biologic treatment

生物治疗
  • 文章类型: Journal Article
    背景:炎症性肠病(IBD)影响育龄妇女。活动性疾病可导致生育能力下降。尽管绝大多数国际指南建议在怀孕期间继续使用抗TNF-α,最近的研究引起了人们对怀孕期间抗肿瘤坏死因子-α(TNF-α)治疗安全性的关注,对于患者和医生来说。
    方法:评估IBD孕妇抗TNF-α治疗安全性的研究是通过文献检索确定的。对妊娠结局进行了更新的荟萃分析,比如活产,流产,仍然出生,早产,低出生体重,先天性异常,和新生儿感染。报告了具有95%置信区间(CI)的赔率比(OR)。疾病活动数据,收集抗TNF-α治疗的时机用于进一步分析.
    结果:总体而言,从在线数据库和国际会议摘要中筛选了11项研究。堕胎风险增加(OR,1.33;95%CI,1.02-1.74;P=0.04)和早产(OR,1.16;95%CI,1.05-1.28;P=0.004),和活产风险降低(OR,与对照组(未使用抗TNF-α治疗)相比,抗TNF-α治疗组发现了0.83;95%CI,0.74-0.94;P=0.002])。基于疾病活动性的亚组分析显示,在妊娠期间使用抗TNF-α治疗与流产的不良妊娠结局之间没有显着关联。早产,和活产。静止出生率,低出生体重,抗TNF-α治疗组的先天性异常与对照组无明显差异。
    结论:抗TNF-α治疗不会增加死胎的风险,低出生体重,和先天性异常;然而,它可能与堕胎和早产的风险增加有关,伴随着较低的活产率。尽管这些发现可能与潜在的疾病活动有关,他们对生物制剂的使用提出了一些相反的观点。因此,需要更多的研究来进一步证实抗TNF-α治疗妊娠合并IBD的安全性.
    BACKGROUND: Inflammatory Bowel Disease (IBD) affects reproductive-aged women. Active disease can lead to decreased fertility. Although the vast majority of international guidelines recommend for the continuation of anti-TNF-α during pregnancy, recent studies have raised concerns about the safety of anti-tumor necrosis factor-α (TNF-α) therapy during pregnancy, both for patients and for physicians.
    METHODS: Studies that evaluate the safety of anti-TNF-α therapy in pregnant women with IBD were identified using bibliographical searches. An updated meta-analysis was performed for pregnancy outcomes, such as live birth, abortion, still birth, preterm birth, low birth weight, congenital abnormalities, and neonatal infection. Odds ratio (OR) with 95% confidence interval (CI) are reported. Data on disease activity, timing of anti-TNF-α therapy were collected for further analysis.
    RESULTS: Overall, 11 studies were screened from on-line databases and international meeting abstracts. An increased risk of abortion (OR, 1.33; 95% CI, 1.02-1.74; P = 0.04) and preterm birth (OR, 1.16; 95% CI, 1.05-1.28; P = 0.004), and a decreased risk of live birth (OR, 0.83; 95% CI, 0.74-0.94; P = 0.002]) were found in the anti-TNF-α therapy group compared with the control group (no use of anti-TNF-α therapy). The subgroup analyses based on the disease activity showed there is no significant association between the use of anti-TNF-α therapy during pregnancy on adverse pregnancy outcomes of abortion, preterm birth, and live birth. The rates of still birth, low birth weight, and congenital abnormalities in the anti-TNF-α therapy group were not significantly different from those in the control group.
    CONCLUSIONS: Anti-TNF-α therapy does not increase the risks of still birth, low birth weight, and congenital abnormalities; however it may be assicated with increased risks of abortion and preterm birth, which are accompanied by a lower rate of live birth. Although these findings may be confounding by potential disease activity, they offer some opposite viewpoints with biologic agent use. Therefore, more studies are required to further confirm the safety of anti-TNF-α therapy in pregnancy with IBD.
