Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries
Abstract Background Patients with rheumatoid arthritis (RA) have an increased risk of infection and malignancy compared with the general population. Infection risk is increased further with the use of disease-modifying antirheumatic drugs (DMARDs), whereas evidence on whether the use of biologic DMA...
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| Format: | Article |
| Language: | English |
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BMC
2023-06-01
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| Series: | Arthritis Research & Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13075-023-03067-x |
| _version_ | 1827922837175795712 |
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| author | Alyssa Dominique Merete Lund Hetland Axel Finckh Jacques-Eric Gottenberg Florenzo Iannone Roberto Caporali Tzuyung Douglas Kou Dan Nordstrom Maria Victoria Hernandez Carlos Sánchez-Piedra Fernando Sánchez-Alonso Karel Pavelka T. Christopher Bond Teresa A. Simon |
| author_facet | Alyssa Dominique Merete Lund Hetland Axel Finckh Jacques-Eric Gottenberg Florenzo Iannone Roberto Caporali Tzuyung Douglas Kou Dan Nordstrom Maria Victoria Hernandez Carlos Sánchez-Piedra Fernando Sánchez-Alonso Karel Pavelka T. Christopher Bond Teresa A. Simon |
| author_sort | Alyssa Dominique |
| collection | DOAJ |
| description | Abstract Background Patients with rheumatoid arthritis (RA) have an increased risk of infection and malignancy compared with the general population. Infection risk is increased further with the use of disease-modifying antirheumatic drugs (DMARDs), whereas evidence on whether the use of biologic DMARDs increases cancer risk remains equivocal. This single-arm, post-marketing study estimated the incidence of prespecified infection and malignancy outcomes in patients with RA treated with intravenous or subcutaneous abatacept. Methods Data were included from seven European RA quality registries: ATTRA (Anti-TNF Therapy in Rheumatoid Arthritis [Czech Republic]), DANBIO (Danish Rheumatologic Database), ROB-FIN (National Registry of Antirheumatic and Biological Treatment in Finland), ORA (Orencia and Rheumatoid Arthritis [France]), GISEA (Italian Group for the Study of Early Arthritis), BIOBADASER (Spanish Register of Adverse Events of Biological Therapies in Rheumatic Diseases), and the SCQM (Swiss Clinical Quality Management) system. Each registry is unique with respect to design, data collection, definition of the study cohort, reporting, and validation of outcomes. In general, registries defined the index date as the first day of abatacept treatment and reported data for infections requiring hospitalization and overall malignancies; data for other infection and malignancy outcomes were not available for every cohort. Abatacept exposure was measured in patient-years (p-y). Incidence rates (IRs) were calculated as the number of events per 1000 p-y of follow-up with 95% confidence intervals. Results Over 5000 patients with RA treated with abatacept were included. Most patients (78–85%) were female, and the mean age range was 52–58 years. Baseline characteristics were largely consistent across registries. Among patients treated with abatacept, IRs for infections requiring hospitalization across the registries ranged from 4 to 100 events per 1000 p-y, while IRs for overall malignancy ranged from 3 to 19 per 1000 p-y. Conclusions Despite heterogeneity between registries in terms of design, data collection, and ascertainment of safety outcomes, as well as the possibility of under-reporting of adverse events in observational studies, the safety profile of abatacept reported here was largely consistent with previous findings in patients with RA treated with abatacept, with no new or increased risks of infection or malignancy. |
| first_indexed | 2024-03-13T04:48:27Z |
| format | Article |
| id | doaj.art-6c324d843bf14aec906a555d8e98797e |
| institution | Directory Open Access Journal |
| issn | 1478-6362 |
| language | English |
| last_indexed | 2024-03-13T04:48:27Z |
| publishDate | 2023-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Arthritis Research & Therapy |
