SAT0283 Secukinumab 150 mg provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 4-year results from the phase iii trial, measure 2
Authors: H. Marzo-Ortega, J. Sieper, A. Kivitz, R. Blanco, M. Cohen, E.M. Delicha, S. Rohrer, H. Richards
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Secukinumab, a fully human monoclonal antibody that neutralises IL-17A, has shown significant and sustained improvement in the signs and symptoms of active ankylosing spondylitis (AS) through 3 years in the MEASURE 2 study (NCT01649375).<sup>1</sup> <h3>Objectives</h3> To report the longer-term (4 year) efficacy and safety of subcutaneous (s.c.) secukinumab 150 mg in the MEASURE 2 study. <h3>Methods</h3> AS patients (pts; n=219) were randomised to receive s.c. secukinumab 150 mg, 75 mg or placebo at baseline, Weeks (Wks) 1, 2 and 3 and every 4 weeks from Wk 4. At Wk 16, placebo-treated pts were re–randomised to receive secukinumab 150/75 mg. Efficacy results are reported for pts initially randomised to secukinumab 150 mg and those who switched from placebo to secukinumab 150 mg at Wk 16. Safety analyses included all pts who received ≥1 dose of secukinumab. Results are reported as observed. <h3>Results</h3> The retention rate from Wk 16 to 208 was 85% (85/100) for secukinumab 150 mg. Sustained improvements were observed with secukinumab 150 mg across all endpoints through 4 years (Table). These improvements were maintained regardless of prior exposure to anti–TNF therapy; greater responses were demonstrated in anti–TNF-naïve pts. Over the entire study period, the mean exposure (±SD) to secukinumab was 1189.3±452.9 days. Exposure-adjusted incidence rates (per 100 pt-years) with any secukinumab dose for selected adverse events were: serious infections/infestations (1.5), <i>Candida</i> infections (1.2), Crohn’s disease (0.6), major adverse cardiovascular events (0.6), uveitis (0.6), and malignant/unspecified tumours (0.4). ASAS; Assessment in SpondyloArthritis International Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; IR, inadequate response; SD, standard deviation; SF-36 PCS, Short Form<sup>36</sup> Health Survey Physical Component Summary; TNF, tumour necrosis factor <h3>Conclusions</h3> Secukinumab 150 mg provided sustained improvement in the signs, symptoms and physical function in pts with AS through 4 years of treatment with 85% retention rate. The safety profile of secukinumab remained favourable and was consistent with previous reports.<sup>1–3</sup> <h3>References</h3> [1] Marzo-Ortega, et al. RMD Open2017;3:e000592. [2] Marzo-Ortega, et al. Ann Rheum Dis2016;75:812–3. [3] Baraliakos, et al. Clin Exp Rheumatol2017. <h3>Disclosure of Interest</h3> H. Marzo-Ortega Grant/research support from: Janssen, Celgene, Speakers bureau: Janssen, Pfizer, AbbVie, Celgene, Novartis, UCB, J. Sieper Grant/research support from: AbbVie, Pfizer, Merck, Consultant for: for AbbVie, Pfizer, Merck, UCB, Novartis, Speakers bureau: AbbVie, Pfizer, Merck, UCB, A. Kivitz Grant/research support from: Altoona Centre for Clinical Research, Consultant for: Vertex, AbbVie, Amgen, Celgene, Horizon, Genetech, Janssen, Merck, Novartis, Pfizer, UCB, Genzyme, Sanofi, Regeneron, SUN Pharma Advanced Research, Boehringer Ingeleheim, R. Blanco Grant/research support from: Abbvie, MSD, Roche, Consultant for: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, Lilly, MSD, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, Lilly, MSD, M. Cohen Consultant for: Abbvie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Paladin, Pfizer, Roche, Sanofi, UCB, E. M. Delicha Employee of: Novartis, S. Rohrer Employee of: Novartis, H. Richards Employee of: Novartis