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 - 18/04/17
, Arnon D. Cohen, MD, PhD c, d, Simone Cazzaniga, PhD e, Ilan Feldhamer, PhD c, d, Antonio Addis, PharmD, PhD f, Gregorio Carretero, MD g, Carlos Ferrándiz, MD, PhD h, Robert S. Stern, MD i, Luigi Naldi, MD, PhD eon behalf of the
Psonet Network
Abstract |
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.
Limitations |
There was lack of power to describe risk of single drugs.
Conclusion |
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.
Le texte complet de cet article est disponible en PDF.Key words : anti-inflammatory agents, anti–tumor necrosis factor, biological agents, immunosuppressive agents, psoriasis/drug therapy, safety
Plan
| Psonet was supported by funding from the European Academy of Dermatology and Venereology and Italian Medicines Agency (AIFA). Biobadaderm was supported by unconditional funding form the Academia Española de Dermatología y Venereología, Agencia Española de Medicamentos y Productos Sanitarios, Abbott, Schering, MSD, Wyeth, Pfizer, and Janssen-Cilag. Psocare was supported by AIFA. None of the funders participated in analysis, writing, or review of the manuscript. |
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| Disclosure: Dr Garcia-Doval received congress travel grants from Pfizer, Janssen, and MSD more than 3 years ago. Dr Cohen served as an advisor, consultant, investigator, or speaker for the following companies: AbbVie, Boehringer Ingelheim, Dexcel Pharma, Janssen, Neopharm, Novartis, Perrigo, Pfizer, and Rafa. Dr Cazzaniga received consultation fees from AbbVie, Janssen-Cilag, and Difa Cooper. Dr Carretero served as a consultant and investigator for Abbott Laboratories, Janssen-Cilag, MSD, and Pfizer; and received grants from Abbott, Jannsen, and Pfizer and equipment from MSD and Pfizer. Dr Ferrándiz served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis including AbbVie, Amgen, Celgene, Janssen-Cilag, Lilly, Novartis, and Pfizer. Dr Stern served as a consultant to Bayer and Bristol Myers Squibb on matters not related to psoriasis. Dr Naldi is a member of the scientific board of the Psolar registry, which is supported by Centocor, and acted as consultant for AbbVie. Drs Feldhamer and Addis have no conflicts of interest to declare. |
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| Supplemental materials are available at www.jaad.org. |
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| Reprints not available from the authors. |
Vol 76 - N° 2
P. 299 - février 2017 Retour au numéro
Article précédent
- From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis
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