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1.
目的:观察银屑病患者接受抗肿瘤坏死因子α制剂治疗后抗核抗体(ANA)、抗dsDNA抗体和抗可提取性核抗原(ENA)抗体的变化。方法回顾分析32例银屑病患者,其中13例使用英夫利西单抗治疗,19例使用依那西普治疗。英夫利西单抗组第0、2、6周各用药1次,此后每隔8周用药,于每次用药前检测患者ANA、抗dsDNA抗体及ENA的情况和临床症状的变化。依那西普组每周用药2次,每3~6个月检测患者ANA、抗dsDNA抗体及ENA的情况和临床症状的变化。采用银屑病皮损面积和严重度指数(PASI)75、疾病活动评分(DAS)28评估临床疗效,间接免疫荧光法检测血清ANA水平,免疫印迹法和ELISA法检测抗dsDNA抗体水平,免疫印迹法检测抗ENA抗体水平。结果32例银屑病患者临床症状有不同程度缓解。32例抗TNF?α治疗的患者中有7例(21.9%)出现自身抗体,其中英夫利西单抗组中4例治疗(8.3±5.1)个月后出现自身抗体,3例ANA阳性,3例ENA阳性;依那西普组中3例治疗(9.0±3.0)个月后出现自身抗体,3例ANA阳性,1例ENA阳性。结论部分银屑病患者接受抗肿瘤坏死因子α制剂治疗后可出现自身抗体。  相似文献   

2.
依那西普是一种人工合成的可溶性肿瘤坏死因子α受体融合蛋白,可有效地拮抗肿瘤坏死因子α引起的一系列生物学效应。初步的临床试验表明,该药对于关节病型银屑病、中重度斑块状寻常型银屑病、红皮病型银屑病以及难治性皮肌炎、天疱疮、坏疽性脓皮病和化脓性汗腺炎等疾病具有较好的疗效。依那西普在临床应用中安全性较高,引起充血性心衰、脱髓鞘疾病等严重不良反应少见。其远期的临床疗效、安全性、适应症尚需进一步研究。  相似文献   

3.
目的 评价用于重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗中重度寻常性银屑病的安全性和疗效。 方法 采用多中心、随机、双盲、阳性药物平行对照的临床研究。两组中重度寻常性银屑病患者均接受重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗,试验组用药商品名为安佰诺,对照组为益赛普。在治疗前(W0)、治疗第2周、第6周及治疗后(疗程12周)分别对各观察指标进行评估记录。 结果 5个研究中心共入组病例180例,完成试验174例,采用SAS统计软件包,按分层分段方法产生随机数,其中试验组88例,对照组86例。疗后12周,全分析集(FAS)分析显示,试验组和对照组银屑病皮损面积和严重程度指数(PASI)50、PASI75的患者分别是75.6%(68/90)、51.1%(46/90)和82.2%(74/90)、50.0%(45/90),两组差异无统计学意义(均P > 0.05);试验组PASI90达30.0%(27/90),高于对照组的16.7%(15/90),差异有统计学意义(χ2 = 4.472,P < 0.05)。与药物有关的不良反应包括转氨酶升高、白细胞减少、上呼吸道感染、注射部位反应、尿常规异常、结核菌素纯蛋白衍化物试验异常等,两组不良反应发生率差异无统计学意义(χ2 = 0.188,P > 0.05)。不良反应一般程度较轻,未经处理或经相应治疗均能恢复正常。 结论 国产重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗中重度寻常性银屑病12周安全有效。  相似文献   

4.
<正>目前美国食品和药品管理局尚未批准用于治疗未成年人银屑病的系统疗法。依那西普已被批准用于系统治疗成人中重度斑块型银屑病,但由于缺乏临床数据及药品说明书适应证的支持,使得其在未成年银屑病患者治疗中的使用受到限制。为期48周的前期临床试验已经证实未成年银屑病患者对依那西普治疗耐受性及疗效均较理想。研究者以评估依那西普长期用于中重度儿童和青少年斑块型银屑病的安全性和疗效为目的,进行了一项为期5年的开放性研究。纳入了已经完成48周前期临床试验的4~17岁中重度斑块型银屑病患者,每周给予依那西普0.8  相似文献   

