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Cited by 174

The DOI matches its Crossref record; 23 of the 23 references it cites were found in a registry or an index.

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

Strangfeld, A, Richter, A, Siegmund, B, Herzer, P, Rockwitz, K, Demary, W, Aringer, M, Meißner, Y, Zink, A, Listing, J·2017·Annals of the Rheumatic Diseases
DOI 10.1136/annrheumdis-2016-209773PMC PMC5445993
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Abstract

OBJECTIVE: To investigate the risk of developing lower intestinal perforations (LIPs) in patients with rheumatoid arthritis (RA) treated with tocilizumab (TCZ). METHODS: herapy, 141 serious gastrointestinal events possibly associated with perforations were reported until 31 October 2015. All events were validated independently by two physicians, blinded for treatment exposure. RESULTS: 37 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. CONCLUSIONS: The 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.

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Figures

Figure 1 Flowchart of case selection and validation process.
Figure 1 Flowchart of case selection and validation process.CC BY-NC · PubMed Central
Figure 2 Incidence rates of lower intestinal perforation stratified by DMARDs. Events/patient years (PYs): csDMARDs=11/18 113; TNFi=13/24 851 (adalimumab=6, etanercept=6, infliximab=1); Abatacept=1/1976; Rituximab=1/4950; Tocilizumab=11/4082. csDMARD, conventional synthetic DMARD; TNFi, tumour necrosis factor-α.
Figure 2 Incidence rates of lower intestinal perforation stratified by DMARDs. Events/patient years (PYs): csDMARDs=11/18 113; TNFi=13/24 851 (adalimumab=6, etanercept=6, infliximab=1); Abatacept=1/1976; Rituximab=1/4950; Tocilizumab=11/4082. csDMARD, conventional synthetic DMARD; TNFi, tumour necrosis factor-α.CC BY-NC · PubMed Central

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Citations

Cites

Research works printed but not linked: 1

  1. van Vollenhoven, 2009, Gastrointestinal safety in patients with rheumatoid arthritis treated with tocilizumab: data from Roche clinical trials, Arthritis Rheum, 60, 1613

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Metadata

Authors
Strangfeld, A., Richter, A., Siegmund, B., Herzer, P., Rockwitz, K., Demary, W., Aringer, M., Meißner, Y., Zink, A., & Listing, J.
Venue
Annals of the Rheumatic Diseases
Publisher
Elsevier BV
Published
2017-03
Volume
76
Issue
3
Pages
504-510
ISSN
0003-4967
DOI
10.1136/annrheumdis-2016-209773
PMC
PMC5445993
Cited by
174
References
23
Language
en
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