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.
- DMARDs (biologic)
- ankylosing spondylitis
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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Contributors All named authors meet the International Committee of Medical Journal Editors criteria for authorship for this article, take responsibility for the integrity of the work as a whole, were involved in the drafting and critical review of the manuscript and approved the final version for submission. All authors agree to be accountable for all aspects of the work and attest to the accuracy and integrity of the work.
Funding The clinical study was sponsored by Novartis Pharma AG, Basel, Switzerland and designed by the scientific steering committee and Novartis personnel. Medical writing support was funded by Novartis.
Competing interests XB: Grant/research support from AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen. Consultant for AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen. Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen. JB: Grant/research support from AbbVie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB. Consultant for: AbbVie (Abbott), Amgen, BMS, Boehringer Ingelheim, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB. Speakers bureau: AbbVie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UC. AD: Honoraria for consulting or speaking for, or has received research grants from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GlaxoSmithKline (GSK), Janssen, Novartis, Pfizer and UCB. DP: Grant/research support from AbbVie, MSD, Novartis and Pfizer. Consultant for AbbVie, BMS, Celgene, MSD, Novartis, Pfizer and UCB. Speakers bureau: AbbVie, BMS, Janssen, MSD, Novartis, Pfizer, Roche, UCB. AJK: Consultant for AbbVie, Pfizer, Genentech, UCB and Sanofi/Regeneron and Celgene. Speakers bureau: Celgene, Pfizer and Sanofi/Regeneron and Genentech. HT: Speakers bureau: Novartis, Eli Lilly and AbbVie. FVdB: Research grants, consultancy fees or speaker honoraria: AbbVie, BMS, Celgene, Galapagos, Janssen, Lilly, Merck, Novartis, Pfizer and UCB. EMD: Consultant for Novartis. ZT: Employee of Novartis with Novartis Stocks. AF: Employee of Novartis with Novartis Stocks.
Patient consent for publication Not required.
Ethics approval and consent to participate The clinical study was conducted in compliance with the Declaration of Helsinki, International Council for Harmonization Guidelines for Good Clinical Practice and local country regulations. All patients provided written informed consent to participate in the respective studies.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement The datasets generated and/or analysed during the current study are not publicly available. Novartis is committed to sharing with qualified external researchers’ access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved based on scientific merit. All data provided are anonymised to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The data may be requested from the corresponding author of the manuscript.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.