Adsorptive Granulocyte/Monocyte Apheresis for the Maintenance of Remission in Patients with Ulcerative Colitis: A Prospective Randomized, Double Blind, Sham-Controlled Clinical Trial

Fukunaga, Ken; Yokoyama, Yoko; Kamokozuru, Koji; Nagase, Kazuko; Nakamura, Shirô; Miwa, Hiroto; Matsumoto, Takayuki

doi:10.5009/gnl.2012.6.4.427

Cited by 22 publications

(17 citation statements)

References 24 publications

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“…Some studies [ 9 , 10 ] evaluated recently diagnosed UC patients with mild clinical activity, where GMA was associated with a good clinical response, but a not so profitable cost-benefit ratio. Consistent results have been drawn for GMA in the maintenance of remission [ 11 ]. Furthermore, other fields of application have been represented by subgroups where the safety profile is very important, such as adolescents [ 12 ], pregnant women [ 13 ], and patients with cytomegalovirus superinfection [ 14 ].…”

Section: Discussionsupporting

confidence: 83%

Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study

Imperiali

Amato

Terpin

et al. 2017

Gastroenterology Research and Practice

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Background Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although it is limited by costs and variability of results. Aim To assess effectiveness of granulocyte-monocyte apheresis in patients with steroid-dependent, azathioprine-intolerant/resistant moderate ulcerative colitis. Methods Consecutive patients fulfilling inclusion criteria were prospectively enrolled, treated by apheresis, and followed up for 12 months. The primary end point of the study was steroid-free clinical remission at 12 months, with no need for biologic therapy or surgery. Results From January to December 2013, 33 patients were enrolled. After one year of follow-up, 12 (36%) patients had clinical remission, were steroid-free, and had no need for biological therapy or surgery; 3 (9%) cases showed a clinical response (but not clinical remission). Moreover, 12 (36%) patients required biologic therapy, 4 (12%) underwent colectomy, and in the other 2 (6%) a reduction, but not withdrawal, of steroid dose was achieved. Conclusions Our study shows that a standard course of granulocyte-monocyte apheresis is associated with a 36% steroid-free clinical remission in patients with steroid-dependent, azathioprine-intolerant or resistant moderate ulcerative colitis. Apheresis might represent an alternative to biologic therapy or surgery in this specific subgroup of patients. This trial is registered with Clinicaltrial.gov NCT03189888.

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Section: Discussionsupporting

confidence: 83%

Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study

Imperiali

Amato

Terpin

et al. 2017

Gastroenterology Research and Practice

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“…Efficacy of CAP for maintenance of remission in UC has been reported [ 134 ], although its evidence level is low and its use has not yet been approved for this purpose. There is only one case report suggesting its efficacy for maintaining remission in CD [ 135 ].…”

Section: Therapeutic Interventions For Ibdmentioning

confidence: 99%

Evidence-based clinical practice guidelines for inflammatory bowel disease

et al. 2018

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Inflammatory bowel disease (IBD) is a chronic disorder involving mainly the intestinal tract, but possibly other gastrointestinal and extraintestinal organs. Although etiology is still uncertain, recent knowledge in pathogenesis has accumulated, and novel diagnostic and therapeutic modalities have become available for clinical use. Therefore, the previous guidelines were urged to be updated. In 2016, the Japanese Society of Gastroenterology revised the previous versions of evidence-based clinical practice guidelines for ulcerative colitis (UC) and Crohn’s disease (CD) in Japanese. A total of 59 clinical questions for 9 categories (1. clinical features of IBD; 2. diagnosis; 3. general consideration in treatment; 4. therapeutic interventions for IBD; 5. treatment of UC; 6. treatment of CD; 7. extraintestinal complications; 8. cancer surveillance; 9. IBD in special situation) were selected, and a literature search was performed for the clinical questions with use of the MEDLINE, Cochrane, and Igaku Chuo Zasshi databases. The guidelines were developed with the basic concept of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Recommendations were made using Delphi rounds. This English version was produced and edited based on the existing updated guidelines in Japanese.

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“…40% in the GMA arm avoided relapse in comparison to 9.1% and 18.2% in the sham and control arm, respectively. Although no significant values were obtained the study concluded that GMA potentially might prevent UC relapse when used as a maintenance therapy .…”

Section: Discussionmentioning

confidence: 68%

Retrospective Single Center Study of Granulocyte Monocyte Adsorption Apheresis Treatment in Inflammatory Bowel Disease

2016

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Patients with active inflammatory bowel disease (IBD) have elevated and activated myeloid leukocytes, which infiltrate the intestinal mucosa. A significant proportion of IBD patients do not respond adequately to conventional treatment regimes. Studies have suggested that treatment with granulocyte monocyte apheresis (GMA) could be a safe and efficacious alternative for these patients. We evaluated the efficacy and safety of granulocyte/monocyte apheresis in patients with IBD in a retrospective cohort study, conducted from a single center in Stockholm. Clinical details from consecutive apheresis treated patients were retrospectively reviewed from 2004 to 2012. A total of 37 patients were included, 23 patients with ulcerative colitis (UC) and 14 with Crohn's disease (CD). Clinical response was seen in 11 patients (30%) and complete remission in 11 patients (30%). The remission rate was higher in UC patients compared to CD patients, 39% (N = 9) and 14% (N = 2) respectively. A total of 9 patients experienced adverse events. Most frequently reported was headache (N = 4). GMA seems to be a valuable adjuvant treatment regime in the care of patients with refractory IBD.

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Adsorptive Granulocyte/Monocyte Apheresis for the Maintenance of Remission in Patients with Ulcerative Colitis: A Prospective Randomized, Double Blind, Sham-Controlled Clinical Trial

Cited by 22 publications

References 24 publications

Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study

Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study

Evidence-based clinical practice guidelines for inflammatory bowel disease

Retrospective Single Center Study of Granulocyte Monocyte Adsorption Apheresis Treatment in Inflammatory Bowel Disease

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