Evidence map›Paper›PMID 20430303›Full record

ReviewSeminars in cutaneous medicine and surgery2010

Assessing long-term drug safety: lessons (re) learned from raptiva.

Nicole M Seminara, Joel M Gelfand

Open access · bronzeAbstract readReview
In one paragraph

Review in Seminars in cutaneous medicine and surgery, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
1.4field-weighted citation impact, top 19% 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.

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

18 citing papers in PubMed, 47 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Integrins in T Cell Physiology.International journal of molecular sciences · 2018
    Review
  13. Old and New Biological Therapies for Psoriasis.International journal of molecular sciences · 2017
    Review
  14. Review
  15. Review
  16. Article
  17. A cutting edge overview: psoriatic disease.Clinical reviews in allergy & immunology · 2013
    Review
  18. 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

2 authors at 1 institution in 1 country.

Nicole M SeminaraDepartment of Dermatology, University of Pennsylvania, Philadelphia, PA, USA.
Joel M Gelfand
University of Pennsylvania · US

Funding

The Risk of Myocardial Infarction in Patients with PsoriasisR01HL089744 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI GELFAND, JOEL M · 2009 to 2013
$3.8M
Comparative Effectiveness of Biologics for PsoriasisRC1AR058204 · NIAMS · UNIVERSITY OF PENNSYLVANIA · PI GELFAND, JOEL M · 2009 to 2010
$1.0M
Investigating the Risk of Lymphoma in Psoriasis PatientsK23AR051125 · NIAMS · UNIVERSITY OF PENNSYLVANIA · PI GELFAND, JOEL M · 2004 to 2008
$662k
NHLBI NIH HHS R01 HL089744NHLBI NIH HHS R01HL089744NIAMS NIH HHS K23 AR051125NIAMS NIH HHS RC1 AR058204
6 · The paper itself

Abstract

Efalizumab was approved for moderate to severe psoriasis in 2003 based on studies in approximately 2700 patients, of whom only 218 were exposed to the drug for more than 1 year. In 2009, after more than 46,000 patients were exposed to efalizumab, the drug was withdrawn from the market after 3 confirmed and 1 suspected case of progressive multifocal leukoencephalopathy (PML) were spontaneously reported. As PML is very rare, it is extremely unlikely that the 4 reported cases were due to chance and given that PML occurs primarily in patients who are immunosuppressed, the association is likely causal. The identification of PML as a serious, but statistically rare risk of efalizumab demonstrates the strengths and weaknesses of the current drug approval and pharmacovigilance processes for fully measuring the safety of a drug. Patients and clinicians need to be aware of the relative completeness and limitations of existing safety data of a drug when selecting a treatment.

Indexed as

Product Surveillance, PostmarketingAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDrug ApprovalDrug-Related Side Effects and Adverse ReactionsHumansPsoriasisAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedefalizumab

Identifiers

PMID20430303
PMCPMC2864916
OpenAlexW2167293386

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.