The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group IMPORTANCE Clinical trials assessing the efficacy of IL-6 antagonists in patients hospitalized for COVID-19 have variously reported benefit, no effect, and harm.OBJECTIVE To estimate the association between administration of IL-6 antagonists compared with usual care or placebo and 28-day all-cause mortality and other outcomes.DATA SOURCES Trials were identified through systematic searches of electronic databases between October 2020 and January 2021. Searches were not restricted by trial status or language. Additional trials were identified through contact with experts.STUDY SELECTION Eligible trials randomly assigned patients hospitalized for COVID-19 to a group in whom IL-6 antagonists were administered and to a group in whom neither IL-6 antagonists nor any other immunomodulators except corticosteroids were administered. Among 72 potentially eligible trials, 27 (37.5%) met study selection criteria. DATA EXTRACTION AND SYNTHESISIn this prospective meta-analysis, risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I 2 statistic. The primary analysis was an inverse variance-weighted fixed-effects meta-analysis of odds ratios (ORs) for 28-day all-cause mortality. MAIN OUTCOMES AND MEASURESThe primary outcome measure was all-cause mortality at 28 days after randomization. There were 9 secondary outcomes including progression to invasive mechanical ventilation or death and risk of secondary infection by 28 days.RESULTS A total of 10 930 patients (median age, 61 years [range of medians, 52-68 years]; 3560 [33%] were women) participating in 27 trials were included. By 28 days, there were 1407 deaths among 6449 patients randomized to IL-6 antagonists and 1158 deaths among 4481 patients randomized to usual care or placebo (summary OR, 0.86 [95% CI, 0.79-0.95]; P = .003 based on a fixed-effects meta-analysis). This corresponds to an absolute mortality risk of 22% for IL-6 antagonists compared with an assumed mortality risk of 25% for usual care or placebo. The corresponding summary ORs were 0.83 (95% CI, 0.74-0.92; P < .001) for tocilizumab and 1.08 (95% CI, 0.86-1.36; P = .52) for sarilumab. The summary ORs for the association with mortality compared with usual care or placebo in those receiving corticosteroids were 0.77 (95% CI, 0.68-0.87) for tocilizumab and 0.92 (95% CI, 0.61-1.38) for sarilumab. The ORs for the association with progression to invasive mechanical ventilation or death, compared with usual care or placebo, were 0.77 (95% CI, 0.70-0.85) for all IL-6 antagonists, 0.74 (95% CI, 0.66-0.82) for tocilizumab, and 1.00 (95% CI, 0.74-1.34) for sarilumab. Secondary infections by 28 days occurred in 21.9% of patients treated with IL-6 antagonists vs 17.6% of patients treated with usual care or placebo (OR accounting for trial sample sizes, 0.99; 95% CI, 0.85-1.16). CONCLUSIONS AND RELEVANCEIn this prospective meta-analysis of clinical trials of patients hosp...
Primary bone marrow edema syndrome (BMES) is characterized by the combination of joint pain and distinctive magnetic resonance imaging changes. It has been suggested that the use of bisphosphonate drugs reduce symptom severity. Our objective was to review cases of patients diagnosed with BMES in the last 7 years who had been treated with zoledronic acid. Access to a pharmaceutical database was gained in order to obtain a list of zoledronic acid prescriptions. Based on clinical and MRI criteria for BMES, patients were selected. Baseline pain intensity was evaluated on a scale of 0 to 3 and was also assessed after 3 and 12 months. Functional recovery was evaluated by noting if a patient had returned to carrying out his or her normal daily activities. Out of 633 patients, 17 cases of BMES were identified (8 men), with a median age of 54 ± 14.1 years. The most frequently affected joint was the ankle (9), followed by the hip. Sixteen patients presented with moderate to severe pain initially. Of those patients, 13 had no pain after 12 months. Zoledronic acid is a option in the management of BMES, since 75% of patients treated with it presented with a complete response.
