Eugeni Domènech 1, Julián Panés 2, Joaquín Hinojosa 3, Vito Annese 4, Fernando Magro 5, Giacomo Carlo Sturniolo 6, Fabrizio Bossa 7, Francisco Fernández 8, Benito González-Conde 9, Valle García-Sánchez 10, Axel Dignass 11, José Manuel Herrera 12, José Luis Cabriada 13, Jordi Guardiola 14, Maurizio Vecchi 15, Francisco Portela 16, Daniel Ginard 17, J Crohns Colitis. 2018 May 25;12(6):687-694.
Tag: randomized
Scientific corner
Addition of granulocyte/monocyte apheresis to oral prednisone for steroid-dependent ulcerative colitis: A randomized, multicentre, clinical trial.
In a randomized trial, the addition of 7 weekly sessions of GMA to a conventional course of oral prednisone did not increase the proportion of steroid-free remissions in patients with active steroid-dependent UC, though it delayed clinical relapse.
Scientific corner
Intermittent granulocyte and monocyte apheresis versus mercaptopurine for maintaining remission of ulcerative colitis: a pilot study.
Atsushi Sakuraba 1, Toshiro Sato, Yuichi Morohoshi, Katsuyoshi Matsuoka, Susumu Okamoto, Nagamu Inoue, Hiromasa Takaishi, Haruhiko Ogata, Yasushi Iwao, Toshifumi 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.
Scientific corner
Clinical Effectiveness of Selective Granulocyte, Monocyte Adsorptive Apheresis with the Adacolumn(®) Device in Ulcerative Colitis.
Brigitte Habermalz 1, Stefan Sauerland, Dig Dis Sci. 2010 May;55(5):1421-8.
The purpose of this meta-analysis was to determine whether selective adsorptive granulocyte and monocyte apheresis (GMA apheresis) using the Adacolumn device can effectively reduce clinical symptoms and endoscopic signs of inflammation in patients with ulcerative colitis (UC). A comprehensive search for randomized controlled trials (RCTs) published up to May 2008 was performed. Each study’s quality was evaluated, and the data reported in the results were abstracted. Pooled relative risk (RR) estimates and 95% confidence intervals (CIs) were calculated using the fixed-effects model. Heterogeneity was quantified statistically and explained by the variation in the trial design. Seven RCTs including 594 patients were found, and six RCTs on active UC contributed to the main analyses. In half of the trials, GMA apheresis was compared to steroids. Only one trial was fully blinded. A response or remission after 6 weeks was achieved more often in patients treated with GMA apheresis (RR 1.42; CI 1.15-1.75). Also, after 12 weeks, GMA apheresis produced significantly higher remission rates (RR 1.41; CI 1.08-1.83), but long-term data were sparse. In the trials that compared GMA apheresis and steroids (n = 220 patients), side effects were much less frequent in the GMA apheresis groups (RR 0.19; CI 0.11-0.34). Homogeneous evidence from seven RCTs shows that GMA apheresis induces a clinical remission in a higher proportion of UC patients as compared to conventional medical therapy.
Scientific corner
Systematic review: granulocyte/monocyte adsorptive apheresis for ulcerative colitis
S Thanaraj 1, P J Hamlin, A C Ford,Aliment Pharmacol Ther . 2010 Dec;32(11-12):1297-306.
Granulocyte/monocyte adsorptive apheresis appears of some benefit in UC. High-quality RCTs comparing granulocyte/monocyte adsorptive apheresis with conventional medical therapy or sham procedure in Western populations, with disease activity confirmed endoscopically, are required.
Scientific corner
An open-label prospective randomized multicenter study of intensive versus weekly granulocyte and monocyte apheresis in active crohn’s disease.
Atsushi Sakuraba 1, Satoshi Motoya, Kenji Watanabe, Masakazu Nishishita, Kazunari Kanke, Toshiyuki Matsui, Yasuo Suzuki, Tadayuki Oshima, Reiko Kunisaki, Takayuki Matsumoto, Hiroyuki Hanai, Ken Fukunaga, Naoki Yoshimura, Toshimi Chiba, Shinsuke Funakoshi, Nobuo Aoyama, Akira Andoh, Hiroshi Nakase, Yohei Mizuta, Ryoichi Suzuki, Taiji Akamatsu, Masahiro Iizuka, Toshifumi Ashida, Toshifumi Hibi, Am J Gastroenterol. 2009 Dec;104(12):2990-5.
Background: Granulocyte and monocyte adsorptive apheresis (GMA) has shown efficacy in patients with active Crohn’s disease (CD). However, with routine weekly therapy, it may take several weeks to achieve remission. This study was performed to assess clinical efficacy and safety of intensive GMA in patients with active CD. Methods: In an open-label, prospective, randomized multicentre setting, 104 patients with CD activity index (CDAI) of 200 to 450 received intensive GMA, at two sessions per week (n = 55) or one session per week (n = 49). Clinical remission was defined as a CDAI score <150. Patients in each arm could receive up to 10 GMA sessions. However, GMA treatment could be discontinued when CDAI decreased to <150 (clinical remission level). Results: Of the 104 patients, 99 were available for efficacy evaluation as per protocol, 45 in the weekly GMA group, and 54 in the intensive GMA group. Remission was achieved in 16 of 45 patients (35.6 %) in the weekly GMA and in 19 of 54 (35.2 %) in the intensive GMA (NS). Further, the mean time to remission was 35.4 ± 5.3 days in the weekly GMA and 21.7 ± 2.7 days in the intensive GMA (P = 0.0373). Elevated leucocytes and erythrocyte sedimentation rate were significantly improved by intensive GMA, from 8005/μL to 6950/μL (P = 0.0461) and from 54.5 mm/hr to 30.0 mm/hr (P = 0.0059), respectively. In both arms, GMA was well tolerated and was without safety concern. Conclusions: In this study, with respect to remission rate, intensive GMA was not superior to weekly GMA, but the time to remission was significantly shorter in the former without increasing the incidence of side effects. UMIN registration # 000003666.
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