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Article ; Online: CYP induction to reverse tacrolimus toxicity resulting from concomitant Paxlovid use.

Cadley, Stephanie M / Sethi, Akash / Knorr, John P

Transplant infectious disease : an official journal of the Transplantation Society

2022 , Page(s) e13982

Language	English
Publishing date	2022-11-09
Publishing country	Denmark
Document type	Letter
ZDB-ID	1476094-0
ISSN	1399-3062 ; 1398-2273
ISSN (online)	1399-3062
ISSN	1398-2273
DOI	10.1111/tid.13982
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Article ; Online: Impact of Removing the Race Coefficient in Renal Function Estimate Equations on Drug Dosage Recommendations.

Miller, Janine / Knorr, John P

The Annals of pharmacotherapy

2021 Volume 56, Issue 1, Page(s) 44–51

Abstract: Background: The appropriateness of including the race coefficient in glomerular filtration rate (GFR) equations in Black patients is debated, and the impact on drug dosing is unknown.: Objective: This study explored the impact of removing the race ... ...

Abstract	Background: The appropriateness of including the race coefficient in glomerular filtration rate (GFR) equations in Black patients is debated, and the impact on drug dosing is unknown. Objective: This study explored the impact of removing the race coefficient on drug dosing in Black patients in comparison to conventional methods. Methods: This was a retrospective study of hospitalized patients who self-identified as Black/African American and were prescribed an antimicrobial that includes renal dosage recommendations in the product labeling. The primary end point was the discordance between drug dosing recommendations derived by body surface area deindexed GFR estimated by the CKD-EPI equation (Chronic Kidney Disease Epidemiology study) with and without race versus recommendations derived from Cockcroft-Gault (CG). Results: A total of 210 Black patients were included. There was an 18% rate of discordance when GFR was estimated with the race coefficient (GFR w/Race) versus without the race coefficient (GFR w/out Race). GFR w/out Race had a higher level of agreement with dosing by creatinine clearance (CrCl; κ = 0.779) than GFR w/Race versus CrCl (κ = 0.651). GFR w/out Race had less within-patient difference than GFR w/Race in comparison to CrCl (mean difference: -6.3 vs -18.0 mL/min). Conclusions and relevance: This represents the first report to examine the removal of the race coefficient and its implication on drug dose discordance. GFR w/out Race had a higher level of agreement and less drug dose discordance than GFR w/Race, in comparison to CrCl estimates. If GFR equations are considered comparable to CrCl for the purposes of guiding drug dosing, GFR w/out Race should be considered.
MeSH term(s)	Creatinine ; Glomerular Filtration Rate ; Humans ; Kidney/physiology ; Pharmaceutical Preparations ; Renal Insufficiency, Chronic ; Retrospective Studies
Chemical Substances	Pharmaceutical Preparations ; Creatinine (AYI8EX34EU)
Language	English
Publishing date	2021-04-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	1101370-9
ISSN	1542-6270 ; 1060-0280
ISSN (online)	1542-6270
ISSN	1060-0280
DOI	10.1177/10600280211010228
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Article ; Online: Perioperative daptomycin for prophylaxis of vancomycin-resistant Enterococcus infection in colonized liver transplant recipients.

Mak, Jordan T / Ha, Seung / Perloff, Sarah / Knorr, John P

Transplant infectious disease : an official journal of the Transplantation Society

2023 Volume 26, Issue 1, Page(s) e14186

Abstract: ... p = .04), but at 90 days posttransplant there was no significant difference (29% vs. 16%, p = .43 ...

