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THU0210 Secukinumab Efficacy in Anti-Tnf-Naive Patients and Patients Previously Exposed to Anti-Tnf Therapy: Results of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (Measure 2) in Active Ankylosing Spondylitis
  1. J. Sieper1,
  2. J. Braun2,
  3. X. Baraliakos2,
  4. D.L. Baeten3,
  5. M. Dougados4,
  6. P. Emery5,
  7. A. Deodhar6,
  8. B. Porter7,
  9. M. Andersson8,
  10. H. Richards8
  1. 1Charité University Medicine Berlin, Berlin
  2. 2Rheumazentrum Ruhrgebiet, Herne, Germany
  3. 3Academic Medical Center, Amsterdam, Netherlands
  4. 4Université Paris René Descartes and Hôpital Cochin, Paris, France
  5. 5University of Leeds, Leeds, United Kingdom
  6. 6Oregon Health and Science University, Portland
  7. 7Novartis Pharmaceuticals Corporation, East Hanover, United States
  8. 8Novartis Pharma AG, Basel, Switzerland

Abstract

Background Current treatment options for ankylosing spondylitis (AS) patients with intolerance or an inadequate response to tumor necrosis factor alpha inhibitors (anti-TNF) are limited. Secukinumab, a human anti–interleukin-17A monoclonal antibody, significantly improved the signs and symptoms of AS in the phase 3 MEASURE 2 study (NCT01649375).1

Objectives To evaluate the efficacy and safety of secukinumab by anti-TNF history in the MEASURE 2 study.

Methods 219 adults with active AS were randomized to receive subcutaneous (s.c.) secukinumab (150 or 75 mg) or PBO at baseline, Wk 1, 2 and 3, and every 4 wks starting at Wk 4. Randomization was stratified according to prior anti-TNF experience: anti-TNF-naive, or inadequate response or intolerance to not more than one anti-TNF biologic agent (anti-TNF-IR). At Wk 16, PBO-treated subjects were re-randomized to secukinumab 150 or 75 mg. Pre-planned subgroup analyses of the primary and secondary endpoints were conducted among anti-TNF-naive and anti-TNF-IR subjects and included: the proportion of subjects achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 response (primary endpoint), ASAS40, high sensitivity C-reactive protein (hsCRP), ASAS 5/6, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Short Form-36 (SF-36), Ankylosing Spondylitis Quality of Life (ASQoL), and ASAS partial remission. Analyses at Wk 16 used non-responder imputation (for binary variables) and mixed-effects repeated measures model (for continuous variables). Wk 52 data are as observed.

Results 62% of subjects enrolled were anti-TNF-naive and 38% were anti-TNF-IR. At Wk 16, secukinumab 150 mg (but not 75 mg) improved ASAS20 response rates compared with PBO in both anti-TNF-naive (68.2% vs 31.1%, respectively; P<0.001) and anti-TNF-IR (50.0% vs 24.1%; P<0.05) subjects. Improvements with secukinumab 150 mg were observed for all secondary endpoints in anti-TNF-naive subjects, except ASAS partial remission, and for most secondary endpoints in anti-TNF-IR subjects (Table). Clinical responses to secukinumab were sustained or continued to improve in both anti-TNF-naive and anti-TNF-IR subjects through 52 wks of therapy (Table).

Conclusions Secukinumab 150 mg s.c. provided sustained improvement in the signs and symptoms of AS, with associated reduction in inflammation and improvement in physical function and health-related QoL in both anti-TNF-naive and anti-TNF-IR subjects.

References

  1. Sieper J, et al. Arthritis Rheumatol. 2014;66(11 Suppl):S232.

Acknowledgements Medical writing support was provided by Jessica Breen at Seren Communications (Tytherington, UK), and was funded by Novartis.

Disclosure of Interest J. Sieper Grant/research support from: AbbVie, Pfizer, and Merck, Consultant for: AbbVie, Pfizer, Merck, UCB, and Novartis, Speakers bureau: AbbVie, Pfizer, Merck, and UCB, J. Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer-Ingelheim, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB, Consultant for: Abbvie (Abbott), Amgen, BMS, Boehringer-Ingelheim, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer-Ingelheim, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB, X. Baraliakos Grant/research support from: AbbVie, Merck, Pfizer, UCB, Novartis, and Chugai, Consultant for: AbbVie, Merck, Pfizer, UCB, Novartis, and Chugai, Speakers bureau: AbbVie, Merck, Pfizer, UCB, Novartis, and Chugai, D. Baeten Grant/research support from: Boehringer-Ingelheim, Janssen, MSD, Novartis, and Pfizer, Consultant for: AbbVie, Boehringer-Ingelheim, BMS, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, M. Dougados Grant/research support from: AbbVie, BMS, Eli Lilly, Merck, and Pfizer, Consultant for: Eli Lilly, P. Emery Consultant for: AbbVie, BMS, Merck, Novartis, Pfizer, Roche, and UCB, A. Deodhar Grant/research support from: AbbVie, Celgene, Janssen, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Celgene, Janssen, Novartis, Pfizer, and UCB, B. Porter Shareholder of: Novartis, Employee of: Novartis, M. Andersson Employee of: Novartis, H. Richards Employee of: Novartis

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