drug sparing

  • 文章类型: Journal Article
    影像学轴性脊柱关节炎(r-axSpA),以前称为强直性脊柱炎(AS),是慢性的,与炎症性背痛等症状相关的炎症性风湿性疾病,早晨僵硬,和关节炎。AS患者的一线建议包括使用非甾体抗炎药(NSAIDs)治疗,以减轻疼痛和僵硬。
    我们研究的目的是评估苏金单抗在目前接受NSAIDs治疗的AS患者中的疗效和短期NSAID保护作用。
    我们评估了国际脊柱炎协会(ASAS20)对苏金单抗的临床评估,并评估了与安慰剂相比,150mg苏金单抗治疗的r-axSpA患者在第4周和第12周之间合并使用NSAID的减少程度。
    ASTRUM是一项为期24周的前瞻性随机对照试验,对患有活跃的r-axSpA[巴斯强直性脊柱炎疾病活动指数(BASDAI)4]的成年患者进行了研究,这些患者对2NSAIDs的反应不足。患者从第0周开始随机(1:1:1)开始使用皮下苏金单抗150mg进行治疗(第1组),第4周(第2组),或第16周(第3组)。从第4周开始,所有组均允许NSAIDs逐渐减少。
    这项研究包括211名患者(第1、2和3组分别为n=71、70和70)。合并组1和2对比组3在第12周时的ASAS20应答为51.1%对比44.3%(p=0.35)。与第3组相比,第1组和第2组的患者在第16周时达到ASAS40和BASDAI50并显示其他次要临床结局的改善。与第3组相比,第1组和第2组中更多的患者从基线到第16周停止NSAID摄入。
    苏金单抗治疗可改善r-axSpA患者的临床结局,并显示出短期的NSAID保护作用,即使没有达到主要终点.
    ClinicalTrials.gov;NCT02763046,EudraCT2015-004575-74。
    UNASSIGNED: Radiographic axial spondyloarthritis (r-axSpA), formerly known as ankylosing spondylitis (AS), is a chronic, inflammatory rheumatic disease associated with symptoms such as inflammatory back pain, morning stiffness, and arthritis. First-line recommendations for patients with AS include treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for reducing pain and stiffness.
    UNASSIGNED: The objective of our study is to evaluate the efficacy and short-term NSAID-sparing effect of secukinumab in patients with AS currently treated with NSAIDs.
    UNASSIGNED: We assessed the clinical Assessment of SpondyloArthritis International Society (ASAS20) response to secukinumab and evaluated the extent to which the use of concomitant NSAID can be reduced between weeks 4 and 12 in r-axSpA patients treated with secukinumab 150 mg compared with placebo.
    UNASSIGNED: ASTRUM was a prospective 24-week randomized controlled trial of adult patients with active r-axSpA [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ⩾4] who had a documented inadequate response to ⩾2 NSAIDs. Patients were randomized (1:1:1) to initiate treatment with subcutaneous secukinumab 150 mg from either week 0 (group 1), week 4 (group 2), or week 16 (group 3). From week 4 onward, tapering of NSAIDs was allowed in all groups.
    UNASSIGNED: This study included 211 patients (n = 71, 70, and 70 in groups 1, 2, and 3, respectively). ASAS20 response at week 12 for pooled groups 1 and 2 versus group 3 was 51.1% versus 44.3% (p = 0.35). A higher proportion of patients in groups 1 and 2 achieved ASAS40 and BASDAI50 and showed improvements in other secondary clinical outcomes as compared to group 3 at week 16. More patients in groups 1 and 2 versus group 3 stopped their NSAID intake from baseline through week 16.
    UNASSIGNED: Treatment with secukinumab improved clinical outcomes and showed a short-term NSAID-sparing effect in patients with r-axSpA, even though the primary endpoint was not met.
    UNASSIGNED: ClinicalTrials.gov; NCT02763046, EudraCT 2015-004575-74.
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  • 文章类型: Comparative Study
    OBJECTIVE: Several attempts have been made to test different drug-sparing strategies to reduce the drug-burden and drug-related toxicities. The objective of this meta-analysis was to evaluate the relative risk (RR) of failure of dual therapies compared to triple therapies in HIV-naïve patients.
    METHODS: We searched MEDLINE, Google Scholar and the Cochrane Library. The following criteria were used: present data from original articles comparing the two treatment regimens; published from January 2007 up to January, 2020. No language or study design restriction was applied. Subjects were HIV-positive naïve patients treated with dual or triple antiretroviral therapy (ART). A systematic review and meta-analysis was performed. Treatment failure (TF) was the primary outcome evaluated; heterogeneity was assessed using the Q statistic and I2.
    RESULTS: Fourteen studies were included, allowing a meta-analysis on 5205 patients. The meta-analysis performed on studies that presented data at 48 weeks showed that the RR of TF (RR > 1 favouring triple therapy) in 10 studies was 1.20 (95% confidence interval (CI): 0.91-1.59, I2: 49.2%); the RR of virological failure (VF) in eight studies was 1.54 (95% CI: 0.84-2.86, I2: 54%); the RR of adverse drug reaction leading to discontinuation of the regimen at 48 weeks in eight studies was 0.76 (95% CI: 0.43-1.33, I2: 17.7%). In patients with less than 200 CD4+, the RR of TF in two studies without maraviroc was 2.09 (95% CI: 1.05-4.17, I2: 0.0%). Regarding the studies at 96 weeks there was no difference except in rate of development of resistance, RR 1.94 (95% CI: 1.06-3.53, I2: 6.2%).
    CONCLUSIONS: Dual therapies are as effective as those with three drugs, showing no difference according to the different dual therapies, except in patients with less than 200 CD4; however, they are associated with a higher selection of resistance-associated mutations at 96 weeks of therapy.
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