Universität zu Köln

Rubbert-Roth, Andrea, Sebba, Anthony, Brockwell, Laura, Kelman, Ariella, Porter-Brown, Benjamin, Pulley, Jennifer, Napalkov, Pavel and van Vollenhoven, Ronald F. (2016). Malignancy rates in patients with rheumatoid arthritis treated with tocilizumab. RMD Open, 2 (1). LONDON: BMJ PUBLISHING GROUP. ISSN 2056-5933

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Abstract

Objective: To analyse malignancy rates in patients with rheumatoid arthritis (RA) treated with tocilizumab. Methods: Patients who received tocilizumab or placebo+methotrexate/disease-modifying antirheumatic drugs in the double-blind phases of 5-phase three trials or who received at least 1 dose of tocilizumab in the long-term extension studies were analysed up to the 2 May 2012 cut-off date. Malignancies were monitored throughout the studies, analysed and adjudicated as malignant by medical review. Risk was compared with that in the general population using standardised incidence ratios (SIRs) based on data from the Surveillance Epidemiology and End Results SEER (US general population) and GLOBOCAN (non-US general population) databases. Results: In total, 4009 patients in the tocilizumab all exposure population were included. Mean treatment duration was 4.0 years (mean 5.1 (range 0.0-6.8); total observation time was 16 120.1 patient-years (PY). The adjudicated malignancy rate (95% CI) was 1.26/100 PY (1.09 to 1.44) and remained constant over time. The SIR (95% CI) for all malignancies combined, excluding non-melanoma skin cancer, was 1.36 (1.01 to 1.80) for US and 1.81 (1.44 to 2.23) for non-US populations, driven primarily by higher rates in lung and bronchus (US/non-US) malignancies and prostate cancer and non-Hodgkin lymphoma (non-US), in contrast to those for the general populations; these higher rates are in line with those expected in patients with RA or in the geographic regions studied. Conclusions: Malignancy rates remained stable with long-term tocilizumab treatment, and malignancy types and rates were consistent with those expected in patients with RA.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Rubbert-Roth, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Sebba, Anthony UNSPECIFIED UNSPECIFIED UNSPECIFIED Brockwell, Laura UNSPECIFIED UNSPECIFIED UNSPECIFIED Kelman, Ariella UNSPECIFIED UNSPECIFIED UNSPECIFIED Porter-Brown, Benjamin UNSPECIFIED UNSPECIFIED UNSPECIFIED Pulley, Jennifer UNSPECIFIED UNSPECIFIED UNSPECIFIED Napalkov, Pavel UNSPECIFIED UNSPECIFIED UNSPECIFIED van Vollenhoven, Ronald F. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-293394
DOI:	10.1136/rmdopen-2015-000213
Journal or Publication Title:	RMD Open
Volume:	2
Number:	1
Date:	2016
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	2056-5933
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language NECROSIS-FACTOR INHIBITORS; INTERLEUKIN-6 RECEPTOR INHIBITION; FACTOR THERAPY; CHRONIC INFLAMMATION; LYMPHOMA RISK; IL-6 RECEPTOR; DOUBLE-BLIND; SKIN-CANCER; METAANALYSIS; EXPOSURE Multiple languages Rheumatology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/29339