Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis: 52-week pooled results from two phase 3 studies

James C.C. Wei, Dominique Baeten, Joachim Sieper, Atulya (Atul) Deodhar, Vaishali Bhosekar, Ruvie Martin, Brian Porter

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Aim: To evaluate efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis (AS) via a pooled subgroup analysis from two phase 3 studies, MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). Methods: In MEASURE 1, patients were randomized to intravenous secukinumab 10 mg/kg or placebo at baseline, Weeks 2 and 4, followed by subcutaneous (s.c.) secukinumab 150 mg, 75 mg or placebo every 4 weeks (q4w) at Week 8. In MEASURE 2, patients were randomized to s.c. secukinumab 150 mg, 75 mg or placebo at baseline, Weeks 1, 2 and 3, and q4w starting at Week 4. Efficacy outcomes were SpondyloArthritis International Society (ASAS) 20/40, high-sensitivity C-reactive protein (hsCRP), ASAS5/6, Bath Ankylosing Spondylitis Disease Activity Index, Short Form-36 physical component summary, AS quality of life (QoL), ASAS partial remission, and Ankylosing Spondylitis Disease Activity Score – CRP at Weeks 16 and 52. Due to lack of efficacy, the secukinumab 75 mg dose in MEASURE 2 was excluded from this pooled Asian subgroup analysis. Safety analysis included patients who received ≥ 1 dose of study treatment. Results: Of 517 patients enrolled into the MEASURE studies, 69 (13.3%) were Asians: 46 in pooled secukinumab and 23 in placebo. At Week 16, ASAS20/40 responses in Asian patients were 69.6%/43.5% with pooled secukinumab versus 26.1%/17.4% with placebo, which were comparable with rates reported in the overall study population. Secukinumab improved predefined efficacy endpoints at Week 16, with responses sustained through Week 52. Secukinumab was well tolerated in Asian patients, with a safety profile consistent with that reported in the overall study population. Conclusion: Secukinumab improved signs and symptoms, physical function, and disease-specific QoL in Asian patients with active AS.

Original languageEnglish (US)
Pages (from-to)589-596
Number of pages8
JournalInternational Journal of Rheumatic Diseases
Volume20
Issue number5
DOIs
StatePublished - May 1 2017

Fingerprint

Ankylosing Spondylitis
Safety
Placebos
Quality of Life
secukinumab
Baths
C-Reactive Protein
Population
Signs and Symptoms

Keywords

  • ankylosing spondylitis
  • Asian
  • biologic
  • IL-17A inhibitor
  • secukinumab

ASJC Scopus subject areas

  • Rheumatology

Cite this

Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis : 52-week pooled results from two phase 3 studies. / Wei, James C.C.; Baeten, Dominique; Sieper, Joachim; Deodhar, Atulya (Atul); Bhosekar, Vaishali; Martin, Ruvie; Porter, Brian.

In: International Journal of Rheumatic Diseases, Vol. 20, No. 5, 01.05.2017, p. 589-596.

Research output: Contribution to journalArticle

Wei, James C.C. ; Baeten, Dominique ; Sieper, Joachim ; Deodhar, Atulya (Atul) ; Bhosekar, Vaishali ; Martin, Ruvie ; Porter, Brian. / Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis : 52-week pooled results from two phase 3 studies. In: International Journal of Rheumatic Diseases. 2017 ; Vol. 20, No. 5. pp. 589-596.
@article{c9f4158e71f64b56a5616ea4709cae19,
title = "Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis: 52-week pooled results from two phase 3 studies",
abstract = "Aim: To evaluate efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis (AS) via a pooled subgroup analysis from two phase 3 studies, MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). Methods: In MEASURE 1, patients were randomized to intravenous secukinumab 10 mg/kg or placebo at baseline, Weeks 2 and 4, followed by subcutaneous (s.c.) secukinumab 150 mg, 75 mg or placebo every 4 weeks (q4w) at Week 8. In MEASURE 2, patients were randomized to s.c. secukinumab 150 mg, 75 mg or placebo at baseline, Weeks 1, 2 and 3, and q4w starting at Week 4. Efficacy outcomes were SpondyloArthritis International Society (ASAS) 20/40, high-sensitivity C-reactive protein (hsCRP), ASAS5/6, Bath Ankylosing Spondylitis Disease Activity Index, Short Form-36 physical component summary, AS quality of life (QoL), ASAS partial remission, and Ankylosing Spondylitis Disease Activity Score – CRP at Weeks 16 and 52. Due to lack of efficacy, the secukinumab 75 mg dose in MEASURE 2 was excluded from this pooled Asian subgroup analysis. Safety analysis included patients who received ≥ 1 dose of study treatment. Results: Of 517 patients enrolled into the MEASURE studies, 69 (13.3{\%}) were Asians: 46 in pooled secukinumab and 23 in placebo. At Week 16, ASAS20/40 responses in Asian patients were 69.6{\%}/43.5{\%} with pooled secukinumab versus 26.1{\%}/17.4{\%} with placebo, which were comparable with rates reported in the overall study population. Secukinumab improved predefined efficacy endpoints at Week 16, with responses sustained through Week 52. Secukinumab was well tolerated in Asian patients, with a safety profile consistent with that reported in the overall study population. Conclusion: Secukinumab improved signs and symptoms, physical function, and disease-specific QoL in Asian patients with active AS.",
keywords = "ankylosing spondylitis, Asian, biologic, IL-17A inhibitor, secukinumab",
author = "Wei, {James C.C.} and Dominique Baeten and Joachim Sieper and Deodhar, {Atulya (Atul)} and Vaishali Bhosekar and Ruvie Martin and Brian Porter",
year = "2017",
month = "5",
day = "1",
doi = "10.1111/1756-185X.13094",
language = "English (US)",
volume = "20",
pages = "589--596",
journal = "International Journal of Rheumatic Diseases",
issn = "1756-1841",
publisher = "Wiley-Blackwell",
number = "5",

