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
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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“the rates of gastrointestinal perforation and lower intestinal perforation were 1.8–2.8 and 1.26–2.7 per 1,000 patient years (PYs), respectively, in tocilizumab-treated RA patients; both values were significantly higher than in TNF-inhibitor-treated patients (0.6–0.9 and 0.2–0.76/1,000 PYs, respectively) (Strangfeld et al., 2017; Xie et al., 2016”
From Targeting Interleukin-6 Signaling in Clinic (2019) · cites this paper as Strangfeld et al., 2017
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Guidelines of Diagnostics and Treatment of Acute Left-Sided Colonic Diverticulitis
Andeweg, C. S., Mulder, I. M., Felt-Bersma, R. J. F., Verbon, A., van der Wilt, G. J., van Goor, H., Lange, J. F., Stoker, J., Boermeester, M. A., & Bleichrodt, R. P. (2013) · Digestive Surgery · doi:10.1159/000354035 · Cited by 844
Integrated safety in tocilizumab clinical trials
Schiff, M. H., Kremer, J. M., Jahreis, A., Vernon, E., Isaacs, J. D., & van Vollenhoven, R. F. (2011) · Arthritis Research & Therapy · doi:10.1186/ar3455 · Cited by 367
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Listing, J., Kekow, J., Manger, B., Burmester, G.-R., Pattloch, D., Zink, A., & Strangfeld, A. (2015) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2013-204021 · Cited by 295
Self-citationPeyrin‐Biroulet, L., Gonzalez, F., Dubuquoy, L., Rousseaux, C., Dubuquoy, C., Decourcelle, C., Saudemont, A., Tachon, M., Béclin, E., Odou, M., et al. (2011) · Gut · doi:10.1136/gutjnl-2011-300370 · Cited by 273
Leptin: A pivotal mediator of intestinal inflammation in mice
Siegmund, B., Lehr, H. A., & Fantuzzi, G. (2002) · Gastroenterology · doi:10.1053/gast.2002.33631 · Cited by 261
Self-citationCAUSE OF DEATH IN RHEUMATOID ARTHRITIS
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Evidence of aspirin use in both upper and lower gastrointestinal perforation
Lanas, Á., Serrano, P., Bajador, E., Esteva, F. J., Benito, R., & Sainz, R. (1997) · Gastroenterology · doi:10.1053/gast.1997.v112.pm9041228 · Cited by 196
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Leptin receptor expression on T lymphocytes modulates chronic intestinal inflammation in mice
Siegmund, B., Sennello, J. A., Jones-Carson, J., Gamboni-Robertson, F., Lehr, H. A., Batra, A., Fedke, I., Zeitz, M., & Fantuzzi, G. (2004) · Gut · doi:10.1136/gut.2003.027136 · Cited by 139
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Research works printed but not linked: 1
- van Vollenhoven, 2009, Gastrointestinal safety in patients with rheumatoid arthritis treated with tocilizumab: data from Roche clinical trials, Arthritis Rheum, 60, 1613
Cited by
Smolen, J. S., Landewé, R., Bijlsma, J., Burmester, G., Chatzidionysiou, K., Dougados, M., Nam, J., Ramiro, S., Voshaar, M., van Vollenhoven, R., et al. (2017) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2016-210715 · Cited by 2,057
Self-citationTargeting Interleukin-6 Signaling in Clinic
Kang, S., Tanaka, T., Narazaki, M., & Kishimoto, T. (2019) · Immunity · doi:10.1016/j.immuni.2019.03.026 · Cited by 904
Tocilizumab: A review in rheumatoid arthritis
Scott, L. J. (2017) · Drugs · doi:10.1007/s40265-017-0829-7 · Cited by 419
Efficacy and Safety of Upadacitinib in a Randomized Trial of Patients With Crohn’s Disease
Sandborn, W. J., Feagan, B. G., Loftus, E. V., Peyrin-Biroulet, L., Van Assche, G., D’Haens, G., Schreiber, S., Colombel, J.-F., Lewis, J. D., Ghosh, S., et al. (2020) · Gastroenterology · doi:10.1053/j.gastro.2020.01.047 · Cited by 322
Xie, F., Yun, H., Bernatsky, S., & Curtis, J. R. (2016) · Arthritis & Rheumatology · doi:10.1002/art.39761 · Cited by 161
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
- PMC
- PMC5445993
- Cited by
- 174
- References
- 23
- Language
- en
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- www.elsevier.com/legal/tdmrep-license (tdm)
- creativecommons.org/licenses/by-nc/4.0/ (vor)
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- The paper
- Strangfeld, A., Richter, A., Siegmund, B., Herzer, P., Rockwitz, K., Demary, W., Aringer, M., Meißner, Y., Zink, A., & Listing, J. (2017). Risk for lower intestinal perforations in patients with rheumatoid arthritis treated with tocilizumab in comparison to treatment with other biologic or conventional synthetic DMARDs. Annals of the Rheumatic Diseases. https://doi.org/10.1136/annrheumdis-2016-209773
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