Subcutaneous rather than intravenous ustekinumab induction is associated with comparable circulating drug levels and early clinical response: a pilot study

2018 ◽  
Vol 48 (3) ◽  
pp. 333-339 ◽  
Author(s):  
C. R. Rowan ◽  
D. Keegan ◽  
K. Byrne ◽  
G. Cullen ◽  
H. E. Mulcahy ◽  
...  
Keyword(s):  
Pilot Study ◽  
Clinical Response ◽  
Drug Levels

scholarly journals Patterns of Clinical Response to PSA Elevation in American Indian/Alaska Native Men: A Multi-center Pilot Study

2013 ◽  
Vol 24 (4) ◽  
pp. 1676-1685
Author(s):  
Jon C. Tilburt ◽  
Kathryn Koller ◽  
James J. Tiesinga ◽  
Robin T. Wilson ◽  
Anne C. Trinh ◽  
...  
Keyword(s):  
Pilot Study ◽  
American Indian ◽  
Clinical Response ◽  
Alaska Native

Ustekinumab serum concentrations are associated with clinical outcomes in Crohn’s disease – a regional multi-center pilot study

2020 ◽  
Vol 58 (05) ◽  
pp. 439-444 ◽  
Author(s):  
Anne Kerstin Thomann ◽  
Lucas-Alexander Schulte ◽  
Anna-Maria Globig ◽  
Peter Hoffmann ◽  
Thomas Klag ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Pilot Study ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Roc Curve ◽  
Response To Therapy ◽  
Therapeutic Drug ◽  
Serum Concentrations ◽  
Serum Samples ◽  
Area Under Roc Curve

Abstract Background and aim The role of therapeutic drug monitoring (TDM) in ustekinumab (UST) therapy for Crohn’s disease (CD) has not been established, as only few studies have analyzed the relationship between UST serum concentrations and clinical outcome. In this pilot study, we retrospectively examined the potential of UST-concentrations (cUST) 8 weeks after induction (cUSTw8) to predict clinical response at week 16. Methods Serum samples and clinical data from patients (n = 72) with moderate to severely active CD who received intravenous induction with UST were retrospectively analyzed. cUST were quantitated using liquid chromatography-tandem mass spectrometry (LC-MSMS). A receiver-operating characteristic (ROC) curve and area under ROC curve (AUROC) was computed to analyze the predictive potential of cUSTw8 for clinical response at week 16 and to determine the minimal therapeutic UST trough concentration. Results Forty-four patients (61 %) achieved clinical response to UST therapy at week 16. cUSTw8 was moderately effective to predict clinical response with a minimal therapeutic cUSTw8 of 2.0 mg/l (AUC 0.72, p = 0.001). Conclusion Trough concentrations of UST 8 weeks after induction predict clinical response to therapy in week 16 with moderate sensitivity and specificity. TDM using LC-MSMS could prove beneficial in personalized UST therapy of patients with CD by identifying individuals with subtherapeutic concentrations who might benefit from dose escalation.

scholarly journals Clinical Response and Complications are not Associated with Drug Levels in Patients with Severe Ulcerative Colitis on IV Cyclosporine Induction Therapy

2018 ◽  
Vol 24 (6) ◽  
pp. 1291-1297 ◽  
Author(s):  
Parita Patel ◽  
Andres Yarur ◽  
Sushila Dalal ◽  
Atsuhi Sakuraba ◽  
David T Rubin ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Postoperative Complications ◽  
Clinical Response ◽  
Induction Therapy ◽  
Kidney Injury ◽  
C Reactive Protein ◽  
Drug Levels ◽  
Protein Levels ◽  
Reactive Protein ◽  
Steroid Refractory

Abstract Background IV ciclosporin therapy is effective in steroid-refractory ulcerative colitis. The optimal drug level to achieve response and minimize complications during induction therapy is not known. Aim The primary aim was to evaluate if serum ciclosporin drug levels are associated with increased risk of colectomy within 90 days of hospitalization. Secondary aims were to determine if ciclosporin levels are associated with avoidance of colectomy at 7 and 30 days, if ciclosporin levels are associated with drug-related and postoperative complications, and if patient-specific factors are associated with response to ciclosporin. Methods We conducted a retrospective analysis of 81 hospitalized patients with steroid-refractory ulcerative colitis treated with ciclosporin. Risk factors for colectomy within 7, 30, and 90 days, medication-specific and postoperative complications were compared by first, mean, and peak ciclosporin level during IV induction therapy. Results There were 47 patients (58%) who underwent surgery. There were no differences between initial, mean, and peak ciclosporin levels among responders and nonresponders and treatment-related or postoperative complications. Responders within 90 days had lower C-reactive-protein levels (20mg/L vs. 38mg/L, P = 0.01), lower serum albumin concentrations (3.4g/dL vs. 3.7g/dL, P = 0.03), and higher rates of kidney injury (50% vs 17%, P = 0.002). Conclusion Initial, mean, and peak serum levels of ciclosporin did not correlate with response or toxicity. However, C-reactive-protein levels levels and kidney injury may be helpful in predicting clinical response to ciclosporin.

Changes in prefrontal activity characterize clinical response in SSRI nonresponders: a pilot study

2005 ◽  
Vol 39 (5) ◽  
pp. 461-466 ◽  
Author(s):  
I COOK ◽  
A LEUCHTER ◽  
M MORGAN ◽  
W STUBBEMAN ◽  
B SIEGMAN ◽  
...  
Keyword(s):  
Pilot Study ◽  
Clinical Response

scholarly journals Augmented ustekinumab dosing is needed to achieve clinical response in patients with anti-TNF refractory pediatric Crohn’s disease: a retrospective chart review

F1000Research ◽  
2021 ◽  
Vol 9 ◽  
pp. 316
Author(s):  
Phinga Do ◽  
John Andersen ◽  
Ashish Patel ◽  
Gaith Semrin ◽  
Luis Sifuentes-Dominguez ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Chart Review ◽  
Pediatric Patients ◽  
Retrospective Chart Review ◽  
Previous Treatment ◽  
Therapeutic Drug ◽  
Duration Of Treatment ◽  
Drug Levels

Background: Ustekinumab is a monoclonal antibody that inhibits interleukins 12 and 23. It is approved for treatment of Crohn’s disease (CD) in adults; however, there is a paucity of data regarding its use in pediatric CD. We describe our experience using ustekinumab in anti-TNF refractory CD pediatric patients. Methods: We performed a retrospective chart review on pediatric patients with CD who were started on ustekinumab from January 2016 to November 2018. We collected patient’s clinical history, previous treatment history, surgeries related to CD, disease severity, as measured by abbrPCDAI, and endoscopic severity as recorded by SES-CD before and after ustekinumab. Results: We identified 10 patients with CD who were started on ustekinumab due to non-response to currently approved agents. Seven patients needed augmented maintenance dosing every 4-6 weeks to achieve clinical response or remission. Six of these seven patients had therapeutic drug monitoring during the course of treatment, with five patients showing subtherapeutic drug levels of <4.5 μg/mL while on standard maintenance dosing every 8 weeks, and four patients showing therapeutic drug levels of >4.5 μg/mL on augmented dosing interval. The remaining three patients were on standard maintenance dosing for the duration of treatment. Conclusion: In this retrospective chart review, 7 out of 10 patients with anti-TNF refractory pediatric-onset CD required augmented maintenance doses of ustekinumab to achieve clinical response or remission. A prospective study is needed to define appropriate ustekinumab dosing and interval in management of pediatric CD.

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