Evidence map›Paper›PMID 30207587›Full record

Trial reportThe British journal of dermatology2019

Granulocyte-macrophage colony-stimulating factor (GM-CSF) as a therapeutic target in psoriasis: randomized, controlled investigation using namilumab, a specific human anti-GM-CSF monoclonal antibody.

K A Papp, M Gooderham, R Jenkins, R Vender, J C Szepietowski, T Wagner, B Hunt, B Souberbielle, NEPTUNE investigators

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of dermatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02129777 (A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding and Proof of Concept Study, to Assess the Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Namilumab/MT203 at 4 Different Subcutaneous Doses - Together With an Open-Label, Dose-Escalated Extension to Assess Safety and Efficacy of One Year Treatment - in Subjects With Moderate to Severe Chronic Plaque Psoriasis), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% of its field
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.

NCT02129777 phase2completednot on this map

A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding and Proof of Concept Study, to Assess the Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Namilumab/MT203 at 4 Different Subcutaneous Doses - Together With an Open-Label, Dose-Escalated Extension to Assess Safety and Efficacy of One Year Treatment - in Subjects With Moderate to Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorTakedaRan2014 to 2016Enrolled122ConditionsPlaque PsoriasisArmsNamilumab, Placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Psoriatic Arthritis: From Diagnosis to Treatment.Journal of clinical medicine · 2025
    Review
  6. Review
  7. Anti-GM-CSF autoantibodies in myeloid leukemias.Best practice & research. Clinical haematology · 2025
    Review
  8. GM-CSFTheranostics · 2025
    Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. GM-CSF in inflammation.The Journal of experimental medicine · 2020
    Review
  17. Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 5 countries.

K A PappK Papp Clinical Research and Probity Medical Research, 135 Union St E, Waterloo, ON, N2J1C4, Canada.ORCID 0000-0001-9557-3642
M GooderhamSKiN Centre for Dermatology, Queen's University and Probity Medical Research, Peterborough, ON, Canada.
R JenkinsClinical Science, Takeda International - U.K. Branch, London, U.K.
R VenderDermatrials Research Inc, Hamilton, ON, Canada.
J C SzepietowskiDepartment of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.
T WagnerModelling and Simulation, Takeda Pharmaceuticals International, Zurich, Switzerland.
B HuntStatistics, Takeda International, Deerfield, IL, U.S.A.
B SouberbielleClinical Science, Takeda International - U.K. Branch, London, U.K.
NEPTUNE investigators
Takeda (United Kingdom) · GBDermatrials Research · CAProbity Medical Research · CAQueen's University · CATakeda (Switzerland) · CHTakeda (United States) · USWroclaw Medical University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe relevance of granulocyte-macrophage colony-stimulating factor (GM-CSF) in the management of psoriasis has not been studied previously. GM-CSF is important in the initiation and maintenance of chronic inflammatory processes.

objectivesTo investigate the clinical use of GM-CSF neutralization by evaluating the efficacy and safety of namilumab (AMG203), a monoclonal antibody GM-CSF inhibitor, in patients with moderate-to-severe plaque psoriasis.

methodsA phase II, multicentre, randomized, double-blind, placebo-controlled, parallel-group, dose-finding, proof-of-concept study (NEPTUNE) was conducted. Four doses of namilumab (20, 50, 80 and 150 mg, via subcutaneous injection) were compared with placebo. Assessment of the primary end point - the proportion of patients achieving ≥ 75% reduction in Psoriasis Area and Severity Index (PASI 75 treatment response) - was performed at week 12. Exploratory investigation at the tissue level was conducted in a subset of the overall study population. The trial was registered with the number NCT02129777.

resultsIn total, 122 patients were enrolled and 106 (86·9%) completed the double-blind treatment; 16 (13·1%) prematurely discontinued study medication. Serum concentration-time profiles were as expected for subcutaneous delivery of an IgG1 monoclonal antibody, and exposure increased proportionally with dose elevation. The number of patients showing PASI 75 treatment response at week 12 was low in all groups; no significant difference was recorded in this end point between placebo and any namilumab group. Similar outcomes were recorded for other clinical study end points. Moreover, no significant treatment-related changes from baseline were observed in laboratory investigations of cell types or subpopulations, or cytokines relevant to inflammatory pathways in psoriasis.

conclusionsGM-CSF blockade is not critical for suppression of key inflammatory pathways underlying psoriasis.

Indexed as

AdultAntibodies, Monoclonal, HumanizedDermatologic AgentsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansMalePsoriasisTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic AgentsGranulocyte-Macrophage Colony-Stimulating Factornamilumab

Identifiers

PMID30207587
PMCPMC7379964
OpenAlexW2891836054

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.