Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study

Xenofon Baraliakos, Juergen Braun, Atulya (Atul) Deodhar, Denis Poddubnyy, Alan Kivitz, Hasan Tahir, Filip Van Den Bosch, Evie Maria Delicha, Zsolt Talloczy, Anke Fierlinger

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Abstract

Objective This study aimed to report end-of-study results on efficacy and safety of secukinumab 150 mg through 5 years in patients with ankylosing spondylitis (AS; MEASURE 1 extension trial (NCT01863732)). Methods After the 2-year core trial, 274 patients receiving subcutaneous secukinumab 150 or 75 mg (following intravenous loading or initial placebo treatment to 16/24 weeks) every 4 weeks were invited to enter the 3-year extension study. Dose escalation from 75 to 150 mg (approved dose) was allowed at or after week 156 based on the judgement of the treating physician. Assessments at week 260 (5 years) included Assessment of SpondyloArthritis international Society (ASAS) 20/40 and other efficacy outcomes. Data are presented as observed. Safety assessment included all patients who received ≥1 dose of study treatment. Results Of the 274 patients who entered the extension study, 84% (230/274) completed 5 years of treatment. ASAS20/40 responses were 78.6/65.2%, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response was 63.4% and mean (±SD) BASDAI total score was 2.6±1.76 with secukinumab 150 mg at 5 years. Improvements in efficacy outcomes were sustained through 5 years. A total of 82 patients on secukinumab 75 mg (56.2%) had their dose escalated to 150 mg after week 168; ASAS40, ASAS-PR, ASAS 5/6 and BASDAI50 responses were improved in patients whose dose was escalated from secukinumab 75 to 150 mg. Secukinumab was well tolerated with a safety profile consistent over the course of the study. Conclusions Secukinumab 150 mg provided sustained efficacy across multiple domains of AS with a favourable and consistent safety profile through 5-year treatment. Over 50% of patients required dose escalation from 75 to 150 mg and efficacy improved in these patients.

Original languageEnglish (US)
Article numbere01005
JournalRMD Open
Volume5
Issue number2
DOIs
StatePublished - Sep 1 2019

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Ankylosing Spondylitis
Safety
Baths
secukinumab
Therapeutics
Placebos
Physicians

Keywords

  • ankylosing spondylitis
  • anti-TNF
  • DMARDs (biologic)
  • inflammation
  • spondyloarthritis

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis : 5-year results from the phase III MEASURE 1 extension study. / Baraliakos, Xenofon; Braun, Juergen; Deodhar, Atulya (Atul); Poddubnyy, Denis; Kivitz, Alan; Tahir, Hasan; Van Den Bosch, Filip; Delicha, Evie Maria; Talloczy, Zsolt; Fierlinger, Anke.

In: RMD Open, Vol. 5, No. 2, e01005, 01.09.2019.

Research output: Contribution to journalArticle

Baraliakos, X, Braun, J, Deodhar, AA, Poddubnyy, D, Kivitz, A, Tahir, H, Van Den Bosch, F, Delicha, EM, Talloczy, Z & Fierlinger, A 2019, 'Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study', RMD Open, vol. 5, no. 2, e01005. https://doi.org/10.1136/rmdopen-2019-001005
Baraliakos, Xenofon ; Braun, Juergen ; Deodhar, Atulya (Atul) ; Poddubnyy, Denis ; Kivitz, Alan ; Tahir, Hasan ; Van Den Bosch, Filip ; Delicha, Evie Maria ; Talloczy, Zsolt ; Fierlinger, Anke. / Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis : 5-year results from the phase III MEASURE 1 extension study. In: RMD Open. 2019 ; Vol. 5, No. 2.
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abstract = "Objective This study aimed to report end-of-study results on efficacy and safety of secukinumab 150 mg through 5 years in patients with ankylosing spondylitis (AS; MEASURE 1 extension trial (NCT01863732)). Methods After the 2-year core trial, 274 patients receiving subcutaneous secukinumab 150 or 75 mg (following intravenous loading or initial placebo treatment to 16/24 weeks) every 4 weeks were invited to enter the 3-year extension study. Dose escalation from 75 to 150 mg (approved dose) was allowed at or after week 156 based on the judgement of the treating physician. Assessments at week 260 (5 years) included Assessment of SpondyloArthritis international Society (ASAS) 20/40 and other efficacy outcomes. Data are presented as observed. Safety assessment included all patients who received ≥1 dose of study treatment. Results Of the 274 patients who entered the extension study, 84{\%} (230/274) completed 5 years of treatment. ASAS20/40 responses were 78.6/65.2{\%}, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response was 63.4{\%} and mean (±SD) BASDAI total score was 2.6±1.76 with secukinumab 150 mg at 5 years. Improvements in efficacy outcomes were sustained through 5 years. A total of 82 patients on secukinumab 75 mg (56.2{\%}) had their dose escalated to 150 mg after week 168; ASAS40, ASAS-PR, ASAS 5/6 and BASDAI50 responses were improved in patients whose dose was escalated from secukinumab 75 to 150 mg. Secukinumab was well tolerated with a safety profile consistent over the course of the study. Conclusions Secukinumab 150 mg provided sustained efficacy across multiple domains of AS with a favourable and consistent safety profile through 5-year treatment. Over 50{\%} of patients required dose escalation from 75 to 150 mg and efficacy improved in these patients.",
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author = "Xenofon Baraliakos and Juergen Braun and Deodhar, {Atulya (Atul)} and Denis Poddubnyy and Alan Kivitz and Hasan Tahir and {Van Den Bosch}, Filip and Delicha, {Evie Maria} and Zsolt Talloczy and Anke Fierlinger",
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T2 - 5-year results from the phase III MEASURE 1 extension study

