Evidence map›Paper›PMID 28815476›Full record

ArticleDermatology and therapy2017

Long-Term Safety and Effectiveness of Adalimumab for Moderate to Severe Psoriasis: Results from 7-Year Interim Analysis of the ESPRIT Registry.

Alan Menter, Diamant Thaçi, Jashin J Wu, William Abramovits, Francisco Kerdel, Dilek Arikan, Dianlin Guo, Arijit Ganguli, Mareike Bereswill, Anne Camez and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Dermatology and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00799877 (A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA®), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing 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.

NCT00799877 completednot on this map

A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS)

TypeobservationalSponsorAbbVieRan2008 to 2023Enrolled6,065ConditionsChronic Plaque Psoriasis
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Challenges and Future Trends in the Treatment of Psoriasis.International journal of molecular sciences · 2023
    Review
  10. Article
  11. TYK2 in Immune Responses and Treatment of Psoriasis.Journal of inflammation research · 2022
    Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis.American journal of clinical dermatology · 2020
    Article
  19. Article
  20. Safety of selective IL-23p19 inhibitors for the treatment of psoriasis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2019
    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

11 authors.

Alan MenterDivision of Dermatology, Baylor University Medical Center, Dallas, TX, USA. amderm@gmail.com.ORCID http://orcid.org/0000-0002-9314-0007
Diamant ThaçiComprehensive Center for Inflammation Medicine, University Medical School Schleswig-Holstein, Campus Lübeck, Germany.
Jashin J WuKaiser Permanente Los Angeles Medical Center, Los Angeles, CA, USA.
William AbramovitsDermatology Treatment and Research Center, Dallas, TX, USA.
Francisco KerdelFlorida Academic Dermatology Centers, Miami, FL, USA.
Dilek ArikanAbbVie Inc, North Chicago, IL, USA.
Dianlin GuoAbbVie Inc, North Chicago, IL, USA.
Arijit GanguliAbbVie Inc, North Chicago, IL, USA.
Mareike BereswillAbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.
Anne CamezAbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.
Wendell C ValdecantosAbbVie Inc, North Chicago, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionESPRIT (NCT00799877) is an ongoing 10-year international prospective observational registry evaluating the long-term safety and effectiveness of originator adalimumab in routine clinical practice for adult patients with chronic plaque psoriasis. Herein, we report the long-term safety, effectiveness, and patient-reported outcomes (PROs) following adalimumab treatment over the first 7 years of the ESPRIT registry.

methodsAll treatment-emergent (All-TE) adverse events (AE) since the initial (first ever) dose of adalimumab were assessed. Physician Global Assessment (PGA) and PROs (PROs for US patients only) were evaluated during registry participation.

resultsAs of 30 November 2015, 6051 patients in the ESPRIT registry were analyzed, representing 23,660.1 patient-years (PY) of overall adalimumab exposure. The incidence rates for All-TE serious AEs, serious infections, and malignancies were 4.4, 1.0, and 1.0 events per 100 PY (E/100PY), respectively. The standardized mortality ratio for TE deaths in the registry was 0.27 (95% CI 0.18-0.38). During the registry's first 7 years, PGA "clear" or "minimal" was achieved by >50% of patients at each annual visit, and among US patients, the mean improvement from baseline in different PROs was maintained.

conclusionNo new safety signals were identified during the first 7 years of the registry, and safety was consistent with the known safety profile of adalimumab. The number of TE deaths was below the expected rate. During the registry's first 7 years, most of the patients remained free of All-TE cardiovascular events, serious infections, and malignancy. As-observed effectiveness of adalimumab and improvements from baseline in PROs were maintained through 7 years of registry participation.

fundingAbbvie.

trial registrationClinicalTrials.gov identifier, NCT00799877.

Indexed as

AdalimumabCardiovascular eventsEffectivenessLong-term safetyMalignancyPatient-reported outcomesPsoriasisRegistrySerious infections

Identifiers

PMID28815476
PMCPMC5574748

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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.