Janssen, GlaxoSmithKline, Boehringer Ingelheim, Celgene, Bristol Myers Squibb, AbbVie, Forest Research, Hermine Brunner Consultant of: Aurina, AbbVie, Astra Zeneca-Medimmune, Biogen, Boehringer, Bristol-Myers Squibb, Celgene, Eli Lilly, EMD Serono, GlaxoSmithKline, F. Hoffmann-La Roche, Merck, Novartis, R-Pharm, Sanofi, Pfizer, Grant/research support from: Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, F. Hoffmann-La Roche, Janssen, Novartis, and Pfizer, Speakers bureau: Pfizer, Roche and GlaxoSmithKline

BackgroundEnthesitis is a common phenotypic manifestation of psoriatic arthritis (PsA) affecting approximately 70% of patients (pts) and may be associated with worse outcomes.1 Secukinumab (SEC), a fully human monoclonal antibody that selectively neutralises IL-17A, provided significant and sustained improvement in the signs and symptoms of active PsA, with sustained resolution of enthesitis in Phase 3 studies.2,3 ObjectivesTo report the impact of SEC treatment on efficacy outcome measures in active PsA pts with or without baseline (BL) enthesitis (defined by Leeds Enthesitis Index) using pooled data from the FUTURE 2 (NCT01752634) and FUTURE 3 (NCT01989468) studies over 2 years.MethodsSEC and placebo (PBO) were administered weekly during the first 4 weeks (wks) followed by subcutaneous maintenance dosing every 4 wks thereafter (PBO until Wk 16/24). The results are reported only for SEC 300 and 150 mg (approved doses). Efficacy outcomes (ACR20/50/70, PASI 90, HAQ-DI, SF-36 PCS and DAS28-CRP) were analysed post-hoc in pts with enthesitis at BL (BLE; n=466) or without enthesitis at BL (No BLE; n=246). Observed data are presented for binary variables and least-square (LS) means from analysis of covariance for continuous variables.ResultsA total of 65% of pts had BLE. BL demographics were balanced between the BLE and No BLE groups except for a higher proportion of females and numerically higher tender joint count, disability (HAQ-DI) and lower physical function (SF-36 PCS) in BLE pts than No BLE pts. At Wk 16, improvements in ACR and PASI responses, HAQ-DI, SF-36 PCS and DAS28-CRP were similar in both groups treated with SEC 300 mg, but were lower (except for PASI) in BLE pts treated with SEC 150 mg (table 1). Improvements in these outcomes followed a similar trend to Wk 104 in SEC-treated pts (table 1).Abstract THU0311 – Table 1Summary of Results with SecukinumabWkBLENo BLE 300 mg150 mgPBO300 mg150 mgPBO ACR20a,b1653.546.519.653.764.618.110456.852.4-62.662.9-ACR50a,b1631.321.46.735.835.45.610444.724.8-47.334.3-ACR70a,b1616.08.21.821.116.51.410426.515.2-34.121.4-PASI 90a,c1650.036.67.942.137.06.710467.959.7-73.544.4-HAQ-DId16−0.5−0.3−0.2−0.5−0.5−0.2104−0.5−0.4-−0.5−0.6-SF-36 PCSd166.43.72.56.57.42.61047.44.3-6.66.9-DAS28-CRPd16−1.5−1.05−0.5−1.35−1.6−0.5104−1.7−1.6-−2.0−1.9-aResponse,%; bAt Wk 16/104, n=144/132 (SEC 300), 159/145 (SEC 150) and 163 (PBO) with enthesitis and n=95/91 (SEC 300), 79/70 (SEC 150) and 72 (PBO) without enthesitis at BL; cAt Wk 16/104, n=66/56 (SEC 300), 82/62 (SEC 150) and 63 (PBO) with enthesitis and n=38/34 (SEC 300), 46/36 (SEC 150) and 30 (PBO) without enthesitis at BL (psoriasis subset); dLS meanConclusionsAlthough pts with BLE had more severe BL clinical characteristics than pts with No BLE, SEC showed higher efficacy than PBO at Wk 16 and sustained efficacy over 104 wks in both groups with greater magnitude of improvement in pts treated with SEC 300 mg than 150 mg.References[1] Schett G, et al. Nat Rev Rheumatol2017;13:731–41.[2] Mease PJ, et al. N Engl J Med2015;373:1329–39.[3] McInnes IB, et al. Lancet2015;386:1137–46.Disclosure of InterestJ. Wallman Consultant for: AbbVie, Celgene, Lilly, Novartis, UCB, G. Schett Grant/research support from: BMS, Celgene, GSK, Lilly, Novartis, Consultant for: AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, UCB, Speakers bureau: AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, I. McInnes Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB, E. Quebe-Fehling Shareholder of: Novartis, Employee of: Novartis, L. Rasouliyan Consultant for: Novartis, Employee of: RTI Health Solutions, L. Pricop Shareholder of: Novartis, Employee of: Novartis, A. Fasth Shareholder of: Novartis, Employee of: Novartis, C. Gaillez Shareholder of: Novartis, Employee of: Novartis

