新型生物制剂英夫利西治疗克罗恩病10例

目的 观察新型生物制剂英夫利西(infliximab)治疗10例克罗恩病(CD)患者的疗效及安全性.方法 前瞻性开放性研究英夫利西静脉滴注治疗经常规治疗无效或激素依赖的中、重度活动性CD患者8例和以反复下消化道大出血为主要临床表现的CD患者2例.在第0、2、6周给予5 mg/kg荆量作为诱导缓解,随后每隔8周给予相同剂量维持,临床与内镜随访30周.结果 ①治疗2周时,8例活动性CD患者中5例有效;30周时4例临床缓解(其中3例停用激素),1例有效;②2例以反复下消化道出血为主要临床表现者随访30周无再出血;③30周时复查肠镜6例,其中溃疡完全愈合或基本愈合4例;④7例发生不良事件,其中严重不良反应2例,分别为肺炎和迟发型过敏反应各1例.结论 英夫利西可诱导并维持部分活动性CD缓解,促进CD肠黏膜病变愈合,严重不良反应发生率不高.     

溃疡性结肠炎和克罗恩病的英夫利西(类克)治疗效果比较

目的分析、比较7例CD和7例UC的英夫利西(类克)治疗效果。方法按5 mg/kg,0、2、6周诱导,每8周巩固一次的方法应用类克。根据国内共识意见评定疗效,分别计算进入缓解期和仍处于活动期患者治疗前后ESR和CRP数据。结果7例CD患者中,4例达到症状缓解,3例好转。仅1例达到黏膜愈合。7例UC患者中,3例达到症状缓解,4例好转,2例黏膜愈合。14例CD和UC患者中,治疗后症状消失较快者提示临床和内镜下病变明显好转。无合并症CD或UC患者类克治疗效果最好。手术后用药可防止CD复发。1例发生过敏反应。结论类克治疗难治性CD和UC有相同的治疗效果。     

英夫利西治疗克罗恩病11例疗效观察

目的分析新型生物制剂英夫利西(infliximab,商品名:类克)治疗11例克罗恩病(CD)的疗效。方法前瞻性应用英夫利西治疗难治性性CD患者11例(活动期急性肠外瘘8例,激素及免疫抑制剂治疗无效CD患者3例)。在第0、2、6周分别给予5mg/kg作为基础剂量,14及22周分别给予相同剂量维持,临床及内镜随访。结果 (1)8例瘘道患者2、6、14和22周分别2例、4例、5例和6例治疗有效。3例常规治疗无效患者治疗后2例缓解,1例有效。(2)30周左右时内镜下黏膜愈合50%8例。(3)治疗前后WBC、CRP明显降低。结论英夫利西可诱导部分出现肠外瘘CD患者渗液量减少,部分患者瘘道完全闭合,同时可诱导并维持部分常规治疗无效的CD缓解,促进病变的黏膜愈合。     

英夫利西联合硫唑嘌呤治疗克罗恩病的临床及内镜随访

目的 观察英夫利西联合硫唑嘌呤治疗克罗恩病(CD)的疗效及黏膜愈合情况与预后的关系.方法 研究对象为广州中山大学附属第一医院接受英夫利西联合硫唑嘌呤治疗的20例活动性CD患者.根据CD活动指数分别评价治疗10周、30周、54周及2年时的临床疗效.根据内镜下黏膜应答情况分别评价治疗10周、30周、54周时的内镜下疗效.两组间比较采用方差分析或Fisher精确概率法.黏膜愈合影响因素采用Logistic回归分析.结果 治疗10周、30周、54周和2年时的无糖皮质激素临床缓解率分别为12/20、16/20、15/20和15/20,10周、30周和54周时的黏膜愈合率分别为8/20、12/20和10/20.Logistic多因素回归分析显示,年轻是影响治疗30周时黏膜愈合的惟一因素((OR=0.774,95％CI:0.630～0.950).30周时黏膜应答者与内镜下无效者在30周及2年时的无糖皮质激素临床缓解率(30周时为14/14比2/6,2年时为14/14比1/6)均差异有统计学意义(Fisher精确概率法,P均＜0.01).30周时获无糖皮质激素临床缓解的16例患者在54周时有4例停用英夫利西,其余12例继续英夫利西治疗,停用和续用英夫利西者的无糖皮质激素临床缓解率(4/4比11/12)和黏膜愈合率(2/4比7/12)均差异无统计学意义(P均＞0.05).结论 英夫利西联合硫唑嘌呤治疗可有效促进和维持CD黏膜愈合,黏膜应答者能维持较长期的无糖皮质激素临床缓解.     