5.
【摘要】 目的 观察长期使用英夫利西单抗治疗中重度寻常性银屑病的疗效。方法 随访分析2016年3月至2018年5月在北京大学第三医院皮肤科应用英夫利西单抗治疗的中重度寻常性银屑病患者,纳入用药超过54周的患者。用药剂量5 mg/kg,总剂量以100 mg为间隔取整数。前两次用药间隔依次为2、4周,然后间隔均为8周。采用Mauchly球性检验法、随机区组的方差分析法及Bonferroni法分析治疗前、治疗2、6、14、22、30、38、46及54周银屑病皮损面积和严重程度指数(PASI)变化,同时记录病情转归及不良反应。结果 12例患者接受治疗,9例持续用药超过54周,遂纳入数据分析。治疗前,9例患者PASI值[M(P25,P75)]为26.3(23.4,27.7)。不同治疗时间点的PASI值不等(F = 7.12,P = 0.0004),且患者PASI值呈总体下降趋势。治疗30周时,PASI值为4(2.5,5.2),PASI改善率为86.38% ± 6.98%。其中,改善率达PASI50的患者8例,达PASI75的患者7例,达PASI90的患者2例。治疗54周时,PASI值为8(3.5,8.9),PASI改善率为64.23% ± 17.32%,8例达PASI50,4例达PASI75,1例达PASI90。Bonferroni法显示,与治疗30周时相比,治疗54周时PASI评分显著升高(t = 3.269,P = 0.0048),但治疗30周及54周时PASI评分值均显著低于治疗前(30周:t = 18.49,P < 0.0001;54周:t = 5.81,P = 0.0004)。结论 英夫利西单抗治疗中重度寻常性银屑病在长达54周的时间内有显著疗效。  相似文献   

6.
依那西普为肿瘤坏死因子α的拮抗剂,可用于治疗斑块状银屑病和银屑病关节炎。近期完成的Ⅱ、Ⅲ期临床试验证明,短期25mg或50mg皮下注射,每周2次连续12周,或者更长期的依那西普治疗.可以明显改善患者的症状和生活质量,不良反应较少且轻微,与对照组之间差异无统计学意义,在治疗儿童重度银屑病方面也有很好前景。依那西普可作为中重度斑块状银屑病和银屑病关节炎患者的治疗选择,但仍需进一步的大规模临床试验以充分明确其各方面特性。  相似文献   

7.
依那西普是肿瘤坏死因子-α(TNF-α)拮抗剂,它通过抑制炎性因子TNF-α达到控制炎症阻断病情进展的作用。通过使用依那西普,关节病型银屑病(PsA)患者在关节损害、皮肤损害和生活质量上有了明显改善,它不但安全、有效、副作用小,而且有良好的耐受性。依那西普已成为治疗关节病型银屑病的重要药物。本文就依那西普在PsA患者的关节症状、皮损及生活质量等方面的治疗机制和疗效进行综述。  相似文献   

8.
目的:评价注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(商品名:益赛普)治疗中、重度寻常性银屑病患者的疗效。方法:采用多中心、随机、双盲、双模拟、阳性平行对照临床试验方法,对144例中、重度寻常性银屑病患者进行银屑病皮损面积和严重度指数(PASI)评分,其中益赛普组72例,甲氨蝶呤(MTX)组72例。结果:144例患者中124例完成了12周的治疗。治疗12周后,益赛普组PASI50、PASI75、PASI90的比例(PP人群)高于MTX组,差异具有统计学意义(P〈0.01)。益赛普组从第4周起PASI评分的改善优于MTX组。且对躯干、四肢的疗效好于MTX组。结论:与MTX比较,益赛普具有起效快、治疗效果明显、PASI评分改善明显的特点。  相似文献   

9.
近来研究发现,肿瘤坏死因子(TNF)在银屑病和中重度活动性银屑病关节炎(PsA)中发挥重要的致炎作用,TNF拮抗剂英利昔单抗(Infliximab)和依那西普(etanercept)也在临床实验中显示出对银屑病和PsA有确切的疗效。阿达木单抗(Adalimumab)是一种完全的人源化抗TNF单克隆抗体。最近,西雅图瑞典医学中心的Mease教授进行了一项随机双盲安慰剂对照临床实验.研究了该单抗对PsA的疗效。  相似文献   

