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Exploratory Study of the Effectiveness of Granulocyte and Monocyte Adsorptive Apheresis Before Initiation of Steroids in Patients With Active Ulcerative Colitis (EXPECT Study): A Multicenter Prospective Clinical Trial

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Efficacy of granulocyte and monocyte apheresis for antibiotic-refractory pouchitis after proctocolectomy for ulcerative colitis: an open-label, prospective, multicentre study

Takayuki Yamamoto 1Toshiaki Tanaka 2Tadashi Yokoyama 3Takahiro Shimoyama 1Hiroki Ikeuchi 4Motoi Uchino 4Toshiaki Watanabe 5 , Therap Adv Gastroenterol. 2017 Feb;10(2):199-206.

GMA has a good safety profile, but its efficacy appears to be limited in the management of chronic refractory pouchitis. However, a large controlled study should be conducted to evaluate the efficacy of GMA therapy in patients with pouchitis at an earlier clinical stage, before the disease has become refractory to conventional medical therapy.

https://pubmed.ncbi.nlm.nih.gov/28203278/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5298477/pdf/10.1177_1756283X16679348.pdf

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

Gianni Imperiali 1Arnaldo Amato 1Maria Maddalena Terpin 2Ivo Beverina 3Aurora Bortoli 4Massimo Devani 4Chiara Viganò 5,Gastroenterol Res Pract2017;2017:9728324.

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

https://pubmed.ncbi.nlm.nih.gov/29403531/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5748298/pdf/GRP2017-9728324.pdf

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An open-label prospective randomized multicenter study of intensive versus weekly granulocyte and monocyte apheresis in active crohn’s disease.

Atsushi Sakuraba 1Satoshi MotoyaKenji WatanabeMasakazu NishishitaKazunari KankeToshiyuki MatsuiYasuo SuzukiTadayuki OshimaReiko KunisakiTakayuki MatsumotoHiroyuki HanaiKen FukunagaNaoki YoshimuraToshimi ChibaShinsuke FunakoshiNobuo AoyamaAkira AndohHiroshi NakaseYohei MizutaRyoichi SuzukiTaiji AkamatsuMasahiro IizukaToshifumi AshidaToshifumi Hibi, Am J Gastroenterol. 2009 Dec;104(12):2990-5.

Intensive GMA in patients with active UC seems to be more efficacious than weekly treatment, and significantly reduced the patients’ morbidity time without increasing the incidence of side effects.

https://pubmed.ncbi.nlm.nih.gov/19724269/

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Intermittent granulocyte and monocyte apheresis versus mercaptopurine for maintaining remission of ulcerative colitis: a pilot study.

Atsushi Sakuraba 1Toshiro SatoYuichi MorohoshiKatsuyoshi MatsuokaSusumu OkamotoNagamu InoueHiromasa TakaishiHaruhiko OgataYasushi IwaoToshifumi Hibi,Ther Apher Dial. 2012 Jun;16(3):213-8.

The effect of granulocyte and monocyte adsorption apheresis (GMA) on prevention of relapse of ulcerative colitis (UC) is not clear. This was a pilot open-labeled, prospective, randomized, unblinded study to compare the tolerability and efficacy of intermittent GMA (once every 2 weeks) with mercaptopurine to maintain remission of UC. Twenty-one patients with UC, who had achieved remission by induction therapies were randomly assigned to receive either intermittent GMA (N = 10) or oral mercaptopurine (0.5 mg/kg per day; N = 11). The study period was 24 months. The rate of the patients maintaining remission and the incidences of adverse effects were compared between the two groups. At 24 months, seven of 10 patients (70.0%) on intermittent GMA and seven of 11 patients (63.6%, P = 1.00) on oral mercaptopurine were still in remission. Three patients relapsed in each group. One patient taking mercaptopurine, but none receiving intermittent GMA, dropped out because of adverse effects. Intermittent therapy with GMA was well tolerated and a substantial proportion of patients maintained remission. Intermittent GMA therapy in maintaining remission of UC merits further investigation.

https://pubmed.ncbi.nlm.nih.gov/22607563/

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Daily granulocyte and monocyte adsorptive apheresis in patients with active ulcerative colitis: a prospective safety and feasibility study

Takayuki Yamamoto 1Satoru UmegaeKoichi Matsumoto, J Gastroenterol 2011 Aug;46(8):1003-9.

This is the first report on daily GMA in the treatment of patients with UC. Daily GMA was safe and well tolerated without serious AE. Furthermore, daily GMA was associated with rapid improvement of clinical symptoms in patients with moderately active UC. However, controlled trials are warranted to assess a definite efficacy for daily GMA therapy.

https://pubmed.ncbi.nlm.nih.gov/21681409/

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Leukocytapheresis in Patients with Moderate-Severe Steroid-Dependant Ulcerative Colitis: Clinical Response without Endoscopic Response

Irene Modesto, Daniela Scimeca, Ambrogio Orlando, Mario Cottone, Inflamm Bowel Dis 12 (10), October 2006

We report the results of an open prospective study of LCAP in moderate to severe steroid-dependent UC. LCAP is an effective procedure in obtaining discontinuation of steroids in 36% of patients with UC for at least 3 months. Overall 4 of 11(36%) patients could discontinue steroids within 3 months. No relevant side effects were observed. The procedure was well tolerated. In our series, there was no endoscopic response. Most of the patients obtained a clinical temporary response, but many relapsed

https://pubmed.ncbi.nlm.nih.gov/17012976/

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Treatment of active steroid-refractory inflammatory bowel diseases with granulocytapheresis: Our experience with a prospective study

Bresci Giampaolo 1Parisi GiuseppeBertoni MicheleMazzoni AlessandroScatena FabrizioCapria Alfonso, World J Gastroenterol. 2006 Apr 14;12(14):2201-4.

