Abstract:
INTRODUCTION:To assess the impact of certolizumab pegol (CZP) treatment on clinical, patient-reported, and musculoskeletal ultrasound outcomes and to determine the treatment response time point most predictive of long-term outcomes in Italian patients with rheumatoid arthritis (RA). METHODS:CZP-SPEED (NCT01443364) was a 52-week, open-label, prospective, interventional, multicenter study. Biologic-naïve patients with moderate-to-severe active RA, who had failed at least one DMARD treatment, received CZP (400 mg at weeks 0, 2, and 4, then 200 mg every 2 weeks) concomitantly with methotrexate. The primary objective was to identify the time point of clinical response {decrease in 28-joint Disease Activity Score [DAS28(ESR)] ≥ 1.2} most predictive of a clinical response at week 52. Additional clinical and patient-reported outcomes were measured. Power Doppler (PD) ultrasound was used to assess synovial effusion, synovial proliferation, PD signal, cartilage damage, and bone erosion according to international guidelines. RESULTS:A total of 132 patients were enrolled and received CZP; 91/132 (69%) completed to week 52. Predicted 52-week responses for early responders (week 2 onwards) were between 65% and 70%. Rapid improvements in joint cavity widening and PD signal were observed to week 8 and maintained to week 52. Cartilage damage and bone erosion were stable over 52 weeks. No new safety signals were identified. CONCLUSION:In Italian CZP-treated patients with moderate-to-severe RA, week 12 clinical responses may be predictive of long-term response at week 52. Rapid improvements in clinical, patient-reported, and musculoskeletal ultrasound outcomes were maintained to week 52. These data may aid rheumatologists to make earlier treatment decisions. TRIAL REGISTRATION:ClinicalTrials.gov identifier, NCT01443364. FUNDING:UCB Pharma.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Sarzi-Puttini P,Filippucci E,Adami S,Meroni PL,Batticciotto A,Idolazzi L,De Lucia O,Talavera P,Kumke T,Grassi Wdoi
10.1007/s12325-018-0751-8subject
Has Abstractpub_date
2018-08-01 00:00:00pages
1153-1168issue
8eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-018-0751-8journal_volume
35pub_type
临床试验,杂志文章,多中心研究abstract:INTRODUCTION:This study characterized the multidose pharmacokinetic (PK) characteristics of posaconazole tablets used as prophylactic antifungal therapy in Chinese patients with acute myelogenous leukemia (AML) at risk for invasive fungal infection (IFI). METHODS:Participants in this open-label, single-arm, phase 1b s...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-020-01341-x
更新日期:2020-05-01 00:00:00
abstract:INTRODUCTION:Endometriosis symptoms are nonspecific and overlap with other gynecologic and gastrointestinal diseases, leading to long diagnostic delays. The burden of endometriosis has been documented; however, little is known about the impact of diagnostic delays on healthcare costs leading up to diagnoses. The purpos...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01215-x
更新日期:2020-03-01 00:00:00
abstract::This study was conducted to determine the reasons for the choice of self-prescribed laxatives and to acquire information on how they were used and tolerated. From November 1999 to February 2000, 70 pharmacies, uniformly located throughout the Campania region of southern Italy, distributed a questionnaire to purchasers...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850360
更新日期:2002-09-01 00:00:00
abstract:INTRODUCTION:The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced safety surveillance (ESS) of seasonal influenza vaccines including a near real-time evaluation of collected data. The objective was to identify whether the use of passive surveillance or active surveillance provides diff...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0747-4
更新日期:2018-08-01 00:00:00
abstract:INTRODUCTION:This retrospective study evaluates the efficacy of palliative chemotherapy with a modified docetaxel, cisplatin, 5-fluorouracil (5-FU; "TPF" regimen) regimen (mTPF; reduced doses of docetaxel, cisplatin, and 5-FU with reduction of intravenous 5-FU from 4 days to 2 days) in Asian patients with recurrent and...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-011-0085-2
更新日期:2012-01-01 00:00:00
