英夫利昔单抗治疗中、重度斑块状银屑病系统评价

目的系统评价英夫利昔单抗治疗中重度斑块状银屑病的疗效和安全性。方法检索MEDLINE、Cochrane图书馆、EMBASE、ISI、CNKI、CBM和VIP,收集所有关于英夫利昔单抗治疗银屑病的随机对照试验。根据纳入与排除标准筛选文献、评价质量、提取资料,采用RevMan5.0软件进行Meta分析。结果共纳入5个随机对照试验,包括1 549例患者。Meta分析结果显示:静滴英夫利昔单抗能显著提高达到PASI 75的例数(P<0.001);静滴英夫利昔单抗与安慰剂组比较,在1个或多个不良反应的发生率方面有统计学意义(P<0.001),而在严重不良反应的发生率方面无统计学意义(P=0.22)。结论现有证据表明,静滴英夫利昔单抗对中重度斑块状银屑病具有良好的疗效和较好的耐受性。     

Brodalumab治疗中、重度斑块状银屑病随机对照试验的Meta分析

目的 :系统评价Brodalumab治疗中、重度斑块状银屑病的疗效和安全性。方法 :计算机检索2000—2017年中国期刊全文数据库(CNKI)、万方数据库、中国生物医学文献数据库、Pub Med、Medline及Embase,纳入Brodalumab治疗中、重度斑块状银屑病的随机对照试验(RCT)。由2名研究者单独使用Jadad评分量表对文献进行质量评价,采用Rev Man 5.3软件进行系统分析。结果:共纳入5篇RCT,包括4 076例中、重度斑块状银屑病患者。Meta分析示治疗12周时,Brodalumab组疗效和不良反应与安慰剂组比较,差异均有统计学意义(P0.05)。Brodalumab组皮下注射140 mg或210 mg连续治疗12周后,银屑病患者银屑病皮损面积和严重程度指数(PASI)积分下降达75%(PASI 75)、PASI 90、PASI 100和疾病严重度静态测量级别达s PGA 0或1的例数均显著高于安慰剂组,差异有统计学意义(P0.05)。Brodalumab组治疗后发生的主要不良反应为鼻咽炎。结论 :皮下注射Brodalumab 140 mg(2周1次)或210 mg(2周1次)连续12周治疗中、重度斑块状银屑病有效,但需注意不良反应的发生,仍需要更多RCT证实剂量与疗效及安全性的关系。     

托法替尼治疗斑块状银屑病的效果和安全性的Meta分析

目的系统评价不同剂量的托法替尼治疗斑块状银屑病的效果和安全性,以探讨托法替尼最佳用药方案。方法检索PubMed、Embase、CNKI、维普网、万方数据、"www.clinictrials.gov"等,检索时限均为建库起至2019年3月6日。收集托法替尼治疗银屑病的所有随机对照试验,对符合纳入标准研究中银屑病皮损面积和严重指数积分下降75%的例数(psoriasis area and severity index score,PASI75)、医生总体评价皮损获得清除或几乎清除的例数(Physician's Global Assessment 0/1,PGA0/1)和不良反应发生率采用RevMan5.3软件进行统计学分析。结果共纳入5个随机对照试验,共包括2 945例患者。Meta分析结果显示:与安慰剂组相比,托法替尼组的疗效高于对照组,PASI75及PGA0/1比较差异均具有统计学意义(P均<0.01)。托法替尼10 mg组与托法替尼5 mg组比较,前者治疗疗效优于后者,其PASI70及PGA0/1比较差异均有统计学意义(P均<0.01)。与对照组轻微不良反应率相比,托法替尼组头痛(P<0.01)、上呼吸道感染(P=0.04)的发生率较安慰剂组高,差异有统计学意义;而两者的严重不良反应发生率差异无统计学意义(P=0.56)。不同剂量托法替尼组的严重不良反应发生率差异无统计学意义(P>0.05)。结论托法替尼治疗银屑病,10 mg组疗效较5 mg组更具有优势,但严重不良反应发生率,并未随着剂量的增大而增加。托法替尼可以作为对其他药物治疗效果不佳、耐受差或偏爱口服药物患者的替代方案。     

