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

2016 ◽  
Vol 176 (3) ◽  
pp. 643-649 ◽  
Author(s):  
I. García-Doval ◽  
M.V. Hernández ◽  
F. Vanaclocha ◽  
A. Sellas ◽  
P. de la Cueva ◽  
...  
2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S338-S339
Author(s):  
P Andersson ◽  
P Karling

Abstract Background Immunomodulators (IM) and tumour necrosis factor antagonist therapy (anti-TNF) are effective treatments for inflammatory bowel disease (IBD) but has been associated with an increased risk for infectious diseases. We investigated the frequency of infectious events in patients with IBD and the association of infectious events with concomitant treatment with IM and anti-TNF therapy. Methods We performed a retrospective medical chart review of patients with IBD, 18 to 65 years of age, included in the Swedish Registry of IBD (SWIBREG) and treated in the catchment area of Umeå University Hospital, Sweden. Data were collected from the period January 1, 2006, to January 31, 2019. An infectious event was defined as an outpatient prescription of antimicrobials or a positive diagnostic test for infection. Results Among the 593 included patients (397 patients with UC and 195 patients with CD), 1398 events occurred. The proportion of events that occurred on treatment with corticosteroids, IM, anti-TNF, combination therapy (IM + anti-TNF) and without any immunosuppressive treatments was 8.3%, 35.8%, 17.7%, 10.0% and 47.4%. Of all patients, 60.4% had at least one infectious event, and 29.3% had >0.3 events per year. Compared with patients not receiving immunosuppressive therapy, an event rate of >0.3 per year was more common among those receiving immunomodulator monotherapy or combination therapy (Table), and was more common in patients with Crohn’s disease than ulcerative colitis (35.0% vs. 26.1%, p = 0.022). There were no significant differences in infectious events between patients who had received immunomodulator monotherapy and patients who had received combination therapy. Conclusion We found an increased frequency of infection associated with the use of combination therapy and immunomodulator monotherapy, but no difference between the two treatments.


2011 ◽  
Vol 71 (3) ◽  
pp. 382-385 ◽  
Author(s):  
Juan J Gómez-Reino ◽  
Carlos Rodríguez-Lozano ◽  
Cristina Campos-Fernández ◽  
María Montoro ◽  
Miguel Ángel Descalzo ◽  
...  

ObjectiveTo investigate in rheumatoid arthritis (RA) the rate and reason of discontinuation of tumour necrosis factor (TNF) antagonists over the past decade.MethodsRA patients in BIOBADASER 2.0 were stratified according to the start date of their first TNF antagonist into 2000–3, 2004–6 and 2007–9 interval years. Cumulative incidence function of discontinuation for inefficacy or toxicity was estimated with the alternative reason as competing risk. Competing risks regression models were used to measure the association of study groups with covariates and reasons for discontinuation. Association is expressed as subhazard ratios (SHR).Results2907 RA patients were included in the study. Competing risk regression for inefficacy shows larger SHR for patients starting treatment in 2004–6 (SHR 2.57; 95% CI 1.55 to 4.25) and 2007–9 (SHR 3.4; 95% CI 2.08 to 5.55) than for those starting in 2000–3, after adjusting for TNF antagonists, clinical activity and concomitant treatment. Competing risk regression analysis for adverse events revealed no differences across the three time intervals.ConclusionsIn RA, the discontinuation rate of TNF antagonists in the first year of treatment is higher more recently than a decade ago, inefficacy being the main reason for the increased rate. The rate of discontinuation for adverse events has remained stable.


2015 ◽  
Vol 45 (5) ◽  
pp. 1510-1512 ◽  
Author(s):  
Richard J. Hewitt ◽  
Aran Singanayagam ◽  
Saranya Sridhar ◽  
Melissa Wickremasinghe ◽  
Onn Min Kon

BMJ Open ◽  
2014 ◽  
Vol 4 (9) ◽  
pp. e005532-e005532 ◽  
Author(s):  
A. Fisher ◽  
K. Bassett ◽  
J. M. Wright ◽  
M. A. Brookhart ◽  
H. J. Freeman ◽  
...  

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