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Abstract Number: 1509

Impact of Age and Disease Duration on the Response to IL-17A Inhibitor (Secukinumab) Treatment in Ankylosing Spondylitis: Pooled Results from the Phase 3 MEASURE Studies

Atul Deodhar1, Philip Mease 2, Paula Machado 3, Xiangyi Meng 3, Vibeke Strand 4 and Marina Magrey 5, 1Oregon Health & Science University, Portland, OR, 2Swedish Medical Center/Providence St Joseph Health, and University of Washington, Seattle, WA, 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, 4Division of Immunology/Rheumatology, Stanford University, Stanford, CA, 5Division of Rheumatology, The MetroHealth System and School of Medicine, Case Western Reserve University, Cleveland, OH

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Ankylosing spondylitis (AS), axial spondyloarthritis, C-reactive protein (CRP), Disease Activity and interleukins (IL)

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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), a chronic inflammatory disease involving the sacroiliac joints and spine, is associated with pain, stiffness, disability, and reduced quality of life.1,2 Therefore, prompt diagnosis and treatment of patients (pts) is critical. In this post hoc analysis, we assessed the impact of age and disease duration (DD; defined as time since diagnosis) on responses in pts with AS treated with secukinumab (SEC) or placebo (PBO) in the phase 3 MEASURE trials.

Methods: Pts with active AS from MEASURE 1 (M1; NCT01358175), 2 (M2; NCT01649375), 3 (M3; NCT02008916), and 4 (M4; NCT02159053) randomized controlled trials (RCTs) were included.3-8 Pts received subcutaneous (SC) SEC 300 or 150 mg with an intravenous (IV) loading dose (M1, M3), SEC 150 mg with an SC loading dose (M2, M4), or PBO (M1-4). Pooled data from different RCTs (IV or SC loading) may be considered heterogeneous and are generalizable to a wider patient population. Data were pooled from M1-4 at the end of the 16-wk treatment period, and responses were analyzed according to 4 age groups: 18-33, 34-42, 43-51, and 52-79 y. Responses were assessed using outcome measures such as ASAS20/40, BASDAI, BASMI, hsCRP, SF-36 (PCS/MCS), and disease activity/back pain instruments. Similar analyses assessed treatment responses by quartiles of time since diagnosis (0-0.97 y [Q1], 0.98-3.47 y [Q2], 3.49-9.79 y [Q3], and 9.88-50.19 y [Q4]). Time since diagnosis was used as a surrogate marker of DD as symptom duration was not collected. No adjustment was made for multiple comparisons.

Results: 852 pts were included in this analysis (SEC, n = 463; PBO, n = 389) (Table 1); 95.5% completed 16 wk of treatment. Baseline demographics were similar across trials (Table 1). Mean time since AS diagnosis differed across age groups: 3.2 y in the 18-33 group and 11.3 y in the 52-79 group. The proportion of TNF inhibitor–naive pts was higher in the 18-33 group vs the 52-79 group (74.4% vs 65.0%). At Wk 16, greater improvements in ASAS20/40, BASDAI, SF-36, hsCRP, and VAS disease activity/back pain scores were reported in younger (18-33 and 34-42) vs older age groups (43-51 and 52-79) treated with SEC (Fig. 1). When stratified by DD, there was a higher proportion of TNF inhibitor–naive pts in Q1 vs Q4 (92.0% vs 61.8%), and pts with a shorter DD (Q1-Q2) had greater improvements in ASAS40; reductions in hsCRP levels were greatest in Q1 pts (Fig. 2).

Conclusion: SEC treatment led to rapid and sustained improvements in all outcome measures at Wk 16, regardless of age or DD. Older pts reported greater burden of disease. A trend toward higher responses was evident in those with shorter DD. Younger pts had better responses, likely due to shorter DD and a higher proportion being biologic naive. These results emphasize the importance of early AS treatment to delay disease progression and improve pt outcomes.

