Evidence map›Paper›PMID 31493163›Full record

Trial reportAmerican journal of clinical dermatology2019

Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study.

Mark G Lebwohl, Andrew Blauvelt, Alan Menter, Kim A Papp, Scott Guenthner, Radhakrishnan Pillai, Robert J Israel, Abby Jacobson

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of clinical 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 NCT01101100 (A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 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.

NCT01101100 phase2terminatednot on this map

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2010 to 2015Enrolled181ConditionsPsoriasisArmsAMG 827
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Biologic and Small-Molecule Therapies for Moderate-to-Severe Psoriasis: Focus on Psoriasis Comorbidities.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
  14. Article
  15. Immunosuppression in Rheumatologic and Auto-immune Disease.Handbook of experimental pharmacology · 2022
    Article
  16. Review
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

8 authors.

Mark G LebwohlIcahn School of Medicine at Mount Sinai, 5 East 98th Street, 5th Floor, New York, NY, 10029, USA. Lebwohl@aol.com.
Andrew BlauveltOregon Medical Research Center, 9495 SW Locust Street, Suite G, Portland, OR, 97223, USA.ORCID http://orcid.org/0000-0002-2633-985X
Alan MenterBaylor Scott & White, 3900 Junius Street, Suite 145, Dallas, TX, 75246, USA.ORCID http://orcid.org/0000-0002-9314-0007
Kim A PappProbity Medical Research and K. Papp Clinical Research, 135 Union Street East, Waterloo, ON, N2J 1C4, Canada.ORCID http://orcid.org/0000-0001-9557-3642
Scott GuenthnerThe Dermatology Center of Indiana, 1100 Southfield Drive, Suite 1240, Plainfield, IN, 46168, USA.ORCID http://orcid.org/0000-0002-6660-2245
Radhakrishnan PillaiBausch Health Americas, 1330 Redwood Way #A, Petaluma, CA, 94954, USA.
Robert J IsraelBausch Health US, LLC, 400 Somerset Corporate Boulevard, Bridgewater, NJ, 08807, USA.
Abby JacobsonOrtho Dermatologics, 400 Somerset Corporate Boulevard, Bridgewater, NJ, 08807, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic inflammatory diseases such as psoriasis require treatment options that maintain efficacy and tolerability during extended treatment.

objectiveThe aim of the study was to assess the long-term efficacy and safety of brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, in patients with moderate-to-severe plaque psoriasis.

methodsPatients who completed a 12-week, phase II, dose-ranging clinical trial received brodalumab 210 mg every 2 weeks in an open-label extension study. Efficacy was assessed by static physician's global assessment (sPGA) and psoriasis area and severity index (PASI). Quality of life, assessed by dermatology life quality index (DLQI), and safety were also evaluated.

resultsOverall, 181 patients received brodalumab for a median of 264 weeks. Brodalumab treatment resulted in rapid improvements in sPGA, PASI, and DLQI that were maintained through week 264. Achieving PASI 90 to < 100 or PASI 100 at weeks 12, 240, and 264 was associated with greater likelihood for DLQI 0 or 1 compared with achieving PASI 75 to < 90. Over 5 years, one adverse event of suicidal ideation was reported, no suicides occurred, and no new safety signals emerged.

conclusionsBrodalumab demonstrated skin clearance and improved quality of life, with an acceptable safety profile, throughout 5 years of treatment. CLINICALTRIALS. GOV IDENTIFIER: NCT01101100.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeAdolescentAdultAgedAntibodies, Monoclonal, HumanizedDermatologic AgentsFemaleHumansInterleukin-17Long-Term CareMaleMiddle AgedPsoriasisSeverity of Illness IndexSkinAntibodies, Monoclonal, HumanizedbrodalumabDermatologic AgentsIL17A protein, humanInterleukin-17

Identifiers

PMID31493163
PMCPMC6872506

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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.