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  • 文章类型: Journal Article
    Takayasu动脉炎(TAK)是复杂的疾病,没有可靠的生物标志物。这里,我们旨在探讨TAK相关因子组及其在生物治疗后的变化.确定了五个因素组:1.全身性炎症:C3,ESR,CRP,PLT,IL-6、C4和IgG;2.血管炎症:YKL40、IL-16、PTX3和CCL2;3.免疫调节组:IL-10,IFN-γ,CCL5和MMP1;4.血管生成和纤维化:FGF,PDGFAB,和VEGF;和5.血管重塑:CD19+B细胞比例,MMP3和瘦素.第1组参数与疾病活动密切相关,而面板5参数,特别是CD19+B细胞比例和瘦素,在缺血性患者中明显更高。治疗后,托珠单抗对第1组参数有更强的抑制作用,PTX3和YKL-40,而阿达木单抗导致IL-16,CCL2和瘦素水平增加。总之,这些数据扩展了我们对TAK开发中分子背景的认识,并为未来研究中的精确治疗提供了启示.
    Takayasu arteritis (TAK) is complicated disorder without reliable biomarkers. Here, we aimed to explore TAK-associated factor panels and their changes after biologic treatment. Five factor panels were identified: 1. systemic inflammation: C3, ESR, CRP, PLT, IL-6, C4, and IgG; 2. vascular inflammation: YKL40, IL-16, PTX3, and CCL2; 3. immune regulation panel: IL-10, IFN-γ, CCL5, and MMP1; 4. angiogenesis and fibrosis: FGF, PDGFAB, and VEGF; and 5. vascular remodeling: CD19+ B cell ratio, MMP3, and leptin. Panel 1 parameters were closely related to disease activity, while Panel 5 parameters, particularly CD19+ B cell ratio and leptin, were significantly higher in ischemic patients. After treatment, tocilizumab had a stronger inhibitory effect on Panel 1 parameters, PTX3, and YKL-40, while adalimumab led to an increase in IL-16, CCL2, and leptin levels. Altogether, these data expanded our knowledge regarding molecular background in TAK development and shed light on precise treatment in future studies.
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  • 文章类型: Journal Article
    背景:在中国,评估guselkumab在中度至重度银屑病中的长期疗效的实际研究有限且不可用。
    方法:在这项现实生活中的研究中,我们回顾性检查了总共27例接受guselkumab[100mg,皮下(s.c.)]在皮肤科进行的现实生活中至少52周的随访期,湘雅医院,中南大学银屑病系,大连皮肤病医院。研究的主要终点是长期有效性[减少银屑病面积和严重程度指数(PASI)评分,皮肤病生活质量指数(DLQI)的改善],安全,和guselkumab的耐受性。
    结果:Guselkumab治疗在12周和52周时,平均PASI评分从基线时的12.46±6.34降至4.03±3.25(P<0.001)和0.77±1.25(P<0.001)。12周时,PASI75、90和100应答率达到44.4%,18.5%,和11.1%的患者,分别。在1年,PASI75、90和100反应在88%中实现,72%,48%的病人,分别。52周时,96%的患者达到PASI评分≤3,80%的患者达到DLQI(0/1)。没有患者因原发性或继发性无效或未能坚持药物治疗而退出研究。在后续期间,仅报告了2起不良事件(头癣和腹泻).
    结论:我们的发现证实guselkumab在常规临床实践中是一种合适的治疗选择。特别是在治疗有合并症或以前生物治疗失败的复杂患者时。
    BACKGROUND: Real-life studies evaluating the long-term efficacy of guselkumab in moderate-to-severe psoriasis in China are limited and not available.
    METHODS: In this real-life study, we retrospectively examined a total of 27 patients with moderate-to-severe psoriasis treated with guselkumab [100 mg, subcutaneous (s.c.)] with a follow-up period of at least 52 weeks in a real-life setting conducted at the Department of Dermatology, Xiangya Hospital, Central South University and Department of Psoriasis, Dalian Dermatosis Hospital. The primary endpoint of the study was long-term effectiveness [reduction of Psoriasis Area and Severity Index (PASI) score, improvement of Dermatology Life Quality Index (DLQI)], safety, and tolerability of guselkumab.
