The efficacy and tolerability of AST-120 (spherical carbon adsorbent) in active pouchitis

Bo Shen, Darrell S. Pardi, Ana E. Bennett, Elaine Queener, Patricia Kammer, Jefferey P. Hammel, Caroline LaPlaca, M. Scott Harris

Research output: Contribution to journalArticle

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Abstract

OBJECTIVES:Although a majority of patients with pouchitis respond favorably to antibiotic therapy, many relapse frequently, and nonabsorbable and non-antibiotic-based agents are desirable for reducing bacterial resistance and the systemic adverse effects associated with long-term antibiotic exposure. AST-120 (a spherical carbon adsorbent) comprises highly adsorptive, porous carbon microspheres with the ability to adsorb small-molecular-weight toxins, inflammatory mediators, and harmful bile acids. The aim of this pilot trial was to evaluate the efficacy and tolerability of AST-120 in the treatment of active pouchitis.METHODS:Eligible patients were recruited from two subspecialty pouchitis clinics. Inclusion criteria were (i) ileal pouch-anal anastomosis performed for ulcerative colitis; (ii) active pouchitis with Pouchitis Disease Activity Index (PDAI) scores 7; and (iii) discontinuation of antibiotic therapy for at least 2 weeks. Exclusion criteria included Crohn's disease of the pouch, isolated cuffitis, pouch strictures, abscess, and sinuses. All eligible patients received AST-120 in 2-g sachets (oral) open label, thrice a day for 4 weeks. The primary efficacy end point was remission as defined by a PDAI score of <7 points; the main secondary end point was clinical response, defined by a reduction of the PDAI score of 3 points.RESULTS:Nineteen of 20 patients completed the trial. Eleven patients (55.0) had a clinical response to the therapy and 10 patients (50.0) entered remission. Median reduction in the PDAI symptom, endoscopy, and histology subscores, and PDAI total scores after 4 weeks were -2 (P0.002), -2 (P0.003), 0 (P0.32), and -4 (P0.001) points, respectively. The agent was well tolerated; one patient experienced transient mild elevation of alkaline phosphatase of uncertain significance and one patient experienced an upper respiratory infection after taking one dose of AST-120 and was excluded from the final analysis for the calculation of pre- and post-trial PDAI scores.CONCLUSIONS:AST-120 seems to be effective and well tolerated in treating patients with active pouchitis. A randomized, placebo-controlled trial is warranted for assessing the long-term efficacy and safety of AST-120 in the disease.

Original languageEnglish (US)
Pages (from-to)1468-1478
Number of pages11
JournalAmerican Journal of Gastroenterology
Volume104
Issue number6
DOIs
StatePublished - Jun 2009

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Pouchitis
Carbon
Anti-Bacterial Agents
AST 120
Colonic Pouches
Reducing Agents
Therapeutics
Bile Acids and Salts
Microspheres
Ulcerative Colitis
Crohn Disease
Respiratory Tract Infections
Abscess
Endoscopy
Alkaline Phosphatase
Histology
Pathologic Constriction

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Shen, B., Pardi, D. S., Bennett, A. E., Queener, E., Kammer, P., Hammel, J. P., ... Harris, M. S. (2009). The efficacy and tolerability of AST-120 (spherical carbon adsorbent) in active pouchitis. American Journal of Gastroenterology, 104(6), 1468-1478. https://doi.org/10.1038/ajg.2009.138

The efficacy and tolerability of AST-120 (spherical carbon adsorbent) in active pouchitis. / Shen, Bo; Pardi, Darrell S.; Bennett, Ana E.; Queener, Elaine; Kammer, Patricia; Hammel, Jefferey P.; LaPlaca, Caroline; Harris, M. Scott.

In: American Journal of Gastroenterology, Vol. 104, No. 6, 06.2009, p. 1468-1478.

Research output: Contribution to journalArticle

Shen, B, Pardi, DS, Bennett, AE, Queener, E, Kammer, P, Hammel, JP, LaPlaca, C & Harris, MS 2009, 'The efficacy and tolerability of AST-120 (spherical carbon adsorbent) in active pouchitis', American Journal of Gastroenterology, vol. 104, no. 6, pp. 1468-1478. https://doi.org/10.1038/ajg.2009.138
Shen, Bo ; Pardi, Darrell S. ; Bennett, Ana E. ; Queener, Elaine ; Kammer, Patricia ; Hammel, Jefferey P. ; LaPlaca, Caroline ; Harris, M. Scott. / The efficacy and tolerability of AST-120 (spherical carbon adsorbent) in active pouchitis. In: American Journal of Gastroenterology. 2009 ; Vol. 104, No. 6. pp. 1468-1478.
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abstract = "OBJECTIVES:Although a majority of patients with pouchitis respond favorably to antibiotic therapy, many relapse frequently, and nonabsorbable and non-antibiotic-based agents are desirable for reducing bacterial resistance and the systemic adverse effects associated with long-term antibiotic exposure. AST-120 (a spherical carbon adsorbent) comprises highly adsorptive, porous carbon microspheres with the ability to adsorb small-molecular-weight toxins, inflammatory mediators, and harmful bile acids. The aim of this pilot trial was to evaluate the efficacy and tolerability of AST-120 in the treatment of active pouchitis.METHODS:Eligible patients were recruited from two subspecialty pouchitis clinics. Inclusion criteria were (i) ileal pouch-anal anastomosis performed for ulcerative colitis; (ii) active pouchitis with Pouchitis Disease Activity Index (PDAI) scores 7; and (iii) discontinuation of antibiotic therapy for at least 2 weeks. Exclusion criteria included Crohn's disease of the pouch, isolated cuffitis, pouch strictures, abscess, and sinuses. All eligible patients received AST-120 in 2-g sachets (oral) open label, thrice a day for 4 weeks. The primary efficacy end point was remission as defined by a PDAI score of <7 points; the main secondary end point was clinical response, defined by a reduction of the PDAI score of 3 points.RESULTS:Nineteen of 20 patients completed the trial. Eleven patients (55.0) had a clinical response to the therapy and 10 patients (50.0) entered remission. Median reduction in the PDAI symptom, endoscopy, and histology subscores, and PDAI total scores after 4 weeks were -2 (P0.002), -2 (P0.003), 0 (P0.32), and -4 (P0.001) points, respectively. The agent was well tolerated; one patient experienced transient mild elevation of alkaline phosphatase of uncertain significance and one patient experienced an upper respiratory infection after taking one dose of AST-120 and was excluded from the final analysis for the calculation of pre- and post-trial PDAI scores.CONCLUSIONS:AST-120 seems to be effective and well tolerated in treating patients with active pouchitis. A randomized, placebo-controlled trial is warranted for assessing the long-term efficacy and safety of AST-120 in the disease.",
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AU - Shen, Bo