10.
目的:评价沙利度胺治疗中重度寻常型银屑病的疗效并明确对血清血管内皮生长因子(VEGF)和碱性成纤维细胞生长因子(bFGF)的影响。方法:30例中重度寻常型银屑病患者口服沙利度胺100 mg/次,每日2次,治疗8周。治疗前后采用银屑病皮损面积和严重程度指数评分标准(PASI)进行疗效评定。采用酶联免疫吸附试验(ELISA)测定患者治疗前后血清VEGF和bFGF水平。结果:30例中重度寻常银屑病患者有效率为60.00%;治疗后血清VEGF和bFGF水平明显低于治疗前(P0.01);银屑病患者血清VEGF、bFGF水平与PASI评分呈正相关(均P0.01)。结论:沙利度胺治疗中重度寻常型银屑病有一定疗效,其作用机制可能与抑制血清VEGF和bFGF表达有关。  相似文献   

11.
Background  Targeted biologic therapies have made a significant impact on the treatment for moderate to severe psoriasis. In the United Kingdom, the National Institute for Health and Clinical Excellence recommends etanercept, a human recombinant tumour necrosis factor (TNF) receptor fusion protein, for moderate to severe psoriasis patients who have failed conventional therapies. There is, however, no data available on the role of other TNF antagonists for patients who have failed etanercept. Adalimumab, a fully human, anti-TNF monoclonal antibody, is approved for treatment of moderate to severe psoriasis.
Objectives  To assess the efficacy and safety of adalimumab (40 mg weekly) in psoriasis patients who were non-responders to high-dosage etanercept (50 mg twice weekly).
Methods  All patients attending a tertiary referral service for severe psoriasis who were non-responders to high-dosage etanercept [i.e. failed to achieve ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) after 12 weeks of treatment] were considered for open-label adalimumab therapy for 12 weeks. Details on clinical course, PASI, Dermatology Life Quality Index (DLQI) and adverse events were recorded at baseline and weeks 2, 4, 8, and 12.
Results  Four of five patients in this study had reached at least PASI 50 by week 12. Of these, two patients achieved a 75% improvement in PASI (PASI 75). No serious adverse events were reported.
Conclusions  Initial data from this open-label prospective evaluation suggests that weekly adalimumab therapy is an effective treatment for patients with severe psoriasis who had failed to respond to at least 3 months of high-dosage etanercept.  相似文献   

12.
Background The reported efficacy and safety of some biologic agents for psoriasis vary between Caucasians and Asians. Few reports of etanercept exist in psoriasis patients within the Asia‐Pacific region. Objectives The study aims to report our clinical experience of etanercept in the treatment of patients with moderate‐to‐severe psoriasis in Taiwan. Methods A retrospective analysis of 59 patients with moderate‐to‐severe psoriasis who received etanercept was conducted in a tertiary referral center. Results Etanercept therapy resulted in a reduction of mean Psoriasis Area and Severity Index (PASI) of 47% at week 12 and 61% at week 24. After 12 weeks of treatment, 48%, 26%, and 3.4% of the patients achieved at least PASI50, 75 and 90 response, respectively. At week 24, the proportion of patients achieving at least PASI50, 75 and 90 response was 59%, 37%, and 14%, respectively. Etanercept efficacy in achieving PASI75 improvement was, however, lower than that reported in previous pivotal placebo‐controlled trials. No cases of active tuberculosis, viral hepatitis or malignancies were observed during the observation period. Conclusion Our case series demonstrated the efficacy and safety of etanercept for the management of moderate‐to‐severe psoriasis in Taiwan.  相似文献   