AU - Baraliakos, Xenofon

AU - Braun, Juergen

AU - Deodhar, Atulya (Atul)

AU - Poddubnyy, Denis

AU - Kivitz, Alan

AU - Tahir, Hasan

AU - Van Den Bosch, Filip

AU - Delicha, Evie Maria

AU - Talloczy, Zsolt

AU - Fierlinger, Anke

PY - 2019/9/1

Y1 - 2019/9/1

N2 - Objective This study aimed to report end-of-study results on efficacy and safety of secukinumab 150 mg through 5 years in patients with ankylosing spondylitis (AS; MEASURE 1 extension trial (NCT01863732)). Methods After the 2-year core trial, 274 patients receiving subcutaneous secukinumab 150 or 75 mg (following intravenous loading or initial placebo treatment to 16/24 weeks) every 4 weeks were invited to enter the 3-year extension study. Dose escalation from 75 to 150 mg (approved dose) was allowed at or after week 156 based on the judgement of the treating physician. Assessments at week 260 (5 years) included Assessment of SpondyloArthritis international Society (ASAS) 20/40 and other efficacy outcomes. Data are presented as observed. Safety assessment included all patients who received ≥1 dose of study treatment. Results Of the 274 patients who entered the extension study, 84% (230/274) completed 5 years of treatment. ASAS20/40 responses were 78.6/65.2%, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response was 63.4% and mean (±SD) BASDAI total score was 2.6±1.76 with secukinumab 150 mg at 5 years. Improvements in efficacy outcomes were sustained through 5 years. A total of 82 patients on secukinumab 75 mg (56.2%) had their dose escalated to 150 mg after week 168; ASAS40, ASAS-PR, ASAS 5/6 and BASDAI50 responses were improved in patients whose dose was escalated from secukinumab 75 to 150 mg. Secukinumab was well tolerated with a safety profile consistent over the course of the study. Conclusions Secukinumab 150 mg provided sustained efficacy across multiple domains of AS with a favourable and consistent safety profile through 5-year treatment. Over 50% of patients required dose escalation from 75 to 150 mg and efficacy improved in these patients.

AB - Objective This study aimed to report end-of-study results on efficacy and safety of secukinumab 150 mg through 5 years in patients with ankylosing spondylitis (AS; MEASURE 1 extension trial (NCT01863732)). Methods After the 2-year core trial, 274 patients receiving subcutaneous secukinumab 150 or 75 mg (following intravenous loading or initial placebo treatment to 16/24 weeks) every 4 weeks were invited to enter the 3-year extension study. Dose escalation from 75 to 150 mg (approved dose) was allowed at or after week 156 based on the judgement of the treating physician. Assessments at week 260 (5 years) included Assessment of SpondyloArthritis international Society (ASAS) 20/40 and other efficacy outcomes. Data are presented as observed. Safety assessment included all patients who received ≥1 dose of study treatment. Results Of the 274 patients who entered the extension study, 84% (230/274) completed 5 years of treatment. ASAS20/40 responses were 78.6/65.2%, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response was 63.4% and mean (±SD) BASDAI total score was 2.6±1.76 with secukinumab 150 mg at 5 years. Improvements in efficacy outcomes were sustained through 5 years. A total of 82 patients on secukinumab 75 mg (56.2%) had their dose escalated to 150 mg after week 168; ASAS40, ASAS-PR, ASAS 5/6 and BASDAI50 responses were improved in patients whose dose was escalated from secukinumab 75 to 150 mg. Secukinumab was well tolerated with a safety profile consistent over the course of the study. Conclusions Secukinumab 150 mg provided sustained efficacy across multiple domains of AS with a favourable and consistent safety profile through 5-year treatment. Over 50% of patients required dose escalation from 75 to 150 mg and efficacy improved in these patients.

KW - ankylosing spondylitis

KW - anti-TNF

KW - DMARDs (biologic)

KW - inflammation

KW - spondyloarthritis

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