BackgroundPatients with Systemic Autoimmune Diseases (SADs), in particular, systemic sclerosis, are prone to suffer from severe Raynaud's phenomenon (RP), accompanied with digital ulcers secondary to ischemia and associated with a high rate of morbidity and mortality. Bosentan, a dual endothelin receptor antagonist, is a therapeutic option for refractory cases with an inadequate response to conventional management.ObjectivesThe objectives of our study were: i) to assess safety and efficacy of bosentan in patients suffering from different kinds of SADs and active digital ulcers secondary to RP, ii) to determine predictive factors of response, and iii) to identify predictive factors for survival.MethodsThis is a retrospective observational study of patients suffering from SADs and digital ulcers secondary to RP, treated with bosentan in our department between January 1st, 2005 and December 31st, 2014. Patients with ischemic ulcers caused by other factors were excluded. The following baseline independent variables were considered: type of SAD, exposition to cold or to toxic substances, clinical and epidemiological characteristics, concomitant treatments, the coexistence of pulmonary hypertension, and number and location of digital ulcers. Therapeutic response, adverse effects, the need for amputation and death were considered as dependent outcome variables. Chi-square, Student t test, and Mann-Whitney U test were used to establish statistical significance in the univariate analysis between independent baseline variables and outcomes. A p<0.05 was considered significant.ResultsWe included 31 patients (26 women, mean age 57 years). Twenty patients had systemic sclerosis (10 cases the limited form, and 10 cases the diffuse form). Eight patients had concomitant pulmonary hypertension. Mean follow-up after starting bosentan was 1470 days. Six patients had, at least, an adverse effect, being the most frequent alterations of liver function tests. In 87% of the cases, ulcers improved significantly, with a clinical response within the first 12 weeks of treatment in 77% of the cases. Ninety percent of the patients received concomitant treatment with calcium channel blockers and 45% had received previous treatment with prostaglandins. Despite bosentan therapy, amputation was done in 4 patients. Type of SAD, gender, or exposition to cold did not show any significant correlation with morbidity and mortality. Nine patients died. Smoking habit showed a correlation with death (p=0.05). There was a significant correlation between the duration of the disease and death (p=0.0235), as well as with the age of the patient (p=0.0013). Pulmonary hypertension was predictive of a poor therapeutic response (p=0.043) and mortality (p=0.015).ConclusionsThis open study suggests that bosentan is an effective agent for ischemic digital ulcers in patients with SADs, with a favorable safety profile. Age and associated pulmonary hypertension are predictors of mortality and poor outcome.Disclosure of InterestNone declared
BackgroundDenosumab (DB) is a monoclonal antibody to RANK ligand that, like all biological drugs, can be associated with an increased risk of infections. However, there are few studies concerning the risk of infection in these patients treated concomitantly with DB and other biologic drugs.ObjectivesThis study aims at determining whether the treatment with biological drugs and DB combined is associated with an increased risk of adverse effects in patients with autoimmune diseases.MethodsRetrospective observational study of patients treated with DB combined with other biological drugs at the Hospital of León between 2010–2017. For proper patient selection, the data obtained from the medical prescription program of primary care and the data from the registry of outpatients and walk-in patients of hospital pharmacy were cross-referenced.To determine the increased risk, a control group of patients treated both with bisphosphonates (BF) and with biological agents was selected.The data collected in both groups were: age, sex, diagnosis, comorbidities and other prescribed drugs. Infection, tumour or other adverse effects appeared three months, six months, one year and two years after starting the concomitant treatment. When performing the statistical analysis, it was analysed the time elapsed until the first adverse effect appeared.ResultsA total n of 28 patients was registered. 16 were treated with BF and biological agents, and 12 were treated with DB and other biological drugs. The prevalence of women was higher in both groups (87.5% BF, 91.7% DB). The mean age at the beginning of the concomitant treatment was similar, being 69.1±8.5 years in the BF group and 69.7±7.1 years in the DB group. All patients treated with DB were diagnosed with RA. Regarding the comorbidities, it seems that those patients treated with DB had fewer CVRF than those treated with BF (68.8% HBP in BF versus 50% in DB, 37.5% dyslipidaemia in BF versus 33.3% in DB). The biological drugs prescribed to be used concomitantly with DB were: 49.7%anti-TNFα, 33.3%rituximab, 8.3%abatacept and 8.3%tocilizumab.In addition, there were no significant differences regarding the application time of the concomitant treatment with biological agents in the BF (35.7±26.7 months) and DB (58.6±43.7 months) groups; being in both groups similar. By comparing both groups, it is observed that those patients treated concomitantly with DB and other biological drugs, have more infections and these appear earlier in time than in patients treated with BF and biological agents (p<0.005). Only one patient in the DB group had a tumour of pulmonary nature as an adverse effect.There were no differences in the appearance of adverse effects in patients with other comorbidities or concomitant treatments.ConclusionsIt seems that the treatment of DB combined with other biological drugs is associated with a greater number of adverse effects, mainly caused by infections, and having an earlier appearance.More studies and a larger sample would be necessary to confirm this association and to ...
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