13.
Background Etanercept is a tumour necrosis factor‐alpha antagonist used for the treatment of moderate‐to‐severe psoriasis. Current opinion suggests that etanercept may have reduced efficacy in obese patients. Narrowband ultraviolet B (NB‐UVB) phototherapy is unaffected by body weight and the addition of NB‐UVB to etanercept therapy may supplement the efficacy of etanercept in these patients. Objective To evaluate the efficacy and safety of NB‐UVB phototherapy when administered in conjunction with 50 mg of etanercept once weekly in the treatment of obese patients with moderate‐to‐severe plaque psoriasis. Methods Thirty psoriasis patients with a body mass index (BMI) greater than 30 were enrolled into this randomized, ‘head‐to‐head’ comparison study. All subjects received 50 mg of etanercept twice weekly for 12 weeks and then randomized to receive either etanercept monotherapy or combination etanercept and NB‐UVB three times weekly for an additional 12 weeks. Treatment response was evaluated using Psoriasis Area and Severity Index (PASI), body surface area (BSA) and Physician’s Global Assessment (PGA) scores. Results Twenty‐five subjects completed the study. At 12 weeks, 48% of all patients achieved PASI 75. By Week 24, 62.5% of all patients achieved PASI 75. Patients in the etanercept monotherapy and combination etanercept and NB‐UVB phototherapy arms had similar rates of achieving PASI 75 (46.7% vs. 53.3% of each group, respectively). Conclusion Combination etanercept and NB‐UVB has similar efficacy to etanercept monotherapy in obese patients. This result indicates that even in the setting of obesity, the majority of patients respond well to etanercept, with or without NB‐UVB.  相似文献   

14.
BackgroundFew studies exist that evaluate the therapeutic response among switchers of tumor necrosis antagonists in patients with psoriasis, especially Asian patients.ObjectiveThis study aimed to evaluate the safety and effectiveness of adalimumab in patients with moderate-to-severe psoriasis who had inadequate therapeutic response to prior etanercept.MethodsThis is a single-center, open-labeled, retrospective study on the effects of adalimumab in patients with moderate-to-severe psoriasis who had inadequate therapeutic responses to prior etanercept. We included 13 patients who had received etanercept for at least 3s months but showed inadequate therapeutic response, as defined by less than 50% improvement in psoriasis area and severity index (PASI) 50, compared to baseline after 6 months or less than PASI25 improvement after 3 months in our hospital during 2006–2012. Adalimumab 40 mg was given every other week with a loading dose of 80 mg. Patients were evaluated monthly for safety and effectiveness. PASI, physician global assessment, and scores of scalp lesions were calculated at Weeks 12 and 24. Scalp lesions were assessed separately.ResultsAt Week 12, one patient (7%) had at least PASI90, two (15%) had at least PASI75, four (31%) had at least PASI50, and eight (61.5%) had at least PASI25 response. At Week 24, two patients (15%) had at least PASI90, three (23%) had at least PASI75, six (46%) had at least PASI50, and nine (69%) had at least PASI25 response. No severe adverse events were recorded in our series. For scalp lesion, adalimumab showed similar efficacy to etanercept nonresponders.ConclusionSafety profiles of adalimumab were similar to those of etanercept, and PASI50 was achieved in 46% of patients, who failed prior etanercept therapy, after 24 weeks of adalimumab treatment.  相似文献   

15.
Treatment of erythrodermic psoriasis with etanercept   总被引:3,自引:0,他引:3  
BACKGROUND: Severe variants of psoriasis, such as erythrodermic psoriasis, may be associated with serious morbidity and mortality. Current treatment options for erythrodermic psoriasis are limited, unsatisfactory and potentially associated with organ-specific toxicity. Recently, a new class of agents, targeted biological therapies, has emerged. Etanercept is a recombinant human fusion protein acting as a competitive inhibitor of tumour necrosis factor-alpha. The safety and efficacy of etanercept have been widely demonstrated in psoriatic arthritis and moderate to severe plaque-type psoriasis. OBJECTIVES: To assess the efficacy and tolerability of etanercept in the treatment of erythrodermic psoriasis over a period of 24 weeks. METHODS: Ten patients, eight men and two women, were selected to receive etanercept 25 mg subcutaneously twice weekly. The Psoriasis Area and Severity Index (PASI) score, ranging from 0 to 72, was used to assess the severity of disease. RESULTS: Etanercept was well tolerated and led to a significant reduction in the severity of disease over the period of treatment. After 24 weeks, the mean PASI score decreased from 39.1 (baseline) to 5.1. At week 12, five of 10 (50%) patients achieved an improvement of PASI score from baseline exceeding 75%. At week 24, six of 10 patients (60%) achieved or maintained an improvement of PASI score from baseline exceeding 75% while two patients (20%) maintained an improvement of between 50% and 75%. CONCLUSIONS: In this study, etanercept has been demonstrated to be an effective treatment for erythrodermic psoriasis, providing a safe and convenient alternative to current therapies.  相似文献   

