ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1504

Subcutaneous Secukinumab 150 Mg Provides Rapid and Sustained Relief in Total and Nocturnal Back Pains, Morning Stiffness, and Fatigue in Patients with Active Ankylosing Spondylitis over 4 Years

Helena Marzo-Ortega1, Corinne Miceli-Richard 2, Sonja Gill 3, Marina Magrey 4, Paula Machado 5, Abhijit Shete 6, Jianyuan Wang 6, Susanne Rohrer 6 and Atul Deodhar 7, 1NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, University of Leeds, Leeds, Leeds, United Kingdom, 2Paris Descartes University, Department of Rheumatology - Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France, 3412 – 3075 Hospital Gate, Oakville, Canada, 4Division of Rheumatology, The MetroHealth System and School of Medicine, Case Western Reserve University, Cleveland, OH, 5Novartis Pharmaceuticals Corporation, East Hanover, NJ, 6Novartis Pharma AG, Basel, Switzerland, 7Oregon Health & Science University, Portland, OR

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , , ,

Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Ankylosing spondylitis (AS) is a chronic inflammatory condition. Pain, stiffness, and fatigue are reported as the most troubling symptoms by 70–80%, 20–40%, and 50–60% of patients (pts) with AS, respectively.1-5 Early and sustained relief of these symptoms are essential for effective AS management.4,6 Secukinumab (SEC) provided sustained relief in pain and fatigue in AS pts over 2 years in the MEASURE 2 study.7 Here we report the effect of subcutaneous (s.c.) SEC 150mg on key clinical symptoms (pain, morning stiffness, and fatigue) in pts with AS over 208 weeks (wks) in the MEASURE 2 study.

Methods: The MEASURE 2 study design has been reported previously. This post hoc analysis assessed the mean change from baseline at Week (Wk) 208 in total and nocturnal back pain scores (by visual analog scale [0–100]; ASAS outcome component), overall level of spinal pain (neck, back, or hip) from BASDAI score, and morning stiffness (overall level; mean of question 5 and 6 of BASDAI score). Additionally, the SF-36 physical component summary (PCS) score, overall level of fatigue (BASDAI question 1), FACIT-Fatigue score, and pts meeting minimal clinically important difference (MCID) criteria across multiple clinical domains were also assessed. Data are shown for pts originally randomized to SEC 150mg and placebo. Data are reported as observed for overall population and by prior anti-TNF therapy status (naïve vs inadequate response/intolerance [IR]).

Results: Baseline clinical characteristics were generally comparable across the treatment groups SEC 150mg (N=72) and placebo (N=74); total mean back pain score was 67.7±17.79, nocturnal back pain score (0–100 mm scale) was 64.9±19.58, and morning stiffness was 6.5±2.11. SEC 150mg-treated pts reported rapid and early reductions in pain scores by Wk 4, which were sustained through Wk 208 (Table). Improvements with SEC 150mg were also reported in nocturnal back pain, morning stiffness, physical function (SF-36 PCS) and fatigue (overall level of fatigue and FACIT-Fatigue) as early as Wk 4, which were sustained at Wk 208 (Table). A higher proportion of SEC 150mg-treated pts met MCID criteria at Wk 16 vs placebo across multiple clinical domains, which was sustained or further improved through Wk 208. Improvements were observed in both anti-TNF-naïve and -IR pts, with a greater magnitude of improvement in anti-TNF-naïve pts.

Conclusion: SEC 150mg was associated with rapid and clinically meaningful improvement in total back pain and nocturnal back pain, morning stiffness, and fatigue, with improvements sustained over 4 years of treatment.

References:

  1. Ward MM, et al. Arthritis Care Res. 1999;12:247-55.
  2. Calin A, et al. J Rheumatol. 1993;20:991-5.
  3. Jones SD, et al. J Rheumatol. 1996;23:487-90.
  4. Aissaoui N, et al. Rheumatol Int. 2012;32:2117-24.
  5. Steven DW. Atlas of Uncommon Pain Syndromes (3rd edition). 2014;chapter-79:230.
  6. Brophy S, et al. Semin Arthritis Rheum. 2013;42:361-7.
  7. Deodhar A, et al. Clin Exp Rheumatol. 2019;37:260-9.