Even if the number of our patients with steroid-refractory IBDs was not big, we can assert that GCAP is well tolerated and effective, especially in the first six months after the treatment, in a significant percentage of cases. The rate of sustained response drops slightly after 6 mo and significantly after 12 mo, however the absence of severe side effects can be a stimulus for further evaluating new schedules of treatment.

https://pubmed.ncbi.nlm.nih.gov/16610021/

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[Granulocyte and monocyte adsorption apheresis in Korean conventional treatment-refractory patients with active ulcerative colitis: a prospective open-label multicenter study]

[Article in Korean ]Hyo Jong Kim 1Joo Sung KimDong Soo HanSuk-Kyun YangKi Baik HahmWoo In LeeSeog-Woon KwonJai Hyun ChoiWon Ho KimKyu Yong ChoiIn Sung Song Korean J Gastroenterol  2005 Jan;45(1):34-44. PMID: 15665566

Background/aims: In chronic inflammatory conditions such as ulcerative colitis (UC), the migration of granulocytes and monocytes/macrophages from the circulation into the colonic mucosa is especially important in maintaining inflammation. The aim of this trial was to assess safety and efficacy of granulocyte and monocyte adsorption apheresis in patients with moderate-to-severe UC refractory to conventional drug therapies. Methods: Twenty-seven patients with moderate (55.6%) to severe (44.4%) active UC refractory to conventional drug therapies who had no changes in their conventional therapy regimen in the past two weeks before the recruitment were enrolled in an open-label trial. Concomitant medications were allowed, and steroids were tapered down according to the clinical activity during the course. We used an adsorptive type extracorporeal column (Adacolumn; JIMRO, Takasaki, Japan), which selectively adsorb granulocytes and monocytes. Patients took five apheresis sessions, each with 60 minutes duration for 5 consecutive weeks. The primary efficacy variables were clinical disease activity, short inflammatory bowel disease questionnaire (SIBDQ), C-reactive protein (CRP), and endoscopic scores. These variables were scored at regular intervals, and analyzed at week 7 on an intention-to-treat (ITT) principles. Results: At 7 weeks, 70.4% of patients showed overall improvement. Clinical disease activity (p < 0.0001), endoscopic score (p < 0.001), and the quality of life as assessed by SIBDQ (p < 0.0001) were significantly improved after the therapy. In 56.3% of concomitant steroid users, tapering down or discontinuation of steroids was possible. Treatment was well tolerated, and no severe adverse events were observed. Conclusions: Adacolumn was very efficacious in patients with moderate-to-severe active UC refractory to conventional drug therapy, but further assessment is needed.

https://pubmed.ncbi.nlm.nih.gov/15665566/

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Granulocyteaphaeresis in steroid-dependent inflammatory bowel disease: a prospective, open, pilot study

E Domènech 1J HinojosaM Esteve-ComasF GomollónJ M HerreraG BastidaA ObradorR RuizC SaroM A GassullSpanish Group for the Study of Crohn’s Disease and Ulcerative Colitis (GETECCU)

Aliment Pharmacol Ther. 2004 Dec;20(11-12):1347-52. doi: 10.1111/j.1365-2036.2004.02288.x.

Background: Uncontrolled studies suggest that granulocyteaphaeresis might be useful in the management of active ulcerative colitis. Aim: To assess the efficacy of granulocyteaphaeresis treatment in active steroid-dependent inflammatory bowel disease. Methods: We conducted a multicentre, prospective, open, pilot study in patients with steroid-dependent inflammatory bowel disease. All patients were started on 60 mg/day of prednisone; after 1 week, a five-session programme of granulocyteaphaeresis (once per week) was started. The steroid dose was tapered weekly if there was clinical improvement. Remission was defined as an inactive clinical activity index together with complete withdrawal of steroids at week 6. The patients were followed up for at least 6 months or until disease relapse. Results: Twenty-six patients (14 ulcerative colitis, 12 Crohn’s disease) were included. More than a half had been previously treated with immunomodulators. Remission was achieved in 62 and 70% of ulcerative colitis and Crohn’s disease, respectively. During a median follow-up of 12.6 months, six of eight ulcerative colitis patients maintained their clinical remission; however, only one Crohn’s disease patient remained in remission after the first 6 months of follow-up. Conclusions: Granulocyteaphaeresis is a safe treatment option in inflammatory bowel disease. A five-session programme of granulocyteaphaeresis seems to be efficient in the treatment of steroid-dependent ulcerative colitis, but not in Crohn’s disease.

https://pubmed.ncbi.nlm.nih.gov/15606397/

https://onlinelibrary.wiley.com/doi/epdf/10.1111/j.1365-2036.2004.02288.x

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