16.
Objective  To evaluate the efficacy and safety of etanercept in the treatment of patients with moderate to severe plaque psoriasis.
Methods  An observational, longitudinal, and retrospective study involving two groups of dose of treatment with etanercept (50 vs. 100 mg/week). The selected patients presented moderate to severe plaque psoriasis, and they had received treatment with the mentioned drug. A total of 58 patients were included in the study. The efficacy of the drug was evaluated by measuring the psoriasis area and severity index (PASI), body surface area (BSA) and physician's global assessment (PGA) in weeks 8, 16, 24, 32, 40 and 48.
Results  A statistically significant improvement was observed in the PASI, BSA and PGA indexes after 24 and 48 weeks of therapy. As for PASI, and after 48 weeks of treatment, PASI 50, 75 and 90 were 100.0%, 92.3% and 69.2%, respectively. In our series, etanercept 50 mg/week reached the same results after 48 weeks as etanercept 100 mg/week, though the initial response was faster in the last group. The PASI, BSA and PGA indexes diminished significantly with the treatment, though without statistically significant differences between both groups. As for the safety, etanercept was well tolerated, and no serious adverse events were recorded. There were no cases of tuberculosis or opportunistic infections.
Conclusions  Our study confirms the efficacy and safety outcomes of the clinical trials of etanercept in psoriasis with both doses of treatment. As for the safety, etanercept was well tolerated, and all the recorded adverse events coincided with the known potential side-effects of treatment.

Conflicts of interest


None declared  相似文献   

17.
Etanercept is a fully humanized soluble tumor necrosis factor (TNF)-alpha receptor that competitively inhibits the interaction of TNF-alpha with cell-surface receptors. It was approved as monotherapy for psoriasis in the USA in 2004, but in Korea, no clinical reports on its use for psoriasis are available. We performed a retrospective analysis of 26 moderate-to-severe psoriasis patients who had been treated with etanercept. Patients received twice-weekly injections of 25 mg etanercept s.c. for at least 4 weeks. When the patients achieved a 50% reduction of the psoriasis area severity index (PASI 50) they received once-weekly injections, then biweekly injections were provided for maintenance. Patients were evaluated biweekly by clinical photographs and PASI scoring. Treatment efficacy was as follows. A PASI 75 was achieved in 14 patients (54%) and the mean number of injections before achieving a PASI 75 was 10 +/- 7.5. Patients whose initial PASI was less than 10 (iPASI < 10) showed an earlier response (2.6 +/- 1.3 weeks) and a higher PASI 75 rate (63%), than with iPASI > or = 10 (6.9 +/- 4.5 weeks, 50%). Eight patients (31%) received additional phototherapy or systemic therapy because of insufficient responses or for faster improvements and they were excluded in the efficacy evaluation. Adverse events were observed in eight patients (31%), but were not serious. This is the first report on the effectiveness of low-dose etanercept regimen on Asian psoriasis patients. Results in this study showed that low-dose etanercept therapy is effective for moderate-to-severe Asian psoriasis patients, and it may be a valuable treatment option even for relatively moderate psoriasis patients not responsive to conventional treatment. In addition, the medical cost was relatively low compared to that of the standard regimen for white patients.  相似文献   

