Use of off-label doses is frequent in biologic therapy for moderate to severe psoriasis: A cross-sectional study in clinical practice
Por:
Carrascosa JM, Garcia-Doval I, Pérez-Zafrilla B, Carretero G, Vanaclocha F, Daudén E, De la Cueva-Dobao P, Belinchon I, Alsina M, López-Estebaranz JL, Ferrán M, Torrado R, Rivera R, Carazo C, Barboza L and Ferrándiz C
Publicada:
1 ene 2015
Ahead of Print:
17 abr 2015
Categoría:
Dermatology
Resumen:
Introduction: 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%). Conclusion: Off-label doses of biologic agents for psoriasis are frequent in clinical practice. This information is especially relevant for pharmacoeconomic models.
Filiaciones:
Carrascosa JM:
a Department of Dermatology , Hospital Universitari Germans Trías i Pujol, Universitat Autònoma de Barcelona , Badalona , Barcelona , Spain
Garcia-Doval I:
b Department of Dermatology, Research Unit , Fundación Academia Española de Dermatología y Venereología [Spanish Academy of Dermatology and Venereology Foundation] , Madrid , Spain
Pérez-Zafrilla B:
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
Carretero G:
d Department of Dermatology , Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria , Spain
Vanaclocha F:
e Department of Dermatology , Hospital Universitario 12 de Octubre , Madrid , Spain
Daudén E:
f Department of Dermatology , Hospital Universitario la Princesa , Madrid , Spain
De la Cueva-Dobao P:
g Departamento de Dermatología , Hospital Infanta Leonor , Madrid , Spain
Belinchon I:
h Hospital General Universitario de Alicante , Alicante , Spain
Alsina M:
i Department of Dermatology , Hospital Clinic de Barcelona , Barcelona , Spain
López-Estebaranz JL:
j Hospital Universitario Fundación de Alcorcón , Madrid , Spain , and
Ferrán M:
k Department of Dermatology , Hospital del Mar, Parc de Salut Mar , Barcelona , Spain
Torrado R:
d Department of Dermatology , Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria , Spain
Rivera R:
e Department of Dermatology , Hospital Universitario 12 de Octubre , Madrid , Spain
Carazo C:
f Department of Dermatology , Hospital Universitario la Princesa , Madrid , Spain
Barboza L:
a Department of Dermatology , Hospital Universitari Germans Trías i Pujol, Universitat Autònoma de Barcelona , Badalona , Barcelona , Spain
Ferrándiz C:
a Department of Dermatology , Hospital Universitari Germans Trías i Pujol, Universitat Autònoma de Barcelona , Badalona , Barcelona , Spain
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