Evidence map›Paper›PMID 32207067›Full record

ArticleAmerican journal of clinical dermatology2020

Malignancy Rates in Brodalumab Clinical Studies for Psoriasis.

Alice Gottlieb, Mark Lebwohl, Clive Liu, Robert J Israel, Abby Jacobson

5 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in American journal of clinical dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 24% 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.

NCT00975637 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2009 to 2010Enrolled198ConditionsPsoriasisArms70 mg SC, 210 mg SC, 140 mg SC, 280 mg SC, Placebo
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
NCT01708590 phase3terminatednot on this map

A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2012 to 2015Enrolled661ConditionsPsoriasisArms210 mg brodalumab, 140 mg brodalumab, placebo
NCT01708603 phase3terminatednot on this map

A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2012 to 2015Enrolled1,831ConditionsModerate to Severe Plaque PsoriasisArms210 mg brodalumab, 140 mg brodalumab, ustekinumab, placebo
NCT01708629 phase3terminatednot on this map

A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2012 to 2015Enrolled1,881ConditionsPlaque PsoriasisArms210 mg brodalumab, 140 mg brodalumab, ustekinumab, placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 18 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Biologic and Small-Molecule Therapies for Moderate-to-Severe Psoriasis: Focus on Psoriasis Comorbidities.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
  6. Review
  7. 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

5 authors at 4 institutions in 1 country.

Alice GottliebIcahn School of Medicine at Mount Sinai, 10 Union Square East, New York, NY, 10003, USA. alice.gottlieb@mountsinai.org.
Mark LebwohlIcahn School of Medicine at Mount Sinai, 10 Union Square East, New York, NY, 10003, USA.
Clive LiuBellevue Dermatology Clinic, Bellevue, WA, USA.
Robert J IsraelBausch Health US, LLC, Bridgewater, NJ, USA.
Abby JacobsonOrtho Dermatologics, Bridgewater, NJ, USA.
Icahn School of Medicine at Mount Sinai · USBausch Health (United States) · USBellevue College · USOrtho Clinical Diagnostics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBrodalumab is a fully human anti-interleukin-17 receptor A monoclonal antibody efficacious for the treatment of adults with moderate-to-severe plaque psoriasis.

objectiveThis study summarizes malignancy rates in psoriasis clinical studies of brodalumab.

methodsData were pooled from one phase II study and three large, multicenter, phase III randomized studies of brodalumab for the treatment of psoriasis, including two studies with randomization to brodalumab, ustekinumab, or placebo. Data from the 52-week (brodalumab and ustekinumab) and long-term (brodalumab) pools were summarized as exposure-adjusted or follow-up time-adjusted event rates per 100 patient-years (PY).

resultsExposure-adjusted event rates per 100 PY at 52 weeks were lower with brodalumab (n = 4019; 3446 total PY of exposure) than with ustekinumab (n = 613; 495 total PY of exposure), including adjudicated malignancies (0.9 vs 2.6) and Surveillance, Epidemiology, and End Results (SEER)-adjudicated malignancies (0.3 vs 0.4). The exposure-adjusted event rate of adjudicated malignancies in the brodalumab group remained stable in the long-term analysis (0.9 [82 events]).

conclusionsRates of malignancy among brodalumab-treated patients with psoriasis were generally low. TRIAL REGISTRY: ClinicalTrials.gov identifier NCT00975637; NCT01101100; NCT01708590 (AMAGINE-1); NCT01708603 (AMAGINE-2); NCT01708629 (AMAGINE-3).

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDermatologic AgentsFemaleFollow-Up StudiesHumansMaleMiddle AgedMulticenter Studies as TopicNeoplasmsPlacebosAntibodies, Monoclonal, HumanizedbrodalumabDermatologic AgentsIL17RA protein, humanPlacebosReceptors, Interleukin-17Ustekinumab

Identifiers

PMID32207067
PMCPMC7275023
OpenAlexW3012736954

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.