Risk of serious infections, cutaneous bacterial infections, and granulomatous infections in patients with psoriasis treated with anti-tumor necrosis factor agents versus classic therapies: Prospective meta-analysis of Psonet registries.
BACKGROUND
Anti-tumor necrosis factor (TNF) therapy in psoriasis has been associated with an increased risk of serious infections compared with nonbiologic systemic therapies.


OBJECTIVE
We sought to quantify the risk of: (1) serious infections (leading to hospitalization, sequelae, or death); and (2) "any infection," bacterial cutaneous infections, and granulomatous infections among patients receiving anti-TNF therapy compared with nonbiologics (acitretin, methotrexate, cyclosporine).


METHODS
We used prospective meta-analysis to combine data from the Psocare registry (Italy), Biobadaderm registry (Spain), and Clalit Health Services database (Israel), including 17,739 patients and 23,357.5 person-years of follow-up.


RESULTS
For serious infections, age, gender, and Charlson morbidity index adjusted hazard ratio of exposure to anti-TNFs compared with nonbiologics was 0.98 (95% confidence interval 0.80-1.19), for bacterial cutaneous infections it was 1.00 (95% confidence interval 0.62-1.61), and for granulomatous infections it was 1.23 (95% confidence interval 0.82-1.84). Using methotrexate as comparator and comparing first year of exposure with later exposure did not modify the results. For any infectious episode, risks and relative risks were heterogeneous among registries, probably because of different definitions of outcome.


CONCLUSIONS
There was lack of power to describe risk of single drugs.


CONCLUSIONS
In current clinical practice, treatment with anti-TNF drugs was not associated with a higher risk of serious infections than treatment with nonbiologic systemic therapy.
Research Unit, Fundación Academia Española de Dermatología y Venereología, Madrid, Spain; Department of Dermatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain. Electronic address: Ignacio.garcia.doval@sergas.es.
Ignacio
I
Garcia-Doval
Department of Quality Measures and Research, Chief Physician Office, Clalit Health Services, Tel Aviv, Israel; Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Arnon D
AD
Cohen
Centro Studi Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED), Fondazione per la Ricerca, Ospedale Maggiore, Bergamo, Italy.
Simone
S
Cazzaniga
Department of Quality Measures and Research, Chief Physician Office, Clalit Health Services, Tel Aviv, Israel; Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Ilan
I
Feldhamer
Department of Epidemiology of the Regional Health Service-Lazio, Rome, Italy.
Antonio
A
Addis
Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain.
Gregorio
G
Carretero
Hospital Universitario Germans Trias i Pujol, Badalona, Universitat Autónoma de Barcelona, Barcelona, Spain.
Carlos
C
Ferrándiz
Department of Dermatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Robert S
RS
Stern
Centro Studi Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED), Fondazione per la Ricerca, Ospedale Maggiore, Bergamo, Italy.
Luigi
L
Naldi
D006099:Granuloma / Q000139:chemically induced / Q000382:microbiology; D006801:Humans; D007239:Infections / Q000139:chemically induced* / Q000453:epidemiology; D011446:Prospective Studies; D011565:Psoriasis / Q000188:drug therapy*; D012042:Registries; D018570:Risk Assessment; D012720:Severity of Illness Index; D017192:Skin Diseases, Bacterial / Q000139:chemically induced* / Q000453:epidemiology; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D014409:Tumor Necrosis Factor-alpha
anti-inflammatory agents; anti–tumor necrosis factor; biological agents; immunosuppressive agents; psoriasis/drug therapy; safety