BackgroundPooled safety data from secukinumab (SEC) studies in psoriasis and psoriatic arthritis (PsA) have been reported previously.1 ObjectivesTo report updated longer-term safety data with up to 5 years of SEC treatment from psoriasis and PsA studies.MethodsThe moderate to severe plaque psoriasis and active PsA data pool consisted of 15 and 3 Phase III studies, respectively. Different SEC doses in the studies included intravenous (up to 10 mg/kg) or subcutaneous (s.c.; 75–300 mg) loading, followed by s.c. maintenance dosing (300, 150 or 75 mg). Placebo patients were re-randomised to SEC at 12–24 weeks depending on study design. Adverse events (AEs) were reported as exposure adjusted incident rates (EAIR) per 100 patient-years and analyses included all patients who received ≥1 dose of SEC.ResultsA total of 5181 and 1380 patients from psoriasis and PsA studies representing an exposure of 10416.9 and 3866.9 patient years, respectively, were included in this study. The most frequently reported AE was viral upper respiratory tract infection (table 1). EAIRs for serious infections, Candida infections, inflammatory bowel disease (IBD) and major adverse cardiac events (MACE) were low and similar in both psoriasis and PsA indications (table 1). No cases of tuberculosis were reported.Abstract THU0325 – Table 1Summary of Secukinumab Safety across Psoriasis and PsA studies: Entire Safety PeriodPsoriasisPsA Any secukinumabn=5181Any secukinumabn=1380 Total exposure, patient-years10416.93866.9Min–max exposure (days)1–18258–1827Exposure (days), mean (SD)734.4 (562.9)1023.5 (472.3)Death, n (%)9 (0.2)11 (0.8)EAIR per 100 Patient-years (95% Cl)Any AE204.4 (198.4, 210.5)147.0 (138.9,155.5)Any serious AE6.9 (6.3, 7.4)7.9 (7.0–8.9)Most Common AEs1Viral upper respiratory tract infection21.0 (19.9–22.0)12.1 (10.9–13.4)Headache6.2 (5.8, 6.8) 3.8 (3.2, 4.5)Upper respiratory tract infection5.4 (4.9, 5.9)9.1 (8.1, 10.2)AEs of Selected InterestSerious infections21.4 (1.2, 1.6)1.9 (1.5, 2.4)Candida infections32.2 (1.9, 2.5) 1.5 (1.1, 2.0)IBD4Crohn’s disease4Ulcerative colitis40.01 (0.0–0.05)0.05 (0.02–0.11)0.13 (0.07–0.23)0.05 (0.01–0.19)0.08 (0.02–0.23)0.08 (0.02–0.23)MACE50.3 (0.2, 0.5)0.4 (0.3–0.7)1AEs in the SEC group that occurred with an EAIR of ≥5 during the entire safety period in either of the pooled groups;2Rates are for system organ class;3Rates are for high level term;4Rates are for PT (IBD PT data are reported for unspecified IBD);5Rates are for Novartis MedDRA Query term; EAIR, exposure adjusted incidence rate per 100 patient-years; N, number of patients in the analysis; SD, standard deviationConclusionsSEC demonstrated a favourable safety profile during long-term treatment (up to 5 years) in patients with moderate to severe plaque psoriasis or PsA, hence, supporting long-term use. The safety profile was consistent with previous reports and comparable across psoriasis and PsA patients.Reference[1] Mease, et al. Arthritis Rheumatol2017; 69(suppl 10):A606.Disclosure of InterestP. Mease Grant/research support from: AbbVie, Amgen, BMS, Janssen, Lilly, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, SUN Pharma, UCB,, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Lilly, Pfizer, and UCB, 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, K. Reich Consultant for: Abbvie, Affibody, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, Merck Sharp and Dohme Corp., Novartis, Ocean Pharma, Pfizer, Regeneron, Sanofi, Takeda, UCB Pharma, Xenoport, Speakers bureau: Abbvie, Affibody, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, Merck Sharp and Dohme Corp., Novartis, Ocean Pharma, Pfizer, Regeneron, Sanofi, Takeda, UCB Pharma, Xenoport., P. Nash Grant/research support from: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Hospira, MSD, Pfizer, Janssen, UCB, Novartis, Roche, Consultant for: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Hospira, MSD, Pfizer, Janssen, UCB, Novartis, Roche, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Hospira, MSD, Pfizer, Janssen, UCB, Novartis, Roche, A. Widmer Shareholder of: Novartis Stock, Employee of: Novartis, K. Abrams Shareholder of: Novartis Stock, Employee of: Novartis, L. Pricop Shareholder of: Novartis Stock, Employee of: Novartis, T. Fox Shareholder of: Novartis Stock, Employee of: Novartis

