scholarly journals Baseline Characteristics of Erosive Hand Osteoarthritis Subjects Enrolled in the ILLUSTRATE-H Study of the Anti-interleukin-1alpha/beta dual Variable Domain Immunoglobulin ABT-981 and Factors Associated with exclusion from the Trial

2017 ◽  
Vol 25 ◽  
pp. S352-S353 ◽  
Author(s):  
M.C. Levesque ◽  
S. Chen ◽  
C. Peterfy ◽  
L. Wang ◽  
J.K. Medema
Keyword(s):  
Variable Domain ◽  
Hand Osteoarthritis ◽  
Dual Variable ◽  
Factors Associated ◽  
Erosive Hand Osteoarthritis ◽  
Baseline Characteristics

scholarly journals Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1α and anti-interleukin-1β dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis

2018 ◽  
Vol 78 (3) ◽  
pp. 413-420 ◽  
Author(s):  
Margreet Kloppenburg ◽  
Charles Peterfy ◽  
Ida K Haugen ◽  
Féline Kroon ◽  
Su Chen ◽  
...  
Keyword(s):  
Study Drug ◽  
High Sensitivity ◽  
Variable Domain ◽  
Analysis Of Covariance ◽  
Hand Osteoarthritis ◽  
Dual Variable ◽  
Randomised Study ◽  
Protein Levels ◽  
Blood Neutrophils ◽  
Erosive Hand Osteoarthritis

ObjectiveTo assess the efficacy, safety, pharmacokinetics and pharmacodynamics of the anti-interleukin (IL)-1α/β dual variable domain immunoglobulin lutikizumab (ABT-981) in erosive hand osteoarthritis (HOA).MethodsPatients with ≥1 erosive and ≥3 tender and/or swollen hand joints were randomised to placebo or lutikizumab 200 mg subcutaneously every 2 weeks for 24 weeks. The primary endpoint was change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain subdomain score from baseline to 16 weeks. At baseline and week 26, subjects had bilateral hand radiographs and MRI of the hand with the greatest number of baseline tender and/or swollen joints. Continuous endpoints were assessed using analysis of covariance models, with treatment and country as main factors and baseline measurements as covariates.ResultsOf 132 randomised subjects, 1 received no study drug and 110 completed the study (placebo, 61/67 (91%); lutikizumab, 49/64 (77%)). AUSCAN pain was not different among subjects treated with lutikizumab versus placebo at week 16 (least squares mean difference, 1.5 (95% CI –1.9 to 5.0)). Other clinical and imaging endpoints were not different between lutikizumab and placebo. Lutikizumab significantly decreased serum high-sensitivity C reactive protein levels, IL-1α and IL-1β levels, and blood neutrophils. Lutikizumab pharmacokinetics were consistent with phase I studies and not affected by antidrug antibodies. Injection site reactions and neutropaenia were more common in the lutikizumab group; discontinuations because of adverse events occurred more frequently with lutikizumab (4/64) versus placebo (1/67).ConclusionDespite adequate blockade of IL-1, lutikizumab did not improve pain or imaging outcomes in erosive HOA compared with placebo.

Etiologies, Clinical Manifestations, and Factors Associated with Severe Symptomatic Hyponatremia among Hospitalized Hyponatremia Patients

2020 ◽  
Vol 103 (5) ◽  
pp. 465-471
Keyword(s):  
Clinical Manifestations ◽  
Cross Sectional Study ◽  
Hospitalized Patients ◽  
Sectional Study ◽  
Close Attention ◽  
Cross Sectional ◽  
Factors Associated ◽  
Present Cross Sectional Study ◽  
Important Health ◽  
Baseline Characteristics

Background: Hyponatremia is associated with unfavorable outcomes in many cases. The mainstay of hyponatremia treatment depends on its symptoms and etiology. However, etiologies, clinical manifestations, and factors associated with severe symptomatic hyponatremia have been rarely reported. Objective: To analyze and report etiologies, clinical manifestations, and factors associated with severe symptomatic hyponatremia. Materials and Methods: In the present cross-sectional study, the authors enrolled hospitalized patients with hyponatremia who had consulted a nephrologist between October 1, 2017, and October 31, 2018. Their baseline characteristics and clinical manifestations were recorded. Etiologies were confirmed by the attending nephrology staff. Factors associated with severe symptomatic hyponatremia were evaluated using logistic regression analysis. Results: One hundred patients were included in this study. The syndrome of inappropriate antidiuresis (SIAD), hypovolemia, and hydrochlorothiazide use were the leading hyponatremia etiologies. Hyponatremia etiologies differed between patients with community-acquired hyponatremia (n=50) and those with hospital-associated hyponatremia (n=50). Patients with communityacquired hyponatremia were older, presented with a higher frequency of severe symptomatic hyponatremia, and showed lower SNa-levels. Low SNa-levels were significantly associated with severe symptomatic hyponatremia (p=0.014). Conclusion: Hyponatremia remains an important health problem. SIAD, hypovolemia, and hydrochlorothiazide use are among the leading etiologies of hyponatremia. Low SNa-levels are associated with severe symptomatic hyponatremia; thus, physicians should pay close attention to low SNa-levels in hospitalized patients. Keywords: Hyponatremia, Symptomatic Hyponatremia, Community-acquired hyponatremia, Hospital-associated hyponatremia

scholarly journals A Low Level of Darunavir Resistance–Associated Mutation Emergence in Patients With Virological Failure During Long-term Use of Darunavir in People With HIV. The ANRS CO3 Aquitaine Cohort

2020 ◽  
Vol 7 (12) ◽  
Author(s):  
Hélène Chaussade ◽  
Camille Tumiotto ◽  
Fabien Le Marec ◽  
Olivier Leleux ◽  
Lucile Lefèvre ◽  
...  
Keyword(s):  
Protease Inhibitor ◽  
Virological Failure ◽  
Resistance Test ◽  
Resistance Testing ◽  
Factors Associated ◽  
Viral Loads ◽  
Hiv Resistance ◽  
Baseline Characteristics

Abstract Background Ritonavir-boosted darunavir (DRV/r) is a protease inhibitor (PI) indicated for the treatment of naïve and pretreated HIV-infected patients since 2007. Our study aims to describe DRV/r-treated patients experiencing virological failure (VF) documented with HIV resistance testing. Methods Data from patients belonging to the ANRS CO3 Aquitaine Cohort treated with a regimen including DRV/r between February 2007 and December 2015 were analyzed. Baseline characteristics of patients experiencing VF (defined by 2 consecutive plasma viral loads >50 copies/mL) were compared with those without VF. We then described factors associated with VF as emergence of IAS DRV resistance–associated mutations (RAMs). Results Among the 1458 patients treated at least once with a DRV/r-based regimen, 270 (18.5%) patients experienced VF during follow-up, including 240 with at least 1 genotype resistance test (GRT). DRV RAMs were detected in 29 patients (12%). Among them, 25/29 patients had ≥2 DRV RAMs before DRV/r initiation, all of whom had experienced VF during previous PI treatments. For 18/29, DRV/r was maintained after VF, and controlled viremia was restored after modification of DRV-associated antiretroviral molecules or increased DRV dose. Finally, only 6/29 patients selected new DRV RAMs after DRV/r initiation. All of these experienced previous VFs while on other PIs. Conclusions These results highlight the efficacy and robustness of DRV/r, as the emergence of DRV RAMs appeared in <0.4% of patients receiving a DRV/r-based regimen in our large cohort.

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