英夫利西治疗对炎症性肠病患者骨代谢的影响

[目的]研究英夫利西治疗对炎症性肠病(inflammatory bowel diseases,IBD)患者骨代谢的影响。[方法]收集经英夫利西治疗(英夫利西组)或柳氮磺砒啶(柳氮磺砒啶组)治疗前和治疗6个月后的IBD患者各40例,测定其治疗前后血清中肿瘤坏死因子-α(TNF-α),骨钙素(BGP)、I-型胶原C末端肽(CTX)水平以及股骨颈骨密度(BMD)。另选年龄、性别匹配健康志愿者43例作为对照(健康对照组)。[结果]英夫利西组与柳氮磺砒啶组患者治疗前血清TNF-α、CTX及BMD比较均差异无统计学意义,与健康对照组相比均差异有统计学意义(P0.05);英夫利西组、柳氮磺砒啶组治疗前BGP与健康对照组比较均差异无统计学意义(P0.05)。血清TNF-α与CTX呈正相关、与BMD呈负相关(P0.05)。英夫利西组治疗6个月后与治疗前相比,其血清中的TNF-α、CTX表达水平均显著下降(P0.05),同时BMD增高(P0.01);柳氮磺吡啶组治疗前后TNF-α、CTX、BMD比较均差异无统计学意义(P0.05)。与柳氮磺吡啶组治疗后比较,英夫利西组治疗后TNF-α、CTX显著性下降,BMD回升(P0.05);但2组患者治疗后血清BGP水平比较差异无统计学意义(P0.05)。[结论]IBD患者高水平表达的TNF-α促进骨吸收加强,是IBD骨质疏松的重要原因之一。应用英夫利西降低血清TNF-α水平,能有效阻止IBD患者的骨丢失及改善骨质疏松。     

英夫利西单抗治疗克罗恩病的疗效分析

目的 探讨TNFα单克隆抗体英夫利西(infliximab,IFX)单抗治疗活动性克罗恩病(CD)的疗效与安全性.方法 对传统药物治疗后未能完全缓解、手术治疗后复发或对药物不耐受的CD患者,于0、2、6周时静脉输注IFX(5 mg/kg)诱导缓解治疗,并对第一次输注后14周内的临床疗效,包括疾病活动度、血生化指标及结肠镜表现作出评估.结果 10例患者接受了IFX治疗,其中男8例,女2例,中位年龄31.4岁.5例患者IFX治疗1周后即感症状得到改善,主观症状评分从2.2±0.6降为1.2±0.4(P<0.05);简化CD活动性指数(H-B指数)从6.6±1.6降为2.1±1.0(P<0.05);ESR、C反应蛋白、血清总蛋白及白蛋白也有明显改善;内镜下CD严重度指数也得到明显改善.治疗过程中未观察到输注反应;1例患者在第3次IFX输注后,血ALT及AST暂时性升高;1例患者输注后35周出现严重贫血(三系列均减少).结论 经3次IFX静脉输注方案治疗,本组患者的临床症状及结肠镜下表现可获得较快、较好的改善.IFX长期应用的安全性尚需进一步扩大样本的研究.     