Abstract	Background: Infection with vancomycin-resistant Enterococcus (VRE) in liver transplant recipients (LTR) has been associated with extended hospital stays, increased readmission rates, graft failure, and death. A tailored perioperative surgical prophylaxis regimen targeting VRE may reduce postoperative infections in VRE-colonized patients. This study investigated the outcomes of perioperative daptomycin in this patient population. Methods: This retrospective, single-center cohort study included LTR ≥ 18 years old who were VRE-colonized from June 2018 to November 2022. VRE colonization was identified by a VRE rectal swab screen or a positive VRE culture prior to transplant. Two groups were analyzed: daptomycin versus no daptomycin. All LTR received perioperative piperacillin-tazobactam for 24 h. If VRE-colonized, one dose of daptomycin (6 mg/kg) was given pre- and postoperatively. Demographics, clinical characteristics, risk factors for VRE infection, and daptomycin dose were collected. The primary outcome was VRE infection at 14 days and 90 days post-transplant. Results: There were 36 VRE-colonized LTR; 19 received daptomycin and 17 did not. Baseline characteristics and risk factors for VRE infection were similar between groups. More VRE infections occurred in the no daptomycin group within 14 days post-transplant (24% vs. 0%, p = .04), but at 90 days posttransplant there was no significant difference (29% vs. 16%, p = .43). The average daptomycin dose was 7.1 mg/kg. Conclusion: Perioperative daptomycin reduced the rate of VRE infections in VRE-colonized LTR within 14 days posttransplant but not at 90 days. Future studies should evaluate if higher doses and/or longer duration of perioperative daptomycin can reduce VRE infections beyond 14 days post-transplant.
MeSH term(s)	Humans ; Adolescent ; Daptomycin/therapeutic use ; Vancomycin/therapeutic use ; Anti-Bacterial Agents/therapeutic use ; Anti-Bacterial Agents/pharmacology ; Retrospective Studies ; Liver Transplantation/adverse effects ; Cohort Studies ; Vancomycin Resistance ; Gram-Positive Bacterial Infections/epidemiology ; Gram-Positive Bacterial Infections/prevention & control ; Gram-Positive Bacterial Infections/drug therapy ; Vancomycin-Resistant Enterococci ; Risk Factors
Chemical Substances	Daptomycin (NWQ5N31VKK) ; Vancomycin (6Q205EH1VU) ; Anti-Bacterial Agents
Language	English
Publishing date	2023-11-01
Publishing country	Denmark
Document type	Journal Article
ZDB-ID	1476094-0
ISSN	1399-3062 ; 1398-2273
ISSN (online)	1399-3062
ISSN	1398-2273
DOI	10.1111/tid.14186
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Zs.A 5100: Show issues

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Article: Evaluating Factors Associated With Blood Pressure Control in the Early Post-Kidney Transplant Period.

Zuziela, Matthew A / Vidal, Jennifer / Knorr, John P

Hospital pharmacy

2020 Volume 56, Issue 4, Page(s) 359–367

Abstract: Background: ...

Abstract	Background:
Language	English
Publishing date	2020-02-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	1468893-1
ISSN	0018-5787
ISSN	0018-5787
DOI	10.1177/0018578720906614
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Zs.B 1758: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Impact of Clotrimazole Fungal Prophylaxis on Tacrolimus Exposure in Kidney Transplant Recipients: A Retrospective Study.

El-Sayed, Anas / Vidal, Jennifer / Khanmoradi, Kamran / Knorr, John P

Transplantation proceedings

2021 Volume 53, Issue 5, Page(s) 1583–1588

Abstract: ... by cytochrome P450 and is a substrate for P-glycoprotein. Many medications affect tacrolimus concentrations ... in tacrolimus trough level was -1.3 ng/mL (confidence interval, -2.5, -1.0; P < .001) at day 7 and -2.8 ng/mL ... confidence interval, -3.3, -1.6; P < .001) at day 14 after clotrimazole discontinuation, from a median baseline of 8.9 ...

Abstract	Tacrolimus, an immunosuppressant prescribed to reduce the risk of organ rejection, is metabolized by cytochrome P450 and is a substrate for P-glycoprotein. Many medications affect tacrolimus concentrations, making it difficult to maintain exposure within its narrow therapeutic index. Clotrimazole troches, prescribed to posttransplant recipients immediately for the first 30 days for oral candidiasis prevention, are considered nonsystemic. However, data suggest a potential drug interaction, affecting tacrolimus exposure. To assess the magnitude of the effect of clotrimazole on tacrolimus trough levels, 97 kidney transplant recipients, on a stable dose of tacrolimus, were retrospectively evaluated. Tacrolimus trough concentrations were analyzed 7 and 14 days before and after discontinuation of clotrimazole. The median change in tacrolimus trough level was -1.3 ng/mL (confidence interval, -2.5, -1.0; P < .001) at day 7 and -2.8 ng/mL (confidence interval, -3.3, -1.6; P < .001) at day 14 after clotrimazole discontinuation, from a median baseline of 8.9 ng/mL. Overall, a reduction in tacrolimus level was observed in 60% of patients after discontinuation of clotrimazole. When assessing the effect of race and sex, no influence was found on the degree of change in tacrolimus level after clotrimazole discontinuation. In conclusion, clotrimazole exerts a significant interaction on tacrolimus where close monitoring of tacrolimus trough levels after discontinuation of clotrimazole is warranted.
Language	English
Publishing date	2021-05-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	82046-5
ISSN	1873-2623 ; 0041-1345
ISSN (online)	1873-2623
ISSN	0041-1345
DOI	10.1016/j.transproceed.2021.03.032
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Zs.A 835: Show issues

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Article ; Online: A single dose of pre-operative pregabalin reduces post-operative opioid use after orthotopic liver transplantation.

