Evidence map›Paper›PMID 29380251›Full record

Trial reportAmerican journal of clinical dermatology2018

Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis.

Caitriona Ryan, Jeffrey M Sobell, Craig L Leonardi, Charles W Lynde, Mahinda Karunaratne, Wendell C Valdecantos, Barbara A Hendrickson

12 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in American journal of clinical dermatology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 12 registered trials, which are not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.7field-weighted citation impact, top 7% 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.

NCT00055497 phase3completednot on this map

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease

TypeinterventionalSponsorAbbottRan2002 to 2008Enrolled276ConditionsCrohn's DiseaseArmsDouble-blind (DB) adalimumab placebo, DB adalimumab 40 mg eow, DB adalimumab 40 mg ew, OL adalimumab 40 mg
NCT00077779 phase3completednot on this map

A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

TypeinterventionalSponsorAbbottRan2003Enrolled854ConditionsCrohn's DiseaseArmsAdalimumab
NCT00195715 phase3completednot on this map

A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

TypeinterventionalSponsorAbbottRan2004 to 2008Enrolled777ConditionsCrohn's DiseaseArmsAdalimumab
NCT00348283 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

TypeinterventionalSponsorAbbottRan2006Enrolled135ConditionsCrohn's DiseaseArmsadalimumab, placebo
NCT00385736 phase3completednot on this map

A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

TypeinterventionalSponsorAbbottRan2006 to 2010Enrolled576ConditionsUlcerative ColitisArmsadalimumab, placebo
NCT00408629 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

TypeinterventionalSponsorAbbottRan2006 to 2010Enrolled518ConditionsUlcerative ColitisArmsadalimumab, placebo
NCT00573794 phase3completednot on this map

A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2007 to 2016Enrolled592ConditionsUlcerative ColitisArmsadalimumab
NCT00645814 phase2completednot on this map

Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorAbbottRan2003Enrolled148ConditionsPsoriasisArmsplacebo for adalimumab, adalimumab
NCT00918255 phase2completednot on this map

A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

TypeinterventionalSponsorAbbottRan2009 to 2010Enrolled154ConditionsHidradenitis SuppurativaArmsadalimumab, Placebo
NCT01070303 phase3completednot on this map

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension

TypeinterventionalSponsorAbbottRan2002 to 2008Enrolled177ConditionsCrohn's DiseaseArmsAdalimumab 40 mg eow or ew
NCT01468207 phase3completednot on this map

A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER I

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2011 to 2014Enrolled307ConditionsHidradenitis Suppurativa (HS)Armsadalimumab, placebo
NCT01468233 phase3completednot on this map

A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER II

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2011 to 2014Enrolled326ConditionsHidradenitis Suppurativa (HS)Armsadalimumab, placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 32 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Hidradenitis Suppurativa: New Targets and Emerging Treatments.American journal of clinical dermatology · 2024
    Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. New and Emerging Targeted Therapies for Hidradenitis Suppurativa.International journal of molecular sciences · 2022
    Review
  12. Review
  13. Biosimilars in dermatology: The wind of change.Experimental and therapeutic medicine · 2019
    Review
  14. Article
  15. Review
  16. 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

7 authors at 4 institutions in 2 countries.

Caitriona RyanDepartment of Dermatology, Blackrock Clinic, Co. Dublin, Ireland. caitrionaryan80@gmail.com.
Jeffrey M SobellDepartment of Dermatology, Tufts University School of Medicine, Boston, MA, USA.
Craig L LeonardiDepartment of Dermatology, St. Louis University, St. Louis, MO, USA.
Charles W LyndeDepartment of Medicine, University of Toronto, Toronto, ON, Canada.
Mahinda KarunaratneAbbVie Inc., North Chicago, IL, USA.
Wendell C ValdecantosAbbVie Inc., North Chicago, IL, USA.
Barbara A HendricksonAbbVie Inc., North Chicago, IL, USA.
AbbVie (United States) · USSaint Louis University · USTufts University · USUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdalimumab is approved for the treatment of hidradenitis suppurativa (HS), plaque psoriasis, and other inflammatory conditions.

objectiveOur objective was to examine the safety of adalimumab administered every other week (EOW) and every week (EW) in patients with HS and psoriasis and to investigate informative data from non-dermatologic indications.

methodsThe safety of adalimumab 40-mg EOW versus EW dosing was examined during placebo-controlled and open-label study periods in patients with HS (three studies), psoriasis (two studies), Crohn's disease (six studies), ulcerative colitis (three studies), and rheumatoid arthritis (one study).

resultsNo new safety risks or increased rates of particular adverse events (AEs) were identified with EW dosing. In patients with HS or psoriasis, the overall safety of adalimumab 40-mg EOW and EW was generally comparable. In studies of adalimumab for non-dermatologic indications, including Crohn's disease, ulcerative colitis, and rheumatoid arthritis, the overall AE rates were similar for EW and EOW dosing.

conclusionIn patients with HS or psoriasis, the safety of adalimumab EW and EOW was comparable and consistent with the expected adalimumab AE profile. The safety of adalimumab EW dosing in patients with dermatologic conditions is supported by data comparing adalimumab EW and EOW dosing for Crohn's disease, ulcerative colitis, and rheumatoid arthritis.

trial registrationClinicalTrials.gov NCT00918255, NCT01468207, NCT01468233, NCT00645814, NCT00077779, NCT00055497, NCT01070303, NCT00195715, NCT00348283, NCT00385736, NCT00408629, and NCT00573794.

Indexed as

AdalimumabAdultAnti-Inflammatory AgentsDouble-Blind MethodDrug Administration ScheduleFemaleHidradenitis SuppurativaHumansInjections, SubcutaneousMalePlacebosPsoriasisTreatment OutcomeTumor Necrosis Factor-alphaYoung AdultAdalimumabAnti-Inflammatory AgentsPlacebosTumor Necrosis Factor-alpha

Identifiers

PMID29380251
PMCPMC5945711
OpenAlexW2785647181

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 6 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.