英夫利西治疗克罗恩病的疗效评价及对黏膜愈合影响的初步研究

目的 评价克罗恩病(CD)患者使用英夫利西(IFX)的疗效及对黏膜愈合和促进瘘管闭合的影响.方法 收集2007年9月至2011年2月上海交通大学医学院附属瑞金医院消化科使用IFX治疗的CD患者的临床资料,回顾性分析IFX的疗效和安全性.IFX治疗后疗效评价内容包括实验室指标、临床疗效、瘘管治疗疗效和黏膜修复.统计学处理采用t检验和Wilcoxon符号秩和检验.结果 共22例患者纳入本次研究,男11例,女11例,平均29.3岁.予IFX 5～I0 mg/kg剂量在第0、2、6周诱导缓解治疗,随后每隔8周维持治疗.22例患者中,有16例活动性CD,1例中途退出,其余15例在治疗第14周时,11例缓解、2例临床有效、2例无效.14周时克罗恩病活动指数(CDAI)评分(112±80)和ESR[( 13±11)mm/1 h]与0周时的(186±88)、(21±15)mm/1 h相比均下降(Z值分别为-2.712和-2.378,P值分别=0.04和0.007).10例有瘘管的患者中2例无效退出,8例患者的瘘管对IFX部分反应;6例在维持治疗期间持续有反应,但未见瘘管完全闭合消失.7例患者在使用IFX治疗5次(24周)后内镜复查,治疗后简化克罗恩病内镜评分(SES-CD)评分(3.21±2.89)较治疗前(5.86±3.02)下降(Z=-2.38,P＝0.018).9例患者共发生11次不良事件,以输注反应、呼吸道感染多见,无严重不良反应发生.结论 IFX可快速改善患者临床症状,安全性高.而且IFX在黏膜愈合和瘘管治疗方面的作用可在用药早期显现.     

英夫利西治疗激素抵抗型溃疡性结肠炎临床观察

激素抵抗型溃疡性结肠炎(ulcerative colitis,UC)传统治疗效果不理想,并发症多,严重危害患者健康,需要寻找新的更为特异的治疗方法[1-2].英夫利西(infliximab)是一种抗肿瘤坏死因子(TNF)-α人鼠嵌合体IgG1单克隆抗体,通过拮抗UC免疫炎性发病通路中起关键作用的前炎性因子TNF-α而发挥治疗作用.     

美沙拉嗪灌肠剂治疗溃疡性结肠炎疗效观察

目的 探讨美沙拉嗪灌肠剂在溃疡性结肠炎(UC)治疗中的应用效果及其安全性.方法 选取住院治疗的轻、中度UC患者41例,随机分为两组;治疗组给予美沙拉嗪灌肠剂(含美沙拉嗪4.0 g)每晚1次保留灌肠1周;对照组地塞米松5 mg加入生理盐水60 ml每晚1次保留灌肠1周.两组均给予地塞米松10 mg加入生理盐水100 m1...     

5-氨基水杨酸维持治疗溃疡性结肠炎114例

目的:评估5-氨基水杨酸(5-ASA)对溃疡性结肠炎(UC)缓解期患者维持治疗及影响UC复发的相关因素.方法:回顾性分析2004-01/2010-08在北京大学第一医院消化内科就诊的114例缓解期UC患者的临床资料,纳入分析病例114例.其中,男64例,女50例,年龄16-76岁.结果:选择应用5-ASA诱导缓解治疗病例75例(65.8%).结果显示:(1)UC复发与性别无关;(2)病程>5年的UC患者复发率显著高于病程≤5年的UC患者(62.1%vs35.7%,P>0.05);(3)轻度UC患者5-ASA维持治疗剂量>2g/d者复发率显著低于≤2g/d者(10%vs33.3%,P<0.05);(4)轻度UC患者复发率显著低于中度和重度患者(24.6%vs83.3%,80.6%,P<0.05);(5)直肠型UC患者复发率(19.2%)较低;(6)诱导缓解治疗达到黏膜愈合患者的复发率显著低于未达到黏膜愈合的患者(4.8%vs89.6%,P<0.05);(7)UC患者诱导缓解后第2年始复发率随时间逐年上升.结论:黏膜愈合及疾病活动程度是影响UC复发率的重要因素,5-ASA是轻-中度UC维持缓解治疗的首选药物,5-...     