Guselkumab治疗银屑病关节炎疗效及安全性meta分析

目的：评价guselkumab治疗银屑病关节炎的疗效及安全性。方法：检索Pubmed、Embase、Cochrane Library、维普期刊数据库、万方数据库及中国知网数据库与guselkumab治疗银屑病关节炎的随机对照试验（RCT），检索时间均为建库起至2020年4月。文献质量根据Cochrane系统评价进行评估。两位评论员独立选择文献并收集数据。文献用Revman 5.3软件进行meta分析。结果：纳入符合标准的文献共3篇，共涉及896例银屑病关节炎患者，试验组475例，对照组421例。meta分析结果示皮下注射guselkumab与安慰剂比较，在第24周时能显著提高达到ACR 20，ACR 50，ACR 70和PASI 75，PASI 90患者的例数；HAQ-D1较基线提高0.35的患者例数也高于安慰剂组；Guselkumab与安慰剂比较，总的不良事件的发生率方面差异无统计学意义。结论：Guselkumab是改善银屑病关节炎安全、有效的选择。     

HLA-Cw6基因对生物制剂治疗银屑病疗效影响的Meta分析

目的：Meta分析评价HLA-Cw6基因阳性对生物制剂治疗银屑病疗效的影响。方法：检索1976年1月至2018年12月Pubmed、Embase、The Cochrane Library、中国生物医学文献数据库、万方数据库及中国知网等数据库中关于HLA-Cw6基因与生物制剂疗效关联的文献，对最终符合入选标准的文献进行Meta分析。结果：符合入选标准的文献共11篇，涉及三种生物制剂，包括：2项关于IL17A拮抗剂Secukinumab研究，3项抗肿瘤坏死因子α(TNF-α)拮抗剂的研究及6项IL-12/IL-23拮抗剂Ustekinumab的研究。对Ustekinumab疗效关联的6项研究Meta分析显示治疗后HLA-Cw6阳性患者中PASI评分下降75%的比例(PASI75)高于HLA-Cw6阴性患者，差异有统计学意义(P<0.05)。Secukinumab的2项研究及TNF-α拮抗剂治疗的3项研究Meta分析显示HLA-Cw6阳性患者中PASI75较HLA-Cw6阴性者无明显增高，差异无统计学意义(P>0.05)。结论：携带HLA-Cw6基因患者对IL-12/IL-23拮抗剂Ustekinumab的疗效优于未携带者，HLA-Cw6对Secukinumab和TNF-α拮抗剂疗效无明显影响。     

奥马珠单抗治疗慢性自发性荨麻疹疗效与安全性的Meta分析

目的 系统评价（Meta分析）奥马珠单抗治疗慢性自发性荨麻疹（CSU）的疗效及安全性。方法 在PubMed、Clinicaltrials.gov、the Cochrane Database of Systematic Reviews和the Cochrane Central Register of Controlled Trials等数据库搜索关于奥马珠单抗治疗CSU疗效和安全性的随机对照临床试验（RCT）。2位系统评价员根据纳入与排除标准独立筛选文献,提取资料并评价纳入RCT的质量后,采用 RevMan 5.3软件进行Meta分析,比较奥马珠单抗75、150、300、600 mg（1个月）剂量亚组与安慰剂组之间及合并剂量后的奥马珠单抗组与安慰剂组之间的疗效及安全性。结果 共纳入7个RCT,共1 365例病例。结果显示,奥马珠单抗组及各剂量亚组在改善1周荨麻疹活动评分（UAS7）、1周风团数量评分方面均优于安慰剂组（P < 0.05）;奥马珠单抗组及75、150、300 mg亚组在改善1周瘙痒严重程度评分（ISS）、主要症状完全控制率方面优于安慰剂组（P < 0.05）,尚不能认为600 mg亚组优于安慰剂组（P = 0.07）;奥马珠单抗组及150、300 mg亚组在改善皮肤病生活质量指数（DLQI）方面均优于安慰剂组（P < 0.05）,尚不能认为75 mg亚组优于安慰剂组（P = 0.50）。奥马珠单抗组及各剂量亚组的一般不良事件发生率、严重不良事件发生率与安慰剂组差异均无统计学意义（P > 0.05）。结论 奥马珠单抗可改善CSU患者的临床症状及生活质量,在改善UAS、ISS、风团数量评分、DLQI和控制主要症状（UAS = 0）方面均有效,安全性高;皮下注射150 mg/月或300 mg/月奥马珠单抗改善CSU患者临床症状及生活质量的效果最佳。     

