Artikel
Malignancy and hospitalised infections in patients with RA treated with abatacept and other DMARDs: results from a 10-year international post-approval study
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Autoren
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Teresa A. Simon
- Bristol-Myers Squibb, Princeton, USA
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Samy Suissa
- McGill University, Montreal, Canada
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Mary Lou Skovron
- Bristol-Myers Squibb, Princeton, USA
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Thomas Frisell
- Karolinska Institutet, Stockholm, Sweden
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Johan Askling
- Karolinska Institutet, Stockholm, Sweden
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Kaleb Michaud
- University of Nebraska Medical Center, Omaha, USA
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Sofia Pedro
- FORWARD, The National Databank for Rheumatic Diseases, Wichita, USA
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Anja Strangfeld
- Deutsches Rheuma-Forschungszentrum (DRFZ), Programmbereich Epidemiologie, Berlin
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Yvette Meissner
- Deutsches Rheuma-Forschungszentrum (DRFZ), Forschungsbereich Epidemiologie, Berlin
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M. Boers
- VU University Medical Center, Amsterdam, Netherlands
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Diane Lacaille
- Arthritis Research Center, Richmond, Canada
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Marc Hochberg
- University of Maryland, Baltimore, USA
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Veena Hoffman
- Optum Epidemiology, Ann Arbor, USA
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Andres Gomez
- Bristol-Myers Squibb, Princeton, USA
| Veröffentlicht: | 8. Oktober 2019 |
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Gliederung
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Background: The global post-marketing epidemiology programme for abatacept consists of observational studies based on registries and healthcare claims databases to assess malignancy and infection risks associated with abatacept treatment vs conventional synthetic (cs)DMARDs and other biologic (b) or targeted synthetic (ts)DMARDs in patients with RA.
Methods: Data were analysed from two biologic registries (Anti-Rheumatic Therapy in Sweden register [ARTIS] and Rheumatoid Arthritis Observation of Biologic Therapy German registry [RABBIT]), a disease registry (FORWARD, The National Databank for Rheumatic Diseases in the USA) and two healthcare claims databases (the population-based British Columbia Canadian RA Cohort [BC] and US Optum Research Database [infections only]). Crude incidence rates (IRs; per 1000 patient-years of exposure) with 95% CIs were calculated for overall malignancy (solid tumour only) and hospitalised infections. Adjusted rate ratios (RRs) with 95% CIs were estimated with multivariate models adjusting for demographics, co-morbidities and other potential confounders within each database and subsequently pooled with a random effects model for meta-analyses [1].
Results: Overall, patients treated with abatacept (~6.4K), csDMARDs (~137K) and other b/tsDMARDs (~54K) were followed up for a mean of 2.3–3.7, 2.2–6.2 and 2.3–4.7 years, respectively. Patients were mainly female (71–86%), with a mean age ranging from 49–63 years, 4–34% had prior malignancy and 3–18% had prior severe infection. More patients treated with abatacept (44–85%) compared with other forms of DMARDs (csDMARDs: 11% [FORWARD]; other b/tsDMARDs: 0–19%) had a history of ≥2 prior biologics. The IRs for malignancy and hospitalised infections are shown in Tables 1 and 2, respectively. Adjusted RRs for abatacept vs csDMARDs and vs other b/tsDMARDs showed no increased risk in overall malignancy (Table 1 [Tab. 1]) or hospitalised infections (Table 2 [Tab. 2]).
Conclusion: The risks of overall malignancy and hospitalised infections were not significantly increased in patients treated with abatacept. Differences in results across cohorts may be attributed to prior biologic exposure, study design and practice pattern differences. These data are consistent with the current safety profile of abatacept.
