Adverse Events in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Receiving Long-Term Biological Agents in a Real-Life Setting.

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. No other predisposing factors were associated with risk of ADR. The monitoring of patients (medical consultation and laboratory test) was only completed by 48 patients (30.4%). Conclusion: These data showed the early biological experience in Brazil that 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.

Patient reports of the frequency and severity of adverse reactions associated with biological agents prescribed for psoriasis in Brazil.

BACKGROUND: The safety of biological agents used to treat psoriasis remains uncertain. OBJECTIVE: The authors determined the frequency and severity of adverse effects associated with use of biologic agents for psoriasis through patient-registered lawsuits to the government of Sao Paulo, Brazil. METHODS: Sources of information included legal records, dispensing pharmacy data and interviews with patients. Research staff conducted telephone interviews with patients who used biologic drugs during 2004 - 2011, inquiring about medication-related adverse drug reactions (ADRs) and serious adverse events (SAEs). RESULTS: Of the 218 patients identified, 15 proved ineligible or refused participation. 203 patients were interviewed, with 111 (54.7%) taking infliximab, 43 (21.2%) efalizumab, 35 (17.2%) etanercept and 14 (6.9%) adalimumab. Of 84 (41.4%) patients who experienced one or more ADR related to biological agents, 57 (67.9%) experienced one or more SAE. The only risk factor associated with ADRs was comorbidity odds ratio = 6.54 (95% confident interval [CI] 3.20 - 13.32), p < 0.0001. CONCLUSION: Biologic agents were associated with high rates of ADRs and SAEs. The data suggests that for patients taking a biologic agent to treat psoriasis and who have one or more comorbidities, warnings of possible adverse events and enhanced surveillance are warranted.

Adherence to guidelines in the use of biological agents to treat psoriasis in Brazil.

OBJECTIVE: In São Paolo, Brazil, patients can appeal to the courts, registering law suits against the government claiming the need for biological agents for treatment of psoriasis. If the lawsuits are successful, which is usually the case, the government then pays for the biologic agent. The extent to which the management of such patients, after gaining access to government payment for their biologic agents, adheres to authoritative guidelines, is uncertain. METHODS: We identified patients through records of the State Health Secretariat of São Paulo from 2004 to 2011. We consulted guidelines from five countries and chose as standards only those recommendations that the guidelines uniformly endorsed. Pharmacy records provided data regarding biological use. Guidelines not only recommended biological agents only in patients with severe psoriasis who had failed to respond to topical and systemic therapies (eg, ciclosporin and methotrexate) but also yearly monitoring of blood counts and liver function. RESULTS: Of 218 patients identified in the database, 3 did not meet eligibility criteria and 12 declined participation. Of the 203 patients interviewed, 91 were still using biological medicine; we established adherence to laboratory monitoring in these patients. In the total sample, management failed to meet standards of prior use of topical and systemic medication in 169 (83.2%) patients. Of the 91 patients using biological medicine at the time of the survey, 23 (25.2%) did not undergo appropriate laboratory tests. CONCLUSIONS: Important discrepancies exist between clinical practice and the recommendations of guidelines in the management of plaintiffs using biological drugs to treat psoriasis.