Abstract

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.

Links

Publisher Full Text

Authors

Garcia-Doval I, Carretero G, Vanaclocha F, Ferrandiz C, Daudén E, Sánchez-Carazo JL, Alsina M, Herrera-Ceballos E, Gómez-García FJ, Ferrán M, López-Estebaranz JL, Hernanz JM, Belinchón-Romero I, Vilar-Alejo J, Rivera R, Carrascosa JM, Carazo C

Institution

Department of Dermatology, Complexo Hospitalario de Pontevedra, SERGAS (Servizo Galego de Saude), Pontevedra, Spain. ignacio.garcia.doval@sergas.es

Source

Archives of dermatology 148:4 2012 Apr pg 463-70

MeSH

Adult
Age Factors
Aged
Anti-Inflammatory Agents
Antibodies, Monoclonal
Biological Agents
Female
Humans
Immunosuppressive Agents
Keratolytic Agents
Male
Middle Aged
PUVA Therapy
Patient Selection
Proportional Hazards Models
Psoriasis
Randomized Controlled Trials as Topic
Risk Assessment
Spain

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22508869