Infections in Moderate to Severe Psoriasis Patients Treated with Biological Drugs Compared to Classic Systemic Drugs: Findings from the BIOBADADERM Registry.
Information regarding the safety of biological drugs prescribed to psoriasis patients on daily and long-term bases is insufficient. We used data from the BIOBADADERM registry (Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases) to generate crude rates of infection during therapy with systemic drugs, including biological drugs (infliximab, etanercept, adalimumab, and ustekinumab) and nonbiological drugs (acitretin, cyclosporine, and methotrexate). We also calculated unadjusted and adjusted risk ratios (RRs) (with propensity score adjustment) of infection, serious infections, and recurrent infections of systemic therapies compared with methotrexate, using Poisson regression. Our study included records of 2,153 patients (7,867.5 person-years). The adjusted RR of overall infection was significantly increased in the groups treated with adalimumab with methotrexate (adjusted RR = 2.13, 95% confidence interval [CI] = 1.2-3.7), infliximab (adjusted RR = 1.71, 95% CI = 1.1-2.65), cyclosporine (adjusted RR = 1.58, 95% CI = 1.17-2.15), ustekinumab with methotrexate (adjusted RR = 1.56, 95% CI = 1.08-2.25), and etanercept (adjusted RR = 1.34, 95% CI: 1.02-1.76) compared with methotrexate alone. Cyclosporine had a significant risk of serious infection (adjusted RR = 3.12, 95% CI = 1.1-8.8), followed by adalimumab combined with methotrexate (adjusted RR = 3.28, 95% CI = 0.8-13.5). Adalimumab in combination with methotrexate had the highest risk of infection recurrence (adjusted RR = 4.33, 95% CI = 2.27-8.24).
Research Unit, Fundación Academia Española de Dermatología y Venereología, Madrid, Spain; Dermatology and Venereology Department, Umeå University Hospital, Umeå, Sweden. Electronic address: pauladavilaseijo@gmail.com.
Paula
P
Dávila-Seijo
Dermatology Department, Hospital Universitario La Princesa, Madrid, Spain.
Esteban
E
Dauden
Research Unit, Fundación Academia Española de Dermatología y Venereología, Madrid, Spain.
M A
MA
Descalzo
Dermatology Department, Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain.
Gregorio
G
Carretero
Dermatology Department, Hospital Universitario Germans Trias i Pujol, Badalona, Spain.
José-Manuel
JM
Carrascosa
Dermatology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
Francisco
F
Vanaclocha
Dermatology Department, Hospital Universitario Reina Sofía, Córdoba, Spain.
Francisco-José
FJ
Gómez-García
Dermatology Department, Hospital Infanta Leonor, Madrid, Spain.
Pablo
P
De la Cueva-Dobao
Dermatology Department, Hospital Universitario Virgen de la Victoria, Málaga, Spain.
Enrique
E
Herrera-Ceballos
Dermatology Department, Hospital General Universitario de Alicante, Departamento de Medicina Clínica, Universidad Miguel Hernández, ISABIAL-FISABIO, Alicante, Spain.
Isabel
I
Belinchón
Dermatology Department, Hospital Universitario Fundación Alcorcón, Madrid, Spain.
José-Luis
JL
López-Estebaranz
Dermatology Department, Hospital Clinic de Barcelona, Barcelona, Spain.
Merce
M
Alsina
Dermatology Department, Hospital General Universitario de Valencia, Valencia, Spain.
José-Luis
JL
Sánchez-Carazo
Dermatology Department, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain.
Marta
M
Ferrán
Dermatology Department, Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain.
Rosa
R
Torrado
Dermatology Department, Hospital Universitario Germans Trias i Pujol, Badalona, Spain.
Carlos
C
Ferrandiz
Dermatology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
Raquel
R
Rivera
Dermatology Department, Hospital Universitario La Princesa, Madrid, Spain.
Mar
M
Llamas
Dermatology Department, Hospital Universitario Reina Sofía, Córdoba, Spain.
Rafael
R
Jiménez-Puya
Research Unit, Fundación Academia Española de Dermatología y Venereología, Madrid, Spain; Dermatology Derpartment, Complexo Hospitalario Universitario de Vigo, Vigo, Spain.
Ignacio
I
García-Doval
D000068879:Adalimumab / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000209:etiology*; D001688:Biological Products / Q000009:adverse effects*; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D016012:Poisson Distribution; D011565:Psoriasis / Q000150:complications / Q000188:drug therapy*; D012042:Registries
D001688:Biological Products; D016572:Cyclosporine; D000068879:Adalimumab; D008727:Methotrexate