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Abstract

Background:

The association between drugs and adverse events (AEs) has been investigated using various AE databases. The aim of this study was to provide useful information for risk minimization of antirheumatic agents by investigating the safety profiles of antirheumatic agents using the Japanese Adverse Drug Event Report database (JADER), focusing on some important serious AEs (SAEs) and their relation to time.

Methods:

Tumor necrosis factor-alpha inhibitors (TNF-Is), interleukin-6 inhibitors (IL-6-Is), and methotrexate (MTX) were selected as antirheumatic agents. Tuberculosis, malignant tumors, and bone marrow disorders were focused as typical SAEs. Disproportionate reporting of these SAEs was evaluated using the reporting odds ratio. Time to onset of each SAE was calculated using date information.

Results:

Increased reporting odds ratios were observed in tuberculosis and malignant tumors associated with TNF-I, in tuberculosis and malignant tumors associated with IL-6-I, and in tuberculosis, malignant tumors, and bone marrow disorders associated with MTX. The median time to onset of the focused SAEs associated with TNF-I were 501, 681, and 254 days, respectively; those associated with IL-6-I were 387, 636, and 116 days; and those associated with MTX were 537, 1125, and 328 days. These results suggested different profiles for the focused SAEs.

Conclusion:

The time-to-onset profiles of the SAEs for TNF-I, IL-6-I, and MTX as antirheumatic agent were different among different SAEs, which suggests that they should be monitored carefully based on the profiles. The information from JADER is expected to contribute to the risk minimization of drugs in the actual clinical practice.

Keywords

JADER serious adverse event SAE antirheumatic agent reporting odds ratio time to onset

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References

Berghen

Teuwen

Westhovens

Verschueren

. Malignancies and anti-TNF therapy in rheumatoid arthritis: a single-center observational cohort study. Clin Rheumatol. 2015;34:1687–1695.

Liu

Fan

Chen

. Risk of breast cancer and total malignancies in rheumatoid arthritis patients undergoing TNF-α antagonist therapy: a meta-analysis of randomized control trials. Asian Pac J Cancer Prev. 2014;15:3403–3410.

Salk

Stobaugh

Deepak

Ehrenpreis

. Ischaemic colitis in rheumatoid arthritis patients receiving tumour necrosis factor-α inhibitors: an analysis of reports to the US FDA Adverse Event Reporting System. Drug Saf. 2013;36:329–334.

Krishnan

Stobaugh

Deepak

. Assessing the likelihood of new-onset inflammatory bowel disease following tumor necrosis factor-alpha inhibitor therapy for rheumatoid arthritis and juvenile rheumatoid arthritis. Rheumatol Int. 2015;35:661–668.

Deepak

Stobaugh

Sherid

Sifuentes

Ehrenpreis

. Neurological events with tumour necrosis factor alpha inhibitors reported to the Food and Drug Administration Adverse Event Reporting System. Aliment Pharmacol Ther. 2013;38:388–396.

Japan Pharmaceuticals and Medical Devices Agency. Japanese adverse drug event report database (JADER) [in Japanese]. http://www.info.pmda.go.jp/fukusayoudb/CsvDownload.jsp. Accessed February 19, 2017.

Nomura

Takahashi

Hinomura

. Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases. Drug Design Dev Ther. 2015;9:3031–3041.

Sasaoka

Matsui

Abe

. Evaluation of the association of hand-foot syndrome with anticancer drugs using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases [in Japanese]. Yakugaku Zasshi. 2016;136:507–515.

Nakamura

Umetsu

Abe

. Analysis of the time-to-onset of osteonecrosis of jaw with bisphosphonate treatment using the data from a spontaneous reporting system of adverse drug events. J Pharm Health Care Sci. 2015;1:34–42.

10.

Kobayashi

. Comparative study of the time period between the initiation of various interferon therapies and the onset of suicide- or diabetes-related side effect [in Japanese]. Bull Natl Inst Health Sci. 2013;131:45–49.

11.

Yamada

Handa

. Comparison of the onset time profile among the interferon formulations in adverse drug reaction of suicide- or diabetes related [in Japanese]. Jpn J Pharmacoepidemiol. 2014;19:23–30.

12.

Hazell

Shakir

SAW

. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29:385–396.

13.

Japan College of Rheumatology (2017) guidelines for use of TNF inhibitors [in Japanese]. http://www.ryumachi-jp.com/info/guideline_TNF.html. Accessed April 4, 2017.

14.

Japan College of Rheumatology (2017) guidelines for use of tocilizumab [in Japanese]. http://www.ryumachi-jp.com/info/guideline_tcz.html. Accessed November 23, 2016.

15.

Japan College of Rheumatology (2011) guidelines for use of methotrexate [in Japanese]. http://www.ryumachi-jp.com/info/newsMTX-text_2011.html. Accessed November 23, 2016.

16.

MedDRA. https://www.meddra.org/. Accessed May 27, 2017.

17.

MedDRA Maintenance and Support Services Organization. “Introductory Guide for Standardized MedDRA Queries (SMQs) Version 19.1.” https://www.meddra.org/sites/default/files/guidance/file/smq_intguide_19_1_english.pdf. Published 2016. Accessed May 27, 2017.

18.

van Puijenbroek

Diemont

van Grootheest

. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf. 2003;26:293–301.

19.

van Puijenbroek

Bate

Leufkens

HGM

Lindquist

Orre

Egberts

ACG

. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002;11:3–10.

20.

Singh

Saag

, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016;68:1–26.

21.

Japan College of Rheumatology. Guidelines for the management of rheumatoid arthritis, Japan College of Rheumatology 2014 [in Japanese]. Japan: Medicalreview; 2014.

22.

Chen

Shen

. The risk of cancer in patients with rheumatoid arthritis taking tumor necrosis factor antagonists: a nationwide cohort study. Arthritis Res Ther. 2014;16:449–460.

23.

Matsuda

Aoki

Kawamata

. Bias in spontaneous reporting of adverse drug reactions in Japan. PLoS One. 2015;10:e0126413.

24.

Hoffman

Demakas

Dimbil

Tatonetti

Erdman

. Stimulated reporting: the impact of US Food and Drug Administration-issued alerts on the Adverse Event Reporting System (FAERS). Drug Saf. 2014;30:891–898.

25.

Hoffman

Dimbil

Erdman

Tatonetti

Overstreet

. The Weber effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): analysis of sixty-two drugs approved from 2006 to 2010. Drug Saf. 2014;37:283–294.

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Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database

Abstract

Background:

Methods:

Results:

Conclusion:

Keywords

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References

Supplementary Material