The results of the study show that initial surgical treatment in patients with native joint septic arthritis is not superior to IMT. However, half of the patients with shoulder and hip infections treated with IMT eventually required surgical intervention, suggesting that perhaps this should be the preferred initial approach in these cases.This is an open-access article distributed under the terms of the Creative Commons Attribution -Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
Background:Sialodochitis fibrinosa is a rare disease which is characterized by recurring episodes of pain and swelling of the salivary glands due to the formation of mucofibrinous plugs. Analytic studies ascertain elevated levels of eosinophils and immunoglobulin E (IgE). Imaging studies such as magnetic resonance imaging (MRI) and sialography reveal dilation of the main salivary duct (duct ectasia). Treatment is initially supportive, consisting of compressive massages, and use of antihistamines and/or corticosteroids.Material and methods:In the following, 3 cases of sialodochitis fibrinosa are presented which were diagnosed in a third level hospital during the period of 2008 and 2016, as well as a literature review of all cases reported to our knowledge.Results:Of the 41 cases found, including the 3 of this article, 66% were women with an average age of 45 years old. However, 75% of reported cases were of Japanese heritage. Involvement of the parotid glands was more frequent than the submandibular glands. In more than half of all cases treatment with compressive massages, antihistamines and/or corticosteroids was effective.Conclusion:Clinicians should consider sialodochitis fibrinosa as a diagnostic possibility when presented with cases of recurring parotid and submandibular gland tumescence.
Background:Gender-related biochemical, hormonal and psychological factors could play an important role in the response to TNF blocker therapy in psoriatic arthritis (PsA). Scarce data are available analyzing differences in effectiveness and safety of the antiTNFs, and none in particular with Certolizumab Pegol (CZP) according to the gender.Objectives:To evaluate the influence of the gender in the effectiveness and safety of CZP in the routine clinical setting in PsA patients.Methods:Observational, national and muticentric cohort (approved by local ethical committee), PsA patients treated with CZP according to routine clinical practice were studied for 12 months. Clinical and disease characteristics and disease activity between gender were compared. Safety analysis: adverse events and withdrawn.Results:347 PsA patients were analyzed. No statistical differences were found between women and men at baseline in demographics, clinical variables, except for previous biologic treatment and ESR (Table 1). In both genders, a statistical significant decreased was observed after 1 year of CZP treatment in the following variables: DAS28(CRP); SJC; TJC; PGA (patient global ssesment);% patients with enthesitis, dactilytis and nail disease; but with no differences between females and males. Variables that influence the response at 12 months are: disease duration, CRP and TJC at baseline. Drug survival of CZP was 80.1%, and no differences were observed in gender. Adverse events related to CZP were observed in 9.5% and 19.9% withdrawn treatment: 12.4% due to lack of effectiveness, 4.0% due to intolerance and 3.5% other reasons.Conclusion:CZP has shown to be effective and safe in PsA patient after a year of treatment in clinical practice regardless patient’s gender.Abstract aB0749 Table 1Baseline demographic, clinical and disease activity characteristics. Demographic variables Female Male Gender, n (%)196 (56.5) N=347151 (43.5) N=347Age, median (min-max), years48.5(22.3;81.1) N=18850.5 (22.0;78.0) N=137No smoking, n (%)137 (79.2) N=17379 (56.8) N=139 Disease characteristics Disease duration, mean (Q1-Q3)6.5 (1.8-8.7) N=1886.9 (1.2-10.0) N=137Presence of HLAB2728 (20.3) N=13813 (13.0) N=100Previous biologics· 0· 1· ≥2N=15537 (23.9)67 (43.2)51 (32.9)N=12448 (38.7)42 (33.9)34 (27.4) Disease activity TJC (28 joints), mean (Q1-Q3)7.3 (4.0-10.0) N=1676.5 (3.0- 8.0) N=125SJC (28 joints), mean (Q1-Q3)5.2 (2.0-8.0) N=1564.8 (2.0-6.0) N=116PtGA (VAS), mean (Q1-Q3)7.0 (6.0-8.0) N=1956.8 (6.0-8.0) N=150PhGA (VAS), mean (Q1-Q3)6.2 (5.0-8.0) N=1936.1 (5.0-7.0) N=150CRP (mg/L), mean (Q1-Q3)10.1 (1.0-14.0) N=1959.4 (0.9-11.4) N=151ESR (mm/h), mean (Q1-Q3)24.8 (8.8-37.3) N=9016.6 (5.0-21.3) N=58Abstract aB0749 Table 2.CZP effectiveness at 1 year of treatment Basal 3 months 12 months F M F M F M DAS28 (CRP); mean (SD)4.7 (0.9)4.5 (0.8)3.9 (0.9)3.9 (1.0)3.7 (1.0)3.4 (1.0)TJC; mean (SD)7.3 (5.1)6.5 (4.4)5.2 (4.3)5.1 (4.3)4.4 (4.3)4.0 (4.3)SJC; mean (SD)5.2 (3.8)4.8 (3.5)3.8 (3.1)3.9 (3.3)3.6 (3.1)3.7 (3.4)Enthesitis, n (%)*38 (21.3)35 (25)3...
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