abstract:INTRODUCTION:Patients with chronic kidney disease (CKD) have an increased risk of comorbid conditions, including cardiovascular disease (CVD). Anemia is prevalent in the CKD population and worsens as kidney function declines, resulting in a diminished quality of life and increased morbidity/mortality. The purpose of th...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0566-z
更新日期:2017-07-01 00:00:00
abstract:INTRODUCTION:Synthesis of evidence on the long-term use of first-line biologic therapy in patients with early rheumatoid arthritis (RA) is required. We compared the efficacy of up to 5 years' treatment with first-line tumor necrosis factor inhibitors (TNFis) versus other treatment strategies in this population. METHOD...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
doi:10.1007/s12325-018-0869-8
更新日期:2019-03-01 00:00:00
abstract:BACKGROUND:The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak is a serious health concern. Repurposing of existing drugs indicated for other conditions seems to be the first choice for immediate therapeutic management. The quality of early evidence favoring the different treatment options needs t...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01460-5
更新日期:2020-10-01 00:00:00
abstract:INTRODUCTION:Healthy eating is a critical aspect of the prevention and management of type 2 diabetes (T2DM). Disrupted eating patterns can result in poor glucose control and increase the likelihood of diabetic complications. Teneligliptin inhibits dipeptidyl peptidase-4 activity for 24 h and suppresses postprandial hyp...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0704-2
更新日期:2018-06-01 00:00:00
abstract::Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19), which can induce multisystem disease. Human angiotensin-converting enzyme 2 (ACE2) widely expressing in arterial and venous endothelial cells and arterial smooth muscle cells has been identified as a functional rec...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01399-7
更新日期:2020-07-01 00:00:00
abstract:INTRODUCTION:Although chronic opioid therapy is usually initiated using short-acting opioids, many patients with chronic pain are subsequently converted to long-acting and extended-release preparations. In clinical practice, optimal management requires careful individualization of dosage in order to achieve an appropri...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-012-0051-7
更新日期:2012-10-01 00:00:00
abstract::The aim of this prospective, randomized, open-label, blinded endpoint (PROBE) study was to compare the antihypertensive efficacy of 2 angiotensin II (AII) receptor antagonists with different pharmacologic profiles, valsartan and olmesartan, in patients with mild-to-moderate essential hypertension. After an initial 2-w...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF02850182
更新日期:2005-01-01 00:00:00
abstract:OBJECTIVES:This study set out to examine the efficacy and tolerability of two innovative implant forms of leuprorelin acetate in men with advanced hormone-dependent prostate cancer in everyday clinical practice. METHODS:Data were collected from 818 patients (from 273 centers across Germany) who were pretreated with sl...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0010-y
更新日期:2013-03-01 00:00:00
abstract::The single-tablet combination of vildagliptin and metformin addresses key defects of type 2 diabetes for improved glycemic control. By inhibiting the dipeptidyl peptidase-4 (DPP-4) enzyme, vildagliptin raises the levels of the active incretin hormones, glucagon-like peptide 1 and glucose-dependent insulinotropic pepti...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-009-0010-0
更新日期:2009-02-01 00:00:00
abstract:INTRODUCTION:Type 2 diabetes mellitus (T2DM) is a complex disease in which multiple organs and hormones contribute to the pathogenesis of disease. The intestinal hormone, glucagon-like peptide-1 (GLP-1), secreted in response to nutrient ingestion, increases insulin secretion from pancreatic β-cells and reduces glucagon...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-015-0262-9
更新日期:2015-11-01 00:00:00
abstract:INTRODUCTION:To evaluate the retinal function and the relative neural conduction along the visual pathway after treatment with citicoline in liposomal formulation (CLF) eye drops in patients with open angle glaucoma (OAG). METHODS:Twelve OAG patients (mean age ± standard deviation 52.58 ± 11.39 years, intraocular pres...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-0897-z
更新日期:2019-04-01 00:00:00
