No abstract

BackgroundTofacitinib is a new small molecule, Janus kinase 1 and 3 inhibitor, interfering with the JAK-STAT signaling pathway. The JAK-STAT transmits the extracellular information in the cell nucleus, influencing DNA transcription. Its efficacy and safety in Rheumatoid Arthritis (RA) has been demonstrated in different phase II, III and long-term clinical studies. It has been approved in Argentina for the treatment of patients with moderate to severe rheumatoid arthritis RA with failure to conventional DMARDs.ObjectivesTo communicate real world safety data from patients with RA under treatment with Tofacitinib.MethodsA retrospective, descriptive study from patients with RA (ACR/EULAR2010) under treatment with Tofacitinib from September 2014 to December 2016 was conducted. Medical records from patients being treated with Tofacitinib were reviewed and demographic data were recorded. Comorbidities, concomitant treatments, and reported adverse effects were documented.Results62 patients were treated with Tofacitinib. 53 were female and 9 were male, with a mean age of 57.91±14.72 years and average disease duration of 140.09±130.83 months. 18 patients (29%) had at least one comorbidity, the most frequent being hypertension (77%).Of the 62 patients studied, 54 (87%) had established RA (duration of illness greater than 24 months) and 8 patients (13%) with early RA (less than 24 months).In 54 patients Tofacitinib was indicated in combination with another DMARD (87%), and only 6 patients received treatment as monotherapy.The most commonly used DMARD in combination therapy was methotrexate (MTX) in 92.5%Treatments were indicated by failure to MTX or other conventional DMARDs, 12/62 treatments were indicated by failure to treatment with 1 biological DMARD and 13/62 treatments were indicated by failure to two or more biological DMARDs.The maximum exposure time was 21 months.During the time of exposure to Tofacitinib the following adverse events were observed: Herpes Zoster infection 2 cases (monometameric, no visceral involvement in unvaccinated patients), upper airway infection 1 case, transient increase in liver enzymes 1 case, peripheral facial paralysis 1 case, tachycardia 1 case. There were no cases of serious infections, opportunistic infections, cytopenias, dyslipidemia, or increased CPK.Three patients discontinued Tofacitinib: one due to tachycardia, another case peripheral facial paralysis and another case due inefficacy.ConclusionsMost patients received combined treatment with DMARDs being the most commonly used Methotrexate. There were no cases of serious infections, opportunistic infections, cytopenias or dyslipidemia. The use of Tofacitinib in RA patients in our cohort showed a comparable safety profile with long-term extension studies in the treatment of patients with RA diagnosed with failure of conventional or biological DMARDs.Disclosure of InterestNone declared

No abstract

No abstract

BackgroundDysphagia has been reported to occur in 10% to 73% of these patients and can be present at any time during the disease process (1).ObjectivesThe primary objective of the study was to evaluate the prevalence of dysphagia in a cohort of patients with idiopathic inflammatory myopathy (MII) and to evaluate factors associated with the presence of dysphagia. The secondary objective was to evaluate the factors associated with severe dysphagia.MethodsRetrospective, observational study, which included patients with a diagnosis of MII according to modified classification criteria of Bohan and Peter (1992-2018). Demographic data, clinical characteristics, laboratory data, autoantibodies, imaging studies, videodeglution, muscle biopsy and EMG were recorded.Severe dysphagia was considered: one in which oral feeding was contraindicated and/or which required nasogastric tube feeding (SNG) either by clinical evaluation or by videodeglution study. The rest of the patients with dysphagia who did not present a contraindication to oral intake during the course of the disease were considered mild/moderate dysphagia.Results94/110 patients were included, 76% female, mean age at diagnosis: 48 years (SD ± 14). Idiopathic dermatomyositis was the most frequent subtype of myopathy (64%). Dysphagia occurred in 53/94 patients (56.4%) and it was presented at the beginning of the disease in 31/94 (32%). Severe dysphagia was found in (22/94) 23%.When analyzing the clinical features of patients with myopathy and dysphagia, it was found that Idiopathic dermatomyositis was the most frequent MII in these patients (71%). Patients with dysphagia presented: proximal muscle weakness 90%, neck muscles weakness 47%, and respiratory muscle weakness 27%.Treatment received: 90/94 (97%) oral glucocorticoids, mean dose 48 mg of prednisone (Range 4 -100 mg.), pulses of Intravenous methylprednisolone was indicated in 25 patients (27.5%).The main steroid sparing agents used were: 72% methotrexate, followed by 33% azathioprine.Significant association was found between dysphagia and weakness of neck muscles, respiratory muscles, of glucocorticoid pulses, gamma globulin and mortality (data not shown). In the Logistic Regression analysis, no variable was independently associated with the presence of dysphagia.When analyzing the relationship of severe dysphagia and factors associated, a significant association was found with the requirement of mechanical ventilation, hospitalization in an intensive care unit, serious infections, neoplasia and mortality (Table 1). In the multivariate analysis: no associated factors were found independently.Table 1Variable severe dysphagia (present) n=22 (%) severe dysphagia (absent) n=72 (%) p ORIC Weak neck muscles 15 (68%) 18 (25%) <0.001 8.86 2.75-8.86 Weakness of respiratory muscles 10 (45%) 6 (8%) <0.001 9.5 2.8-32 pulses of corticosteroids 17 (77%) 8 (11%) <0.001 25 7.5-89.5 intravenous gammaglobulin 10 (45%) 7 (9%) <0.001 7.73 2.46-24 intensive care unit 8 (36%) 8 (11%) <0.001 4.57 1.46-14.2...