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  1. Helena Marzo-Ortega1,
  2. Joachim Sieper2,
  3. Alan Kivitz3,
  4. Ricardo Blanco4,
  5. Martin Cohen5,
  6. Karel Pavelka6,
  7. Eumorphia Maria Delicha7,
  8. Anna Stefanska8,
  9. Hanno Richards7,
  10. Susanne Rohrer7
  1. 1NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, University of Leeds, Leeds, United Kingdom
  2. 2University Clinic Benjamin Franklin, Berlin, Germany
  3. 3Altoona Center for Clinical Research, Duncansville, United States of America
  4. 4Hospital Universitario Marqués de Valdecilla, Santander, Spain
  5. 5McGill University, Montreal, Canada
  6. 6Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University in Prague, Prague, Czech Republic
  7. 7Novartis Pharma AG, Basel, Switzerland
  8. 8Novartis Ireland Limited, Dublin, Ireland


Background Evaluation of long-term efficacy and safety for treatments for ankylosing spondylitis (AS) is important. Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has shown significant and sustained improvement in the signs and symptoms of AS through 3 years in the MEASURE 2 study (NCT01649375).1

Objectives We report the 5-year end-of-study results of subcutaneous (s.c.) secukinumab 150 mg in the MEASURE 2 study.

Methods 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 wks 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 (N = 106). An optional dose escalation from secukinumab 75 mg to 150 mg was initiated beginning Wk 140. Outcome measures at Wk 260 included ASAS20/40, BASDAI50, BASMI, BASFI, SF-36 PCS and ASAS partial remission. Analyses stratified by anti-TNF status (anti–TNF-naïve and anti-TNF inadequate response [IR]) were performed. Safety analysis included all pts who received ≥1 dose of secukinumab. Results are reported as observed.

Results The retention rate to Wk 260 was 77% (82/106) for secukinumab 150 mg. Sustained efficacy was observed with secukinumab 150 mg across all endpoints through 5 years (Table). Improvements were maintained regardless of prior exposure to anti–TNF therapy with greater responses in anti–TNF-naïve pts. A total of 49 pts on secukinumab 75 mg (46.7%) escalated dose to 150 mg after Wk 140; efficacy responses improved in pts whose dose was escalated. Over the entire study period, the mean exposure (±SD) to secukinumab was 1459.1 ± 597.8 days. Exposure-adjusted incidence rates (per 100 pt-years) with any secukinumab dose for selected adverse events were: Candida infections (1.0), Crohn’s disease (0.5), major adverse cardiovascular events (0.7), uveitis (0.5), and malignant/unspecified tumours (0.5).

Conclusion Secukinumab 150 mg provided sustained improvement in the signs, symptoms, and physical function in pts with AS through 5 years of treatment. The safety profile of secukinumab remained consistent with previous reports.1–3

References [1] Marzo-Ortega, et al. RMD Open. 2017;3:e000592; 2. Marzo-Ortega, et al. Ann Rheum Dis. 2016;75:812–3; 3. Baraliakos X,et al. Clin Exp Rheumatol2017.

Disclosure of Interests Helena Marzo-Ortega Grant/research support from: Janssen, Novartis and Pfizer, Consultant for: AbbVie, Celgene, Janssen, Eli-Lilly, Novartis and UCB, Speakers bureau: AbbVie, Celgene, Janssen, Eli-Lilly, Novartis and UCB, Joachim Sieper Consultant for: Abbvie, Böhringer Ingelheim, Janssen, Lilly, Merck, Mylan, Novartis, Pfizer, UCB., Speakers bureau: Abbvie, Böhringer Ingelheim, Janssen, Lilly, Merck, Mylan, Novartis, Pfizer, UCB., Alan Kivitz Shareholder of: Novartis, Consultant for: Abbvie, Janssen, Pfizer, UCB, Genzyme, Sanofi, Regeneron, Boehringer Ingelheim, Sun Pharma Advanced Research, Flexion., Paid instructor for: Celgene, Horizon, Merck, Novartis, Pfizer, Genzyme, Sanofi, Regeneron, Speakers bureau: Celgene, Horizon, Merck and Genetech, Flexion, Ricardo Blanco Grant/research support from: Abbvie, MSD and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen and MSD, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen and MSD, Martin Cohen Consultant for: AbbVie, Amgen, Celgene, Lilly, Novartis, Pfizer, Sandoz, Sanofi and UCB, Speakers bureau: AbbVie, Amgen, Celgene, Janssen, Merck, Novartis and Pfizer, Karel Pavelka: None declared, Eumorphia Maria Delicha Employee of: Novartis, Anna Stefanska Shareholder of: Novartis, Employee of: Novartis, Hanno Richards Shareholder of: Novartis Pharma AG, Employee of: Novartis Pharma AG, Susanne Rohrer Shareholder of: Novartis, Employee of: Novartis


Efficacy Endpoints with Secukinumab 150 mg at Week 260 (5 year)

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