Safety and Effectiveness of Biologic Disease-Modifying Antirheumatic Drugs in Older Patients with Rheumatoid Arthritis:
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ORIGINAL RESEARCH ARTICLE
Safety and Effectiveness of Biologic Disease‑Modifying Antirheumatic Drugs in Older Patients with Rheumatoid Arthritis: A Prospective Cohort Study Raquel Freitas1 · Fátima Godinho1 · Nathalie Madeira2 · Bruno Miguel Fernandes3 · Flávio Costa4 · Mariana Santiago4 · Agna Neto5 · Soraia Azevedo6 · Maura Couto7 · Graça Sequeira8 · João Madruga Dias9,10 · Miguel Bernardes3,11 · Luís Miranda2 · Joaquim Polido Pereira12,13,14 · João Eurico Fonseca12,13,14 · Maria José Santos1,14 Accepted: 19 September 2020 / Published online: 18 November 2020 © Springer Nature Switzerland AG 2020
Abstract Background and Objective The number of older patients with rheumatoid arthritis is increasing, but data on drug effectiveness and safety in these patients are scarce. This study assessed the effectiveness and safety of biologic disease-modifying antirheumatic drugs in older patients with rheumatoid arthritis. Methods This prospective cohort study was based on data recorded in the Rheumatic Diseases Portuguese Register (Reuma. pt). Treatment persistence, European League Against Rheumatism response at 6 and 12 months, and adverse events were compared between adult (age 1.2 and DAS28 > 5.1). Good and moderate EULAR responses were combined in one category. Adverse events were categorized as infections, opportunistic infections, neoplasia, allergic reactions, and cytopenia. Time to AE was defined as months since bDMARD initiation until first AE occurrence. Adverse events were described according to the available patient information. Serious adverse events (SAEs) were classified according to the regulatory reporting obligations.
2.4 Study Outcomes The primary study outcome was bDMARD persistence during follow-up. Secondary outcomes included efficacy analyses at 6 and 12 months, which consisted of the proportion of patients who achieved good/moderate EULAR response, and variations in DAS28 (ΔDAS), CDAI (ΔCDAI), SDAI (ΔSDAI), and HAQ (ΔHAQ). An additional secondary
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Safety and Effectiveness of bDMARDs in Older Patients with RA
outcome included a safety analysis measured by the overall occurrence of AEs and SAEs during follow-up.
2.5 Statistical Analysis Continuous variables with normal distributions were reported as the means and standard deviations. If continuous variables had skewed distributions, the medians and interquartile ranges were reported. Categorical variables were presented as frequencies and percentages. Baseline characteristics were compared across the three age groups (
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