司库奇尤单抗300 mg和150 mg治疗银屑病性关节炎长期疗效比较meta分析

目的：比较司库奇尤单抗300 mg和150 mg治疗银屑病性关节炎(PsA)长期疗效的差异。方法：在Pubmed、Cochrane Library、 MEDLINE、EMBASE、中国知网、万方数据库和维普数据库中检索司库奇尤单抗300 mg和150 mg治疗PsA的随机对照试验（RCTs），提取相关数据，用RevMan5.3软件进行meta分析。结果：根据纳入标准共纳入5篇文献进行分析，包括3项RCTs。52周时，司库奇尤单抗300 mg治疗后美国风湿病学会疗效标准改善20%、50%及70%（ACR 20/50/70）的应答率、起止点炎缓解率、指趾炎缓解率与150 mg相比无显著差异，而300 mg治疗的PASI提高75%、90%（PASI 75/90）应答率均高于150 mg（P=0.002，0.01）。52周时，接受过肿瘤坏死因子抑制剂治疗(TNFi-exposed)的患者司库奇尤单抗300 mg治疗后ACR 20和PASI 75应答率均高于150 mg（P=0.006，0.04），而在未接受过肿瘤坏死因子抑制剂治疗(TNFi-naive)患者中300 mg和150 mg治疗后ACR 20和PASI 75应答率无显著差异(P=0.85，0.59)。结论：在长期疗效方面，司库奇尤单抗300 mg对PsA患者关节损害及功能的改善与150 mg无显著差异，而对皮损的改善有优势；对TNFi-exposed的PsA患者，司库奇尤单抗300 mg比150 mg有更好的疗效。     

二丁酰环磷腺苷钙联合阿维A治疗中重度斑块状银屑病的临床疗效观察

目的探讨二丁酰环磷腺苷钙治疗中重度斑块状银屑病的有效性和安全性。方法 84例中重度斑块状银屑病患者随机分为试验组(43例)和对照组(41例)。对照组根据患者体质量给予阿维A胶囊20 mg/d或30 mg/d口服,同时给予卤米松软膏外用,2次/d;试验组在对照组相同用药基础上给予二丁酰环磷腺苷钙40 mg/次,1次/d静脉滴注,疗程均为2周。治疗结束后分别观察2组患者的银屑病皮损面积和严重程度指数(PASI)评分、临床疗效、皮肤病生活质量指数(DLQI)评分以及不良反应。结果治疗后2组患者PASI评分均较治疗前降低,差异有统计学意义(P0.05),且试验组下降更为明显(P0.05);试验组总有效率74.42%,对照组总有效率53.66%,2组差异有统计学意义(P0.05);治疗后2组患者DLQI评分均较治疗前降低,差异有统计学意义(P0.05),且试验组下降更为明显(P0.05);2组均未见明显不良反应。结论二丁酰环磷腺苷钙治疗中重度斑块状银屑病安全有效。     

甲氨蝶呤治疗中重度寻常型银屑病的临床疗效观察

目的:评价甲氨蝶呤治疗中重度寻常型银屑病的临床疗效和安全性.方法:将72例中重度寻常型银屑病患者随机分为治疗组和对照组,治疗组36例口服甲氨蝶呤片,每次5 mg,每12小时1次,每周连服3次;对照组36例口服复方氨肽素片,每次5片,每天3次;两组患者均连续治疗8周.结果:治疗组患者治疗后基愈率为44.44%、显效率为38.89%、进步率为16.67%、无效率为0,有效率为83.33%;对照组治疗后基愈率为30.56%、显效率为30.56%、进步率为27.78%、无效率为11.11%,有效率为61.11%.两组有效率比较差异有统计学意义(2=4.43,P=0.035).两组患者均无明显不良反应.结论:甲氨蝶呤治疗中重度寻常型银屑病安全、有效.     