Granulocytapheresis is useful as an alternative therapy in patients with steroid-refractory or -dependent ulcerative colitis

BACKGROUND: Recently, granulocyte and monocyte adsorption apheresis (GCAP) has been shown to be safe and effective for active ulcerative colitis (UC). We analyzed the safety and efficacy of GCAP (G-1 Adacolumn) in patients with steroid-refractory and -dependent UC. G-1 Adacolumn is filled with cellulose acetate carriers that selectively adsorb granulocytes and monocytes/macrophages. METHODS: Forty-four patients with UC were treated with GCAP. These patients received 5 apheresis sessions over 4 weeks. Twenty patients had steroid-refractory UC (group 1) and 10 had steroid-dependent UC (group 2). Fourteen patients who did not want readministration of steroids were treated with GCAP at the time of relapse, just after discontinuation of steroid therapy (group 3). RESULTS: Of 44 patients treated with GCAP, 24 (55%) obtained remission (CAI < or = 4), 9 (20%) showed a clinical response, and 11 (25%) remained unchanged. Only 2 of 10 patients (20%) with severe steroid-refractory UC (CAI > or = 12) achieved remission, whereas 7 of 10 patients (70%) with moderate steroid-refractory UC achieved remission (p < 0.05). The dose of corticosteroids was tapered in 9 of 10 (90%) patients with steroid-dependent UC after GCAP therapy. Twelve (86%) of 14 patients in group 3 showed an improvement in symptoms and could avoid re-administration of steroids after GCAP. No severe adverse effects occurred. CONCLUSIONS: The findings of this study suggest that GCAP may be a useful alternative therapy for patients with moderate steroid-refractory or -dependent UC, although cyclosporin A or colectomy is necessary in patients with severe UC. GCAP may also be useful for avoiding re-administration of steroids at the time of relapse. Randomized, controlled clinical trials are needed to confirm these findings.     

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

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.     

Efficacy of combination of intravenous cyclosporin A and steroid therapy versus prolonged intravenous steroid therapy alone in patients with severe ulcerative colitis refractory to initial intravenous steroid therapy]

BACKGROUND/AIMS: Maximal duration of intravenous (IV) corticosteroid (CS) treatment and efficacy of cyclosporin A (CsA) have not been clarified for patients with severe ulcerative colitis. We aimed to evaluate and compare the effectiveness of CS and CsA combination therapy with prolonged CS therapy alone in patients with severe UC refractory to initial CS therapy. METHODS: We retrospectively reviewed the medical records of 84 episodes of severe UC in 59 patients between April 1999 and May 2005. RESULTS: Among 84 episodes with IV CS therapy, 45 (53.6%) experienced an early response, while 39 (46.4%) did not respond within 2 weeks. The remaining 36 episodes excluding 3 which underwent colectomy were assigned to either combination therapy of IV CS and CsA or prolonged IV CS treatment alone for additional 2 weeks. Twelve of 16 episodes (75.0%) responded to therapy with combinations of IV CsA and CS, and 16 of 20 episodes (80.0%) to prolonged IV CS treatment alone. There was no statistical difference in response and colectomy rate after 4 weeks between CsA-use group and CsA-non-use group (p=1.00). CONCLUSIONS: These results suggest that CS and CsA combination has no additional benefit over prolonged CS therapy alone in terms of short-term response and that CS can be safely prolonged even after the first 14 days of treatment for severe UC.     

Adsorptive granulocyte and monocyte apheresis versus prednisolone in patients with corticosteroid-dependent moderately severe ulcerative colitis

BACKGROUND/AIM: Active ulcerative colitis (UC) is often associated with increased peripheral granulocytes and monocytes/macrophages which show activation behavior and prolonged survival time. Further, mucosal granulocyte level parallels intestinal inflammation and can predict UC relapse. Accordingly, our aim was to see if adsorptive granulocyte/monocyte apheresis (GMA) can promote remission and spare steroid in patients with steroid-dependent (SD) UC. METHODS: 69 SD patients, at the time of relapse, were randomly assigned to groups I (n = 46) and II (n = 23). The mean dose of prednisolone (PSL) was 12 mg/day/patient, CAI (clinical activity index) 9.2 in both groups. Group I patients were given up to 11 GMA sessions over 10 weeks with Adacolumn; in group II, the mean dose of PSL was increased to 30 mg/day/patient. RESULTS: At week 12, 83% of group I and 65% of group II patients were in remission, CAI in group I was 1.7 (p < 0.001) and in group II, 2.5 (p < 0.001). Further, during the 12 weeks of treatment, the cumulative amount of PSL received per patient was 1,157 mg in group I and 1,938 mg in group II (p = 0.001). CONCLUSIONS: GMA appeared to be an effective adjunct to standard drug therapy of moderately severe UC by promoting remission and sparing steroids.     

