ISFA-EIFA-2021
Tag: Safety
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S-05-05 Efficacy and safety of cytapheresis in elderly patients with ulcerative colitis (poster)
Remission induction was more challenging in elderly UC patients. However, CAP was safe and effective for remission induction as a non-pharmacological treatment, even in elderly UC patients, after the incorporation of practical measures. Optimized and contrived CAP is still useful as the sole or concomitant treatment.
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Security of therapeutic apheresis in pediatrics. prospective study during 2018 in 171 apheresis sessions
Víctor López Baez, Pedro Arango Sancho, Yolanda Calzada Baños, Elena Codina Sampera, Ana Vinuesa Jaca, Lina Hernández Zúñiga, Álvaro Madrid Aris, Nephrology Dialysis Transplantation, Volume 35, Issue Supplement_3
The apheresis techniques in pediatrics had been presented with few complications in our center, none derived from vascular access, anticoagulation, infections or adverse effects due to use of replacement fluid. The training of medical and nursing staff is essential to identify risk situations. The use of protocols and international guidelines ensure safety in pediatrics.
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Safety and efficacy of single-needle leukocyte apheresis for treatment of ulcerative colitis
Yoichiro Shindo 1, Keiichi Mitsuyama 2, Hiroshi Yamasaki 1 2 3, Tetsuro Imai 4, Shinichiro Yoshioka 1 2, Kotaro Kuwaki 1 2, Ryosuke Yamauchi 1 2, Tetsuhiro Yoshimura 1 2, Toshihiro Araki 1 2, Masaru Morita 1 2, Kozo Tsuruta 1 2, Sayo Yamasaki 1, Kei Fukami 5, Takuji Torimura, Ther Apher Dial 2020 Oct;24(5):503-510.
Single-needle (SN) apheresis may be safe and effective and may reduce patient burden during UC treatment. Nevertheless, further comparative studies are needed.
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Apheresis in Inflammatory Bowel Disease: Current Evidence
Daniel Vasile Balaban and Mariana Jinga Crohn’s Disease Recent Advances book, October 15th, 2020 DOI: 10.5772/intechopen.93605
Inflammatory bowel diseases (IBD) have become a major focus for gastroenterologists worldwide, with the increasing incidence and complexity of cases, which pose therapeutic challenges. Currently available approaches fail in controlling the disease activity in a significant proportion of patients and some of the therapies are associated with significant adverse events. Although new molecules are on the horizon and treatment strategies have been optimized, novel therapeutic tools are much needed in IBD for patients who fail to attain control of the disease. Apheresis is now a common non-pharmacological therapeutic modality used in several pathologies, IBD also. In the current review, we summarize currently available evidence with respect to selective apheresis in IBD.
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Pyoderma gangrenosum in an ulcerative colitis patient during treatment with vedolizumab responded favorably to adsorptive granulocyte and monocyte apheresis
Tomoyoshi Shibuya,Keiichi Haga,Michio Saeki,Mayuko Haraikawa,Hitoshi Tsuchihashi,Koki Okahara,Osamu Nomura,Hirofumi Fukushima,Takashi Murakami Dai Ishikawa,Shigaku Ikeda,Akihito Nagahara
J Clin Apher. 2020 Sep;35(5):488-492. doi: 10.1002/jca.21821. Epub 2020 Aug 7.
Pyoderma gangrenosum (PG) is an extra-intestinal skin lesion in inflammatory bowel disease (IBD) as is erythema nodosum. Vedolizumab (VED) is a monoclonal antibody that targets α4β7 integrin and has an intestinal selective mechanism. Despite good therapeutic effects on colitis, the effect on extra-intestinal manifestations (EIMs) remains unclear. Here we report a case of ulcerative colitis complicated by PG during treatment with VED, which was successfully treated with prednisolone in combination with adsorptive granulocyte and monocyte apheresis (GMA). The patient was a 50-year-old woman with a past medical history of extensive ulcerative colitis managed by golimumab (GLM). She developed flare symptoms due to loss of response to GLM, and treatment was switched to VED. Her gastrointestinal symptoms were improved with VED treatment with less frequent bowel movements. However, infiltrative erythema with pain appeared on the right lower leg and right knee, and expanded and gradually ulcerated. Her skin lesions were treated with corticosteroid, but showed poor improvement. Therefore, granulocyte and monocyte apheresis (GMA) treatment was administered in combination with prednisolone. After 3 months, the ulcer gradually improved, and at the time of this writing, the eruptions were nearly replaced by epithelial tissue. This case study showed that patients with UC and EIMS may respond well to combination therapy of VED and GMA. GMA has a very favorable safety profile. On the other hand, the causal connection between VED and PG is still unclear. We believe that a combination therapy involving VED and GMA in IBD patients with EIMs warrants consideration.
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Adsorptive granulocyte and monocyte apheresis: A potentially relevant therapeutic option for COVID-19
https://pubmed.ncbi.nlm.nih.gov/32721534/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834290/pdf/main.pdf
Takuro Kanekura 1, Koichi Kawahara 2 , Int J Infect Dis 2020 Oct;99:1-2.
To our knowledge, GMA has a good safety profile; serious adverse effects are rarely reported. Its modes of action together with the findings of this case report support our notion that GMA is a relevant therapeutic option for patients with COVID-19 and warrants an immediate clinical trial to evaluate its full therapeutic efficacy in a large cohort of COVID-19 patients.