银屑病和银屑病关节炎与溃疡性结肠炎相关性Meta分析

目的:有研究报道银屑病或银屑病关节炎患者溃疡性结肠炎发生率明显高于正常人,本文目的在于进一步明确银屑病、银屑病关节炎与溃疡性结肠炎的相关性。方法:通过Pubmed、Cochrane Library、Embase、知网、万方等数据库检索银屑病、银屑病关节炎并溃疡性结肠炎相关文献,采用Review Manager 5.3软件进行Meta分析。结果:共纳入13篇文献,横断面研究3篇、病例对照研究2篇、队列研究8篇,包含银屑病723402例,银屑病关节炎37059例,Meta分析结果显示银屑病与溃疡性结肠炎[RR=1.65(95%CI 1.55~1.76),OR=1.76(95%CI 1.43~2.17)],差异具有统计学意义,银屑病关节炎与溃疡性结肠[RR=2.14(95%CI 1.72~2.66),OR=2.05(95%CI 1.50~2.80)],差异具有统计学意义。结论:银屑病、银屑病关节炎可能增加溃疡性结肠炎的发生率。     

Efficacy and safety of secukinumab in Taiwanese patients with moderate to severe plaque psoriasis: Subanalysis from ERASURE phase III study

The efficacy and safety of secukinumab, a fully human anti‐interleukin‐17A monoclonal antibody, has been evaluated for moderate to severe plaque psoriasis in global trials which have included a low proportion of Asian subjects. We analyzed the efficacy and safety of secukinumab in Taiwanese patients in a phase III global clinical trial (ERASURE). Fifty‐one Taiwanese patients were randomized into s.c. placebo, 150 and 300 mg secukinumab treatment groups. The proportions of patients who achieved 75% or more improvement in Psoriasis Area and Severity Index (PASI‐75) at week 12 were 87.5% with 300 mg secukinumab, 70% with 150 mg secukinumab, 0% with placebo. Of the patients receiving 300 mg secukinumab, 68.8% achieved PASI‐90 at week 12. Analysis of overall patients receiving 300 mg secukinumab for 12 weeks showed that the proportion of PASI‐75 responders was less in patients with body mass index of 25 or more than less than 25. During the entire 52 weeks, the incidence of adverse events (AE) was consistent with the overall population in ERASURE. The most common AE (cases/per 100 patient‐year) during the entire treatment period were upper respiratory tract infection and pruritus. The duration of upper respiratory tract infection per 100 patient‐year was approximately 399 days in placebo, 1261 days in 150 mg secukinumab and 1805 days in 300 mg secukinumab. The safety and efficacy of secukinumab in Taiwanese patients was compatible with the global phase III study in the treatment of moderate to severe plaque psoriasis.     

司库奇尤单抗治疗七例银屑病疗效评价

目的：评价司库奇尤单抗治疗银屑病的疗效和安全性。方法：选取中重度斑块状银屑病患者及泛发性脓疱型银屑病患者，给予司库奇尤单抗,300 mg/次，0～4周每周一次，后每4周一次，并分别于治疗前、1周后、4周后、8周后记录斑块状银屑病患者的银屑病皮损面积和严重度指数(PASI)、泛发性银屑病患者银屑病症状量表(PSS)评分。结果：共治疗6例斑块状银屑病和1例脓疱型银屑病患者，所选的患者均接受至少8周的司库奇尤单抗治疗，起效时间为（1.6±0.73)天；治疗4周时，6例斑块状银屑病患者中全部达到PASI 75，3例达到PASI 90；脓疱型患者PSS评分为2。治疗8周时6例斑块状银屑病患者均达到PASI 100；脓疱型患者PSS评分为0。所有患者治疗期间均未出现严重的药物不良反应。结论：司库奇尤单抗治疗中重度银屑病起效迅速，疗效显著，不良反应少。     

Secukinumab efficacy and safety in Japanese patients with moderate‐to‐severe plaque psoriasis: Subanalysis from ERASURE,a randomized,placebo‐controlled,phase 3 study

