Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1)

Atulya (Atul) Deodhar, Maxime Dougados, Dominique L. Baeten, James Cheng-Chung Wei, Piet Geusens, Aimee Readie, Hanno B. Richards, Ruvie Martin, Brian Porter

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Abstract

Objective: To evaluate the effect of secukinumab (interleukin-17A inhibitor) on patient-reported outcomes in patients with active ankylosing spondylitis (AS). Methods: In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV→150 mg group), or SC secukinumab 75 mg every 4 weeks (IV→75 mg group), or placebo. Patient-reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50% improvement (BASDAI 50), Short Form 36 (SF-36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5-domain (EQ-5D) questionnaire, Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), and Work Productivity and Activity Impairment–General Health questionnaire (WPAI-GH). Results: At week 16, secukinumab IV→150 mg or IV→75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (−2.3 for both regimens versus −0.6; P < 0.0001 and P < 0.001, respectively), SF-36 PCS (5.6 for both regimens versus 1.0; P < 0.0001 and P < 0.001, respectively), and ASQoL (−3.6 for both regimens versus −1.0; P < 0.0001 and P < 0.001, respectively). Clinically significant improvements in the SF-36 MCS, BASFI, EQ-5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT-F and WPAI-GH. All improvements were sustained through week 52. Conclusion: Our findings indicate that secukinumab provides significant and sustained improvements in patient-reported disease activity and health-related quality of life, and reduces functional impairment, fatigue, and impact of disease on work productivity in patients with active AS.

Original languageEnglish (US)
Pages (from-to)2901-2910
Number of pages10
JournalArthritis and Rheumatology
Volume68
Issue number12
DOIs
StatePublished - Dec 1 2016

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Ankylosing Spondylitis
Baths
Placebos
Quality of Life
Chronic Disease
secukinumab
Patient Reported Outcome Measures
Interleukin-17
Health
Fatigue
Surveys and Questionnaires

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis : A Phase III Randomized Trial (MEASURE 1). / Deodhar, Atulya (Atul); Dougados, Maxime; Baeten, Dominique L.; Cheng-Chung Wei, James; Geusens, Piet; Readie, Aimee; Richards, Hanno B.; Martin, Ruvie; Porter, Brian.

In: Arthritis and Rheumatology, Vol. 68, No. 12, 01.12.2016, p. 2901-2910.

Research output: Contribution to journalArticle

Deodhar, AA, Dougados, M, Baeten, DL, Cheng-Chung Wei, J, Geusens, P, Readie, A, Richards, HB, Martin, R & Porter, B 2016, 'Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1)', Arthritis and Rheumatology, vol. 68, no. 12, pp. 2901-2910. https://doi.org/10.1002/art.39805
Deodhar, Atulya (Atul) ; Dougados, Maxime ; Baeten, Dominique L. ; Cheng-Chung Wei, James ; Geusens, Piet ; Readie, Aimee ; Richards, Hanno B. ; Martin, Ruvie ; Porter, Brian. / Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis : A Phase III Randomized Trial (MEASURE 1). In: Arthritis and Rheumatology. 2016 ; Vol. 68, No. 12. pp. 2901-2910.
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abstract = "Objective: To evaluate the effect of secukinumab (interleukin-17A inhibitor) on patient-reported outcomes in patients with active ankylosing spondylitis (AS). Methods: In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV→150 mg group), or SC secukinumab 75 mg every 4 weeks (IV→75 mg group), or placebo. Patient-reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50{\%} improvement (BASDAI 50), Short Form 36 (SF-36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5-domain (EQ-5D) questionnaire, Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), and Work Productivity and Activity Impairment–General Health questionnaire (WPAI-GH). Results: At week 16, secukinumab IV→150 mg or IV→75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (−2.3 for both regimens versus −0.6; P < 0.0001 and P < 0.001, respectively), SF-36 PCS (5.6 for both regimens versus 1.0; P < 0.0001 and P < 0.001, respectively), and ASQoL (−3.6 for both regimens versus −1.0; P < 0.0001 and P < 0.001, respectively). Clinically significant improvements in the SF-36 MCS, BASFI, EQ-5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT-F and WPAI-GH. All improvements were sustained through week 52. Conclusion: Our findings indicate that secukinumab provides significant and sustained improvements in patient-reported disease activity and health-related quality of life, and reduces functional impairment, fatigue, and impact of disease on work productivity in patients with active AS.",
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T2 - A Phase III Randomized Trial (MEASURE 1)

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AU - Dougados, Maxime

AU - Baeten, Dominique L.

AU - Cheng-Chung Wei, James

AU - Geusens, Piet

AU - Readie, Aimee

AU - Richards, Hanno B.

AU - Martin, Ruvie

AU - Porter, Brian

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N2 - Objective: To evaluate the effect of secukinumab (interleukin-17A inhibitor) on patient-reported outcomes in patients with active ankylosing spondylitis (AS). Methods: In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV→150 mg group), or SC secukinumab 75 mg every 4 weeks (IV→75 mg group), or placebo. Patient-reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50% improvement (BASDAI 50), Short Form 36 (SF-36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5-domain (EQ-5D) questionnaire, Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), and Work Productivity and Activity Impairment–General Health questionnaire (WPAI-GH). Results: At week 16, secukinumab IV→150 mg or IV→75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (−2.3 for both regimens versus −0.6; P < 0.0001 and P < 0.001, respectively), SF-36 PCS (5.6 for both regimens versus 1.0; P < 0.0001 and P < 0.001, respectively), and ASQoL (−3.6 for both regimens versus −1.0; P < 0.0001 and P < 0.001, respectively). Clinically significant improvements in the SF-36 MCS, BASFI, EQ-5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT-F and WPAI-GH. All improvements were sustained through week 52. Conclusion: Our findings indicate that secukinumab provides significant and sustained improvements in patient-reported disease activity and health-related quality of life, and reduces functional impairment, fatigue, and impact of disease on work productivity in patients with active AS.

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