Purpose: To evaluate the clinical efficacy of including Ivermectin (single dose on day 1 of 400 ug/kg PO) in the standard of care in hospitalized adults with severe COVID-19. Methods: Double-blinded, parallel, placebo-controlled, single-center, randomized clinical trial. Seventy-five patients were randomly assigned (1:1) to receive standard of care plus ivermectin or placebo and were followed up for 21 days. Primary outcome measure was admission to ICU and secondary outcomes were the requirement of intensive mechanical ventilation (IMV) and in-hospital death. Intention-to-treat analyses, estimated risk differences (RD), and Hazard ratios (HR) with Cox regression were performed. Results: Enrollment stopped due to the lack of eligible patients. Thirty-seven patients were assigned to intervention and 38 to placebo. Patients in the ivermectin group were 54.5 years on average, 62.2% were male. Comorbidities were more prevalent in the control group (78.9% vs. 56.8%). There was no difference in the 21-day risk of admission to the ICU between ivermectin (21.6%) and placebo (15.8%) (RD= 5.8%; 95%CI: -11.8%-23.5%); neither in the risk of requirement of IMV (18.9% vs 13.2%), mortality (5.4% vs 10.5%) or in adverse events (32.4% vs. 28.9%). Discussion: Ivermectin showed no significant benefit in reducing the requirement of ICU, IMV, or mortality for severe COVID-19 patients.
BackgroundAdherence in the treatment of rheumatoid arthritis (RA) ranges 20% to 70% in worldwide population.1 In Colombia there are no studies comparing adherence and persistence to conventional and biological treatment.ObjectivesTo determine adherence and persistence and associated factors to the treatment of conventional disease-modifying anti-rheumatic drugs (cDMARD) and biological DMARD (bDMARD) in patients with RA under real world data.MethodsWe conducted an observational, analytical retrospective cohort study from January 2015 to December 2016. The study population was 552 RA patients older than 18 years who received any cDMARD treatment in monotherapy or combined with two or more cDMARD and bDMARD (Rituximab and Tofacitinib were excluded). Clinical information was obtained from electronic clinical records and Morisky-Green test was performed during the follow-up. Univariate analysis (proportions and medians), bivariate analysis [relative risk (RR)] and multivariate analysis (logistic regression and Kaplan-Meier survival curve) were developed.ResultsEighty nine percent were women, the median age was 59 years, 50% have ≥12 years of duration of disease. Adherence for cDMARD was 61% and for bDMARD 56%. There was an association between adherence and high degree education level (adjusted RR=2.1; CI: 1.09–4.14) and non-adherence with clinical factors such as high disease activity (adjusted RR=0.41; CI: 0.22–0.75); in the cDMARD group the greatest persistence was leflunomide (mean: 631 days) followed by methotrexate (mean: 526 days) and in the bDMARD group was etanercept (mean 1577 days) and tocilizumab (mean 1064 days). Patients with social support had greater persistence in the treatment with cDMARD (adjusted HR=2.1; CI: 1.11–4.28).Abstract THU0213 – Table 1Sociodemographic, clinical and therapeutic characteristics in 552 Colombian patients with rheumatoid arthritisCharacteristicsn(%) Rheumatoid factor(+)41581 ACPA(+)15071DAS-28<2,6267492,6–3,268123,2–4,912923>58816Methotrexate28155cDMARDLeflunomide13025Sulfasalazine7114Chloroquine306bDMARDTocilizumab4124Adalimumab3822Abatacept3219Etanercept2917Infliximab148,2Golimumab116,4Certolizumab63,5IQR: interquartile range, ACPA: anti-cyclic citrullinated protein/peptide antibodiesAbstract THU0213 – Figure 1The median time of follow-up of the studied population was 822 days, IQR 429–727 days.ConclusionsIn real world data, education level and disease activity significantly impact adherence level in RA patients. Social support positively impacts the persistence of the treatment of RA patients, which suggest the implementation of care programs taking this aspect into consideration in order to improve outcomes.Reference[1] De Klerk E, van der Heijde D, Landewé R, van der Tempel H, Urquhart J, van der Linden S. Patient compliance in rheumatoid arthritis, polymyalgia rheumatica, and gout. J Rheumatol2003;(1):44–54.Disclosure of InterestNone declared
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