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Single Needle Granulocyte and Monocyte Apheresis for Ulcerative Colitis: A Retrospective Safety Analysis
Tetsurou Imai 1, Hiroshi Yamasaki 2 3 4, Keiichi Mitsuyama 3, Osamu Yamaga 1, Gaku Sugihara 1, Yusuke Kaida 5, Ryo Shibata 5, Takuma Hazama 5, Shinichiro Yoshioka 2 3, Takuji Torimura 2, Kei Fukami 5, Norio Yamashita 6
Introduction: Granulocyte and monocyte apheresis (GMA) is an effective treatment strategy for active ulcerative colitis (UC) in Japan. Single needle (SN) apheresis reduces needle puncture pain in patients because it requires only one puncture site. We evaluated whether single-needle apheresis could be a safe and effective means of reducing patient burden. Method: We performed a retrospective study of active UC patients who were treated with either SN apheresis or conventional double-needle (DN) apheresis at the Kurume university hospital from April 2014 to March 2018. All the patients treated with GMA after September 2016 underwent SN apheresis. Thus, the two groups predominantly belonged to different time periods. We assessed the safety of SN apheresis. Result: Six patients underwent SN apheresis, and 6 underwent DN apheresis. The average time to the start of apheresis was significantly reduced from 23.1 minutes in the case of DN apheresis to 12.6 minutes for SN apheresis. In addition, the number of difficult punctures was significantly reduced with SN apheresis. There were no differences in adverse events between SN and DN apheresis. Treatment benefits, remission rate and disease activity were similar between SN and DN apheresis.Conclusion: SN apheresis reduced both the time to treatment initiation and pain during puncture, and there was no difference in the number of blood clotting episodes as compared with DN. Although further comparative studies are needed, SN apheresis may be a safe alternative for patients to reduce the strain of treatment.
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Cytapheresis for pyoderma gangrenosum associated with inflammatory bowel disease: A review of current status
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7281039/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7281039/pdf/WJCC-8-2092.pdf
Kentaro Tominaga, Kenya Kamimura, Hiroki Sato, Masayoshi Ko, Yuzo Kawata, Takeshi Mizusawa, Junji Yokoyama, and Shuji Terai, World J Clin Cases. 2020 Jun 6; 8(11): 2092–2101.
Pyoderma gangrenosum (PG) is a neutrophilic dermatosis clinically characterized by the presence of painful skin ulcerations with erythematous. As it is frequently associated with inflammatory bowel diseases, including ulcerative colitis, gastroenterologists should be familiar with the disease including therapeutic options. Pyoderma gangrenosum is one of the neutrophilic dermatoses often complicated with ulcerative colitis. The corticosteroid and other immune modulator have been used for the treatment, however, as its disease mechanism has not been clarified, there is no additional option for those who showed poor response and refractory to the conventional therapies. Therefore, we have conducted a review focusing on the cytapheresis for PG in cases of inflammatory bowel diseases. A literature search was conducted to extract studies published in the last 20 years, with information on demographics, clinical symptoms, treatment, and the clinical course from a total of 22 cases reported and our recent case. In most patients, cytapheresis was associated with improvement or resolution of PG after failure of conventional therapeutic options such as corticosteroids, antibiotics, immunosuppressive agents and immunoglobulin. Based on the recent reports, we have summarized the clinical course of 23 cases and efficacy of cytapheresis..Cytapheresis is helpful in the majority of patients with PG refractory to medical treatment associated with inflammatory bowel diseases and could be further studied in a multicenter, randomized trial.
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Adsorptive Granulocyte and Monocyte Apheresis Is Effective in Ulcerative Colitis Patients Both with and without Concomitant Prednisolone
https://pubmed.ncbi.nlm.nih.gov/32232053/
https://karger.com/iid/article-pdf/5/1/36/2995465/000505484.pdf
Keiji Matsuda 1 2, Kohei Ohno 1, Yuka Okada 1, Takahiro Yagi 1, Mitsuo Tsukamoto 1, Yoshihisa Fukushima 1, Atsushi Horiuchi 1, Ryu Shimada 1 2, Tsuyoshi Ozawa 1 2, Tamuro Hayama 1 2, Takeshi Tsuchiya 1 2, Junko Tamura 1, Hisae Iinuma 1, Keijiro Nozawa 1 2, Hitoshi Aoyagi 2 3, Akari Isono 2 3, Koichiro Abe 2 3, Shinya Kodashima 2 3, Takatsugu Yamamoto 2 3, Yoshitaka Kawasaki 4, Yoshifuru Tamura 4, Yuko Sasajima 5, Fukuo Kondo 5, Yojiro Hashiguchi 1 2 , Inflamm Intest Dis, 2020 Feb;5(1):36-41.
The effect of GMA with concomitant PSL (Prednisolone) and that of GMA without PSL were not different, and GMA was effective irrespective of PSL administration. The present study showed that GMA had efficacy and led many UC patients treated by PSL to be steroid free with no safety concern in the real world, although there is the possibility of recruitment bias due to the retrospective nature of the study.
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Combination Therapy With Tofacitinib Plus Intensive Granulocyte and Monocyte Adsorptive Apheresis as Induction Therapy for Refractory Ulcerative Colitis
https://pubmed.ncbi.nlm.nih.gov/32010420/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6968921/pdf/jocmr-12-036.pdf
Satoshi Tanida 1, Keiji Ozeki 1, Tsutomu Mizoshita 1, Mika Kitagawa 1, Takanori Ozeki 1, Mamoru Tanaka 1, Hirotada Nishie 1, Takaya Shimura 1, Eiji Kubota 1, Hiromi Kataoka 1 , J Clin Med Res, 2020 Jan;12(1):36-40.
Based on these outcomes, combination therapy with TOF plus intensive GMA was well tolerated and may be useful for induction of clinical remission in patients with refractory UC.
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