Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries

Dominique, Alyssa; Hetland, Merete Lund; Finckh, Axel; Gottenberg, Jacques-Eric; Iannone, Florenzo; Caporali, Roberto; Kou, Tzuyung Douglas; Nordstrom, Dan; Hernandez, Maria Victoria; Sánchez-Piedra, Carlos; Sánchez-Alonso, Fernando; Pavelka, Karel; Bond, T. Christopher; Simon, Teresa A.

doi:10.1186/s13075-023-03067-x

Table 1 Characteristics of registries used for identifying patients with RA in the post-marketing epidemiology abatacept study

From: Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries

	ATTRA	DANBIO [33, 34]	ROB-FIN	ORA	GISEA	BIOBADASER	SCQM
Country	Czech Republic	Denmark	Finland	France	Italy	Spain	Switzerland
Year of registry initiation	2002	2000	1999	2007	2008	2007	1996
Register design	National register	National register	National register	Multicentre registry^a	Multicentre registry of bDMARDs	National register	National register
Age (years)	≥ 18	≥ 18	≥ 18	≥ 18	≥ 18	≥ 18	≥ 16
Data availability	8 August 2007 to 27 November 2017	15 June 2007 to 3 December 2017^b	September 2007 to 31 December 2015	June 2007 to 3 June 2018	Through March 2014 (outcomes data) and through November 2015 (baseline data)	2007 to 15 November 2017^c	Follow-up 1 January 2009 to 30 June 2017 (infections requiring hospitalization) or 1 October 2007 to 30 June 2017 (tuberculosis, malignancies)
Infection outcomes
Hospitalized infections	Yes	Yes	Yes	Yes	Yes^d	Yes	Yes
Opportunistic infections	Yes	Yes	NR	NR	NR	Yes	NR
Tuberculosis	Yes	Yes	Yes	NR	NR	Yes	Yes
Malignancy outcomes
Overall malignancy	Yes	Yes	Yes	Yes	Yes^d	Yes	Yes
Breast Cancer	Yes	Yes	Yes	Yes^e	NR	Yes	Yes
Lung cancer	Yes	Yes	Yes	Yes^e	NR	Yes	Yes
Lymphoma	Yes	Yes	Yes	Yes^e	NR	Yes	Yes
Confirmation of infections^f	MedDRA	ICD-10 codes	ICD-10 codes	Patient adverse event summary narratives	ICD codes	MedDRA	Identified by the treating rheumatologist
Confirmation of malignancy	MedDRA	ICD-10 codes	Linkage to national hospitalization discharge register (HILMO); ICD codes^g	Patient adverse event summary narratives	ICD-codes based on the reports of pathologists	MedDRA	Identified by the treating rheumatologist^e

ATTRA Anti-TNF Therapy in Rheumatoid Arthritis, bDMARD biologic disease-modifying antirheumatic drug, BIOBADASER Spanish Register of Adverse Events of Biological Therapies in Rheumatic Diseases, DANBIO Danish Rheumatologic Database, GISEA Italian Group for the Study of Early Arthritis, HILMO Finnish nationwide social and healthcare data collection and reporting system, ICD International Classification of Diseases, MedDRA Medical Dictionary for Drug Regulatory Activities, NR not reported, ORA Orencia and Rheumatoid Arthritis, RA rheumatoid arthritis, ROB-FIN National Registry of Biological Treatment in Finland, SCQM Swiss Clinical Quality Management
^aEstablished by the French Society of Rheumatology to investigate the long-term safety and effectiveness of intravenous abatacept in patients with RA
^bFor DANBIO, the study period corresponds to the time period when abatacept became available in Denmark; patients were also required to have follow-up data from the Danish National Patient Registry for the final report
^cBIOBADASER 2.0 and 3.0
^dReported as adverse event counts
^eReported in patient adverse event summary narratives
^fFor infections resulting in hospitalization, the infection code was the first code indicating the primary reason for hospitalization. In DANBIO, both primary and secondary codes were included as patients with RA may have had RA as the primary code
^gIf the description of the malignancy or the infection was not clear, an SCQM data analyst or study nurse could request additional information on the specific type or location of the malignancy

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ISSN: 1478-6362

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