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Leukocytapheresis: Filtering Out the Facts
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Recently, successful results of ulcerative colitis (UC) treatments with leukocyte apheresis have been reported by several institutes. To certify the efficacy of leukocyte apheresis in refractory UC patients, a multicenter open label trial was conducted, and results were analyzed. Fifty patients diagnosed with active steroid-resistant UC were enrolled in this study from 14 medical centers. Using a centrifugal cell separator (Component Collection System, Haemonetics), leukocyte apheresis was performed once a week for 5 weeks. General conditions and abdominal symptoms were recorded daily, and laboratory tests were followed weekly. Changes of colonoscopic and histological manifestations of luminal activity through the study period were evaluated. At the end of the study period, stool frequency was decreased to less than 4 times a day in 68.4% (26 of 38) and serum C-reactive protein (CRP) concentration was normalized in 56.7% (17 of 30) of the patients. Colonoscopic remission was achieved in 57.7% (26 of 45), and histological improvement was noted in 54.1% (20 of 37) of the patients tested. Improved disease activity was demonstrated in 74% (37 of 50) of the patients by general assessment criteria. Analysis of the trial data confirmed the valid clinical efficacy of leukocyte apheresis by centrifugal cell separator in refractory UC patients.
Corticosteroids are effective in bringing about clinical remission for ulcerative colitis. However, relapsed cases are frequently refractory to corticosteroids. In addition, the long-term use of corticosteroids often causes serious side effects. We have already reported that leukocyte apheresis using a centrifugal procedure was effective for patients with corticosteroid-resistant ulcerative colitis after conducting a pilot study in 14 patients. In the present paper, the clinical efficacy of leukocyte apheresis using a centrifugal procedure was evaluated again for corticosteroid-resistant ulcerative colitis. Twenty-three patients with corticosteroid-resistant severely active ulcerative colitis were treated by centrifugal leukocyte apheresis. Eighteen patients (78.3%) achieved clinical remission which was evaluated by the clinical activity index within 4 weeks after apheresis. Both colonoscopic and histological examinations confirmed the beneficial effect of this procedure. No significant side effects were noticed throughout the therapy.
Recently leukocytapheresis (LCAP) has attracted attention as a new therapy for ulcerative colitis. We reviewed the complications associated with LCAP carried out in our department during the period from December 1992 to September 1997. There were side effects during 195 (9.9%) of the 1,978 sessions performed, involving 47 (51.1%) of the 92 patients treated. Moderate reactions, which caused considerable discomfort to the patients and required the transient interruption of the administration or some medical treatment depending on the state, occurred during 31 (1.6%) of all therapy sessions, involving 15 (16%) patients. All patients recovered soon and never fell into a life-threateningly severe state. They also did not have any symptoms afterwards. The common side effects were nausea, vomiting, fever, chills, and nasal obstruction. Reactions such as palpitations, respiratory distress, or chest oppressions were common, especially when heparin sodium (HS) was used as the anticoagulant. The type and frequency of side effects depended somewhat on the length of the therapy series or the duration of one session. Other complications such as clotting in the leukocyte removal filter and/or blood line during administration were encountered frequently. These latter problems occurred during 46% of all sessions, but most of them had little significance. Sessions in which HS was used as the anticoagulant showed more severe clotting than those in which nafamostat mesilate (NM) was used. In our series, we experienced a relatively low rate of serious complications. We require, of course, careful observation during and after each session.
To certify the feasibility of leukapheresis, 37 ulcerative colitis (UC) patients, who had failed to recover by conventional treatment were enrolled in this treatment. Imugard (Terumo Co., Ltd., Tokyo Japan) or Cellsorba (Asahi Medical) filters were used. The schedule was one session weekly for 3 weeks and then twice monthly for 2 months. The laboratory tests performed were complete blood count, complements, immunoglobulins, and lymphocyte subsets. Endoscopic examination was done before and 3 months after initiation. Thirty-four of thirty-seven patients had some beneficial effects, and no patient's condition deteriorated. Corticosteroids were tapered or stopped in 18 patients out of 21. Seventeen of twenty patients experienced endoscopical remission. In laboratory data, leukocytes decreased with time. The C-reactive protein (CRP) levels and erythrocyte sedimentation rates (ESRs) improved. The percentage of CD3+HLA-DR+ cells, CD8+HLA-DR+ cells decreased. Six patients discontinued the treatment. Three of them showed no favorable effects. No severe side effects were observed. This treatment is cost effective and will be a feasible treatment.
We prospectively examined the effect of leukocytapheresis (LA) on the maintenance of remission in 7 patients with ulcerative colitis (UC) who were initially refractory to corticosteroid therapy (steroid resistant or steroid dependent). The patients with refractory UC had been in remission due to LA (induction LA) in combination with the steroid therapy. They were then treated with LA once or twice a month for the purpose of maintaining remission (maintenance LA). The maintenance LA was performed by either a centrifuge method in 5 patients or a polyester adsorbent column method in 2 patients. Steroid dosage was gradually tapered as little as possible without recurrence based on clinical and/or colonoscopical judgments. Four patients were maintained in remission without steroids over 12 months. Recurrence was observed in 3 patients at 3, 3, and 6 months after the beginning of the maintenance LA, respectively. Two of the 3 patients were again conducted to remission by the second induction LA and maintained in remission by the second maintenance LA. Two patients finally underwent total colectomy because of recurrence of UC in a severe form. It is concluded that the maintenance LA therapy might be effective in some patients with steroid dependent or resistant UC for the maintenance of remission without steroids.
Cellsorba is a leukocyte removal filter developed by Asahi Medical Co., which adsorbs white blood cells through the perfusion of peripheral blood by means of simple extracorporeal circulation. Leukocytapheresis (LCAP) therapy using the Cellsorba column has been reported to show therapeutic effects for many autoimmune related and inflammatory diseases, such as inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, neurologic disease, and so on. At present, Cellsorba is listed as a medical device covered by the Japanese national health insurance system for the treatment of active ulcerative colitis (UC) in Japan, and contributes to the improvement of quality of life in many UC patients. This paper reviews the use of Cellsorba and introduces several reports on therapeutic results.
Ulcerative colitis is a chronic inflammatory disease of the rectum and colon. Although the pathogenesis of ulcerative colitis is not fully elucidated, cell-mediated immunity plays an important role in disease pathogenesis. Leukocytapheresis is a newly emerging therapy to eliminate activated leukocyte from systemic circulation. We have studied the effects of leukocytapheresis on patients with ulcerative colitis who had failed to respond to conventional therapy. A total of 51 patients with ulcerative colitis were treated with apheresis using a non-woven polyester fiber filter (Finecell, Asahi Medical Co.,Tokyo, Japan) originally developed as a microcoagulation elimination filter for massive transfusion. Of the 51 patients, 33 (64.7%) achieved clinical remission manifested by clinical activity and colonoscopic findings without any adverse effects. This result suggested that leukocytapheresis using Finecell might serve as an alternative therapy for ulcerative colitis as other leukocytapheresis using centrifugation or column.