Original Research ARTICLE
Adverse events in patients with rheumatoid arthritis and psoriatic arthritis receiving long-term biological agents in a real-life setting
- 1Pharmaceutical Sciences Graduate Program, Universidade de Sorocaba, Brazil
- 2Federal University of São Paulo, Brazil
Background: Biological agents used for the treatment of psoriatic arthritis (PsA) and rheumatoid arthritis (RA) are associated with serious adverse effects (SAEs). Although several biologics have demonstrated good efficacy and tolerability in short-term trials, treatment guidelines recommend them as third line therapies due to a relative lack of long-term safety data.
Objective: To determine the frequency and severity of adverse effects associated with
the long-term use of biologics in the treatment of PsA and RA, and possible risk factors
for such events in a real-life setting.
Methods: We conducted a longitudinal study in PsA and RA patients only taking long-term biological agents from 2003 to 2011. Sources of information included dispensing
pharmacy data and interviews with patients. Research staff conducted telephone interviews with patients inquiring about any apparent medication-related adverse drug
reactions (ADRs) or SAEs. ADR/SAE’s data was based on pharmacy reports. We conducted a multivariate analysis to identify the factors associated with the risk of ADRs.
Results: Of the 305 patients identified, we interviewed 268 patients. Most of these were
taking adalimumab 127 (47.4%), 52 (19.4%) etanercept, 42 (15.7%) infliximab, 25 (9.3%) rituximab, 10 (3.7%) abatacept, 9 (3.4%) efalizumab, and 3 (1.1%) tocilizumab. Of the 268 patients, 116 (43.3%) experienced one or more adverse events related to biological agents with 1.6 events per patient, and of these 29 (25%) experienced one or more SAEs, with majority subjected to hospitalizations. The most frequently reported ADRs were administration site reactions as observed in 73 patients (27.2%), infections in 30 patients (11.2%), effects on nervous system in 22 patients (8.2%), and 15 (5.6%) patients withdrew due to ADRs. The use of rituximab was related with less risk of ADR [PR 0.42, 95% CI 0.18-0.96; p = 0.04] than other agents. The monitoring of patients (medical consultation and laboratory test) was only completed by 48 patients (30.4%).
Conclusion: the data showed the early of the biologic agents experience in Brazil, which were associated with ADRs, withdrawals due to ADRs and SAEs. The quantification of adverse effects (serious or nonserious) considering close monitoring and patients’ perceptions are increasingly important for future decision-making.
Keywords: adverse reaction, Biologic agents, psoriatic arthritis, Rheumatoid arthritis, Safety
Received: 30 Jan 2019;
Accepted: 29 Jul 2019.
Copyright: © 2019 de Camargo, Barros, Fulone, Silva, Silveira, de Camargo, Barberato-Filho, DEL FIOL and Lopes. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Dr. Luciane C. Lopes, Universidade de Sorocaba, Pharmaceutical Sciences Graduate Program, Sorocaba, 18023-000, Sao Paulo, Brazil, email@example.com