POS1156 INFECTIONS AND OTHER ADVERSE EFFECTS WITH BIOLOGICAL THERAPIES OVER THE PAST 10 YEARS

Abstract

Background: Biological therapies have marked a difference in the treatment of many autoimmune conditions. As all treatments, they have their side effects although little evidence of long-term effects has been reported. Objectives: Analyze retrospectively the appearance of infections that required hospitalization and other side effects in patients treated with biological therapies over the past 10 years. Methods: Biological drugs dispensed in our center to non-cancer patients from 2008 to 2018 were reviewed. Health records were collected from our database and all statistical analyzes were performed with the SPSS program. Results: 24 different biological drugs applied to 34 medical conditions; 847 treatments were dispensed over a total of 555 patients. The median age was 44 years with a mean duration of 3.6 years of treatment. The most commonly used drug were adalimumab (n = 280, 33%), infliximab (n = 119, 12%), etanercept (n = 97.13%), rituximab (n = 63, 7%), vedolizumab (n = 47, 5.5%) and omalizumab (n = 43.5%). The rest of the drugs were administered <30 times each (ustekinumab, golimumab, certolizumab, tocilizumab, secukinumab and abatacept), representing <4% of the total sample. The underlying conditions included Crohn's Disease (n = 262, 31%), rheumatoid arthritis (n = 133, 16%), ulcerative colitis (n = 118, 14%), spondyloarthropathies (n = 86, 10%), psoriatic arthritis (n = 56, 7%), psoriasis (n = 49, 6%), asthma (n = 34, 4%), nephropathies (n = 19, 2%) and vasculitis (n = 13, 1.5%). The rest were pathologies with <10 cases. During treatment, infection requiring hospitalization occurred in 10.2% (n = 86). The most frequent focus of infection was respiratory (n = 23, 27%), abdominal (n = 19, 22%), soft tissue-bone (n = 17 cases, 20%), urinary (n = 7, 8%) and tuberculosis (n = 4, 5%). No case of hepatitis reactivation was observed. At the time of hospital admission, 46% of patients were only under biological therapy, 21% had another non-corticosteroid immunosuppressant, 17% were associated with corticosteroid, and 15% had triple therapy (corticosteroids, another immunosuppressant and the biological drug). The drugs associated with more infections were: abatacept 20%, rituximab 16% and adalimumab 13%. During the study period, 14 deaths (1.7%) were observed; being the cause cancer-related (n=5), infection (n=5), the disease itself for which was receiving biological treatment (n=2), and endocrine metabolic causes (n=2). At the end of the review, 48% of the treatments were still in use, while 52% had stopped for various reasons: 20% ineffectiveness, 12% side effects, 12% maintained complete remission. The remaining low percentage was due to death, pregnancy, or study entry. The side effects that led to a change in treatment was: non-immune hematological disorders in 4.1% (14% of tocilizumab, 7% of rituximab and 6% of vedolizumab), immune disorders in 3.8% (6% of secukinumab, 5% of tocilizumab and 4.5% of certolizumab), nervous system involvement in 2.4% (11.5% of golimumab,10% of abatacept, 5% of tocilizumab), debut or worsening of heart failure in 1.4% (9, 5% of tocilizumab, 2.5% of etanercept and 1.4% of adalimumab) and cancer-related in 0.7% (2% of infliximab, 1.7% of etanercept). Conclusion: In these 10 years of follow-up and and evaluating 847 treatments, there were 10% hospitalizations due to infections (n = 86) causing death in 5 patients. In light of these results, and pending an exhaustive statistical analysis, we did not find high frequencies of serious side effects in our series. Very little long-term evidence exists on the safety of these drugs.