Risk of Serious Adverse Events Associated With Biologic and Nonbiologic Psoriasis Systemic Therapy
| Autor: | Jose-Manuel Hernanz, José Manuel Carrascosa, Gregorio Carretero, Ignacio García-Doval, Cristina Carazo, Raquel Rivera, Mercè Alsina, J.L. Sánchez-Carazo, Esteban Daudén, J Vilar-Alejo, Enrique Herrera-Ceballos, F.J. Gómez-García, Francisco Vanaclocha, Isabel Belinchón-Romero, Marta Ferran, Carlos Ferrándiz, José Luis López-Estebaranz |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male medicine.medical_specialty Anti-Inflammatory Agents Dermatology Rate ratio Risk Assessment Systemic therapy law.invention Keratolytic Agents Randomized controlled trial law Psoriasis Internal medicine Humans Medicine Adverse effect PUVA Therapy Aged Proportional Hazards Models Randomized Controlled Trials as Topic Biological Products business.industry Patient Selection Age Factors Antibodies Monoclonal General Medicine Hepatitis C Middle Aged Hepatitis B medicine.disease Surgery Spain Female Skin cancer business Immunosuppressive Agents |
| Zdroj: | Archives of Dermatology. 148:463 |
| ISSN: | 0003-987X |
| DOI: | 10.1001/archdermatol.2011.2768 |
| Popis: | Objective To describe the use of systemic therapy for psoriasis (biologic and nonbiologic [classic] drugs) in patients not adequately represented in randomized controlled trials (RCTs) and the risk of serious adverse events (SAEs) in these patients. Design A registry inception cohort was used. Setting Thirteen dermatology departments in Spain participated. Patients A consecutive sample of patients treated with biologics and a systematic sample of patients treated with classic systemic therapy were evaluated. A total of 1042 patients (2179 person-years) were included. Exposure Inadequate representation in trials was defined as the presence of any of the following factors: elderly age (>70 years); type of psoriasis other than chronic plaque psoriasis; history of infection caused by hepatitis B, hepatitis C, or human immunodeficiency virus; history of cancer (excluding nonmelanoma skin cancer); and chronic renal or hepatic disease. Main Outcome Measures Serious adverse events as defined by the International Conference on Harmonization were evaluated. Results In all, 29.8% of patients receiving systemic therapy for psoriasis would not have been eligible for RCTs. These individuals had an increased risk of SAEs (incidence rate ratio, 2.7; 95% CI, 1.5-4.7). Patients exposed to biologics had an adjusted increased risk of SAEs (incidence rate ratio, 2.3; 95% CI, 1.1-4.8) that was similar in patients eligible and ineligible for RCTs. Conclusions Patients ineligible for RCTs are an important proportion (30%) of those receiving systemic therapy for psoriasis. These patients have a higher risk of SAEs and should be closely monitored. Patients exposed to biologics (whether these patients are eligible for RCTs or ineligible) are susceptible to the same increase in risk of SAEs, but biologics add to a higher baseline risk in patients who are ineligible for RCTs. The risk-benefit ratio in ineligible patients receiving biologics might be different from the ratio in eligible patients. |
| Databáze: | OpenAIRE |
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