scholarly journals Switching to an Infliximab Biosimilar Was Safe and Effective in Dutch Sarcoidosis Patients

Cells ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 441
Author(s):  
Bas J. M. Peters ◽  
Anish Bhatoe ◽  
Adriane D. M. Vorselaars ◽  
Marcel Veltkamp
Keyword(s):  
Adverse Event ◽  
Cohort Study ◽  
Adverse Events ◽  
Inflammatory Response ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Single Center ◽  
Secondary Endpoints ◽  
Trough Levels

The effect of switching from originator infliximab to biosimilar infliximab in patients with sarcoidosis is unknown. The objective of this study is to investigate the effect of switching from Remicade® or Inflectra® to Flixabi® in patients with severe refractory sarcoidosis. This single center retrospective cohort study was performed at St Antonius Hospital Nieuwegein, The Netherlands. All patients diagnosed with severe refractory sarcoidosis receiving Remicade® or Inflectra® switched to Flixabi®. The primary outcome was infliximab discontinuation within 6 months of switching. Secondary endpoints included adverse events and loss of clinical, functional, or inflammatory response. Out of 86 patients who switched to Flixabi®, 79 patients had complete data. None of the 79 patients discontinued infliximab during the first 6 months after switching. Five patients reported an adverse event related to Flixabi® treatment. We found no change from baseline in FVC, FEV1, DLCOc, 6MWT, and infliximab trough levels 26 weeks after switching. An improvement in physical functioning of 7.3 ± 13.4 points (p = 0.002) with RAND/SF36 and in biomarker sIL-2R (−475.58 ± 1452.39; p = 0.005) was observed. Switching from originator infliximab Remicade® or biosimilar infliximab Inflectra® to biosimilar infliximab Flixabi® did not result in treatment discontinuation or loss of clinical/functional/inflammatory remission.

The effects of propofol on extracorporeal membrane oxygenation oxygenator exchange

2021 ◽  
pp. 039139882110160
Author(s):  
Kelsey L Browder ◽  
Ayesha Ather ◽  
Komal A Pandya
Keyword(s):  
Cohort Study ◽  
Extracorporeal Membrane Oxygenation ◽  
Cumulative Dose ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Ecmo Support ◽  
Single Center ◽  
Membrane Oxygenation ◽  
Vv Ecmo

The objective of this study was to determine if propofol administration to veno-venous (VV) extracorporeal membrane oxygenation (ECMO) patients was associated with more incidents of oxygenator failure when compared to patients who did not receive propofol. This was a single center, retrospective cohort study. The primary outcome of the study is oxygenator exchanges per ECMO day in patients who received propofol versus those who did not receive propofol. Patients were 18 years or older on VV-ECMO support between January 1, 2015 and January 31, 2018. Patients were excluded if they required ECMO support for less than 48 h or greater than 21 days. There were five patients in the propofol arm that required oxygenator exchanges and seven patients in the control arm. The total number of oxygenator exchanges per ECMO day was not significantly different between groups ( p = 0.50). When comparing those who required an oxygenator exchange and those who did not, there was no difference in the cumulative dose of propofol received per ECMO hour (0.64 mg/kg/h vs 0.96 mg/kg/h; p = 0.16). Propofol use in patients on VV-ECMO does not appear to increase the number of oxygenator exchanges.

ECMO Transport without Physicians or Additional Clinicians

2020 ◽  
pp. 1-7
Author(s):  
Anna Condella ◽  
Jeremy B. Richards ◽  
Michael A. Frakes ◽  
Christian J. Grant ◽  
Jason E. Cohen ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Nurse Practitioner ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Hub And Spoke ◽  
Current Guidelines ◽  
Major Adverse Events

Abstract Background: Extracorporeal membrane oxygenation (ECMO) has accelerated rapidly for patients in severe cardiac or respiratory failure. As a result, ECMO networks are being developed across the world using a “hub and spoke” model. Current guidelines call for all patients transported on ECMO to be accompanied by a physician during transport. However, as ECMO centers and networks grow, the increasing number of transports will be limited by this mandate. Objectives: The aim of this study was to compare rates of adverse events occurring during transport of ECMO patients with and without an additional clinician, defined as a physician, nurse practitioner (NP), or physician assistant (PA). Methods: This is a retrospective cohort study of all adults transported while cannulated on ECMO from 2011-2018 via ground and air between 21 hospitals in the northeastern United States, comparing transports with and without additional clinicians. The primary outcome was the rate of major adverse events, and the secondary outcome was minor adverse events. Results: Over the seven-year study period, 93 patients on ECMO were transported. Twenty-three transports (24.7%) were accompanied by a physician or other additional clinician. Major adverse events occurred in 21.5% of all transports. There was no difference in the total rate of major adverse events between accompanied and unaccompanied transports (P = .91). Multivariate analysis did not demonstrate any parameter as being predictive of major adverse events. Conclusions: In a retrospective cohort study of transports of ECMO patients, there was no association between the overall rate of major adverse events in transport and the accompaniment of an additional clinician. No variables were associated with major adverse events in either cohort.

scholarly journals Flucloxacillin decreases tacrolimus blood trough levels: a single-center retrospective cohort study

