ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2556

Secukinumab 150mg Provides Sustained Improvements in the Signs and Symptoms of Active Ankylosing Spondylitis with Consistent Safety Profile and High Retention Rate: 4-Year Results from a Phase III Trial

Helena Marzo-Ortega1, Joachim Sieper2, Alan J. Kivitz3, Ricardo Blanco4, Martin Cohen5, Evie Maria Delicha6, Susanne Rohrer6 and Hanno Richards6, 1NIHR LBRC, LTHT and LIRMM, University of Leeds, Leeds, United Kingdom, 2University Clinic Benjamin Franklin, Berlin, Germany, 3Altoona Center for Clinical Research, Duncansville, PA, 4Hospital Universitario Marqués de Valdecilla, Santander, Spain, 5McGill University, Montreal, QC, Canada, 6Novartis Pharma AG, Basel, Switzerland

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: , , ,

Session Information

Date: Tuesday, October 23, 2018

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster III: Treatment

Session Type: ACR Poster Session C

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

Background/Purpose: Secukinumab, a fully human monoclonal IgG1 antibody that neutralizes IL-17A, has shown significant and sustained improvement in the signs and symptoms of active ankylosing spondylitis (AS) through 3 years in the MEASURE 2 study (NCT01649375).1 Here, we report the longer-term (4-year) efficacy and safety of subcutaneous (s.c.) secukinumab 150 mg in the MEASURE 2 study.

Methods: AS patients (pts; N = 219) were randomized to receive s.c. secukinumab 150 mg, 75 mg or placebo at baseline, Weeks (Wks) 1, 2 and 3 and every 4 wks from Wk 4. At Wk 16, placebo-treated pts were re‑randomized to receive secukinumab 150/75 mg. Efficacy results are reported for pts initially randomized to secukinumab 150 mg and those who switched from placebo to secukinumab 150 mg at Wk 16 (N = 106). Outcome measures at Wk 208 included ASAS20 and 40, BASDAI, SF-36 PCS, and ASAS partial remission. Analyses stratified by anti-TNF status (anti–TNF-naïve and anti-TNF inadequate response [IR]) were pre-specified. Safety analysis included all pts who received ≥1 dose of secukinumab. Results are reported as observed.

Results: The retention rate from Wk 16 to 208 was 85% (85/100) for secukinumab 150 mg. Sustained improvements were observed with secukinumab 150 mg across all endpoints through 4 years (Table). These improvements were maintained regardless of prior exposure to anti–TNF therapy; greater responses were demonstrated in anti–TNF-naïve pts. Over the entire study period, the mean exposure (±SD) to secukinumab was 1189.3 ± 452.9 days. Exposure-adjusted incidence rates (per 100 pt-years) with any secukinumab dose for selected adverse events were: serious infections/infestations (1.5), Candida infections (1.2), Crohn’s disease (0.6), major adverse cardiovascular events (0.6), uveitis (0.6), and malignant/unspecified tumours (0.4).

Conclusion: Secukinumab 150 mg provided sustained improvement in the signs, symptoms, and physical function in pts with AS through 4 years of treatment with 85% retention rate. The safety profile of secukinumab remained favorable and was consistent with previous reports.1–3 References: 1. Marzo-Ortega, et al. RMD Open. 2017;3:e000592; 2. Marzo-Ortega et al. Ann Rheum Dis. 2016;75:812‒3; 3. Baraliakos X, et al. Clin Exp Rheumatol 2017.

Table. Clinical improvements with secukinumab 150 mg at Weeks 52 and 208

Variable

Week

Secukinumab 150 mga

Total

Anti–TNF-naïve

Anti–TNF-IR

ASAS20, % responders (n)

52

74.2 (93)

80.0 (60)

63.6 (33)

208

73.3 (86)

74.6 (59)

70.4 (27)

ASAS40 , % responders (n)

52

57.0 (93)

63.3 (60)

45.5 (33)

208

60.5 (86)

62.7 (59)

55.6 (27)

BASDAI, mean change ± SD (n)

52

-3.2 ± 2.3 (93)

-3.3 ± 2.3 (60)

-3.0 ± 2.1 (33)

208

-3.2 ± 2.3 (86)

-3.5 ± 2.4 (59)

-2.7 ± 2.0 (27)

SF-36 PCS, mean change ± SD (n)

52

7.6 ± 7.7 (94)

8.0 ± 7.5 (61)

6.9 ± 8.1 (33)

208

8.3 ± 8.3 (85)

9.4 ± 8.5 (58)

6.2 ± 7.8 (27)

ASAS partial remission, % responders (n)

52

24.7 (93)

28.3 (60)

18.2 (33)

208

27.9 (86)

32.2 (59)

18.5 (27)

aIncludes placebo switchers. Data are reported as observed.

ASAS; Assessment in SpondyloArthritis International Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; IR, inadequate response; SD, standard deviation; SF-36 PCS, Short Form (36) Health Survey Physical Component Summary; TNF, tumor necrosis factor

Disclosure: H. Marzo-Ortega, Janssen and Pfizer, 2,Abbvie, Celgene, Janssen and UCB, 8,Abbvie, Celgene, Janssen, Novartis and UCB, 5; J. Sieper, AbbVie, Pfizer and Merck, 2,: AbbVie, Pfizer, Merck, UCB and Novartis, 5,AbbVie, Pfizer, Merck and UCB, 8; A. J. Kivitz, AbbVie, Pfizer, Genentech, UCB, Sanofi/Regeneron and Celgene, 5,Celgene, Pfizer, Sanofi/Regeneron, Horizon and Merck, 8; R. Blanco, None; M. Cohen, Abbvie, Amgen, BMS, Celgene, Hospira, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and UCB, 5,bbvie, Amgen, BMS, Celgene, Hospira, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and UCB, 8; E. M. Delicha, Novartis, 1, 3; S. Rohrer, Novartis, 1, 3; H. Richards, Novartis, 1, 3.

To cite this abstract in AMA style:

Marzo-Ortega H, Sieper J, Kivitz AJ, Blanco R, Cohen M, Delicha EM, Rohrer S, Richards H. Secukinumab 150mg Provides Sustained Improvements in the Signs and Symptoms of Active Ankylosing Spondylitis with Consistent Safety Profile and High Retention Rate: 4-Year Results from a Phase III Trial [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/secukinumab-150mg-provides-sustained-improvements-in-the-signs-and-symptoms-of-active-ankylosing-spondylitis-with-consistent-safety-profile-and-high-retention-rate-4-year-results-from-a-phase-iii-tri/. Accessed .

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