    RESULTS: Guselkumab treatment decreased the mean PASI score from 12.46 ± 6.34 at baseline to 4.03 ± 3.25 (P < 0.001) and 0.77 ± 1.25 (P < 0.001) at 12 and 52 weeks. At 12 weeks, PASI 75, 90, and 100 response was achieved in 44.4%, 18.5%, and 11.1% of patients, respectively. At 1 year, PASI 75, 90, and 100 response was achieved in 88%, 72%, and 48% of patients, respectively. At 52 weeks, 96% of patients achieved a PASI score of ≤ 3 and 80% of patients achieved DLQI (0/1). No patients withdrewed from the study due to primary or secondary ineffectiveness or failure to adhere to the medication. During the follow-up period, only two adverse events were reported (tinea capitis and diarrhea).
    CONCLUSIONS: Our findings confirm that guselkumab is an appropriate therapeutic option in routine clinical practice, particularly when treating sophisticated patients with comorbidities or who failed to previous biologic therapy.
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  • 文章类型: Letter
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  • 文章类型: Journal Article
    银屑病是一种慢性免疫介导的皮肤病。HIV感染者(PLHIV)中银屑病的发病率高于普通人群。机制很复杂,表现形式是多种多样的,治疗很困难。生物疗法大大缓解了牛皮癣,但是临床试验通常排除PLHIV,证据仅限于病例报告。这里,我们报告了一名患有银屑病关节炎的男子,他对传统治疗反应不佳。在接受抗白细胞介素(IL)-17单克隆抗体(ixekizumab)后,关节炎症状明显缓解,而与抗逆转录病毒治疗(ART)联合使用时,CD4+T细胞计数增加,HIV-1的病毒载量仍未检测到。总之,抗IL-17单克隆抗体是治疗HIV阳性患者银屑病关节炎的一种有前途且安全的治疗方法.
    Psoriasis is a chronic immune-mediated disease of the skin. The incidence of psoriasis among people living with HIV (PLHIV) is higher than that in the general population. The mechanism is complex, the manifestations are varied, and the treatment is difficult. Biotherapy has greatly alleviated psoriasis, but clinical trials often exclude PLHIV, and evidence is limited to case reports. Here, we report a man living with psoriatic arthritis who had poor response to traditional treatments. After receiving the anti-interleukin (IL)-17 monoclonal antibody (ixekizumab), the arthritis symptoms were significantly relieved, while CD4+ T cell count increased and the viral load of HIV-1 remained undetectable in combination with antiretroviral therapy (ART). In conclusion, anti-IL-17 monoclonal antibody is a promising and safe treatment for psoriatic arthritis in HIV-positive patients.
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    文章类型: Journal Article
    OBJECTIVE: To investigate the serum level of Myeloid-Related Protein 8/14 complex (MRP8/14) and to predict and monitor the response to biologic treatment in rheumatoid arthritis (RA) patients.
    METHODS: Each patient underwent clinical examination and blood sampling for assessment of serum high-sensitivity C-reactive protein (hs-CRP) levels, erythrocyte sedimentation rate (ESR), rheumatoid factors (RF), anti-cyclic citrullinated protein antibodies (anti-CCP), and serum concentrations of MRP8/14 protein complexes (myeloid-related proteins, MRP8/14) were measured at baseline, and weeks 4 and 12 (after initiation of treatment).
    RESULTS: Serum MRP8/14 protein complex levels correlated with DAS28 and anti-CCP antibody. MRP8/14 protein complex levels decreased significantly after 12 weeks treatment with biological therapy: mono-rhTNFR-Fc active group. rhTNFR-Fc plus methotrexate (MTX) decreased MRP8/14 protein complex levels from 11839±1849 ng/ml to 5423±1130 ng/ml (p<0.01) a reduction of 54.2% compared with 32.9% in the rhTNFR-Fc group.
    CONCLUSIONS: MRP8/14 protein complex levels were increased in active stage RA patients. MRP8/14 levels were decreased with rhTNFR-Fc treatment, suggesting serum concentrations of MRP8/14 protein complex might be a promising biomarker to predict responses to biological therapy in active RA patients at baseline and could be used to monitor responses to treatment across different mechanisms of action.
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