Evidence map›Paper›PMID 29767728›Full record

Trial reportJournal of Crohn's & colitis2018

Andecaliximab [Anti-matrix Metalloproteinase-9] Induction Therapy for Ulcerative Colitis: A Randomised, Double-Blind, Placebo-Controlled, Phase 2/3 Study in Patients With Moderate to Severe Disease.

William J Sandborn, Bal R Bhandari, Charles Randall, Ziad H Younes, Tomasz Romanczyk, Yan Xin, Emily Wendt, Hao Chai, Matt McKevitt, Sally Zhao and 3 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Challenges and opportunities in inflammatory bowel disease: from current therapeutic strategies to organoid-based models.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2024
    Review
  9. Matrix metalloproteinases in intestinal fibrosis.Journal of Crohn's & colitis · 2024
    Review
  10. Observational
  11. Neutrophils: from IBD to the gut microbiota.Nature reviews. Gastroenterology & hepatology · 2024
    Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Selected Cytokines and Metalloproteinases in Inflammatory Bowel Disease.International journal of molecular sciences · 2023
    Review
  17. Review
  18. Review
  19. Article
  20. Article
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.

William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Bal R BhandariDelta Research Partners, Monroe, LA, USA.
Charles RandallGastroenterology Research America and University of Texas, San Antonio, TX, USA.
Ziad H YounesGastro One, Germantown, TN, USA.
Tomasz RomanczykH-T Centrum Medyczne, Tychy, Poland.
Yan XinGilead Sciences, Inc., Foster City, CA, USA.
Emily WendtGilead Sciences, Inc., Foster City, CA, USA.
Hao ChaiGilead Sciences, Inc., Foster City, CA, USA.
Matt McKevittGilead Sciences, Inc., Foster City, CA, USA.
Sally ZhaoGilead Sciences, Inc., Foster City, CA, USA.
John S SundyGilead Sciences, Inc., Foster City, CA, USA.
Satish KeshavTranslational Gastroenterology Unit, University of Oxford, Oxford, UK.
Silvio DaneseInflammatory Bowel Diseases Center, Humanitas Research Hospital, Rozzano, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsMatrix metalloproteinase-9 [MMP9] is implicated in the pathogenesis of ulcerative colitis [UC] via disruption of intestinal barrier integrity and function. A phase 2/3 combined trial was designed to examine the efficacy, safety, and pharmacokinetics of the anti-MMP9 antibody, andecaliximab [formerly GS-5745], in patients with moderately to severely active UC.

methodsPatients were randomised [1:1:1] to receive placebo, 150 mg andecaliximab every 2 weeks [Q2W], or 150 mg andecaliximab weekly [QW], via subcutaneous administration. The primary endpoint was endoscopy/bleeding/stool [EBS]-defined clinical remission [endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and at least a 1-point decrease from baseline in stool frequency to achieve a subscore of 0 or 1] at Week 8. The phase 2/3 trial met prespecified futility criteria and was terminated before completion. This study describes results from the 8-week induction phase.

resultsNeither 150 mg andecaliximab Q2W or QW resulted in a significant increase vs placebo in the proportion of patients achieving EBS clinical remission at Week 8. Remission rates [95% confidence intervals] were 7.3% [2.0%-17.6%], 7.4% [2.1%-17.9%], and 1.8% [0.0%-9.6%] in the placebo, andecaliximab Q2W, and andecaliximab QW groups, respectively. Similarly, Mayo Clinic Score response, endoscopic response, and mucosal [histological] healing did not differ among groups. Rates of adverse events were comparable among andecaliximab and placebo.

conclusionsEight weeks of induction treatment with 150 mg andecaliximab in patients with UC did not induce clinical remission or response. Andecaliximab was well tolerated and pharmacokinetic properties were consistent with those previously reported.

Indexed as

AdultAntibodies, Monoclonal, HumanizedColitis, UlcerativeDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMatrix Metalloproteinase 9Matrix Metalloproteinase InhibitorsMiddle AgedRemission InductionTreatment OutcomeandecaliximabAntibodies, Monoclonal, HumanizedMatrix Metalloproteinase 9Matrix Metalloproteinase Inhibitorsinflammationmatrix metalloproteinase-9Ulcerative colitis

Identifiers

PMID29767728
PMCPMC6113706

What OpenQuestion holds

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Registered trials

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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.