title: Use of off-label doses is frequent in biologic therapy for moderate to severe psoriasis: A cross-sectional study in clinical practice.
abstract: BACKGROUND
  Biologic medications increase dramatically the burden of a chronic and high prevalent disease like psoriasis. The objective of the study was to quantify the use of dose reduction or dose escalation strategies, not reflected in the drug summary of product characteristics, in clinical practice.
  
  
  METHODS
  An observational, cross-sectional study of a subset of patients from the Spanish Registry for Systemic Treatments in Psoriasis (BIOBADADERM) treated for over six consecutive months with the same biologic agent.
  
  
  RESULTS
  The study included 637 patients. At the cut-off date, the initial dose had been reduced in 223 patients (35%; 95% CI: 31.3-38.9%) and escalated in 46 (7.2%; 95% CI: 5.3-9.5%). When compared with the patients treated with standard doses, the patients on reduced doses had a lower PASI score at the cut-off date (a mean 2.6 versus 1; -1.6 points) and exhibited greater improvement in PASI since the start of biologic therapy (mean reduction over baseline 75% versus 87%). By contrast, the patients receiving an escalated dose had higher PASI scores (2.6 versus 8.0) and showed less improvement in PASI (75% versus 46.8%).
  
  
  CONCLUSIONS
  Off-label doses of biologic agents for psoriasis are frequent in clinical practice. This information is especially relevant for pharmacoeconomic models.
authors.affiliation: a Department of Dermatology , Hospital Universitari Germans Trías i Pujol, Universitat Autònoma de Barcelona , Badalona , Barcelona , Spain .
authors.forename: Jose-Manuel
authors.initials: JM
authors.lastname: Carrascosa
authors.affiliation: b Department of Dermatology, Research Unit , Fundación Academia Española de Dermatología y Venereología [Spanish Academy of Dermatology and Venereology Foundation] , Madrid , Spain .
authors.forename: Ignacio
authors.initials: I
authors.lastname: Garcia-Doval
authors.affiliation: b Department of Dermatology, Research Unit , Fundación Academia Española de Dermatología y Venereología [Spanish Academy of Dermatology and Venereology Foundation] , Madrid , Spain .|c Research Unit , Complejo Hospitalario Universitario de Albacete , Albacete , Spain .
authors.forename: Beatriz
authors.initials: B
authors.lastname: Pérez-Zafrilla
authors.affiliation: d Department of Dermatology , Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria , Spain .
authors.forename: Gregorio
authors.initials: G
authors.lastname: Carretero
authors.affiliation: e Department of Dermatology , Hospital Universitario 12 de Octubre , Madrid , Spain .
authors.forename: Francisco
authors.initials: F
authors.lastname: Vanaclocha
authors.affiliation: f Department of Dermatology , Hospital Universitario la Princesa , Madrid , Spain .
authors.forename: Esteban
authors.initials: E
authors.lastname: Daudén
authors.affiliation: g Departamento de Dermatología , Hospital Infanta Leonor , Madrid , Spain .
authors.forename: Pablo
authors.initials: P
authors.lastname: De la Cueva-Dobao
authors.affiliation: h Hospital General Universitario de Alicante , Alicante , Spain .
authors.forename: Isabel
authors.initials: I
authors.lastname: Belinchón
authors.affiliation: i Department of Dermatology , Hospital Clinic de Barcelona , Barcelona , Spain .
authors.forename: Merce
authors.initials: M
authors.lastname: Alsina
authors.affiliation: j Hospital Universitario Fundación de Alcorcón , Madrid , Spain , and.
authors.forename: Jose-Luis
authors.initials: JL
authors.lastname: López-Estebaranz
authors.affiliation: k Department of Dermatology , Hospital del Mar, Parc de Salut Mar , Barcelona , Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Ferrán
authors.affiliation: d Department of Dermatology , Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria , Spain .
authors.forename: Rosa
authors.initials: R
authors.lastname: Torrado
authors.affiliation: e Department of Dermatology , Hospital Universitario 12 de Octubre , Madrid , Spain .
authors.forename: Raquel
authors.initials: R
authors.lastname: Rivera
authors.affiliation: f Department of Dermatology , Hospital Universitario la Princesa , Madrid , Spain .
authors.forename: Cristina
authors.initials: C
authors.lastname: Carazo
authors.affiliation: a Department of Dermatology , Hospital Universitari Germans Trías i Pujol, Universitat Autònoma de Barcelona , Badalona , Barcelona , Spain .
authors.forename: Lorena
authors.initials: L
authors.lastname: Barboza
authors.affiliation: a Department of Dermatology , Hospital Universitari Germans Trías i Pujol, Universitat Autònoma de Barcelona , Badalona , Barcelona , Spain .
authors.forename: Carlos
authors.initials: C
authors.lastname: Ferrándiz
mesh_terms: D000328:Adult; D001691:Biological Therapy / Q000379:methods*; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D011565:Psoriasis / Q000188:drug therapy*
keywords: Biologic; dose reduction; intensification; psoriasis; therapy