Secukinumab, a fully human anti‐IL‐17A monoclonal antibody, neutralizes IL‐17A, a key cytokine in the pathogenesis of psoriasis. Efficacy and safety of secukinumab was evaluated in Japanese patients with moderate‐to‐severe plaque psoriasis as part of a large Phase 3 global study (ERASURE). In this 52‐week, double‐blind study (ClinicalTrials.gov Identifier: NCT01365455, JapicCTI‐111529), 87 patients from Japan (11.8% of 738 patients randomized in the overall study population) were equally randomized to receive secukinumab 300 mg or 150 mg, or placebo once weekly at baseline and at Weeks 1, 2, 3 and 4, then every 4 weeks. Co‐primary endpoints (Week 12) were ≥75% improvement in psoriasis area‐and‐severity index (PASI 75) from baseline and a score of 0 (clear) or 1 (almost clear) on a 5‐point Investigator's Global Assessment scale (IGA mod 2011 0/1) versus placebo. PASI 75 and IGA mod 2011 0/1 responses at Week 12 were superior with secukinumab 300 mg (82.8% and 55.2%, respectively) or 150 mg (86.2% and 55.2%, respectively) versus placebo (6.9% and 3.4%, respectively; P < 0.0001 for all). Greater than 90% improvement in PASI (PASI 90) was also superior with secukinumab 300 mg (62.1%) or 150 mg (55.2%) versus placebo (0.0%) at Week 12 (P < 0.0001 for both). Clinical responses were sustained up to Week 52 in the majority of patients. During a 12‐week induction period, adverse event incidences were 48.3% with secukinumab 300 mg, 55.2% with 150 mg, and 41.4% with placebo. Secukinumab showed robust and sustainable efficacy in symptom reduction for moderate‐to‐severe plaque psoriasis in the Japanese patients.     

Is risankizumab better than secukinumab in the treatment of plaque psoriasis?

Plaque psoriasis is a common inflammatory disease that causes raised, flaky plaques or patches on the skin. An abnormal immune system can be an important cause of psoriasis. Risankizumab and secukinumab are biologic drugs that are injected under a patient’s skin to treat different parts of the immune system. Both drugs are approved in the U. S. and E. U. to treat moderate‐to‐severe plaque psoriasis. This international clinical study compared how well risankizumab and secukinumab treated moderate‐to‐severe plaque psoriasis (efficacy) and evaluated how safe these drugs were for patients to use. Risankizumab (150 mg) or secukinumab (300 mg) were given to 327 adult psoriasis patients. After 16 weeks of treatment, researchers saw that risankizumab was not worse than secukinumab (noninferior) in treating psoriasis: 73·8% of patients treated with risankizumab achieved at least 90% improvement in the severity of their disease compared with 65·6% of patients treated with secukinumab. After 52 weeks of treatment, researchers saw that risankizumab was more effective than secukinumab (superior) in treating psoriasis: 86·6% of patients treated with risankizumab achieved at least 90% improvement in the severity of their disease compared with 57·1% of patients treated with secukinumab. At the same time, more patients treated with risankizumab than those treated with secukinumab also achieved clear or almost clear skin. Patients in this study were able to take either drug without any unanticipated problems. Linked Article:   Warren et al. Br J Dermatol 2021; 184 :50–59 .     

司库奇尤单抗治疗儿童银屑病六例疗效评价

目的：评价司库奇尤单抗注射液治疗儿童银屑病的临床疗效及安全性。方法：收集2020年1月1日至2020年5月1日传统治疗方法不佳的儿童银屑病患者,在第0、1、2、3、4周进行皮下注射司库奇尤单抗150 mg,每周一次,共5次。记录患者PASI及BSA评分。结果：司库奇尤单抗共治疗6例儿童银屑病,治疗第4周时,6例患者均达到PASI 90,BSA显著降低,未出现不良反应。结论：司库奇尤单抗注射液治疗儿童银屑病安全有效。     

Long‐term efficacy and safety of secukinumab in Japanese patients with moderate to severe plaque psoriasis: 3‐year results of a double‐blind extension study