References:

  1. Braun J, Sieper J. Lancet. 2007;369:1379-1390.
  2. Bodur H, et al. Qual Life Res. 2011;20:543-549.
  3. Baeten D, et al. N Engl J Med. 2015;373:2534-2548.
  4. Wei JC, et al. Int J Rheum Dis. 2017;20:589-596.
  5. Baraliakos X, et al. Clin Exp Rheumatol. 2018;36:50-55.
  6. Marzo-Ortega H, et al. RMD Open. 2017;3:e000592.
  7. Pavelka K, et al. Arthritis Res Ther. 2017;19:285.
  8. Kivitz AJ, et al. Rheumatol Ther. 2018;5:447-462.


Disclosure: 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; P. Mease, Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Genentech, Janssen, Novartis, Pfizer, Roche, UCB, 2, 5, Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB, 8, AbbVie, 2, 5, 8, Abbvie, 2, 5, 8, Abbvie, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 5, Abbvie, Amgen, Bristol Myers Squibb, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, 8, Abbvie, Amgen, Bristol Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Leo, Merck, Novartis, Pfizer and UCB., 5, 8, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, Inc., and UCB, 2, Abbvie, Amgen, Brsitol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 5, Abbvie, Amgen, Brsitol Myers Squibb, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, 8, Abbvie, Amgen, Brsitol Myers Squibb,Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2, Amgen, 2, 5, 6, 8, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, GSK, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, and UCB, 5, BMS, 2, 5, 8, Boehringer Ingelheim, 2, 5, Boerhinger Ingelheim, 5, Bristol Myers Squibb, 2, 5, 8, Bristol Myers Squibb Co., 2, 5, 8, Bristol-Myers Squibb, 2, 5, 6, 8, Celgene, 2, 5, 6, 8, Celgene Corp., 2, 5, 8, CORRONA, 5, Eli Lilly, 2, 5, 8, Galapagos, 2, 5, 8, Genentech, 2, 5, 6, 8, Gilead, 2, 5, 8, Janssen, 2, 5, 6, 8, Janssen Inc, 2, 5, 8, Leo, 2, 5, 8, Lilly, 2, 5, 6, 8, Merck, 2, 5, 8, Novartis, 2, 5, 6, 8, Pfizer, 2, 5, 8, Pfizer Inc, 2, 5, 6, Sun, 2, 5, SUN, 2, 5, Sun Pharma, 2, 5, Sun Pharmaceutical Industries, 2, 5, Sun Pharmaceutical Industries, Inc., 2, 5, 8, UCB, 2, 5, 6, 8, UCB Pharma, 2, 5, 8; P. Machado, Novartis, 1, 3, 4; X. Meng, Novartis, 3, 4; V. Strand, Abbvie, 5, AbbVie, 5, Amgen, 5, Amgen, Abbvie, Bayer, BMS, Boehringer Ingelheim, Celltrion, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, UCB, 5, AstraZeneca, 5, AURA, 8, Bayer, 5, BMS, 5, Boehringer Ingelheim, 5, Celgene, 5, Celltrion, 5, Cleveland Clinic, 8, CORRONA, 5, Crescendo, 5, Crescendo Bioscience, 5, Eli Lilly, 5, EMD Serono, 5, Genentech, 5, GlaxoSmithKline, 5, GSK, 5, Horizon, 5, Inmedix, 5, Janssen, 5, Kezar, 5, Lilly, 5, Merck, 5, NACCME, 8, Novartis, 5, Pfizer, 5, Purdue, 8, RA Forum, 8, RAN, 8, Regeneron, 5, Roche, 5, Samsung, 5, Sandoz, 5, Sanofi, 5, Servier, 5, Setpoint, 5, SLRA, 8, UCB, 5, Up to Date, 7, Washington University, 8, WIR, 8, WRA, 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.

To cite this abstract in AMA style:

Deodhar A, Mease P, Machado P, Meng X, Strand V, Magrey M. Impact of Age and Disease Duration on the Response to IL-17A Inhibitor (Secukinumab) Treatment in Ankylosing Spondylitis: Pooled Results from the Phase 3 MEASURE Studies [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/impact-of-age-and-disease-duration-on-the-response-to-il-17a-inhibitor-secukinumab-treatment-in-ankylosing-spondylitis-pooled-results-from-the-phase-3-measure-studies/. Accessed .
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