Tormentil for active ulcerative colitis: an open-label, dose-escalating study

BACKGROUND: Tormentil extracts (TE) have antioxidative properties and are used as a complementary therapy for chronic inflammatory bowel disease. In individual patients with ulcerative colitis (UC) positive effects have been observed. GOALS: To assess the safety, pharmacology, and clinical effects of different doses of TE in patients with active UC. STUDY: Sixteen patients with active UC [clinical activity index (CAI) >/=5] received TE in escalating doses of 1200, 1800, 2400 and 3000 mg/d for 3 weeks each. Each treatment phase was followed by a 4-week washout phase. The outcome parameters were side effects, CAI, C-reactive protein, and tannin levels in patient sera. RESULTS: Mild upper abdominal discomfort was experienced by 6 patients (38%), but did not require discontinuation of the medication. During therapy with 2400 mg TE per day, median CAI and C-reactive protein improved from 8 (6 to 10.75) and 8 (3 to 17.75) mg/L at baseline to 4.5 (1.75 to 6) and 3 (3 to 6) mg/L, respectively. During therapy, the CAI decreased in all patients, whereas it increased during the washout phase. Neither undegraded nor metabolized tannins could be detected by liquid-mass spectrometry (LC-MS) in patient sera. CONCLUSIONS: TE appeared safe up to 3000 mg/d. Tannins from TE are not systemically absorbed. The efficacy in patients with UC should be further evaluated.     

Exacerbation of ulcerative colitis after rituximab salvage therapy

BACKGROUND: B-cells are considered to play a pathogenic role in human ulcerative colitis (UC) by producing autoantibodies that cause epithelial cell damage. Here we report on a patient with intractable UC who suffered from a severe exacerbation of UC after salvage therapy with rituximab, a B-cell-depleting anti-CD20-antibody. METHODS: A 58-year-old patient with active long-standing UC and unresponsiveness or adverse events to mesalamine, corticosteroids, azathioprine, methotrexate, infliximab, leukapheresis, mycophenolate mofetil, and adalimumab received 375 mg/m(2) rituximab. RESULTS: A severe exacerbation of UC activity was noted upon therapy that required hospitalization. Subsequent studies showed a complete depletion of CD20-positive mucosal B-cells associated with a suppression of local IL-10 production. CONCLUSIONS: In contrast to rheumatoid arthritis patients, rituximab had deleterious effects in our UC patient by blocking IL-10 producing B-cells. Our data suggest an important anti- rather than proinflammatory role of B-cells in UC.     

Sacral neuromodulation for refractory ulcerative colitis: safety and efficacy in a prospective observational series of eight patients

Purpose

Ulcerative colitis (UC) treatment is mainly based on immunosuppressive therapy. As anti-inflammatory effects of sacral neuromodulation (SNM) have been previously reported in animal models, we conducted a pilot study aimed at assessing clinical, biological, and endoscopic response but also safety of SNM use in UC refractory to medical therapy.

Methods

Adult patients with histologically proven UC resistant to immunosuppressive therapy were invited to enroll in the study. Primary outcome was the rate of UC remission (UCDAI score ≤ 2, without any criteria > 1) at 8 weeks (W8). Secondary outcomes were biological and endoscopic response also evaluated at W8 and W16. Subsequently, every patient was followed every 6 months. Adverse events were prospectively collected for safety assessment during the follow-up.

Results

Eight patients, with mean age 47 years old, suffering from UC for 2–13 years were included. There were no complications in relation to SNM procedure. The acceptance of the device was excellent in all patients. Clinical and endoscopic remission was obtained at W8 in one patient (12.5%) and three other patients (37.5%) were responders at W16. At review (mean follow-up of 4 years), two patients (25%) were in remission and two (25%) were responders.

Conclusion

SNM application is safe in patients suffering from refractory UC. Effects on disease activity were mainly observed after 16 weeks. Larger prospective studies are mandatory, but SNM could be a way to reinforce medical therapy and reduce the use of immunosuppressive drugs.

