ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2896

Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Ankylosing Spondylitis: 2-Year Efficacy and Safety Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial

Dominique Baeten1, Jurgen Braun2, Joachim Sieper3, Maxime Dougados4, Atul A. Deodhar5, Xenofon Baraliakos6, Brian Porter7, Yankun Gong8 and Hanno Richards9, 11Academic Medical Center / University of Amsterdam, Amsterdam, Netherlands, 2Rheumazentrum Ruhrgebiet, Herne, Germany, Herne, Germany, 3University Clinic Benjamin Franklin, Berlin, Germany, 4Paris-Descartes University, Paris, France, 5Oregon Health and Sciences University, Portland, OR, 6Rheumazentrum Ruhrgebiet, Herne, Germany, 7Novartis Pharmaceuticals Corporation, East Hanover, NJ, 8Beijing Novartis Pharma Co. Ltd., Beijing, China, 9Novartis Pharma AG, Basel, Switzerland

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: ,

Session Information

Date: Tuesday, November 10, 2015

Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy

Session Type: ACR Poster Session C

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

Background/Purpose:
Secukinumab, an
anti–interleukin-17A monoclonal antibody, improved the signs and symptoms of
ankylosing spondylitis (AS) over 52 weeks (wks) in
the randomized, double-blind, placebo (PBO)-controlled, Phase 3 MEASURE 1 study
(NCT01358175).1 Here, we report the long-term (104 wks) efficacy and safety of secukinumab
in this study.

Methods: 371 patients (pts)
with active AS were randomized to secukinumab or PBO.
Pts on secukinumab received a 10 mg/kg intravenous (i.v.) loading dose at baseline, Wks
2 and 4, and then subcutaneous (s.c.)
150 mg (IV→150 mg) or 75 mg (IV→75 mg) every 4 wks
from Wk 8. PBO was given on the same schedule. PBO
pts were re-randomized to secukinumab 150 or 75 mg s.c. based on ASAS20 response at Wk
16, with non-responders switched at Wk 16 and
responders at Wk 24. Assessments at Wk 104 included ASAS20/40, hsCRP,
ASAS5/6, BASDAI, SF-36 PCS, ASQoL, and ASAS partial
remission. Wk 104 data are presented as observed.
Pre-specified exploratory endpoints included assessment of spinal x-ray
(modified Stoke Ankylosing Spondylitis Spinal Score [mSASSS])
and sacroiliac joint x-ray and magnetic resonance imaging.

Results:
97/125 (77.6%) pts randomized to IV→150 mg and 103/124 (83.1%) pts
randomized to IV→75 mg completed 104 wks. Using observed data, ASAS 20/40 response rates at Wk
104 were 79.3/64.4 % and 72.1/53.5 % with IV→150 mg and IV→75 mg,
respectively (Table). Clinical improvements with secukinumab were sustained through Wk
104 across all other endpoints (Table). Sustained improvements were observed in
pts naïve to anti-tumor necrosis factor (anti-TNF) therapy and in those with an
inadequate response/intolerance to not more than one agent (anti-TNF-IR). ASAS
20/40 response rates at Wk 104 (observed data) in
anti-TNF-naïve pts were 85.5/69.6% and 72.3/52.3% with IV→150 mg and IV→75
mg, respectively; corresponding rates in anti-TNF-IR pts were 55.6/44.4% and
71.4/57.1%.  mSASSS
progression over 2 years was 0.3 units for both treatment arms. Across the
entire study period (mean secukinumab exposure: 631.6
days), the exposure-adjusted incidence rate (EAIR) for serious infections with
secukinumab was 1.0 per 100 pt-years. No cases of TB
were reported. The EAIR for inflammatory bowel disease was 0.8, malignant or
unspecified tumours 0.6, and major adverse cardiac events 0.4, per 100 pt-years, respectively.

Conclusion: Secukinumab provided sustained
improvement through 2 years in the signs and symptoms of AS and improved
physical function and quality of life. These sustained improvements were
observed regardless of anti-TNF status. The safety profile was consistent with
that previously reported.

Reference:

1.    Baeten
D, et al. Arthritis Rheumatol
2014; 66 (11Suppl):S360.

Table. Summary of 104-week Efficacy Results (Observed Data)

Secukinumab

IV → 150 mg

Secukinumab

IV → 75 mg

ASAS20 response, n/N (%)

69/87 (79.3%)

62/86 (72.1%)

ASAS40 response, n/N (%) 

56/87 (64.4%)

46/86 (53.5%)

hsCRP, change from baseline score (Mean ± SD)

–11.14 ± 24.38

–8.90 ± 18.62

ASAS5/6, n/N (%) 

56/87 (64.4%)

49/86 (57.0%)

BASDAI, mean change from baseline score (Mean ± SD)

–3.41 ± 2.12

–3.04 ± 1.81   

SF-36 PCS, mean change from baseline score (Mean ± SD)

8.06 ± 8.08

7.41 ± 6.83

ASQoL, mean change from baseline score (Mean ± SD)

–4.82 ± 4.83

–4.58 ± 4.44

ASAS partial remission, n/N (%)

28/87 (32.2%)

20/86 (23.3%)

ASAS, Assessment of Spondyloarthritis International Society; ASQoL, ankylosing spondylitis quality of life; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; hsCRP, high sensitivity C-reactive protein; n, number of pts meeting criteria; N, total number of pts in the analysis; SD, standard deviation; SF-36 PCS, short form-36 health survey physical component summary

Disclosure: D. Baeten, Boehringer Ingelheim, Janssen, MSD, Novartis, Pfizer, 2,AbbVie, Boehringer Ingelheim, BMS, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, UCB, 5; 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, 9,Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, 9,Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, 5; J. Sieper, AbbVie, Pfizer, Merck, UCB and Novartis, 5,AbbVie, Pfizer and Merck, 2,AbbVie, Pfizer, Merck and UCB, 8; M. Dougados, AbbVie, BMS, Eli Lilly, Merck, Pfizer, 2,Eli Lilly and Company, 5; A. A. Deodhar, AbbVie, Boehringer Ingelheim Celgene, Janssen, Novartis, Pfizer and UCB, 2,AbbVie, Boehringer Ingelheim Celgene, Janssen, Novartis, Pfizer and UCB, 5; X. Baraliakos, AbbVie, Merck, Pfizer, UCB, Novartis, and Chugai, 2,AbbVie, Merck, Pfizer, UCB, Novartis, and Chugai, 5,AbbVie, Merck, Pfizer, UCB, Novartis, and Chugai, 8; B. Porter, Novartis, 3,Novartis, 1; Y. Gong, Novartis, 3; H. Richards, Novartis, 3.

To cite this abstract in AMA style:

Baeten D, Braun J, Sieper J, Dougados M, Deodhar AA, Baraliakos X, Porter B, Gong Y, Richards H. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Ankylosing Spondylitis: 2-Year Efficacy and Safety Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/secukinumab-provides-sustained-improvements-in-the-signs-and-symptoms-of-active-ankylosing-spondylitis-2-year-efficacy-and-safety-results-from-a-phase-3-randomized-double-blind-placebo-controlled/. Accessed .

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