Background The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis. Methods The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudorandom number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178.
Objective. To compare the efficacy of infliximab (IFX) versus adalimumab (ADA) as a first-line biologic drug over 1 year of treatment in a large series of patients with refractory uveitis due to Behçet's disease (BD).Methods.We conducted an open-label multicenter study of IFX versus ADA for BD-related uveitis refractory to conventional nonbiologic treatment. IFX or ADA was chosen as the first-line biologic agent based on physician and patient agreement. Patients received 3-5 mg/kg intravenous IFX at 0, 2, and 6 weeks and every 4-8 weeks thereafter, or 40 mg subcutaneous ADA every other week without a loading dose. Ocular parameters were compared between the 2 groups.Results. The study included 177 patients (316 affected eyes), of whom 103 received IFX and 74 received ADA. There were no significant baseline differences between treatment groups in main demographic features, previous therapy, or ocular sign severity. After 1 year of therapy, we observed an improvement in all ocular parameters in both groups. However, patients receiving ADA had significantly better outcomes in some parameters, including improvement in anterior chamber inflammation (92.31% versus 78.18% for IFX; P = 0.06), improvement in vitritis (93.33% versus 78.95% for IFX; P = 0.04), and best-corrected visual acuity (mean ± SD 0.81 ± 0.26 versus 0.67 ± 0.34 for IFX; P = 0.001). A nonsignificant difference was seen for macular thickness (mean ± SD 250.62 ± 36.85 for ADA versus 264.89 ± 59.74 for IFX; P = 0.15), and improvement in retinal vasculitis was similar between the 2 groups (95% for ADA versus 97% for IFX; P = 0.28). The drug retention rate was higher in the ADA group (95.24% versus 84.95% for IFX; P = 0.042).Conclusion. Although both IFX and ADA are efficacious in refractory BD-related uveitis, ADA appears to be associated with better outcomes than IFX after 1 year of follow-up. 9 Manuel Díaz-Llopis, MD, PhD, ATIENZA-MATEOETAL | PATIENTS AND METHODS Study design, enrollment criteria, and definitions.We conducted an observational, open-label multicenter study including 177 patients with refractory uveitis due to BD who were treated with IFX or ADA as first-line biologic therapy. The dosing schedule was as follows: for IFX, 3-5 mg/kg intravenously (IV) at
Background Recently there have been studies showing the presence of inflammatory joint activity in patients with systemic lupus erythematosous (SLE) without musculoskeletal symptoms. The predictive value of these findings remains unknown. On the other hand, there is a proportion of healthy patients where synovitis can be demonstrated as a result of recent mechanical overexertion. Objectives The aim of this study is to compare the sonographic findings of SLE patients without joint symptoms with healthy people. Methods An ultrasonographic study (USS) was performed, using a linear probe for soft tissues (5-12 MHz), to 15 patients newly diagnosed with SLE and 44 healthy subjects matched for age and sex. The areas studied were: back of the wrist, 2nd and 3rd metacarpophalangeal joint (MCP) and 2nd and 3rd flexor tendon. The studies were performed in the nondominant hand. We determined the presence of synovitis, tenosynovitis and tendinosis and measured the thickness of the flexor tendons. Dichotomous variables were analyzed using the chi-square test and numerical variables through the Student t test. Results Controls were matched with SLE patients of the same sex and age with a maximum difference of ± 3 years. SLE patients came from a cohort previously used in another study with no less than 5 years follow-up. Controls were healthy volunteer patients from the osteoporosis clinics or patients with localized non-inflammatory diseases outside the field of USS. Carpal sinovitis was seen in 33,3% of SLE patients and 27,2% of controls (p<0,05); metacarpophalangeal (MCP) synovitis was seen in 33,3% of SLE patients and 13,6% of controls (p<0,05); carpal tenosynovitis was seen in 40% of SLE patients and 13,6% of controls (p<0,05). The height of the synovial capsule of the carpal joint was 3,67±0,21 in SLE patients and 2,99±0,30 in the control group (p<0,001); Thickness of the extensor sheath was 2,99±0,42 in SLE patients and 2,49±0,36 in the control group (p<0,05); height of the capsule of the 2nd MCP joint was 3,19±0,27 in SLE patients and 3,04±0,19 in the control group (p>0,05); height of the capsule of the 3rd MCP joint was 2,91±0,52 in SLE patients and 2,54±0,32 in the control group. In order to compare MCP capsules height we assay a corection using the lenght of the major axis of the joint. The fixed height of the 2nd MCP was 0,461±0,121 and 0,406±0,098 (SLE/controls) (p<0,001); the fixed height of the 3rd MCP was 0,445±0,200 and 0,3642±0,117 (p<0,001). Conclusions Our results suggest that the population of SLE patients without joint symptoms present sonographic findings suggestive of joint inflammation and tendon involvement that can not be explained by the acceptable changes that can be found in disease-free population, however, interpretation of their evolutionary significance has not been clarified. The role of time since diagnosis in the development of synovitis or tendinosis, or corticoids in the development of tendinosis may be revealed with studies with larger amounts of patients. Disclosure of Interest None D...
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