18.
Background Combination treatments may increase efficacy while reducing dosages and side‐effects of individual agents. No randomized controlled trials have been published combining biologics with conventional agents for psoriasis. Objectives To investigate the efficacy and safety of the association of acitretin and etanercept in the treatment of moderate to severe chronic plaque psoriasis. Methods A 24‐week, randomized, controlled, investigator‐blinded pilot trial was conducted. Sixty adult patients with moderate to severe chronic plaque psoriasis were randomized into three groups to receive etanercept 25 mg twice weekly subcutaneously, oral acitretin 0·4 mg kg?1 daily or etanercept 25 mg once weekly plus acitretin 0·4 mg kg?1 daily. The primary end point was a 75% or greater improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI 75) at week 24. Results At week 24, PASI 75 response was achieved by 10 of 22 patients in the etanercept group (45%), six of 20 in the acitretin group (30%) and eight of 18 (44%) in the group treated with etanercept plus acitretin (P = 0·001 for both etanercept groups compared with acitretin alone). A 50% or greater improvement from baseline in PASI was achieved by 15 of 22 (68%), 10 of 20 (50%) and 12 of 18 (67%) patients, respectively (P = 0·001). The safety profiles of the three groups were similar. Conclusions A combined therapeutic regimen with etanercept 25 mg once weekly and acitretin 0·4 mg kg?1 daily is as effective as etanercept 25 mg twice weekly, and more effective than acitretin alone. Although larger studies are needed to confirm these results, the etanercept/acitretin association could offer several advantages in the therapy of moderate to severe chronic plaque psoriasis.  相似文献   

19.
Background Etanercept plus methotrexate combination therapy has not been adequately investigated in psoriasis. Objectives To evaluate etanercept plus methotrexate vs. etanercept monotherapy in patients with moderate to severe plaque psoriasis who had not failed prior methotrexate or tumour necrosis factor‐inhibitor therapy. Methods Patients received etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks and were randomized 1 : 1 to receive methotrexate (7·5–15 mg weekly) or placebo. The primary endpoint was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 24. Results In total, 239 patients were enrolled in each arm. PASI 75 was significantly higher at week 24 for the combination therapy group compared with the monotherapy group (77·3% vs. 60·3%; P < 0·0001). Other PASI improvement scores at week 12 [PASI 75, 70·2% vs. 54·3% (P = 0·01); PASI 50, 92·4% vs. 83·8% (P = 0·01); and PASI 90, 34·0% vs. 23·1% (P = 0·03)] showed similar results as did week 24 PASI 50 (91·6% vs. 84·6%; P = 0·01) and PASI 90 (53·8% vs. 34·2%; P = 0·01). Significantly more patients receiving combination therapy than monotherapy had static Physician’s Global Assessment of clear/almost clear at week 12 (65·5% vs. 47·0%; P = 0·01) and week 24 (71·8% vs. 54·3%; P = 0·01). Adverse events (AEs) were reported in 74·9% and 59·8% of combination therapy and monotherapy groups, respectively; three serious AEs were reported in each arm. Conclusions Combination therapy with etanercept plus methotrexate had acceptable tolerability and increased efficacy compared with etanercept monotherapy in patients with moderate to severe psoriasis.  相似文献   

20.
BackgroundClinical experience has shown that, in patients with psoriasis, suspending treatment with etanercept at week 24, as indicated in the prescribing information, may lead to a rebound effect. Several clinical trials support long-term use of etanercept, which was shown to have a good safety and efficacy profile.Material and methodsThis was a retrospective, observational study of 43 patients with moderate to severe plaque psoriasis, with and without joint involvement, who received continuous treatment with etanercept for more than 24 weeks.ResultsEtanercept was administered for a mean of 57 weeks. Overall, the Psoriasis Area and Severity Index (PASI) score decreased from a baseline value of 22.5 to 4.3 after treatment.In addition, with continuous treatment, most patients maintained decreases in PASI scores of 50% and even of 75%. Some patients without significant improvement in their PASI score in the first 24 weeks did manage to achieve significant results after prolonged treatment. These outcomes were achieved with a low incidence of adverse effects (reported in 13 patients [30.2%]), which were generally mild.ConclusionWe present our clinical experience with long-term etanercept treatment in patients with moderate to severe psoriasis, with and without associated joint involvement. The efficacy and safety profiles were found to be favorable.  相似文献   

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