BackgroundSecukinumab, a fully human monoclonal antibody that selectively neutralises IL-17A, provided significant and sustained improvement in the signs and symptoms of active psoriatic arthritis (PsA) over 2 years in the FUTURE 2 study (NCT01752634).1 ObjectivesTo report 3 year efficacy and safety results from the FUTURE 2 study.MethodsOverall, 397 patients (pts) with active PsA were randomised to receive subcutaneous secukinumab (300, 150 or 75 mg) or placebo at baseline, Weeks (Wks) 1, 2, 3 and 4, and every 4 wks thereafter.1 Assessments at Wk 156 are from pts originally randomised to secukinumab and included ACR20/50, PASI 75, HAQ-DI, and resolution of dactylitis and enthesitis. Analyses by prior anti-TNF use (naïve/inadequate response [IR]) and with/without concomitant methotrexate (MTX) were assessed. Data are reported as observed for secukinumab 300 and 150 mg (approved doses). Safety analysis included all pts who received ≥1 dose of secukinumab.ResultsIn total, 73/100 (73.0%) and 72/100 (72.0%) pts in the secukinumab 300 and 150 mg groups, respectively, completed 156 wks of treatment. Sustained clinical improvements were observed in those continuing with secukinumab across all endpoints through Wk 156 (table 1). ACR20 response rates at Wk 156 in anti–TNF-naïve pts were 85.2% and 76.5% with secukinumab 300 and 150 mg respectively; corresponding rates in anti–TNF-IR pts were 55.6% and 54.5%. ACR20 response rates in pts receiving concomitant MTX were 73.0% and 77.1% with secukinumab 300 and 150 mg, respectively; rates in pts without concomitant MTX use were 77.3% and 63.2%. Over the study (mean secukinumab exposure of 991.3 days) the type, incidence and severity of adverse events (AEs) were consistent with that reported previously. Exposure adjusted incidence rates with secukinumab for selected AEs of interest were: serious infections (1.8), candida infections (1.8), inflammatory bowel disease (0.1), major adverse cardiovascular event (0.2) and malignant/unspecified tumours (1.2).Abstract THU0322 – Table 1Summary of Efficacy Results at Wk 156Variable% responders (n), unless statedSecukinumab300 mg s.c.(n=100)Secukinumab150 mg s.c.(n=100)* ACR2075.3 (81)69.9 (73)ACR5054.3 (81)38.4 (73)aPASI 7574.3 (35)81.8 (44)HAQ-DI, mean change from BL (n)−0.63 (81)−0.47 (74)bResolution of enthesitis68.9 (45)70.8 (48)cResolution of dactylitis82.1 (39)80.0 (25)aPASI responses assessed in pts with psoriasis affecting ≥3% body surface area at BL (300 mg: n=41; 150 mg: n=58)bAssessed in pts (n=56 [300 mg] and 64 [150 mg]) with this symptom at BLcAssessed in pts (n=46 [300 mg] and 32 [150 mg]) with this symptom at BL*Secukinumab 150 mg arm includes 42 pts who were up-titrated to 300 mg starting at Wk 128BL, baseline; HAQ-DI, health assessment questionnaire-disability index; PASI, psoriasis area and severity indexN, number of pts randomised; n, number of pts with evaluationConclusionsSecukinumab 300 and 150 mg provided sustained improvements in signs and symptoms of active PsA through 3 years. Secukinumab was well tolerated, with a safety profile consistent with that reported previously.1 Reference[1] McInnes IB, et al. Rheumatology (Oxford)2017;56:1993–2003.AcknowledgementsThe study was sponsored by Novartis Pharma AGDisclosure of InterestP. Nash Grant/research support from: Novartis, Abbvie, Roche, Pfizer, BMS, Janssen, and Celgene, Consultant for: Novartis, Abbvie, Roche, Pfizer, BMS, Janssen, and Celgene, 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. Rahman Consultant for: Abbott, Abbvie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer and Roche and pharmaceutical companies dealing with biologic agents in rheumatology, A. Gottlieb Grant/research support from: Janssen, Incyte, Consultant for: Janssen Inc., Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Abbvie, UCB, Novartis, Incyte, Lilly, Reddy Labs, Valeant, Dermira, Allergan, Sun Pharmaceutical Industries, Speakers bureau: Janssen Inc., Celgene Corp., Bristol Myers Squibb Co., Beiersdorf, Inc., Abbvie, UCB, Novartis, Incyte, Lilly, Reddy Labs, Valeant, Dermira, Allergan, Sun Pharmaceutical Industries, B. Kirkham Grant/research support from: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche, and UCB, Consultant for: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche, and UCB, Speakers bureau: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Roche, and UCB, K. Ding Shareholder of: Novartis, Employee of: Novartis, L. Pricop Shareholder of: Novartis, Employee of: Novartis