Evidence map›Paper›PMID 32925287›Full record

Trial reportChinese medical journal2020

Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5.

Feng Huang, Fei Sun, Wei-Guo Wan, Li-Jun Wu, Ling-Li Dong, Xiao Zhang, Tae-Hwan Kim, Raj Sengupta, Ladislav Šenolt, Yi Wang and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Chinese medical journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02896127 (Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis), which is not on this map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02896127 phase3completednot on this map

Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2019Enrolled458ConditionsAnkylosing SpondyloarthritisArmsSecukinumab, Placebo
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Feng HuangDepartment of Rheumatology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.
Fei SunDepartment of Rheumatology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.
Wei-Guo WanDepartment of Rheumatology, Huashan Hospital, Fudan University, Shanghai 200040, China.
Li-Jun WuDepartment of Rheumatology & Immunology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang 830001, China.
Ling-Li DongDepartment of Rheumatology & Immunology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei 430030, China.
Xiao ZhangDepartment of Rheumatology & Immunology, Guangdong General Hospital, Guangzhou, Guangdong 510000, China.
Tae-Hwan KimHanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.
Raj SenguptaRoyal National Hospital for Rheumatic Disease, Upper Borough Walls, Bath BA1 1RL, UK.
Ladislav ŠenoltInstitute of Rheumatology, Prague, Czech Republic.
Yi WangNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Hao-Min QiuChina Novartis Institutes for Biomedical Research, Shanghai 201203, China.
Brian PorterNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Sibylle HaemmerleNovartis Pharma AG, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSecukinumab demonstrated sustained efficacy in patients with ankylosing spondylitis (AS) through 5 years in pivotal Phase III studies. Here, we present efficacy and safety results (52-week) of secukinumab in patients with AS from the MEASURE 5 study.

methodsMEASURE 5 was a 52-week, Phase III, China-centric study. Eligible patients were randomly assigned (2:1) to receive subcutaneous secukinumab 150 mg or placebo weekly for the first five doses and then once every 4 weeks (q4w). All placebo patients switched to secukinumab 150 mg q4w starting at Week 16. Primary endpoint was Assessments of SpondyloArthritis international Society (ASAS) 20 at Week 16. Randomization was stratified by region (China vs. non-China).

resultsOf 458 patients (secukinumab 150 mg, N = 305; placebo, N = 153) randomized, 327 (71.4%) were from China and 131 (28.6%) were not from China. Of these, 97.7% and 97.4% patients completed Week 16 and 91.1% and 95.3% (placebo-secukinumab) patients completed Week 52 of treatment. The primary endpoint was met; secukinumab significantly improved ASAS20 response at Week 16 vs. placebo (58.4% vs. 36.6%; P < 0.0001); corresponding rate in the Chinese population was 56.0% vs. 38.5% (P < 0.01). All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52. No new or unexpected safety signals were reported up to Week 52.

conclusionsSecukinumab 150 mg demonstrated rapid and significant improvement in signs and symptoms of AS. Secukinumab was well tolerated and the safety profile was consistent with previous reports. Efficacy and safety results were comparable between the overall and Chinese populations.

trial registrationClinicalTrials.gov, NCT02896127; https://clinicaltrials.gov/ct2/show/NCT02896127?term=NCT02896127&draw=2&rank=1.

Indexed as

Spondylitis, AnkylosingAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedChinaDouble-Blind MethodHumansTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedsecukinumab

Identifiers

PMID32925287
PMCPMC7722578

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.