Knorr, John P / Barlow, Ashley / Reinaker, Travis S / Zaki, Radi F

Clinical transplantation

2021 Volume 35, Issue 7, Page(s) e14319

Abstract: ... 70% and 54% less opioids within the first 24h and subsequent 24-72h post-OLT, respectively (p-values ... reported a maximum of mild pain (p = .039). This study demonstrated that a single dose of pre-operative PGB ...

Abstract	Multimodal pain management strategies including pregabalin (PGB) have been shown to reduce pain and opioid use after many types of surgeries. This was a single-center, retrospective study aimed to determine whether a single pre-operative dose of PGB reduces opioid requirements and post-operative pain after orthotopic liver transplantation (OLT). Outcomes included the mean morphine milligram equivalents used; the proportion of patients with no pain documented; and the maximum level of pain documented within the first 24h and in the 24-72h following OLT. A total of 44 patients received PGB vs 57 who received standard of care. Baseline demographics were comparable between groups. Patients who received PGB required 70% and 54% less opioids within the first 24h and subsequent 24-72h post-OLT, respectively (p-values < .001). In the first 24h post-OLT, there were more patients with no documented pain, and fewer with severe pain in the PGB group, but these were not significant. A greater proportion in the PGB group reported a maximum of mild pain (p = .039). This study demonstrated that a single dose of pre-operative PGB significantly reduced opioid use in the first 72 h after OLT. Larger studies will help determine the safety and efficacy of PGB in this setting.
MeSH term(s)	Analgesics ; Analgesics, Opioid/therapeutic use ; Humans ; Liver Transplantation ; Pain, Postoperative/drug therapy ; Pain, Postoperative/etiology ; Pain, Postoperative/prevention & control ; Pregabalin/therapeutic use ; Retrospective Studies
Chemical Substances	Analgesics ; Analgesics, Opioid ; Pregabalin (55JG375S6M)
Language	English
Publishing date	2021-05-02
Publishing country	Denmark
Document type	Journal Article
ZDB-ID	639001-8
ISSN	1399-0012 ; 0902-0063
ISSN (online)	1399-0012
ISSN	0902-0063
DOI	10.1111/ctr.14319
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Zs.A 2204: Show issues

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Article: Suspected Simple Appendicitis in Children: Should We Use a Nonoperative, Antibiotic-Free Approach? An Observational Study.

Reis Wolfertstetter, Patricia / Ebert, John Blanford / Barop, Judith / Denzinger, Markus / Kertai, Michael / Schlitt, Hans J / Knorr, Christian

Children (Basel, Switzerland)

2024 Volume 11, Issue 3

Abstract: Background: Simple appendicitis may be self-limiting or require antibiotic treatment or appendectomy. The aim of this study was to assess the feasibility and safety of a nonoperative, antibiotic-free approach for suspected simple appendicitis in ... ...

Abstract	Background: Simple appendicitis may be self-limiting or require antibiotic treatment or appendectomy. The aim of this study was to assess the feasibility and safety of a nonoperative, antibiotic-free approach for suspected simple appendicitis in children. Methods: This single-center, retrospective study included patients (0-17 years old) who were hospitalized at the pediatric surgery department due to suspected appendicitis between 2011 and 2012. Data from patients who primarily underwent appendectomy were used as controls. The follow-up of nonoperatively managed patients was conducted in 2014. The main outcome of interest was appendicitis recurrence. Results: A total of 365 patients were included: 226 were treated conservatively and 139 underwent appendectomy. Fourteen (6.2% of 226) of the primarily nonoperatively treated patients required secondary appendectomy during follow-up, and histology confirmed simple, uncomplicated appendicitis in 10 (4.4% of 226) patients. Among a subset of 53 patients managed nonoperatively with available Alvarado and/or Pediatric Appendicitis Scores and sonographic appendix diameters in clinical reports, 29 met the criteria for a high probability of appendicitis. Three of these patients (10.3% of 29) underwent secondary appendectomy. No complications were reported during follow-up. Conclusions: A conservative, antibiotic-free approach may be considered for pediatric patients with suspected uncomplicated appendicitis in a hospital setting. Only between 6 and 10% of these patients required secondary appendectomy. Nevertheless, the cohort of patients treated nonoperatively was likely to have also included individuals with further abdominal conditions other than appendicitis. Active observation and clinical support during the disease course may help patients avoid unnecessary procedures and contribute to spontaneous resolution of appendicitis or other pediatric conditions as the cause of abdominal pain. However, further studies are needed to define validated diagnostic and management criteria.
Language	English
Publishing date	2024-03-13
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2732685-8
ISSN	2227-9067
ISSN	2227-9067
DOI	10.3390/children11030340
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Article ; Online: Tocilizumab in patients with severe COVID-19: A single-center observational analysis.

