Journal Article

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

Parita Patel, Andres Yarur, Sushila Dalal, Atsuhi Sakuraba, David T Rubin, Stephen B Hanauer, Ira Hanan, Laura H Raffals, Russell D Cohen and Joel Pekow

in Inflammatory Bowel Diseases

Volume 24, issue 6, pages 1291-1297
Published in print May 2018 | ISSN: 1078-0998
Published online March 2018 | e-ISSN: 1536-4844 | DOI: https://dx.doi.org/10.1093/ibd/izx105
Clinical Response and Complications are not Associated with Drug Levels in Patients with Severe Ulcerative Colitis on IV Cyclosporine Induction Therapy

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  • Medicine and Health
  • Clinical Medicine
  • Gastroenterology
  • Patient Education and Information
  • Gastro-intestinal and Colorectal Surgery

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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.

Keywords: ulcerative colitis; ciclosporin; complications; drug levels

Journal Article.  4872 words.  Illustrated.

Subjects: Medicine and Health ; Clinical Medicine ; Gastroenterology ; Patient Education and Information ; Gastro-intestinal and Colorectal Surgery

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