}

TY - JOUR

T1 - Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis

T2 - 52-week pooled results from two phase 3 studies

AU - Wei, James C.C.

AU - Baeten, Dominique

AU - Sieper, Joachim

AU - Deodhar, Atulya (Atul)

AU - Bhosekar, Vaishali

AU - Martin, Ruvie

AU - Porter, Brian

PY - 2017/5/1

Y1 - 2017/5/1

N2 - Aim: To evaluate efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis (AS) via a pooled subgroup analysis from two phase 3 studies, MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). Methods: In MEASURE 1, patients were randomized to intravenous secukinumab 10 mg/kg or placebo at baseline, Weeks 2 and 4, followed by subcutaneous (s.c.) secukinumab 150 mg, 75 mg or placebo every 4 weeks (q4w) at Week 8. In MEASURE 2, patients were randomized to s.c. secukinumab 150 mg, 75 mg or placebo at baseline, Weeks 1, 2 and 3, and q4w starting at Week 4. Efficacy outcomes were SpondyloArthritis International Society (ASAS) 20/40, high-sensitivity C-reactive protein (hsCRP), ASAS5/6, Bath Ankylosing Spondylitis Disease Activity Index, Short Form-36 physical component summary, AS quality of life (QoL), ASAS partial remission, and Ankylosing Spondylitis Disease Activity Score – CRP at Weeks 16 and 52. Due to lack of efficacy, the secukinumab 75 mg dose in MEASURE 2 was excluded from this pooled Asian subgroup analysis. Safety analysis included patients who received ≥ 1 dose of study treatment. Results: Of 517 patients enrolled into the MEASURE studies, 69 (13.3%) were Asians: 46 in pooled secukinumab and 23 in placebo. At Week 16, ASAS20/40 responses in Asian patients were 69.6%/43.5% with pooled secukinumab versus 26.1%/17.4% with placebo, which were comparable with rates reported in the overall study population. Secukinumab improved predefined efficacy endpoints at Week 16, with responses sustained through Week 52. Secukinumab was well tolerated in Asian patients, with a safety profile consistent with that reported in the overall study population. Conclusion: Secukinumab improved signs and symptoms, physical function, and disease-specific QoL in Asian patients with active AS.

AB - Aim: To evaluate efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis (AS) via a pooled subgroup analysis from two phase 3 studies, MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). Methods: In MEASURE 1, patients were randomized to intravenous secukinumab 10 mg/kg or placebo at baseline, Weeks 2 and 4, followed by subcutaneous (s.c.) secukinumab 150 mg, 75 mg or placebo every 4 weeks (q4w) at Week 8. In MEASURE 2, patients were randomized to s.c. secukinumab 150 mg, 75 mg or placebo at baseline, Weeks 1, 2 and 3, and q4w starting at Week 4. Efficacy outcomes were SpondyloArthritis International Society (ASAS) 20/40, high-sensitivity C-reactive protein (hsCRP), ASAS5/6, Bath Ankylosing Spondylitis Disease Activity Index, Short Form-36 physical component summary, AS quality of life (QoL), ASAS partial remission, and Ankylosing Spondylitis Disease Activity Score – CRP at Weeks 16 and 52. Due to lack of efficacy, the secukinumab 75 mg dose in MEASURE 2 was excluded from this pooled Asian subgroup analysis. Safety analysis included patients who received ≥ 1 dose of study treatment. Results: Of 517 patients enrolled into the MEASURE studies, 69 (13.3%) were Asians: 46 in pooled secukinumab and 23 in placebo. At Week 16, ASAS20/40 responses in Asian patients were 69.6%/43.5% with pooled secukinumab versus 26.1%/17.4% with placebo, which were comparable with rates reported in the overall study population. Secukinumab improved predefined efficacy endpoints at Week 16, with responses sustained through Week 52. Secukinumab was well tolerated in Asian patients, with a safety profile consistent with that reported in the overall study population. Conclusion: Secukinumab improved signs and symptoms, physical function, and disease-specific QoL in Asian patients with active AS.

KW - ankylosing spondylitis

KW - Asian

KW - biologic

KW - IL-17A inhibitor

KW - secukinumab

UR - http://www.scopus.com/inward/record.url?scp=85019833056&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85019833056&partnerID=8YFLogxK

U2 - 10.1111/1756-185X.13094

DO - 10.1111/1756-185X.13094

M3 - Article

C2 - 28544533

AN - SCOPUS:85019833056

VL - 20

SP - 589

EP - 596

JO - International Journal of Rheumatic Diseases

JF - International Journal of Rheumatic Diseases

SN - 1756-1841

IS - 5

ER -