2020 ◽  
Vol 76 (12) ◽  
pp. 1667-1673
Author(s):  
Herman Veenhof ◽  
Hugo M. Schouw ◽  
Martine T. P. Besouw ◽  
Daan J. Touw ◽  
Valentina Gracchi
Keyword(s):  
Cohort Study ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Case Reports ◽  
Rank Test ◽  
Single Center ◽  
Transplant Patients ◽  
Signed Rank ◽  
Signed Rank Test ◽  
Trough Levels

Abstract Purpose Tacrolimus and everolimus are widely used to prevent allograft rejection. Both are metabolized by the hepatic cytochrome P450 (CYP) enzyme CYP3A4 and are substrate for P-glycoprotein (P-gp). Drugs influencing the activity or expression of CYP enzymes and P-gp can cause clinically relevant changes in the metabolism of immunosuppressants. Several case reports have reported that flucloxacillin appeared to decrease levels of drugs metabolized by CYP3A4 and P-gp. The magnitude of this decrease has not been reported yet. Methods In this single-center retrospective cohort study, we compared the tacrolimus and everolimus blood trough levels (corrected for the dose) before, during, and after flucloxacillin treatment in eleven transplant patients (tacrolimus n = 11 patients, everolimus n = 1 patient, flucloxacillin n = 11 patients). Results The median tacrolimus blood trough level decreased by 37.5% (interquartile range, IQR 26.4–49.7%) during flucloxacillin treatment. After discontinuation of flucloxacillin, the tacrolimus blood trough levels increased by a median of 33.7% (IQR 22.5–51.4%). A Wilcoxon signed-rank test showed statistically significantly lower tacrolimus trough levels during treatment with flucloxacillin compared with before (p = 0.009) and after flucloxacillin treatment (p = 0.010). In the only available case with concomitant everolimus and flucloxacillin treatment, the same pattern was observed. Conclusions Flucloxacillin decreases tacrolimus trough levels, possibly through a CYP3A4 and/or P-gp-inducing effect. It is strongly recommended to closely monitor tacrolimus and everolimus trough levels during flucloxacillin treatment and up to 2 weeks after discontinuation of flucloxacillin.

scholarly journals The impact of early target attainment of vancomycin in critically ill patients with confirmed Gram-positive infection: A retrospective cohort study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Khalid Al Sulaiman ◽  
Abdulrahman Alshaya ◽  
Ohoud Aljuhani ◽  
Amjad Alsaeed ◽  
Nadiyah Alshehri ◽  
...  
Keyword(s):  
Cohort Study ◽  
Critically Ill ◽  
Retrospective Cohort Study ◽  
Critically Ill Patients ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Kidney Injury ◽  
Gram Positive ◽  
The Impact ◽  
Trough Levels

Abstract Background Vancomycin is a commonly used antibiotic in critically ill patients for various indications. Critical illness imposes pharmacokinetic-pharmacodynamics challenges, which makes optimizing vancomycin in this population cumbersome. Data are scarce on the clinical impact of time to therapeutic trough levels of vancomycin in critically ill patients.  This study aims to evaluate the timing to achieve therapeutic trough level of vancomycin on 30-day mortality in critically ill patients. Method A retrospective cohort study was conducted for all adult critically ill patients with confirmed Gram-positive infection who received IV vancomycin between January 1, 2017, and December 31, 2020. We compared early (< 48 h) versus late (≥ 48 h) attainment of vancomycin therapeutic trough levels. The primary outcome was the 30-day mortality in critically ill patients. Secondary outcomes were the development of resistant organisms, microorganisms eradication within 4–5 days of vancomycin initiation, acute kidney injury (AKI), and length of stay (LOS). Propensity score-matched (1:1 ratio) used based on patient’s age, serum creatinine, and albumin values at baseline. Results A total of 326 patients were included; 110 patients attained the therapeutic trough levels within 48 h of vancomycin initiation. Late achievement of the therapeutic trough levels was associated with higher 30-day mortality (HR: 2.54; 95% CI [1.24–5.22]; p = 0.01). Additionally, patients who achieved therapeutic trough levels of vancomycin late were more likely to develop AKI (OR = 2.59; 95% CI [1.01–6.65]; p = 0.04). Other outcomes were not statistically significant between the two groups. Conclusion Early achievement of vancomycin therapeutic levels in patients with confirmed Gram-positive infection was associated with possible survival benefits.

scholarly journals Infusion-related events during natalizumab: No need for post-infusion monitoring

2019 ◽  
Vol 26 (12) ◽  
pp. 1590-1593
Author(s):  
Floor C Loonstra ◽  
Johannis A van Rossum ◽  
Zoé LE van Kempen ◽  
Theo Rispens ◽  
Bernard MJ Uitdehaag ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Event ◽  
Cohort Study ◽  
Adverse Events ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Relapsing Remitting ◽  
Post Infusion ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

This retrospective cohort study assessed the timing of infusion-related adverse events (IAEs) during natalizumab (NTZ) administration in well-documented relapsing-remitting multiple sclerosis (RRMS) patients who had received NTZ infusions in our centre between 2006 and 2018. In 225 RRMS patients (14,174 NTZ infusions), 276 IAEs (1.95%) occurred in 60 patients. All documented severe IAE occurred during infusion. Of the 19 moderate adverse events, 17 were during infusion. None of the reactions that occurred after the infusion required intervention. These results suggest that post-infusion monitoring is not necessary in patients who do not have an adverse event during infusion.

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