title: Risk of serious adverse events associated with biologic and nonbiologic psoriasis systemic therapy: patients ineligible vs eligible for randomized controlled trials.
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.
  
  
  METHODS
  A registry inception cohort was used.
  
  
  METHODS
  Thirteen dermatology departments in Spain participated.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Dermatology, Complexo Hospitalario de Pontevedra, SERGAS (Servizo Galego de Saude), Pontevedra, Spain. ignacio.garcia.doval@sergas.es
authors.forename: Ignacio
authors.initials: I
authors.lastname: Garcia-Doval
authors.forename: Gregorio
authors.initials: G
authors.lastname: Carretero
authors.forename: Francisco
authors.initials: F
authors.lastname: Vanaclocha
authors.forename: Carlos
authors.initials: C
authors.lastname: Ferrandiz
authors.forename: Esteban
authors.initials: E
authors.lastname: Daudén
authors.forename: Jose-Luis
authors.initials: JL
authors.lastname: Sánchez-Carazo
authors.forename: Mercé
authors.initials: M
authors.lastname: Alsina
authors.forename: Enrique
authors.initials: E
authors.lastname: Herrera-Ceballos
authors.forename: Francisco-José
authors.initials: FJ
authors.lastname: Gómez-García
authors.forename: Marta
authors.initials: M
authors.lastname: Ferrán
authors.forename: Jose-Luis
authors.initials: JL
authors.lastname: López-Estebaranz
authors.forename: Jose-Manuel
authors.initials: JM
authors.lastname: Hernanz
authors.forename: Isabel
authors.initials: I
authors.lastname: Belinchón-Romero
authors.forename: Jaime
authors.initials: J
authors.lastname: Vilar-Alejo
authors.forename: Raquel
authors.initials: R
authors.lastname: Rivera
authors.forename: Jose-Manuel
authors.initials: JM
authors.lastname: Carrascosa
authors.forename: Cristina
authors.initials: C
authors.lastname: Carazo
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects*; D000911:Antibodies, Monoclonal / Q000009:adverse effects; D001688:Biological Products / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects; D007641:Keratolytic Agents / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011701:PUVA Therapy / Q000009:adverse effects; D018579:Patient Selection; D016016:Proportional Hazards Models; D011565:Psoriasis / Q000145:classification* / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D013030:Spain
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D001688:Biological Products; D007166:Immunosuppressive Agents; D007641:Keratolytic Agents