Secukinumab, a fully human monoclonal antibody neutralizing interleukin‐17A, has been shown to have significant efficacy in the treatment of moderate to severe psoriasis. Long‐term (3‐year) efficacy and safety of secukinumab in Japanese patients with moderate to severe psoriasis were evaluated in an extension study of a large phase 3 global study (SCULPTURE). In the core study, 52 Japanese patients with 75% improvement of Psoriasis Area and Severity Index (PASI‐75) response at week 12 were re‐randomized to a fixed interval (FI; every 4 weeks) schedule and retreatment as needed (RAN), in which patients received placebo until start of relapse, at which time secukinumab was reinitiated. Fifty Japanese patients completed the 52‐week core study, and 47 patients entered the extension study with the same double‐blind regimens up to week 152. All patients in the secukinumab 300 mg FI and seven patients in 150 mg FI groups completed 3 years of treatment. PASI‐90 and ‐100 at the end of year 3 were achieved in 69.2% and 53.8%, respectively, in 300 mg FI and 42.9% and 42.9%, respectively, in 150 mg FI, indicating high sustained response in 300 mg FI. Mean absolute PASI was continually low in 300 mg FI and numerically higher in 150 mg FI. Dermatology Life Quality Index of 0/1 was maintained by approximately two‐thirds of 300 mg FI patients, and all EuroQoL 5‐Dimension Health Questionnaire domain measures were also improved. FI dosing was consistently more efficacious than RAN. The safety profile of secukinumab remained favorable, with no new safety concerns identified.     

Effectiveness and safety of secukinumab in 69 patients with moderate to severe plaque psoriasis: A retrospective multicenter study

Secukinumab (anti‐IL17A) is effective as treatment for moderate to severe plaque psoriasis, but real‐life data on effectiveness and safety lack. We aimed to present real‐life data of all Danish patients treated with secukinumab (n = 69). At baseline, before initiation of treatment with secukinumab 300 mg (47.8%) or off‐label treatment with secukinumab 150 mg (52.2%), the median PASI score was 7.1. A total of 66.7% (34/51) and 52.9% (27/51) of patients still on secukinumab at week 12 achieved a PASI (Psoriasis Area and Severity Index)‐50 and PASI‐75 of 66.7% and 52.9%, respectively. A total of 83.0% (44/53) and 60.4% (32/53) of the patients had a PASI‐score < 5 and PASI‐score < 2, respectively, after 12 weeks on treatment with secukinumab. A third of the patients had secukinumab discontinued due to limited clinical improvement or adverse events (n = 23) within a median of 92 days (interquartile range 51–212 days). Notably, the majority of the patients may represent a particularly difficult‐to‐treat group of patients, as 92.8% had been refractory to other biologic treatment. A total of 26.1% (n = 18) experienced adverse events. Secukinumab appears to be an effective treatment option with a favorable side effect profile in patients with plaque psoriasis who are refractory to or have side effects of traditional biologic drugs.     

Secukinumab: supervivencia en práctica clínica real

Secukinumab, an immunoglobulin G1/κ monoclonal antibody that selectively targets interleukin 17a, is used to treat moderate to severe plaque psoriasis in adults who are eligible for systemic treatment. Indirect comparisons of the efficacy of secukinumab, ustekinumab, and anti-tumor necrosis factor agents have found lower drug survival rates for patients on secukinumab, in spite of that biologic's rapid onset of action and efficacy as demonstrated by the large number of patients reaching a Psoriasis Area and Severity Index of 90 or 100. We present data from a retrospective study of 171 patients treated with doses of 300 mg or 150 mg of secukinumab every 4 weeks in 5 hospitals in the Spanish autonomous community of Andalusia. Eighty-seven percent continued on treatment at 132 weeks, contrasting with reports from previously published case series.     

司库奇尤单抗治疗红皮病型银屑病7例的临床疗效及安全性观察

【摘要】 目的 观察司库奇尤单抗治疗红皮病型银屑病的临床疗效及安全性。方法 2019年7月至2021年8月就诊于武汉市中西医结合医院的红皮病型银屑病并接受司库奇尤单抗（300 mg/次皮下注射,分别于第0、1、2、3、4周注射1次,随后每4周1次）治疗的7例患者,在第0、 4、 8、12周时记录患者银屑病皮损面积和严重度指数（PASI）,同时观察药物不良反应。结果 7例患者均接受至少12周的治疗,治疗4周时,4例达到PASI50;治疗12周,4例达到PASI75,2例达到PASI90。均未发生严重药物不良反应,1例治疗过程中出现发热,用药后体温恢复正常;1例出现咳嗽咳痰,予以口服咽炎合剂后症状缓解。结论 司库奇尤单抗治疗红皮病型银屑病疗效显著,不良反应较少,为红皮病型银屑病的治疗提供了新的选择。