Evidence map›Paper›PMID 35305260›Full record

ArticleRheumatology and therapy2022

Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications.

Joseph F Merola, Iain B McInnes, Atul A Deodhar, Amit K Dey, Nicholas H Adamstein, Erhard Quebe-Fehling, Maher Aassi, Michael Peine, Nehal N Mehta

19 registry-linked trialsAbstract read
In one paragraph

Article in Rheumatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 19 registered trials, which are not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 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.

NCT01358578 phase3completednot on this map

A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2013Enrolled1,306ConditionsChronic Plaque PsoriasisArmsPlacebo, secukinumab (AIN457), etanercept
NCT01365455 phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2013Enrolled738ConditionsModerate to Severe Plaque-type PsoriasisArmssecukinumab 150 mg, placebo to secukinumab 150 mg
NCT01406938 phase3completednot on this map

A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2013Enrolled967ConditionsModerate to Severe Plaque-type PsoriasisArmsAIN457 150mg, AIN457 300mg
NCT01555125 phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2016Enrolled177ConditionsModerate to Severe Plaque-type PsoriasisArmssecukinumab 150 mg, secukinumab 300 mg, placebo
NCT01636687 phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2016Enrolled182ConditionsPlaque-type PsoriasisArmsPlacebo, Secukinumab 150mg, Secukinumab 300mg
NCT01649375 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2018Enrolled219ConditionsAnklyosing SpondylitisArmsSecukinumab (75 mg), Placebo, Secukinumab (150 mg)
NCT01752634 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2019Enrolled397ConditionsPsoriatic ArthritisArmsSecukinumab (AIN457), Placebo
NCT01863732 phase3completednot on this map

An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2018Enrolled274ConditionsSpondylitis, AnkylosingArmsSecukinumab, Placebo (Pbo)
NCT01989468 phase3completednot on this map

A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2018Enrolled414ConditionsPsoriatic ArthritisArmsSecukinumab, Placebo
NCT02008916 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2017Enrolled226ConditionsSpondylitis, AnkylosingArmsSecukinumab, Placebo secukinumab
NCT02074982 phase3completednot on this map

A 52-week, Multicenter, Randomized, Double-blind Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Psoriasis Area and Severity Index at 16 Weeks of Treatment Compared to Ustekinumab and to Assess Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2016Enrolled676ConditionsChronic Plaque Type PsoriasisArmsAIN457 300 mg, ustekinumab 45/90 mg, placebo secukinumab
NCT02159053 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing Spondylitis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2018Enrolled350ConditionsSpondylitis, AnkylosingArmsSecukinumab, Placebo
NCT02294227 phase3completednot on this map

A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2017Enrolled341ConditionsArthritis, PsoriaticArmsSecukinumab, Placebo
NCT02404350 phase3completednot on this map

A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2019Enrolled997ConditionsPsoriatic ArthritisArmsSecukinumab
NCT02696031 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2021Enrolled555ConditionsNon-radiographic SpondyloarthritisArmsSecukinumab, Placebo
NCT02745080 phase3completednot on this map

A Randomized, Double-blind, Active Control, Multicenter Study to Evaluate the Efficacy at Week 52 of Secukinumab Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Psoriatic Arthritis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2017 to 2019Enrolled853ConditionsPsoriatic ArthritisArmsSecukinumab, Adalimumab
NCT02752776 phase4completednot on this map

An Open-label, Prospective, Non-randomized, Multicenter Study to Evaluate Clear Skin Effect on Health Related Quality of Life Outcomes at 16 and 52 Weeks in Patients With Moderate to Severe Plaque Psoriasis Treated With Secukinumab 300 mg s.c. With or Without Previous Exposure to Systemic Therapy.

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2018Enrolled1,660ConditionsPlaque PsoriasisArmsSecukinumab
NCT02826603 phase3completednot on this map

A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2016 to 2018Enrolled1,114ConditionsPlaque PsoriasisArmsSecukinumab, Ustekinumab
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

27 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. [Influence of long-term biologic therapy on metabolic biochemical parameters in moderate to severe plaque psoriasis].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2025
    Article
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  12. Review
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  14. Observational
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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

9 authors.

Joseph F MerolaBrigham and Women's Hospital, Harvard Medical School, Boston, USA.
Iain B McInnesUniversity of Glasgow, Glasgow, UK.
Atul A DeodharOregon Health and Science University, Portland, USA.
Amit K DeySection of Inflammation and Cardiometabolic Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, 20892, USA.
Nicholas H AdamsteinBrigham and Women's Hospital, Boston, MA, USA.
Erhard Quebe-FehlingNovartis Pharma AG, Basel, Switzerland.
Maher AassiNovartis Pharma AG, Basel, Switzerland.
Michael PeineNovartis Pharma AG, Basel, Switzerland.
Nehal N MehtaSection of Inflammation and Cardiometabolic Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, 20892, USA. nehal.mehta@nih.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPsoriasis, psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) are chronic immune-mediated inflammatory diseases (IMIDs) associated with cardiovascular (CV) disease. High-sensitivity C-reactive protein (hsCRP) and, more recently, the neutrophil-lymphocyte ratio (NLR) are important inflammatory biomarkers predictive of CV disease and CV disease-associated mortality. Here, we report the effect of interleukin (IL)-17A inhibition with secukinumab on CV risk parameters in patients with psoriasis, PsA, and axSpA over 1 year of treatment.

methodsThis was a post hoc analysis of pooled data from phase 3/4 secukinumab studies in psoriasis, PsA, and axSpA. CV-related exclusion criteria included uncontrolled hypertension and congestive heart failure. Traditional risk factors assessed were body mass index (BMI) > 25, high fasting glucose and blood pressure (systolic and diastolic), and high cholesterol (low-density lipoproteins [LDL], total cholesterol/HDL ratio, and triglycerides). Inflammatory CV risk parameters assessed were hsCRP and NLR. Statistical analysis was descriptive. Subgroup analyses were performed in high-risk patients defined as having baseline hsCRP > 4 mg/L (patients with psoriasis) and > 10 mg/L (patients with PsA/axSpA).

resultsIn total, 9197 patients from 19 clinical trials (8 in psoriasis, n = 4742; 5 in PsA, n = 2475; 6 in axSpA, n = 1980) were included. All traditional CV risk parameters remained stable in secukinumab-treated patients through 1 year. Secukinumab rapidly reduced both hsCRP and the NLR compared with placebo at week 12 (psoriasis) or week 16 (PsA/axSpA) in the overall population and in high-risk patients (all P < 0.01). This reduction was maintained for at least 1 year of secukinumab therapy in all indications.

conclusionsSecukinumab led to a rapid and sustained reduction in hsCRP and the NLR in patients with IMIDs with a high systemic inflammatory burden. Traditional CV risk factors remained stable for at least 1 year in patients with psoriasis, PsA, and axSpA. Taken together, secukinumab had a favorable effect on systemic inflammation without impact on traditional CV risk factors. TRIALS REGISTRATION: ClinicalTrials.gov, NCT01365455, NCT01358578, NCT01406938, NCT01555125, NCT01636687, NCT02752776, NCT02074982, NCT02826603, NCT01752634, NCT01989468, NCT02294227, NCT02404350, NCT02745080, NCT01863732, NCT01649375, NCT02008916, NCT02159053, NCT02896127, NCT02696031.

Indexed as

Axial spondyloarthritisCardiovascularC-reactive proteinNeutrophil–lymphocyte ratioPsoriasisPsoriatic arthritisSecukinumabSystemic inflammation

Identifiers

PMID35305260
PMCPMC9127026

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 13 more above

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.