Evidence map›Paper›PMID 27405509›Full record

Observational studyAnnals of the rheumatic diseases2017

Risk for lower intestinal perforations in patients with rheumatoid arthritis treated with tocilizumab in comparison to treatment with other biologic or conventional synthetic DMARDs.

A Strangfeld, A Richter, B Siegmund, P Herzer, K Rockwitz, W Demary, M Aringer, Y Meißner, A Zink, J Listing

Open access · hybridAbstract readComparative StudyObservational Study
In one paragraph

Observational study in Annals of the rheumatic diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 82 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
82citing papers in PubMed, 3 pooled it
16.6field-weighted citation impact, top 1% 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

82 citing papers in PubMed, 3 syntheses or guidelines pooled it, 187 citations in OpenAlex.

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22 more citing papers are in PubMed but not listed here.

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

10 authors at 2 institutions in 1 country.

A StrangfeldDepartment of Epidemiology, German Rheumatism Research Centre, Berlin, Germany.
A RichterDepartment of Epidemiology, German Rheumatism Research Centre, Berlin, Germany.
B SiegmundCentrum Innere Medizin mit Gastroenterologie und Nephrologie CC 13, Charité University Medicine Berlin, Berlin, Germany.
P HerzerScientific Advisory Board, Munich, Germany.
K RockwitzGoslar, Germany.
W DemaryHildesheim, Germany.
M AringerDepartment of Internal Medicine III, Division of Rheumatology, University Medicine Dresden, Dresden, Germany.
Y MeißnerDepartment of Epidemiology, German Rheumatism Research Centre, Berlin, Germany.
A ZinkDepartment of Epidemiology, German Rheumatism Research Centre, Berlin, Germany.
J ListingDepartment of Epidemiology, German Rheumatism Research Centre, Berlin, Germany.
Charité - Universitätsmedizin Berlin · DEGerman Rheumatism Research Centre · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the risk of developing lower intestinal perforations (LIPs) in patients with rheumatoid arthritis (RA) treated with tocilizumab (TCZ).

methodsIn 13 310 patients with RA observed in the German biologics register

results37 LIPs (32 in the colon/sigma) were observed in 53 972 patient years (PYs). Only two patients had a history of diverticulitis (one in TCZ). Age, current/cumulative glucocorticoids and non-steroidal anti-inflammatory drugs were significantly associated with the risk of LIP. The crude incidence rate of LIP was significantly increased in TCZ (2.7/1000 PYs) as compared with all other treatments (0.2-0.6/1000 PYs). The adjusted HR (ref: conventional synthetic (cs) disease-modifying anti-rheumatic drugs (DMARDs)) in TCZ was 4.48 (95% CI 2.0 to 10.0), in tumour necrosis factor-α inhibitor (TNFi) 1.04 (0.5 to 2.3) and in other biologic DMARDs 0.33 (0.1 to 1.4). 4/11 patients treated with TCZ presented without typical symptoms of LIP (acute abdomen, severe pain). Only one patient had highly elevated C reactive protein (CRP). One quarter of patients died within 30 days after LIP (9/37), 5/11 under TCZ, 2/13 under TNFi and 2/11 under csDMARD treatment.

conclusionsThe incidence rates of LIP under TCZ found in this real world study are in line with those seen in randomised controlled trials of TCZ and higher than in all other DMARD treatments. To ensure safe use of TCZ in daily practice, physicians and patients should be aware that, under TCZ, LIP may occur with mild symptoms only and without CRP elevation.

Indexed as

AbataceptAbdomen, AcuteAdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidBiological ProductsC-Reactive ProteinGermanyHumansIncidenceIntestinal PerforationMiddle AgedProspective StudiesRegistriesAbataceptAntibodies, Monoclonal, HumanizedAntirheumatic AgentsBiological ProductsC-Reactive ProteinRituximabtocilizumabTumor Necrosis Factor-alphaCorticosteroidsDMARDs (biologic)NSAIDsOutcomes research

Identifiers

PMID27405509
PMCPMC5445993
OpenAlexW2471841098

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.