Evidence map›Paper›PMID 39296949›Full record

ReviewJournal of psoriasis and psoriatic arthritis2023

Adverse Events in Patients Receiving Placebo in Phase III Trials of Biologics for Psoriasis: A Systematic Review and Meta-Analysis.

Gayathri Devaraj Ajenthen, Alexander Egeberg, Katrine Elsner Melgaard, Nikolai Loft

Abstract readReview
In one paragraph

Review in Journal of psoriasis and psoriatic arthritis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

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

1 citing paper in PubMed.

  1. 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

4 authors.

Gayathri Devaraj AjenthenDepartment of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
Alexander EgebergDepartment of Dermatology, Bispebjerg Hospital, Denmark.
Katrine Elsner MelgaardDepartment of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
Nikolai LoftDepartment of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.ORCID https://orcid.org/0000-0002-2950-3280

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Patients and practitioners often consider the risk of side effects when starting a treatment for psoriasis and often consult reported adverse events (AE) in studies. However, most of these AEs are unrelated to treatment and patients consider what is the risk of an event should you not start a treatment. This is what would be observed in the placebo-arm of clinical trials. Objective: To investigate the proportion of patients experiencing AEs during treatment with placebo in clinical trials. Methods: We conducted a systematic literature search using PubMed, Embase and Web of Science databases for phase 3 randomized clinical trials that registered adverse events of using placebo vs biological agents for psoriasis. The search term was " Results: Of 7142 screened articles, 54 were included in the metanalysis. The pooled proportion of placebo-treated patients experiencing any AEs was .52 (95% Cl: .51 to .53) after 12 weeks and .53 (95% Cl: .50 to .55) after 16 weeks. The pooled proportion of patients with any serious AEs was .02 (95% Cl: .01 to .02) and .03 (95% Cl: .02 to .03) after 12 and 16 weeks, respectively. The most common AEs in placebo-treated patients were infections, nasopharyngitis, and headache. Conclusion: About half of the patients with moderate-to-severe psoriasis not starting an active treatment would experience disease events that would be categorized as AEs during a 12-16 weeks period.

Indexed as

adverse eventsbiologicplacebopsoriasisPsoriasisside effectstreatment

Identifiers

PMID39296949
PMCPMC11361480

What OpenQuestion holds

Textmetadata
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.