Cargando…

Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2

BACKGROUND: Secukinumab treatment has previously been shown to significantly improve the signs and symptoms of active ankylosing spondylitis (AS), with responses sustained through 2 years. Here, we report the long-term (3 years) efficacy and safety of secukinumab in the MEASURE 2 study. METHODS: MEA...

Descripción completa

Detalles Bibliográficos
Autores principales: Marzo-Ortega, Helena, Sieper, Joachim, Kivitz, Alan, Blanco, Ricardo, Cohen, Martin, Delicha, Evie-Maria, Rohrer, Susanne, Richards, Hanno
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761290/
https://www.ncbi.nlm.nih.gov/pubmed/29435364
http://dx.doi.org/10.1136/rmdopen-2017-000592
_version_ 1783291541614231552
author Marzo-Ortega, Helena
Sieper, Joachim
Kivitz, Alan
Blanco, Ricardo
Cohen, Martin
Delicha, Evie-Maria
Rohrer, Susanne
Richards, Hanno
author_facet Marzo-Ortega, Helena
Sieper, Joachim
Kivitz, Alan
Blanco, Ricardo
Cohen, Martin
Delicha, Evie-Maria
Rohrer, Susanne
Richards, Hanno
author_sort Marzo-Ortega, Helena
collection PubMed
description BACKGROUND: Secukinumab treatment has previously been shown to significantly improve the signs and symptoms of active ankylosing spondylitis (AS), with responses sustained through 2 years. Here, we report the long-term (3 years) efficacy and safety of secukinumab in the MEASURE 2 study. METHODS: MEASURE 2 (NCT01649375) is a 5-year phase III, randomised, double-blind, double-dummy, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of subcutaneous loading and maintenance dosing of secukinumab in adult subjects with active AS. Subjects were randomised to receive subcutaneous secukinumab 150 mg, 75 mg or placebo at baseline, weeks 1, 2 and 3 and every 4 weeks from week 4. At week 16, placebo-treated subjects were rerandomised to receive secukinumab 150/75 mg. RESULTS: Retention rates were high during weeks 16–156 and were 86% and 76% for secukinumab 150 and 75 mg, respectively. Secukinumab 150 mg provided sustained improvements in the Assessment of Spondyloarthritis International Society ASAS 20/40 response rates at week 156 (70.1%/60.9%) compared with week 52 (74.2%/57.0%); however, there was a slight decrease for secukinumab 75 mg (54.3%/37.0% vs 62.5%/43.2%, respectively). Sustained improvements were observed in all other end points, including Bath Ankylosing Spondylitis Disease Activity Index, AS Disease Activity Score with C reactive protein inactive disease, ASAS 5/6, Short Form-36 Physical Component Summary and ASAS partial remission. Clinical benefits were observed regardless of prior exposure to anti-tumour necrosis factor agents. The safety profile remained favourable and was consistent with previous reports. CONCLUSIONS: This study showed sustained improvement through 3 years in signs, symptoms and physical function in subjects with AS. Retention rates were high and secukinumab was well tolerated, with a favourable safety profile.
format Online
Article
Text
id pubmed-5761290
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-57612902018-02-12 Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2 Marzo-Ortega, Helena Sieper, Joachim Kivitz, Alan Blanco, Ricardo Cohen, Martin Delicha, Evie-Maria Rohrer, Susanne Richards, Hanno RMD Open Spondyloarthritis BACKGROUND: Secukinumab treatment has previously been shown to significantly improve the signs and symptoms of active ankylosing spondylitis (AS), with responses sustained through 2 years. Here, we report the long-term (3 years) efficacy and safety of secukinumab in the MEASURE 2 study. METHODS: MEASURE 2 (NCT01649375) is a 5-year phase III, randomised, double-blind, double-dummy, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of subcutaneous loading and maintenance dosing of secukinumab in adult subjects with active AS. Subjects were randomised to receive subcutaneous secukinumab 150 mg, 75 mg or placebo at baseline, weeks 1, 2 and 3 and every 4 weeks from week 4. At week 16, placebo-treated subjects were rerandomised to receive secukinumab 150/75 mg. RESULTS: Retention rates were high during weeks 16–156 and were 86% and 76% for secukinumab 150 and 75 mg, respectively. Secukinumab 150 mg provided sustained improvements in the Assessment of Spondyloarthritis International Society ASAS 20/40 response rates at week 156 (70.1%/60.9%) compared with week 52 (74.2%/57.0%); however, there was a slight decrease for secukinumab 75 mg (54.3%/37.0% vs 62.5%/43.2%, respectively). Sustained improvements were observed in all other end points, including Bath Ankylosing Spondylitis Disease Activity Index, AS Disease Activity Score with C reactive protein inactive disease, ASAS 5/6, Short Form-36 Physical Component Summary and ASAS partial remission. Clinical benefits were observed regardless of prior exposure to anti-tumour necrosis factor agents. The safety profile remained favourable and was consistent with previous reports. CONCLUSIONS: This study showed sustained improvement through 3 years in signs, symptoms and physical function in subjects with AS. Retention rates were high and secukinumab was well tolerated, with a favourable safety profile. BMJ Publishing Group 2017-12-28 /pmc/articles/PMC5761290/ /pubmed/29435364 http://dx.doi.org/10.1136/rmdopen-2017-000592 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Spondyloarthritis
Marzo-Ortega, Helena
Sieper, Joachim
Kivitz, Alan
Blanco, Ricardo
Cohen, Martin
Delicha, Evie-Maria
Rohrer, Susanne
Richards, Hanno
Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2
title Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2
title_full Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2
title_fullStr Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2
title_full_unstemmed Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2
title_short Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2
title_sort secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase iii trial, measure 2
topic Spondyloarthritis
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5761290/
https://www.ncbi.nlm.nih.gov/pubmed/29435364
http://dx.doi.org/10.1136/rmdopen-2017-000592
work_keys_str_mv AT marzoortegahelena secukinumabprovidessustainedimprovementsinthesignsandsymptomsofactiveankylosingspondylitiswithhighretentionrate3yearresultsfromthephaseiiitrialmeasure2
AT sieperjoachim secukinumabprovidessustainedimprovementsinthesignsandsymptomsofactiveankylosingspondylitiswithhighretentionrate3yearresultsfromthephaseiiitrialmeasure2
AT kivitzalan secukinumabprovidessustainedimprovementsinthesignsandsymptomsofactiveankylosingspondylitiswithhighretentionrate3yearresultsfromthephaseiiitrialmeasure2
AT blancoricardo secukinumabprovidessustainedimprovementsinthesignsandsymptomsofactiveankylosingspondylitiswithhighretentionrate3yearresultsfromthephaseiiitrialmeasure2
AT cohenmartin secukinumabprovidessustainedimprovementsinthesignsandsymptomsofactiveankylosingspondylitiswithhighretentionrate3yearresultsfromthephaseiiitrialmeasure2
AT delichaeviemaria secukinumabprovidessustainedimprovementsinthesignsandsymptomsofactiveankylosingspondylitiswithhighretentionrate3yearresultsfromthephaseiiitrialmeasure2
AT rohrersusanne secukinumabprovidessustainedimprovementsinthesignsandsymptomsofactiveankylosingspondylitiswithhighretentionrate3yearresultsfromthephaseiiitrialmeasure2
AT richardshanno secukinumabprovidessustainedimprovementsinthesignsandsymptomsofactiveankylosingspondylitiswithhighretentionrate3yearresultsfromthephaseiiitrialmeasure2