Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis

3-year pooled data from two phase III studies

Jürgen Braun, Atulya (Atul) Deodhar, Robert Landewé, Xenofon Baraliakos, Corinne Miceli-Richard, Joachim Sieper, Erhard Quebe-Fehling, Ruvie Martin, Brian Porter, Kunal K. Gandhi, Désirée Van Der Heijde

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objective To evaluate the magnitude of response to secukinumab treatment over 3 years in patients with ankylosing spondylitis (AS) grouped by baseline C-reactive protein (CRP) levels in a pooled study of two pivotal phase III studies: MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). Methods This post hoc analysis pooled data from all patients with available baseline CRP in the two studies who received subcutaneous secukinumab 150mg (approved dose; N=197) or placebo (N=195). Assessed efficacy endpoints included Assessments of SpondyloArthritis international Society (ASAS)20/40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI50, AS Disease Activity Score inactive disease and ASAS partial remission among patients grouped by baseline CRP based on central laboratory cut-off <5mg/L (normal) or ≥5mg/L (elevated) and a cut-off <10mg/L or ≥10mg/L. Results At baseline, 36.5% (143/392) patients had normal and 63.5% (249/392) had elevated CRP. At week 16, ASAS20/40 response rates were higher for secukinumab versus placebo in normal (56.9%/34.7% vs 28.2%/7.0%; p<0.01/p<0.001) and in elevated (63.2%/42.4% vs 29.0%/15.3%; both p<0.0001) CRP groups. Improvement was reported for all outcomes (p<0.05) in both groups, except for ASAS partial remission in the normal CRP group, where a numerical difference 12.5% vs 2.8%, p=0.07) was observed. Similar trends of improvement were observed in the <10and ≥10mg/L groups across all efficacy outcomes at week 16. Treatment responses to secukinumab in all CRP groups further improved over 156 weeks. Conclusion Secukinumab 150mg demonstrated rapid and sustained efficacy in patients with AS irrespective of baseline CRP, with greater magnitude of response in patients with more elevated CRP.

Original languageEnglish (US)
Article numbere000749
JournalRMD Open
Volume4
Issue number2
DOIs
StatePublished - Nov 1 2018

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Ankylosing Spondylitis
C-Reactive Protein
Placebos
secukinumab
Baths
Therapeutics

Keywords

  • ankylosing spondylitis
  • cytokine
  • DMARDs (biologic)
  • inflammation
  • spondyloarthritis

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis : 3-year pooled data from two phase III studies. / Braun, Jürgen; Deodhar, Atulya (Atul); Landewé, Robert; Baraliakos, Xenofon; Miceli-Richard, Corinne; Sieper, Joachim; Quebe-Fehling, Erhard; Martin, Ruvie; Porter, Brian; Gandhi, Kunal K.; Van Der Heijde, Désirée.

In: RMD Open, Vol. 4, No. 2, e000749, 01.11.2018.

Research output: Contribution to journalArticle

Braun, J, Deodhar, AA, Landewé, R, Baraliakos, X, Miceli-Richard, C, Sieper, J, Quebe-Fehling, E, Martin, R, Porter, B, Gandhi, KK & Van Der Heijde, D 2018, 'Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis: 3-year pooled data from two phase III studies', RMD Open, vol. 4, no. 2, e000749. https://doi.org/10.1136/rmdopen-2018-000749
Braun, Jürgen ; Deodhar, Atulya (Atul) ; Landewé, Robert ; Baraliakos, Xenofon ; Miceli-Richard, Corinne ; Sieper, Joachim ; Quebe-Fehling, Erhard ; Martin, Ruvie ; Porter, Brian ; Gandhi, Kunal K. ; Van Der Heijde, Désirée. / Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis : 3-year pooled data from two phase III studies. In: RMD Open. 2018 ; Vol. 4, No. 2.
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abstract = "Objective To evaluate the magnitude of response to secukinumab treatment over 3 years in patients with ankylosing spondylitis (AS) grouped by baseline C-reactive protein (CRP) levels in a pooled study of two pivotal phase III studies: MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). Methods This post hoc analysis pooled data from all patients with available baseline CRP in the two studies who received subcutaneous secukinumab 150mg (approved dose; N=197) or placebo (N=195). Assessed efficacy endpoints included Assessments of SpondyloArthritis international Society (ASAS)20/40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI50, AS Disease Activity Score inactive disease and ASAS partial remission among patients grouped by baseline CRP based on central laboratory cut-off <5mg/L (normal) or ≥5mg/L (elevated) and a cut-off <10mg/L or ≥10mg/L. Results At baseline, 36.5{\%} (143/392) patients had normal and 63.5{\%} (249/392) had elevated CRP. At week 16, ASAS20/40 response rates were higher for secukinumab versus placebo in normal (56.9{\%}/34.7{\%} vs 28.2{\%}/7.0{\%}; p<0.01/p<0.001) and in elevated (63.2{\%}/42.4{\%} vs 29.0{\%}/15.3{\%}; both p<0.0001) CRP groups. Improvement was reported for all outcomes (p<0.05) in both groups, except for ASAS partial remission in the normal CRP group, where a numerical difference 12.5{\%} vs 2.8{\%}, p=0.07) was observed. Similar trends of improvement were observed in the <10and ≥10mg/L groups across all efficacy outcomes at week 16. Treatment responses to secukinumab in all CRP groups further improved over 156 weeks. Conclusion Secukinumab 150mg demonstrated rapid and sustained efficacy in patients with AS irrespective of baseline CRP, with greater magnitude of response in patients with more elevated CRP.",
keywords = "ankylosing spondylitis, cytokine, DMARDs (biologic), inflammation, spondyloarthritis",
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T1 - Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis

T2 - 3-year pooled data from two phase III studies

AU - Braun, Jürgen

AU - Deodhar, Atulya (Atul)

AU - Landewé, Robert

AU - Baraliakos, Xenofon

AU - Miceli-Richard, Corinne

AU - Sieper, Joachim

AU - Quebe-Fehling, Erhard

AU - Martin, Ruvie

AU - Porter, Brian

AU - Gandhi, Kunal K.

AU - Van Der Heijde, Désirée

PY - 2018/11/1

Y1 - 2018/11/1

N2 - Objective To evaluate the magnitude of response to secukinumab treatment over 3 years in patients with ankylosing spondylitis (AS) grouped by baseline C-reactive protein (CRP) levels in a pooled study of two pivotal phase III studies: MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). Methods This post hoc analysis pooled data from all patients with available baseline CRP in the two studies who received subcutaneous secukinumab 150mg (approved dose; N=197) or placebo (N=195). Assessed efficacy endpoints included Assessments of SpondyloArthritis international Society (ASAS)20/40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI50, AS Disease Activity Score inactive disease and ASAS partial remission among patients grouped by baseline CRP based on central laboratory cut-off <5mg/L (normal) or ≥5mg/L (elevated) and a cut-off <10mg/L or ≥10mg/L. Results At baseline, 36.5% (143/392) patients had normal and 63.5% (249/392) had elevated CRP. At week 16, ASAS20/40 response rates were higher for secukinumab versus placebo in normal (56.9%/34.7% vs 28.2%/7.0%; p<0.01/p<0.001) and in elevated (63.2%/42.4% vs 29.0%/15.3%; both p<0.0001) CRP groups. Improvement was reported for all outcomes (p<0.05) in both groups, except for ASAS partial remission in the normal CRP group, where a numerical difference 12.5% vs 2.8%, p=0.07) was observed. Similar trends of improvement were observed in the <10and ≥10mg/L groups across all efficacy outcomes at week 16. Treatment responses to secukinumab in all CRP groups further improved over 156 weeks. Conclusion Secukinumab 150mg demonstrated rapid and sustained efficacy in patients with AS irrespective of baseline CRP, with greater magnitude of response in patients with more elevated CRP.

AB - Objective To evaluate the magnitude of response to secukinumab treatment over 3 years in patients with ankylosing spondylitis (AS) grouped by baseline C-reactive protein (CRP) levels in a pooled study of two pivotal phase III studies: MEASURE 1 (NCT01358175) and MEASURE 2 (NCT01649375). Methods This post hoc analysis pooled data from all patients with available baseline CRP in the two studies who received subcutaneous secukinumab 150mg (approved dose; N=197) or placebo (N=195). Assessed efficacy endpoints included Assessments of SpondyloArthritis international Society (ASAS)20/40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI50, AS Disease Activity Score inactive disease and ASAS partial remission among patients grouped by baseline CRP based on central laboratory cut-off <5mg/L (normal) or ≥5mg/L (elevated) and a cut-off <10mg/L or ≥10mg/L. Results At baseline, 36.5% (143/392) patients had normal and 63.5% (249/392) had elevated CRP. At week 16, ASAS20/40 response rates were higher for secukinumab versus placebo in normal (56.9%/34.7% vs 28.2%/7.0%; p<0.01/p<0.001) and in elevated (63.2%/42.4% vs 29.0%/15.3%; both p<0.0001) CRP groups. Improvement was reported for all outcomes (p<0.05) in both groups, except for ASAS partial remission in the normal CRP group, where a numerical difference 12.5% vs 2.8%, p=0.07) was observed. Similar trends of improvement were observed in the <10and ≥10mg/L groups across all efficacy outcomes at week 16. Treatment responses to secukinumab in all CRP groups further improved over 156 weeks. Conclusion Secukinumab 150mg demonstrated rapid and sustained efficacy in patients with AS irrespective of baseline CRP, with greater magnitude of response in patients with more elevated CRP.

KW - ankylosing spondylitis

KW - cytokine

KW - DMARDs (biologic)

KW - inflammation

KW - spondyloarthritis

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