Objectives: Interstitial lung disease (ILD) occurs in up to 30% of patients with rheumatoid arthritis (RA), resulting in increased morbidity and death in the absence of proven therapies. The aim of this study is to estimate the number of incident ILD cases reported through development studies with baricitinib in patients with RA. Methods: Estimates were based on 3770 patients with RA from eight randomized clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension study on baricitinib for which ILD was not an exclusion criterion with 12,358 patient-years of exposure (PYE).Results: Twenty-one non-infectious cases of ILD were reported with an exposure-adjusted incidence rate (EAIR) of 0.17 per 100 PYE. Of the 21 cases, six were reported as serious and 15 as non-serious resulting in an incidence rate of 0.05 per 100 PYE and 0.12 per 100 PYE, respectively. There were also 11 cases caused by an infectious agent: seven serious (IR: 0.06 per 100 PYE) and four non-serious cases (IR: 0.03 per 100 PYE). Conclusions: The findings of this analysis in patients with RA treated with baricitinib are consistent with a low risk to develop non-infectious ILD during baricitinib treatment, similar to that observed with other Janus kinase inhibitors.
BackgroundUveitis is the most frequent extra-articular manifestation (EAM) of spondyloarthritis (SpA). Its prevalence is approximately 30% and increases with the duration of the SpA. The characteristic pattern is anterior, acute, recurrent and unilateral uveitis. However, the frequency and characteristics of uveitis in SpA treated with biological therapy (BT) are unknown.ObjectivesThe main target is to describe the frequency and characteristics of uveitis in SpA with BT in a single centre.MethodsDescriptive and retrospective study (January 2003-December 2017) of SpA that develops uveitis in a reference hospital. The epidemiological variables, type of SpA, presence of uveitis and its characteristics, presence of BT at the time of onset and treatment received are collected. For the analysis, frequencies and percentages were used in qualitative variables, and mean and standard deviation (SD) for quantitative variables. Statistical analysis was performed with IBM SPSS v.23.ResultsWe studied 246 patients with SpA. The subtypes of SpA were: ankylosing spondylitis (AS) (n=125, 50.8%), psoriatic arthritis (PsA) (n=101, 41.1%), undifferentiated SpA (n=13, 5.3%), non-radiographic axial Spa (n=3, 1.2%), enteropathic arthropathy (n=3, 1.2%) and reactive arthritis (n=1, 0.4%).Uveitis was observed in 41 patients (16.7%) after an average time of development of 109.47 (73.9) months of the SpA. The incidence rate was 5.5 cases of uveitis/100 patients-year of follow-up. 70.7% were men and the mean age(SD) was 47.4 (12.06) years. 87.8% of the cases were HLAB27 positive and had a family history of SpA 41.5%.Uveitis was observed in 33 patients (80.5%) with AS, in 6 (14.6%) with PsA, in 1 (2.4%) with non-Rx axial SpA and in 1 (2.4%) with undifferentiated SpA. (table 1)The uveitis pattern was anterior (100%), acute (92.7%), unilateral (87.8%) and in 12.2% bilateral (80% in PsA). At the time of onset of uveitis, the mean ESR was 30.11 mm1ªh, CRP 3.56 mg/dL, DAS28 3.66 and BASDAI 3.21.Regarding the diagnosis of SpA, uveitis was after (85.4%), before (12.2%) and simultaneous (2.4%).At the time of the onset of uveitis, 14 patients (34.1%) were with BT (35.7% etanercept, 28.6% infliximab, 21.4% adalimumab, 7.1% golimumab and 7.1% certolizumab). BT was modified in 3 of the cases.The treatment of uveitis was topical (78%), corticoids in oral regimen (57.5%), conventional DMARDs (12.5%), with methotrexate predominating in 60% of cases and BT (15%). The most used biologics were adalimumab (50%), infliximab (33.3%) and sekukinumab (16.7%).Abstract THU0259 – Table 1Characteristics of the UVEITIS in SpA subtypesConclusionsIn our series, uveitis was observed in 16.7% of patients with SpA of which 80.5% were AS and 14.6% PsA. The most frequent uveitis was anterior, unilateral, acute and recurrent. In PsA, the association with HLA B27 was less frequent and was more bilateral. In most cases, the diagnosis was later than the SpA.Disclosure of InterestNone declared
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...
Background The efficacy of ustekinumab in patients with Crohn’s disease (CD) refractory to anti-TNF is worse than in anti-TNF naïve patients. Methods Retrospective study of patients with CD refractory or intolerant to TNF initiating ustekinumab between January 2013 and March 2020, with a minimum follow-up of 12 months, and without corticosteroid treatment. Our aim was evaluated clinical response (reduction of CDAI >100), clinical remission (CDAI <150) and biochemical remission (CDAI <100 and CRP <1 mg/L and faecal calprotectin <100 µg/g) in short and long term. Results A total of 49 patients with a medium follow-up of 28 months (IQR:13-37) were included. Patients baseline characteristics are reflected in Table 1. In 20% patients the induction was made subcutaneous (90 mg/week for 4 weeks). At week 52, clinical response, clinical remission and biochemical remission was 93%, 82% and 54% respectively (Figure 1). In the long term (3 years), 62% had clinical response, 52% remained in clinical remission, and 48% showed biochemical remission. 1/3 of patients needed intensification every year. Ustekinumab treatment discontinuation was observed in 13 patients (27%) mainly due to lack of response (6[12%]: primary, 7[14%]: secondary). No serious adverse effects have been reported. Conclusion About 50% of the patients are in clinical and biochemical remission at week 152 in a real-life cohort of anti-TNF-exposed CD patients. With a harder remission definition including biochemical parameters, our results in real life are similar to pivotal studies at week 152. Nevertheless, at week 52 our remission rates were higher.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.