AU - Pardi, Darrell S.

AU - Bennett, Ana E.

AU - Queener, Elaine

AU - Kammer, Patricia

AU - Hammel, Jefferey P.

AU - LaPlaca, Caroline

AU - Harris, M. Scott

PY - 2009/6

Y1 - 2009/6

N2 - OBJECTIVES:Although a majority of patients with pouchitis respond favorably to antibiotic therapy, many relapse frequently, and nonabsorbable and non-antibiotic-based agents are desirable for reducing bacterial resistance and the systemic adverse effects associated with long-term antibiotic exposure. AST-120 (a spherical carbon adsorbent) comprises highly adsorptive, porous carbon microspheres with the ability to adsorb small-molecular-weight toxins, inflammatory mediators, and harmful bile acids. The aim of this pilot trial was to evaluate the efficacy and tolerability of AST-120 in the treatment of active pouchitis.METHODS:Eligible patients were recruited from two subspecialty pouchitis clinics. Inclusion criteria were (i) ileal pouch-anal anastomosis performed for ulcerative colitis; (ii) active pouchitis with Pouchitis Disease Activity Index (PDAI) scores 7; and (iii) discontinuation of antibiotic therapy for at least 2 weeks. Exclusion criteria included Crohn's disease of the pouch, isolated cuffitis, pouch strictures, abscess, and sinuses. All eligible patients received AST-120 in 2-g sachets (oral) open label, thrice a day for 4 weeks. The primary efficacy end point was remission as defined by a PDAI score of <7 points; the main secondary end point was clinical response, defined by a reduction of the PDAI score of 3 points.RESULTS:Nineteen of 20 patients completed the trial. Eleven patients (55.0) had a clinical response to the therapy and 10 patients (50.0) entered remission. Median reduction in the PDAI symptom, endoscopy, and histology subscores, and PDAI total scores after 4 weeks were -2 (P0.002), -2 (P0.003), 0 (P0.32), and -4 (P0.001) points, respectively. The agent was well tolerated; one patient experienced transient mild elevation of alkaline phosphatase of uncertain significance and one patient experienced an upper respiratory infection after taking one dose of AST-120 and was excluded from the final analysis for the calculation of pre- and post-trial PDAI scores.CONCLUSIONS:AST-120 seems to be effective and well tolerated in treating patients with active pouchitis. A randomized, placebo-controlled trial is warranted for assessing the long-term efficacy and safety of AST-120 in the disease.

AB - OBJECTIVES:Although a majority of patients with pouchitis respond favorably to antibiotic therapy, many relapse frequently, and nonabsorbable and non-antibiotic-based agents are desirable for reducing bacterial resistance and the systemic adverse effects associated with long-term antibiotic exposure. AST-120 (a spherical carbon adsorbent) comprises highly adsorptive, porous carbon microspheres with the ability to adsorb small-molecular-weight toxins, inflammatory mediators, and harmful bile acids. The aim of this pilot trial was to evaluate the efficacy and tolerability of AST-120 in the treatment of active pouchitis.METHODS:Eligible patients were recruited from two subspecialty pouchitis clinics. Inclusion criteria were (i) ileal pouch-anal anastomosis performed for ulcerative colitis; (ii) active pouchitis with Pouchitis Disease Activity Index (PDAI) scores 7; and (iii) discontinuation of antibiotic therapy for at least 2 weeks. Exclusion criteria included Crohn's disease of the pouch, isolated cuffitis, pouch strictures, abscess, and sinuses. All eligible patients received AST-120 in 2-g sachets (oral) open label, thrice a day for 4 weeks. The primary efficacy end point was remission as defined by a PDAI score of <7 points; the main secondary end point was clinical response, defined by a reduction of the PDAI score of 3 points.RESULTS:Nineteen of 20 patients completed the trial. Eleven patients (55.0) had a clinical response to the therapy and 10 patients (50.0) entered remission. Median reduction in the PDAI symptom, endoscopy, and histology subscores, and PDAI total scores after 4 weeks were -2 (P0.002), -2 (P0.003), 0 (P0.32), and -4 (P0.001) points, respectively. The agent was well tolerated; one patient experienced transient mild elevation of alkaline phosphatase of uncertain significance and one patient experienced an upper respiratory infection after taking one dose of AST-120 and was excluded from the final analysis for the calculation of pre- and post-trial PDAI scores.CONCLUSIONS:AST-120 seems to be effective and well tolerated in treating patients with active pouchitis. A randomized, placebo-controlled trial is warranted for assessing the long-term efficacy and safety of AST-120 in the disease.

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