| spelling | doaj.art-6c324d843bf14aec906a555d8e98797e2023-06-18T11:21:13ZengBMCArthritis Research & Therapy1478-63622023-06-0125111110.1186/s13075-023-03067-xSafety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registriesAlyssa Dominique0Merete Lund Hetland1Axel Finckh2Jacques-Eric Gottenberg3Florenzo Iannone4Roberto Caporali5Tzuyung Douglas Kou6Dan Nordstrom7Maria Victoria Hernandez8Carlos Sánchez-Piedra9Fernando Sánchez-Alonso10Karel Pavelka11T. Christopher Bond12Teresa A. Simon13Bristol Myers SquibbDANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and OrthopedicsDivision of Rheumatology, University Hospitals of GenevaStrasbourg University HospitalsDETO-Rheumatology Unit, University of BariDepartment of Clinical Sciences and Community Health, University of MilanBristol Myers SquibbDepartments of Medicine and Rheumatology, Helsinki University Hospital and Helsinki UniversityRheumatology Department, Hospital Clinic of BarcelonaBIOBADASER, Research Unit, Sociedad Española de ReumatologíaBIOBADASER, Research Unit, Sociedad Española de ReumatologíaInstitute of RheumatologyBristol Myers SquibbBristol Myers SquibbAbstract Background Patients with rheumatoid arthritis (RA) have an increased risk of infection and malignancy compared with the general population. Infection risk is increased further with the use of disease-modifying antirheumatic drugs (DMARDs), whereas evidence on whether the use of biologic DMARDs increases cancer risk remains equivocal. This single-arm, post-marketing study estimated the incidence of prespecified infection and malignancy outcomes in patients with RA treated with intravenous or subcutaneous abatacept. Methods Data were included from seven European RA quality registries: ATTRA (Anti-TNF Therapy in Rheumatoid Arthritis [Czech Republic]), DANBIO (Danish Rheumatologic Database), ROB-FIN (National Registry of Antirheumatic and Biological Treatment in Finland), ORA (Orencia and Rheumatoid Arthritis [France]), GISEA (Italian Group for the Study of Early Arthritis), BIOBADASER (Spanish Register of Adverse Events of Biological Therapies in Rheumatic Diseases), and the SCQM (Swiss Clinical Quality Management) system. Each registry is unique with respect to design, data collection, definition of the study cohort, reporting, and validation of outcomes. In general, registries defined the index date as the first day of abatacept treatment and reported data for infections requiring hospitalization and overall malignancies; data for other infection and malignancy outcomes were not available for every cohort. Abatacept exposure was measured in patient-years (p-y). Incidence rates (IRs) were calculated as the number of events per 1000 p-y of follow-up with 95% confidence intervals. Results Over 5000 patients with RA treated with abatacept were included. Most patients (78–85%) were female, and the mean age range was 52–58 years. Baseline characteristics were largely consistent across registries. Among patients treated with abatacept, IRs for infections requiring hospitalization across the registries ranged from 4 to 100 events per 1000 p-y, while IRs for overall malignancy ranged from 3 to 19 per 1000 p-y. Conclusions Despite heterogeneity between registries in terms of design, data collection, and ascertainment of safety outcomes, as well as the possibility of under-reporting of adverse events in observational studies, the safety profile of abatacept reported here was largely consistent with previous findings in patients with RA treated with abatacept, with no new or increased risks of infection or malignancy.https://doi.org/10.1186/s13075-023-03067-xRheumatoid arthritisAbataceptBiologic DMARDSafetyInfectionsMalignancy |
| spellingShingle | Alyssa Dominique Merete Lund Hetland Axel Finckh Jacques-Eric Gottenberg Florenzo Iannone Roberto Caporali Tzuyung Douglas Kou Dan Nordstrom Maria Victoria Hernandez Carlos Sánchez-Piedra Fernando Sánchez-Alonso Karel Pavelka T. Christopher Bond Teresa A. Simon Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries Arthritis Research & Therapy Rheumatoid arthritis Abatacept Biologic DMARD Safety Infections Malignancy |
| title | Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries |
| title_full | Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries |
| title_fullStr | Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries |
| title_full_unstemmed | Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries |
| title_short | Safety outcomes in patients with rheumatoid arthritis treated with abatacept: results from a multinational surveillance study across seven European registries |
| title_sort | safety outcomes in patients with rheumatoid arthritis treated with abatacept results from a multinational surveillance study across seven european registries |
| topic | Rheumatoid arthritis Abatacept Biologic DMARD Safety Infections Malignancy |
| url | https://doi.org/10.1186/s13075-023-03067-x |
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