Should tumour necrosis factor antagonist safety information be applied from patients with rheumatoid arthritis to psoriasis? Rates of serious adverse events in the prospective rheumatoid arthritis BIOBADASER and psoriasis BIOBADADERM cohorts. (3rd October 2016)

• Record Type: Journal Article
• Authors: García‐Doval, I.; Hernández, M.V.; Vanaclocha, F.; Sellas, A.; de la Cueva, P.; Montero, D.
• Other Names: Rodríguez Basilio investigator.; Barceló Mireia investigator.; Farietta Sandra investigator.; Montoro María investigator.; González Ainhoa investigator.; Herráez Elena investigator.; Ruíz‐Montesino Mª Dolores investigator.; Vargas Carmen investigator.; Pérez‐Pampín Eva investigator.; Ortiz Ana Mª investigator.; Tomero Eva investigator.; Sifuentes Alberto investigator.; Antón Fred investigator.; Zea Antonio investigator.; Manero Ruiz Francisco Javier investigator.; Beltrán Chesús investigator.; Giménez Úbeda Eugenio investigator.; Jimenez Zorzo Fernando investigator.; Marzo Jesús investigator.; Medrano Marta investigator.; Pecondón Ángela investigator.; Sanmartí Raimon investigator.; Cañete Juan D. investigator.; Rodriguez Lozano Carlos investigator.; Naranjo Antonio investigator.; Ojeda Soledad investigator.; Hernández Félix Francisco investigator.; Erausquin Celia investigator.; Rúa Íñigo investigator.; Quevedo Juan Carlos investigator.; Manrique Sara investigator.; Ureña Inmaculada investigator.; Irigoyen María Victoria investigator.; Cano Laura investigator.; Pardo Rosa Roselló investigator.; Mateo Isabel investigator.; Garcia Javier investigator.; Enríquez Eugenia investigator.; Campos Cristina investigator.; García Borras Juan José investigator.; Nogueroles Rosa investigator.; Muñoz Luisa investigator.; Luis Valero José investigator.; Ibáñez Andrés investigator.; Carretero Hernández Gregorio investigator.; Torrado Rosa investigator.; Carrascosa Carrillo José Manuel investigator.; Ferrándiz Carlos investigator.; Rivera Raquel investigator.; Dauden Esteban investigator.; Llamas Mar investigator.; Mejías Sagrario Galiano investigator.; Gómez García Francisco José investigator.; Jiménez Puya Rafael investigator.; Herrera Enrique investigator.; Mendiola Mª Victoria investigator.; Belinchón Romero Isabel investigator.; Sánchez Carazo José Luis investigator.; López Estebaranz José Luis investigator.; Ruiz Genao Diana investigator.; Alsina Mercè investigator.; Ferran Marta investigator.;
• Is Part Of: British journal of dermatology. Volume 176:Number 3(2017)
• Page Start: 643
• Page End: 649
• Publication Date: 2016-10-03
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.14776
• Languages: English
• ISSNs: 0007-0963

Abstract

Summary: Background: Information on the safety of tumour necrosis factor (TNF) antagonists frequently arises from their use in rheumatic diseases, their first approved indications, and is later applied to psoriasis. Whether the risk of biological therapy is similar in psoriasis and rheumatoid arthritis has been considered a priority research question. Objectives: To compare the safety profile of anti‐TNF drugs in patients with rheumatoid arthritis and psoriasis. Methods: We compared two prospective safety cohorts of patients with rheumatoid arthritis and psoriasis that share methods (BIOBADASER and BIOBADADERM). Results: There were 1248 serious or mortal adverse events in 16 230 person‐years of follow‐up in the rheumatoid arthritis cohort (3171 patients), and 124 in the 2760 person‐years of follow‐up of the psoriasis cohort (946 patients). Serious and mortal adverse events were less common in patients with psoriasis than in rheumatoid arthritis (incidence rate ratio of serious adverse events in psoriasis/rheumatoid arthritis: 0·6, 95% confidence interval 0·5–0·7). This risk remained after adjustment for sex, age, treatment, disease, hypertension, diabetes, hypercholesterolaemia and simultaneous therapy with methotrexate (hazard ratio 0·54, 95% confidence interval 0·47–0·61), and after excluding patients receiving corticosteroids. Patients with rheumatoid arthritis showed a higher rate of infections, cardiac disorders, respiratory disorders and infusion‐related reactions, whereas patients with psoriasis had more skin and subcutaneous tissue disorders and hepatobiliary disorders. Conclusions: Patients with rheumatoid arthritis clinical practice have almost double the risk of serious adverse events compared with patients with psoriasis, with a different pattern of adverse events. Safety data from rheumatoid arthritis should not be fully extrapolated to psoriasis. These differences are likely to apply to other immune‐mediated inflammatory diseases. Abstract : What's already known about this topic? Safety results from the use of biologics in some immune‐mediated inflammatory diseases, such as rheumatoid arthritis, are frequently applied to others, such as psoriasis. What does this study add? Safety results from studies of rheumatoid arthritis patients are not fully applicable to psoriasis patients, as the rate of serious adverse events in rheumatoid arthritis patients is almost double, and the pattern of adverse events is different. Linked Comment: Puig. Br J Dermatol 2017;176 :567–568 .