Knorr, John P / Colomy, Veronika / Mauriello, Christine M / Ha, Seung

Journal of medical virology

2020 Volume 92, Issue 11, Page(s) 2813–2820

Abstract: Patients with coronavirus disease 2019 (COVID-19) may develop severe respiratory distress, thought to be mediated by cytokine release. Elevated proinflammatory markers have been associated with disease severity. Tocilizumab, an interleukin-6 receptor ... ...

Abstract	Patients with coronavirus disease 2019 (COVID-19) may develop severe respiratory distress, thought to be mediated by cytokine release. Elevated proinflammatory markers have been associated with disease severity. Tocilizumab, an interleukin-6 receptor antagonist, may be beneficial for severe COVID-19, when cytokine storm is suspected. This is a retrospective single-center analysis of the records of patients diagnosed with COVID-19 who received tocilizumab. Outcomes, including clinical improvement, mortality and changes in oxygen-support at 24, 48, and 72 hours, and 7, 14, and 28 days post-tocilizumab, are reported. Patients were evaluated by baseline pre-tocilizumab oxygenation status and changes in proinflammatory markers within 7 days post-tocilizumab are reported. Sixty-six patients received tocilizumab at a mean dose of 724 mg (7.4 mg/kg), 3.7 days from admission. At baseline, 53% of patients were on ventilation support and all had elevated proinflammatory markers, including c-reactive protein (CRP). Common comorbidities were diabetes mellitus (43%) and hypertension (74%). Most patients received concomitant glucocorticoids and hydroxychloroquine. Seven days after tocilizumab, ten patients (15.2%) had clinical improvement in their oxygenation status, and there was a 95% decrease in CRP. Within 14 days of treatment, 29% of patients had clinical improvement, 20% had minimal or no improvement, 17% worsened, 27% died, and 7% were transferred to an outside hospital. Ultimately, 42% of all patients that received tocilizumab expired and 49% were discharged. This study found limited clinical improvement in patients that received tocilizumab in the setting of severe COVID-19. Clinical trials are ongoing to further evaluate tocilizumab's benefit in this patient population.
MeSH term(s)	Antibodies, Monoclonal, Humanized/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; C-Reactive Protein/analysis ; COVID-19/drug therapy ; Cohort Studies ; Cytokine Release Syndrome/drug therapy ; Ferritins/blood ; Fibrin Fibrinogen Degradation Products/analysis ; Humans ; L-Lactate Dehydrogenase/blood ; Oxygen/administration & dosage ; Receptors, Interleukin-6/antagonists & inhibitors ; Respiration, Artificial ; Retrospective Studies
Chemical Substances	Antibodies, Monoclonal, Humanized ; Fibrin Fibrinogen Degradation Products ; Receptors, Interleukin-6 ; fibrin fragment D ; C-Reactive Protein (9007-41-4) ; Ferritins (9007-73-2) ; L-Lactate Dehydrogenase (EC 1.1.1.27) ; tocilizumab (I031V2H011) ; Oxygen (S88TT14065)
Keywords	covid19
Language	English
Publishing date	2020-06-29
Publishing country	United States
Document type	Journal Article ; Observational Study
ZDB-ID	752392-0
ISSN	1096-9071 ; 0146-6615
ISSN (online)	1096-9071
ISSN	0146-6615
DOI	10.1002/jmv.26191
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Article: IL-15 synergizes with CD40 agonist antibodies to induce durable immunity against bladder cancer.

Wong, Jeffrey L / Smith, Patrick / Angulo-Lozano, Juan / Ranti, Daniel / Bochner, Bernard H / Sfakianos, John P / Horowitz, Amir / Ravetch, Jeffrey V / Knorr, David A

bioRxiv : the preprint server for biology

2023

Abstract: CD40 is a central co-stimulatory receptor implicated in the development of productive anti-tumor immune responses across multiple cancers, including bladder cancer. Despite strong preclinical rationale, systemic administration of therapeutic agonistic ... ...

