Adverse events associated with discontinuation of the biologics/classic systemic treatments for moderate-to-severe plaque psoriasis: data from the Spanish Biologics Registry, Biobadaderm
Por:
Belinchon, I, Ramos, J, Carretero, G, Ferrandiz, C, Rivera, R, Dauden, E, De la Cueva-Dobao, P, Gomez-Garcia, F, Herrera-Ceballos, E, Sanchez-Carazo, J, Lopez-Estebaranz, J, Alsina, M, Ferran, M, Torrado, R, Carrascosa, J, Llamas-Velasco, M, Ortiz, P, Garcia-Doval, I, Descalzo, M and Biobadaderm Study Grp
Publicada:
1 oct 2017
Ahead of Print:
6 jun 2017
Resumen:
BackgroundLittle is known about the adverse events (AEs) that lead to suspension of systemic treatments for psoriasis in clinical practice.
ObjectiveThe study aimed to investigate AEs associated with discontinuation of systemic therapy in patients with psoriasis in a clinical setting (Biobadaderm).
Materials and methodsMulticentre, prospective, cohort study of patients with moderate-to-severe plaque psoriasis receiving systemic therapies from January 2008 to November 2015, in 12 hospitals in Spain. The incidence rate (IR) was used to compare biologics and classic systemic therapies.
ResultsA total of 4218 courses of treatment were given to 1938 patients. A total of 447 (11%) treatments were discontinued due to AEs. The IR of AE associated with discontinuation of systemic therapies was 13 events/100 patient-years (PY) (95% CI: 12.14-13.93), 9.34 events/100 PY (95% CI: 8.44-10.33) for biologics and 19.67 (95% CI: 17.9-21.6) events/100 PY for classics (P<0.001). Of 810 discontinuation-related AEs, 117 (14%) were serious. The highest IRs were for cyclosporine [49.18/100 PY (95% CI: 41.91-57.72)] and infliximab [26.52/100 PY (95% CI: 20.98-33.51). Ustekinumab presented the lowest IR (2.6/100 PY (95% CI: 1.83-3.69).
LimitationsObservational study with potential selection bias.
ConclusionBiologic therapies are associated with a lower rate of discontinuation-related AEs than are classic therapies in real clinical practice. Ustekinumab showed the lowest incidence.
Filiaciones:
:
Hosp Gen Univ Alicante ISABIAL, Alicante, Spain
:
Hosp Gen Univ Alicante ISABIAL, Alicante, Spain
Carretero, G:
Hosp Univ Gran Canaria Dr Negrin, Las Palmas Gran Canaria, Spain
Ferrandiz, C:
Hosp Badalona Germans Trias & Pujol, Badalona, Spain
Rivera, R:
Univ Complutense, Med Sch, Hosp Univ 12 Octubre, Inst I 12, Madrid, Spain
Dauden, E:
Hosp Univ la Princesa, IIS IP, Madrid, Spain
De la Cueva-Dobao, P:
Hosp Infanta Leonor, Madrid, Spain
Gomez-Garcia, F:
Hosp Univ Reina Sofia, Cordoba, Spain
Herrera-Ceballos, E:
Hosp Univ Virgen de la Victoria, Malaga, Spain
Sanchez-Carazo, J:
Hosp Gen Univ Valencia, Valencia, Spain
Lopez-Estebaranz, J:
Hosp Univ Fdn Alcorcon, Madrid, Spain
Alsina, M:
Hosp Clin Barcelona, Barcelona, Spain
Ferran, M:
Hosp del Mar, Parc Salut Mar, Barcelona, Spain
Torrado, R:
Hosp Univ Gran Canaria Dr Negrin, Las Palmas Gran Canaria, Spain
Carrascosa, J:
Hosp Badalona Germans Trias & Pujol, Badalona, Spain
Llamas-Velasco, M:
Hosp Univ la Princesa, IIS IP, Madrid, Spain
Ortiz, P:
Univ Complutense, Med Sch, Hosp Univ 12 Octubre, Inst I 12, Madrid, Spain
Garcia-Doval, I:
Fdn Piel Sana Acad Espanola Dermatol & Venereol, Res Unit, Madrid, Spain
Complexo Hosp Univ Vigo, Vigo, Spain
Descalzo, M:
Fdn Piel Sana Acad Espanola Dermatol & Venereol, Res Unit, Madrid, Spain
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