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.
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.


OBJECTIVE
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.
Research Unit, Fundación Academia Española de Dermatología y Venereología, Madrid, Spain.|Dermatology Department, Complexo Hospitalario Universitario de Vigo, Vigo, Spain.
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I
García-Doval
Rheumatology Department, Hospital Clinic, Barcelona, Spain.
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MV
Hernández
Dermatology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
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F
Vanaclocha
Rheumatology Department, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
A
A
Sellas
Dermatology Department, Hospital Universitario Infanta Leonor, Madrid, Spain.
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P
de la Cueva
Division of Pharmacoepidemiology and Pharmacovigilance, Agencia Española del Medicamento y Productos Sanitarios (AEMPS), Madrid, Spain.
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D
Montero
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D018501:Antirheumatic Agents / Q000009:adverse effects*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000453:epidemiology; D001685:Biological Factors / Q000009:adverse effects*; D003879:Dermatologic Agents / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011446:Prospective Studies; D011565:Psoriasis / Q000188:drug therapy* / Q000453:epidemiology; D012307:Risk Factors; D013030:Spain / Q000453:epidemiology; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D018501:Antirheumatic Agents; D001685:Biological Factors; D003879:Dermatologic Agents; D014409:Tumor Necrosis Factor-alpha