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POS0925 (2021)

EFFICACY OF SECUKINUMAB IN TNFI-NAÏVE PATIENTS ACROSS THE AXIAL SPONDYLOARTHRITIS SPECTRUM OVER 52 WEEKS: A POST HOC ANALYSIS OF THE MEASURE AND PREVENT CLINICAL TRIALS

M. Magrey¹, J. A. Walsh², F. Huang³, H. Kameda⁴, J. Wang⁵, C. Herrem⁶, P. Pertel⁷, H. Marzo-Ortega⁸

¹Case Western Reserve University School of Medicine, Division of Rheumatology, Ohio, United States of America
²Salt Lake City Veteran Affairs Medical Center; University of Utah Medical Center, Salt Lake City, Division of Rheumatology, Utah, United States of America
³Chinese PLA General Hospital, Beijing, Department of Rheumatology and Immunology, Beijing, China
⁴Toho University (Ohashi Medical Center), Department of Internal Medicine, Division of Rheumatology, Tokyo, Japan
⁵Novartis Pharmaceuticals Corporation, Immunology, Hepatology and Dermatology, East Hanover, United States of America
⁶Novartis Pharma AG, Rheumatology, Basel, Switzerland
⁷Novartis Pharma AG, Immunology, Hepatology and Dermatology, Basel, Switzerland
⁸NIHR Leeds Biomedical Research Centre, Leeds Training Hospitals NHS Trust and LIRMM, University of Leeds, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, United Kingdom

Background: Secukinumab (SEC) has demonstrated significant efficacy in patients (pts) with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). ^1-5 However, evidence regarding the efficacy of SEC across the axSpA disease spectrum is limited.

Objectives: To assess the efficacy of SEC on key efficacy endpoints in pts with axSpA (nr-axSpA and AS) over 52 weeks from 6 pooled phase 3 clinical trials.

Methods: This post hoc analysis included pooled data from tumour necrosis factor inhibitors (TNFi)-naïve pts in the MEASURE 1-5 (AS) and PREVENT (nr-axSpA) phase 3 trials. Assessments included proportion of patients achieving ASAS40, ASAS 5/6, ASAS partial remission (ASAS-PR), ASDAS-CRP major improvement, ASDAS-CRP inactive disease (ASDAS-CRP ID), BASDAI50 and mean change from baseline in nocturnal back pain and morning stiffness with any SEC 150 mg or SEC 300 mg or placebo (PBO) at Week 16, and sustainability was measured in pts treated with SEC at Week 52. Data are reported as non-responder imputation.

Results: A total of 1558 TNFi-naïve pts (SEC 150 mg, N=932; SEC 300 mg, N=57 and PBO, N=569) with a mean age of 39.3 ± 11.58 years were included in the study. At Week 16, significantly higher improvements in pts treated with SEC versus PBO were observed in all efficacy endpoints ( Table 1 ) with improvements sustained up to Week 52.

Conclusion: SEC 300 mg and 150 mg provided significant and sustained improvement in the signs and symptoms of TNFi-naïve pts with axSpA regardless of radiographic status.

REFERENCES:

[1]Baeten D, et al. N Engl J Med 2015;373:2534–48.

[2]Pavelka K, et al. Arthritis Res Ther 2017;19:285.

[3]Kivitz AJ, et al. Rheumatol Ther 2018;5:447–62.

[4]Feng H, et al. Chin Med J 2020;133:2521–31.

[5]Deodhar A, et al. Arthritis Rheumatol 2021;73:110–20.

Table 1.

Efficacy endpoints at Week 16 and Week 52 in TNFi-naïve patients with axSpA

Endpoints	Week	Any secukinumab 150 mg (N = 932 )	Secukinumab 300 mg (N = 57 )	Placebo (N = 569 )
ASAS40, n (%)	16	399 (42.8) ^†	25 (43.9) ^†	134 (23.6)
ASAS40, n (%)	52	508 (54.5)	33 (57.9)	-
ASAS 5/6, n (%)	16	414 (44.4) ^†	24 (42.1) ^†	125 (22.0)
ASAS 5/6, n (%)	52	508 (54.5)	33 (57.9)	-
ASAS partial remission, n (%)	16	166 (17.8) ^†	12 (21.1) ^†	35 (6.2)
ASAS partial remission, n (%)	52	240 (25.8)	13 (22.8)	-
ASDAS-CRP major improvement, n (%)	16	266 (28.5) ^†	16 (28.1) ^†	43 (7.6)
ASDAS-CRP major improvement, n (%)	52	336 (36.1)	20 (35.1)	-
ASDAS-CRP ID, n (%)	16	171 (18.3) ^†	11 (19.3) ^†	31 (5.4)
ASDAS-CRP ID, n (%)	52	247 (26.5)	13 (22.8)	-
BASDAI50, n (%)	16	356 (38.2) ^†	22 (38.6) ^§	110 (19.3)
BASDAI50, n (%)	52	459 (49.2)	27 (47.4)	-
Nocturnal back pain, mean change from baseline ± SE	16	−31.82 ± 0.87	−37.99 ± 3.56 ^†	−18.12 ±1.13
Nocturnal back pain, mean change from baseline ± SE	52*	−41.31 ± 27.58	−46.56 ± 24.30	-
Overall level of morning stiffness, mean change from baseline ± SE	16	−3.23 ± 0.09 ^†	−3.62 ± 0.35 ^†	−1.95 ± 0.11 ^†
	52*	−4.24 ± 2.75	−4.71 ± 2.74	-

Data presented as NRI.

^† P <0.001; ^§ P <0.01 vs placebo; *mean change ± SD.

ASAS, Assessment of SpondyloArthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CRP, C-reactive protein; ID, inactive disease; NRI, non-responder imputation; SD, standard deviation; SE, standard error; TNFi, tumour necrosis factor inhibitor.

Disclosure of Interests: Marina Magrey Consultant of: Novartis, Pfizer, Abbvie, UCB, Eli Lilly, Grant/research support from: Clinical trials with Abbvie and UCB, Jessica A. Walsh Consultant of: AbbVie, Novartis, Eli Lilly and Company, UCB, Grant/research support from: AbbVie, Pfizer, Janssen, feng huang: None declared, Hideto Kameda Speakers bureau: AbbVie, Asahi-Kasei, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Eli Lilly, Gilead Sciences, Janssen, Kyowa Kirin, Mitsubishi-Tanabe, Novartis, Pfizer and UCB., Consultant of: AbbVie, Asahi-Kasei, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Eli Lilly, Gilead Sciences, Janssen, Kyowa Kirin, Mitsubishi-Tanabe, Novartis, Pfizer and UCB., Grant/research support from: AbbVie, Asahi-Kasei, Astellas, Behringer, Chugai, Eisai, Mitsubishi-Tanabe, Novartis, Jianyuan Wang Employee of: Novartis, Christopher Herrem Employee of: Novartis, Patricia Pertel Employee of: Novartis, Helena Marzo-Ortega Speakers bureau: AbbVie, Celgene, Janssen, Eli Lilly and Company, Novartis, Pfizer, Takeda, and UCB., Consultant of: AbbVie, Celgene, Janssen, Eli Lilly and Company, Novartis, Pfizer, Takeda, and UCB., Grant/research support from: Janssen, Novartis

Citation: Ann Rheum Dis, volume 80, supplement 1, year 2021, page 724

Session: Spondyloarthritis – treatment (POSTERS only)

version:	1.02