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Abstract Number: L13

Long-Term Evaluation of Secukinumab in Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 3 Trial

Xenofon Baraliakos1, Jürgen Braun2, Atul A. Deodhar3, Denis Poddubnyy4, Alan J. Kivitz5, Hasan Tahir6, Filip van Den Bosch7, Evie Maria Delicha8, Zsolt Talloczy9 and Anke Fierlinger9, 1Rheumazentrum Ruhrgebiet, Herne, and Ruhr University Bochum, Herne, Germany, Herne, Germany, 2Rheumazentrum Ruhrgebiet Herne, and Ruhr University Bochum, Herne, Germany, Herne, Germany, 3Oregon Health & Science University, Portland, Portland, OR, 4Rheumatology, Campus Benjamin Franklin Charité – Universitätsmedizin, Germany and German Rheumatism Research Centre, Berlin, Germany, Berlin, Germany, 5Altoona Arthritis & Osteoporosis Center, Duncansville, PA, 6Whipps Cross University Hospital, Barts Health NHS Trust, London, United Kingdom, 7Rheumatology, Universitair Ziekenhuis, Ghent, Belgium, Gent, Belgium, 8Novartis Pharma AG, Basel, Basel, Switzerland, 9Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States, East Hanover, NJ

Meeting: 2018 ACR/ARHP Annual Meeting

Date of first publication: October 4, 2018

Keywords: Ankylosing spondylitis (AS), Late-Breaking 2018

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Session Information

Date: Tuesday, October 23, 2018

Session Title: Late-Breaking Abstract Poster Session

Session Type: ACR Late-breaking Abstract Session

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

Background/Purpose: Clinical evaluation of efficacy and safety for long-term treatment for ankylosing spondylitis (AS) is important for treatment decision-making. Secukinumab (SEC), a fully human mAb that selectively neutralizes IL-17A, is the only approved bDMARD for the treatment of AS other than anti-TNFs.1 Here, we report long-term end-of-study (5 year) efficacy and safety results of the MEASURE 1 extension trial (NCT01863732), including outcomes in patients (pts) who had dose escalation from SEC 75 mg to 150 mg during the study.

Methods: Pts were initially randomized to receive intravenous (IV) SEC 10 mg/kg at baseline, Weeks (Wks) 2 and 4, followed by subcutaneous (SC) SEC 150 mg (IV→150 mg) or 75 mg (IV→75 mg) every 4 wks thereafter or matched placebo (PBO). Based on ASAS20 response at Wk 16, PBO pts were re-randomized to secukinumab 150 or 75 mg SC at Wk 16 (non-responders) or Wk 24 (responders). After the 2-year core trial, 274 pts entered the 3-year extension study. Detailed study design has been reported previously1. Dose escalation from SEC 75 mg to 150 mg was allowed following a protocol amendment. Assessments at Wk 260 included ASAS20, ASAS40, ASAS5/6 and other efficacy outcomes (reported as observed). Clinical efficacy including dose escalation results are reported for all pts who entered the extension trial (i.e. including placebo-switchers); former is based on randomized dose whereas latter is based on treatment dose. Safety is reported as exposure adjusted incidence rate (EAIR)/100 pt-years for all pts (n = 360) who received ≥1 dose of study treatment.

Results: A total of 84.4% (108/128) and 83.6% (122/146) of all the pts (i.e. including PBO switchers) who received SEC 150 mg and 75 mg, respectively, completed 260 wks of treatment. Improvements in ASAS20, ASAS40, BASDAI50, and other efficacy outcomes were sustained through Wk 260 (Table). A total of 82 pts on SEC 75 mg (56.2% of total 75 mg population) had dose escalated to 150 mg after Week 168; ASAS40, ASAS PR, ASAS 5/6, and BASDAI50 responses were improved in pts whose dose was escalated from SEC 75 mg to 150 mg (Table). Across the entire treatment period (SEC exposure [mean±SD]: 206.6±90.17 weeks), SEC was well tolerated with a safety profile consistent over the course of the study.  EAIRs of selected adverse events of interest were 0.1, 0.6, 1.8 and 0.5 per 100 pt-years for ulcerative colitis, Crohn’s disease, uveitis and malignant/unspecified tumors, respectively.

Conclusion: Secukinumab provided sustained efficacy across multiple domains of AS including signs and symptoms, physical function, and objective markers of inflammation through 5 years. Efficacy improved in pts who had dose escalation from 75 mg to 150 mg. Secukinumab was well tolerated over long-term use with no new safety signals identified and a safety profile consistent with previous reports.1

References:

1.      Braun J, et al. Ann Rheum Dis. 2017;76:1070-1077

 

 

 

 


Disclosure: X. Baraliakos, AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer and UCB Pharma, 2, 5, 8; J. Braun, Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, 2, 5,Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis and UCB, 8; A. A. Deodhar, AbbVie Inc., 2,Eli Lilly and Co., 2, 5,Janssen, 2, 5,Novartis, 2, 5,Pfizer, Inc., 2, 5,UCB, Inc., 2, 5,Sun pharma, 2; D. Poddubnyy, AbbVie, Janssen, MSD, Novartis, Pfizer, BMS, Boehringer, UCB and Roche, 2, 5, 8; A. J. Kivitz, AbbVie, Pfizer, Genentech, UCB, Sanofi/Regeneron and Celgene, 5,: Celgene, Pfizer, Sanofi/Regeneron, Horizon and Merck, 8; H. Tahir, Novartis, Eli Lilly, and AbbVie, 8; F. van Den Bosch, AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Co., Janssen, Merck, Novartis, Pfizer, Sanofi, UCB, 2, 5, 8; E. M. Delicha, Novartis, 3; Z. Talloczy, Novartis, 1, 3; A. Fierlinger, Novartis, 1, 3.

To cite this abstract in AMA style:

Baraliakos X, Braun J, Deodhar AA, Poddubnyy D, Kivitz AJ, Tahir H, van Den Bosch F, Delicha EM, Talloczy Z, Fierlinger A. Long-Term Evaluation of Secukinumab in Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 3 Trial [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/long-term-evaluation-of-secukinumab-in-ankylosing-spondylitis-5-year-efficacy-and-safety-results-from-a-phase-3-trial/. Accessed February 23, 2019.
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