Abstract	CD40 is a central co-stimulatory receptor implicated in the development of productive anti-tumor immune responses across multiple cancers, including bladder cancer. Despite strong preclinical rationale, systemic administration of therapeutic agonistic antibodies targeting the CD40 pathway have demonstrated dose limiting toxicities with minimal clinical activity to date, emphasizing an important need for optimized CD40-targeted approaches, including rational combination therapy strategies. Here, we describe an important role for the endogenous IL-15 pathway in contributing to the therapeutic activity of CD40 agonism in orthotopic bladder tumors, with upregulation of trans-presented IL-15/IL-15Rα surface complexes, particularly by cross-presenting cDC1s, and associated enrichment of activated CD8 T cells within the bladder tumor microenvironment. In bladder cancer patient samples, we identify DCs as the primary source of IL-15, however, they lack high levels of IL-15Rα at baseline. Using humanized immunocompetent orthotopic bladder tumor models, we demonstrate the ability to therapeutically augment this interaction through combined treatment with anti-CD40 agonist antibodies and exogenous IL-15, including the fully-human Fc-optimized antibody 2141-V11 currently in clinical development for the treatment of bladder cancer. Combination therapy enhances the crosstalk between Batf3-dependent cDC1s and CD8 T cells, driving robust primary anti-tumor activity and further stimulating long-term systemic anti-tumor memory responses associated with circulating memory-phenotype T and NK cell populations. Collectively, these data reveal an important role for IL-15 in mediating anti-tumor CD40 agonist responses in bladder cancer and provide key proof-of-concept for combined use of Fc-optimized anti-CD40 agonist antibodies and agents targeting the IL-15 pathway. These data support expansion of ongoing clinical studies evaluating anti-CD40 agonist antibodies and IL-15-based approaches to evaluate combinations of these promising therapeutics for the treatment of patients with bladder cancer.
Language	English
Publishing date	2023-02-01
Publishing country	United States
Document type	Preprint
DOI	10.1101/2023.01.30.526266
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Article ; Online: IL-15 synergizes with CD40 agonist antibodies to induce durable immunity against bladder cancer.

Wong, Jeffrey L / Smith, Patrick / Angulo-Lozano, Juan / Ranti, Daniel / Bochner, Bernard H / Sfakianos, John P / Horowitz, Amir / Ravetch, Jeffrey V / Knorr, David A

Proceedings of the National Academy of Sciences of the United States of America

2023 Volume 120, Issue 35, Page(s) e2306782120

Abstract: CD40 is a central costimulatory receptor implicated in productive antitumor immune responses across multiple cancers, including bladder cancer. Despite strong preclinical rationale, systemic administration of therapeutic agonistic antibodies targeting ... ...

Abstract	CD40 is a central costimulatory receptor implicated in productive antitumor immune responses across multiple cancers, including bladder cancer. Despite strong preclinical rationale, systemic administration of therapeutic agonistic antibodies targeting the CD40 pathway has demonstrated dose-limiting toxicities with minimal clinical activity, emphasizing an important need for optimized CD40-targeted approaches, including rational combination therapy strategies. Here, we describe a role for the endogenous IL-15 pathway in contributing to the therapeutic activity of CD40 agonism in orthotopic bladder tumors, with upregulation of transpresented IL-15/IL-15Rα surface complexes, particularly by cross-presenting conventional type 1 DCs (Dendritic Cells), and associated enrichment of activated CD8 T cells. In bladder cancer patient samples, we identify DCs as the primary source of IL-15, although they lack high levels of IL-15Rα at baseline. Using humanized immunocompetent orthotopic bladder tumor models, we demonstrate the ability to therapeutically augment this interaction through combined treatment with anti-CD40 agonist antibodies and exogenous IL-15, including the fully-human Fc-optimized antibody 2141-V11 currently in clinical development for the treatment of bladder cancer. Collectively, these data reveal an important role for IL-15 in mediating antitumor CD40 agonist responses in bladder cancer and provide key proof-of-concept for combined use of Fc-optimized anti-CD40 agonist antibodies and agents targeting the IL-15 pathway. These data support expansion of ongoing clinical studies evaluating anti-CD40 agonist antibodies and IL-15-based approaches to develop combinations of these promising therapeutics for the treatment of patients with bladder cancer.
MeSH term(s)	Humans ; Interleukin-15 ; Urinary Bladder Neoplasms/drug therapy ; Urinary Bladder ; Antibodies, Monoclonal/pharmacology ; Antibodies, Monoclonal/therapeutic use ; Combined Modality Therapy ; CD40 Antigens ; Immunoglobulin Fc Fragments
Chemical Substances	Interleukin-15 ; Antibodies, Monoclonal ; CD40 Antigens ; Immunoglobulin Fc Fragments
Language	English
Publishing date	2023-08-22
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	209104-5
ISSN	1091-6490 ; 0027-8424
ISSN (online)	1091-6490
ISSN	0027-8424
DOI	10.1073/pnas.2306782120
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