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Abstract
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.
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Acknowledgements
We would like to thank pharmacists Livia Marengo and Andressa Colombo that have helped use doing part of extraction and interview of patients. The authors also received adjudication outcomes support from Elton Luis Faggioni Trani and Victor Simezo. We also thank CODES SES-SP (Strategic Coordination Demands of Ministry of Health of São Paulo) for cooperating in giving us the data from the database and helping us find the lawsuit papers in their files.