Table: Summary of results

Disclosure: H. Marzo-Ortega, AbbVie, 5, 8, AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, 5, Abbvie, Celgene, Janssen, Lilly, Novartis, Pfizer, Ucb, 5, 8, AbbVie, Celgene, Janssen, Lilly, Novartis,Pfizer and UCB, 8, Celgene, 5, 8, Eli Lilly and Company, 5, 8, Janssen, 2, 5, 8, Janssen and Novartis, 2, Janssen, Novartis, 2, Novartis, 2, 5, 8, Pfizer, 5, 8, UCB, 5, 8; C. Miceli-Richard, Abbott, Bristol-Myers Squibb, Merck, Pfizer, Roche, Schering-Plough, and Wyeth, 8, Abbvie, 2, 5, AbbVie, Bristol-Myers Squibb, Novartis, Merck, Pfizer, and Wyeth, 2, Biogen, 2, BMS, 5, MSD, 2, Novartis, 2, 5, Pfizer, 2, Pfizer, Roche, UCB, Wyeth, and Merck, 5, UCB, 2; S. Gill, AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Amgen, Sanofi-Genzyme, 5, 8; M. Magrey, AbbVie, 2, Abbvie, 2, Abbvie, UCB and Amgen, 2, Amgen, 2, 5, Eli Lilly, 5, Eli Lilly and Company, 5, Eli Lily, Novartis, 5, Novartis, 5, 9, UCB, 2, UCB Pharma, 2; P. Machado, Novartis, 1, 3, 4; A. Shete, Novartis, 1, 3; J. Wang, Novartis, 1, 3; S. Rohrer, Novartis, 1, 3; A. Deodhar, AbbVie, 2, 5, 9, Abbvie, 5, 8, Abbvie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, and UCB Pharma, 5, 8, AbbVie, Amgen, Boehringer Ingelheim, BMS, Eli Lilly, GSK, Galapagos, Janssen, Novartis, Pfizer and UCB, 5, AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith and Klein, Janssen, Novartis, Pfizer, UCB, 5, Amgen, 5, 8, 9, BMS, 2, 5, 8, BMS, Eli Lilly, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, UCB, 2, BMS, Eli Lilly, GlaxoSmithKline, Janssen, Novartis AG, Pfizer, UCB Pharma, 2, Boehringer Ingelheim, 5, 8, Boehringer-Ingelheim, 5, 8, Bristol Myers Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, 8, Eli Lilly, 2, 5, 8, 9, Eli Lilly and Company, 2, 5, Eli Lilly,, 5, Eli Lilly, GSK, Novartis, Pfizer and UCB, 2, Galagagos, 5, Galapagos, 5, 8, 9, Glaxo Smith & Klein, 2, Glaxo Smith & Kline, 2, 5, 8, Glaxo Smith Klein, 5, Glaxo SmithKlein, 2, 5, GlaxoSmithKlein, 2, 5, GlaxoSmithKline, 2, 5, 8, GSK, 2, 5, Janssen, 2, 5, 8, 9, Janssen Pharmaceutica, 2, 5, Janssen Research & Development, LLC, 2, Lilly, 2, 5, Novartis, 2, 5, 8, 9, Pfizer, 2, 5, 8, 9, UCB, 2, 5, 8, 9.

To cite this abstract in AMA style:

Marzo-Ortega H, Miceli-Richard C, Gill S, Magrey M, Machado P, Shete A, Wang J, Rohrer S, Deodhar A. Subcutaneous Secukinumab 150 Mg Provides Rapid and Sustained Relief in Total and Nocturnal Back Pains, Morning Stiffness, and Fatigue in Patients with Active Ankylosing Spondylitis over 4 Years [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/subcutaneous-secukinumab-150-mg-provides-rapid-and-sustained-relief-in-total-and-nocturnal-back-pains-morning-stiffness-and-fatigue-in-patients-with-active-ankylosing-spondylitis-over-4-years/. Accessed .

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