Evidence map›Paper›PMID 31748904›Full record

ArticleAdvances in therapy2020

Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis.

Gerd R Burmester, Kenneth B Gordon, James T Rosenbaum, Dilek Arikan, Winnie L Lau, Peigang Li, Freddy Faccin, Remo Panaccione

Open access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
7.2field-weighted citation impact, top 3% 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

45 citing papers in PubMed, 1 synthesis or guideline pooled it, 90 citations in OpenAlex.

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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

8 authors at 5 institutions in 3 countries.

Gerd R BurmesterCharité Universitätsmedizin Berlin, Berlin, Germany. gerd.burmester@charite.de.ORCID 0000-0001-7518-1131
Kenneth B GordonMedical College of Wisconsin, Milwaukee, WI, USA.
James T RosenbaumOregon Health and Science University and Legacy Devers Eye Institute, Portland, OR, USA.
Dilek ArikanAbbVie, North Chicago, IL, USA.
Winnie L LauAbbVie, North Chicago, IL, USA.
Peigang LiAbbVie, North Chicago, IL, USA.
Freddy FaccinAbbVie, North Chicago, IL, USA.
Remo PanaccioneUniversity of Calgary, Calgary, AB, Canada.
AbbVie (United States) · USCharité - Universitätsmedizin Berlin · DELegacy Health · USMedical College of Wisconsin · USUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe safety profile of adalimumab was previously reported in 23,458 patients across multiple indications. Here we report the long-term safety of adalimumab in adults with plaque psoriasis (Ps), hidradenitis suppurativa (HS), rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, non-radiographic axial spondyloarthritis, peripheral spondyloarthritis, Crohn's disease (CD), ulcerative colitis (UC), and non-infectious uveitis (UV).

methodsSafety data from 77 clinical trials were pooled. Safety assessments included adverse events (AEs) and serious AEs (SAEs) that occurred after the first study dose and within 70 days (5 half-lives) after the last study dose.

resultsA total of 29,967 patients were included, representing 56,916 patient-years (PY) of exposure. The most frequently reported SAE of interest was infection (3.7/100 PY) with highest incidences in CD, RA, UV, and UC (3.5/100 PY-6.9/100 PY); serious infections in Ps (1.8/100 PY) and HS (2.8/100 PY) were lower. The observed number of deaths was below what would be expected in an age- and sex-adjusted population for most adalimumab-treated patients (including Ps). Lack of real-life data and limited long-term data (> 5 years) for most patients are limitations of this analysis.

conclusionThe safety profile of adalimumab was consistent with previous findings and no new safety signals were observed.

Indexed as

AdalimumabAdultAgedAged, 80 and overAnti-Inflammatory AgentsArthritis, PsoriaticArthritis, RheumatoidColitis, UlcerativeCrohn DiseaseFemaleHidradenitis SuppurativaHumansMaleMiddle AgedUveitisAdalimumabAnti-Inflammatory AgentsAdalimumabAnkylosing spondylitisCrohn’s diseaseHidradenitis suppurativaLong-term safetyPlaque psoriasisPsoriatic arthritisRheumatoid arthritisUlcerative colitisUveitis

Identifiers

PMID31748904
PMCPMC6979455
OpenAlexW2990283038

What OpenQuestion holds

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LicenceCC BY-NC
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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.