     

Leukocytapheresis (LCAP) for Management of Fulminant Ulcerative Colitis with Toxic Megacolon

Leukocytapheresis (LCAP) is a method of therapeutic apheresis to remove patients peripheral leukocytes by extracorporeal circulation. Previous studies showed that LCAP for the treatment of ulcerative colitis (UC) was more effective and had fewer adverse effects compared to high-dose steroid therapy. However, there are no reports on the application of LCAP for UC patients with toxic megacolon (TM). This study reports the effectiveness and safety of LCAP in treating patients with severe or fulminant UC with TM. Six patients were enrolled in this study and LCAP sessions were performed three times per week for 2 weeks, followed by four further times in the next 4 weeks. After completion of therapy, four patients improved in TM and went into the remission stage of UC. The average Rachmilewitz clinical activity index of these four patients improved from 19.5 to 1. The remaining two patients had to undergo colectomy, however, the symptoms had been mitigated by LCAP and the operations were completed without any problems. These results suggest that LCAP is an additional effective and safe option for TM management in preventing colectomy or for bridging to a safer operation.     

Short- and long-term efficacy of adalimumab salvage therapy after failure of calcineurin inhibitors in steroid-refractory ulcerative colitis

Objective: Calcineurin inhibitors are highly effective in patients with corticosteroid-refractory ulcerative colitis (UC). When therapy with calcineurin inhibitors fails, adalimumab can be considered to avoid colectomy. The efficacy and safety of this sequential alternative salvage therapy remain unknown. Therefore, the present study was performed to investigate the short- and long-term efficacy and safety of adalimumab after failure of calcineurin inhibitors in corticosteroid-refractory UC.

Materials and methods: Patients with a corticosteroid-refractory flare of UC who did not respond to calcineurin inhibitors and received continuing salvage therapy with adalimumab were included in this retrospective, observational, single-centre study. The cumulative rates of colectomy were calculated using the Kaplan–Meier method. Clinical remission and response were evaluated based on the Rachmilewitz index. The cumulative rates of colectomy were calculated. Predictive factors for clinical remission and colectomy were identified. In the safety evaluation, any adverse event occurring after the administration of adalimumab was considered.

Results: Forty-one patients were enrolled; 78% had extensive colitis and 87% had moderate to severe colitis. Seventeen patients (41%) underwent colectomy during the follow-up period. At week 8, 26, and 52 after adalimumab injection, 27%, 39%, and 32% of patients achieved clinical remission, respectively. The adverse event rate was 17%, including one case of tuberculosis.

Conclusions: The efficacy of adalimumab for calcineurin inhibitor-refractory UC was examined for the first time. Treatment with adalimumab avoided the need for colectomy in two-thirds of patients with corticosteroid-refractory UC in whom calcineurin inhibitors had failed. However, attention is needed to avoid adverse events, especially infection.     

Leukocytapheresis therapy for steroid-naïve patients with active ulcerative colitis: its clinical efficacy and adverse effects compared with those of conventional steroid therapy

Background: Steroid administration currently plays a central role in the medical management of ulcerative colitis (UC); however, long‐term steroid usage causes adverse effects, which necessitates stoppage of drug intake, leading to worsening of the disease. A steroid‐sparing, well‐tolerated treatment is therefore required. As several investigators have reported the efficacy of leukocytapheresis (LCAP) combined with steroid therapy, we investigated the clinical usefulness and safety of LCAP for steroid‐naïve patients with active UC for comparison with those of conventional steroid therapy. Methods: Twenty‐nine Japanese patients with active UC without a history of steroid usage were selected to be treated with LCAP (n = 9) or prednisolone (PSL) (n = 20). LCAP administration continued for 10 weekly cycles. In the PSL group, patients with moderately severe disease received 0.5 mg/kg per day of PSL and those with severe disease 1.0 mg/kg per day. The PSL dosage was gradually tapered in accordance with improvement. Results: Eight (88.9%) of the LCAP group and 16 (80.0%) of the PSL group showed clinical improvement and three (33.3%) of the LCAP group and seven (35.0%) of the PSL group achieved remission. As for the treatment complications, three major adverse effects were observed in the PSL group, but none were observed in the LCAP group. Conclusion: The results of this study suggest that the efficacy and safety of LCAP are equivalent, and in terms of severe adverse effects, superior to those of steroid therapy. LCAP therapy may thus be a promising candidate therapy for steroid‐naïve patients with active UC. © 2005 Blackwell Publishing Asia Pty Ltd