abstract::Traveling through several time zones results in a constellation of symptoms known as jet lag. These include reduced alertness, daytime fatigue, loss of appetite, reduced cognitive skills, and disruption of the sleep/wake cycle. In susceptible air travel passengers, jet lag may exacerbate affective illness and result i...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0065-y
更新日期:2010-11-01 00:00:00
abstract::Two patients with thalassemia minor and end-stage renal failure on hemodialysis were treated with epoetin zeta (Silapo, Retacrit; STADA, Germany), a medicinal product that was developed and registered as biosimilar to epoetin alfa. Dosing was titrated individually for two patients to achieve a stable hemoglobin (Hb) c...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0119-6
更新日期:2008-12-01 00:00:00
abstract:INTRODUCTION:In FRESCO (Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients) trial, fruquintinib demonstrated a statistically significant and clinically meaningful overall survival benefit in Chinese patients with metastatic colorectal cancer (mCRC). However, its safety profile, including adverse eve...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01477-w
更新日期:2020-11-01 00:00:00
abstract::This 6-month randomized study evaluated the safety and efficacy of sibutramine in 57 overweight Hispanic patients with hypertension. Following a 2-week washout to confirm the diagnosis of hypertension, antihypertensive medication was adjusted to achieve a blood pressure less than 140/90 mm Hg before institution of eit...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF02850257
更新日期:2003-03-01 00:00:00
abstract::Many doubts surround the numerous forms of nonsurgical treatment of nonresectable hepatocellular carcinoma (HCC). Our study aimed to reach reliable conclusions on the actual efficacy of these treatments. We examined 85 studies involving a total of 6746 patients: 6113 were treated; the remaining 633 were not. We applie...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
doi:
更新日期:1994-11-01 00:00:00
abstract:INTRODUCTION:Diabetes-related healthcare costs are increasing in the United States, with inpatient hospitalization the largest component of medical expenditures. The aims of this study were to characterize hospitalized type 2 diabetes mellitus (T2DM) patients, understand the relationship between hospitalization and hea...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-015-0223-3
更新日期:2015-07-01 00:00:00
abstract::Life expectancy has increased substantially over the last few decades, leading to a worldwide increase in the prevalence and burden of aging-associated diseases. Recent evidence has proven that cellular senescence contributes substantially to the development of these disorders. Cellular senescence is a state of cell c...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01287-0
更新日期:2020-04-01 00:00:00
abstract::This prospective study was performed to determine whether gentamicin can be prescribed routinely to patients with spinal cord injury undergoing urologic procedures, or whether antibiotic therapy must be selected on the basis of recent urine microbiologic test results. Between January 2004 and June 2005, procedures wer...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章
doi:10.1007/BF02850350
更新日期:2006-01-01 00:00:00
abstract::This study compared technetium-99m-hexakis-2-methoxyisobutyl-isonitrile (Tc-99m MIBI) with technetium-99m methylene iphosphonate (Tc-99m MDP) to determine whether Tc-99m MIBI could distinguish vertebral metastases from traumatic vertebral fractures. Twenty patients with traumatic vertebral fracture (and no malignant d...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850344
更新日期:2006-01-01 00:00:00
abstract:INTRODUCTION:Oral supplementation of chondroitin sulfate (CS) and glucosamine (GlcN), symptomatic slow-acting molecules, is recommended by European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis and Musculoskeletal Diseases (ESCEO) and other European Union (EU) guidelines for the restorati...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01064-8
更新日期:2019-11-01 00:00:00
abstract::Clarithromycin, an advanced-generation macrolide antibiotic, has demonstrated excellent in vitro activity against group A beta-hemolytic streptococcus (GABHS). Potent activity against Streptococcus pyogenes and a favorable pharmacokinetic profile have made it a reasonable alternative for treatment of patients with str...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1007/BF02868027
更新日期:2000-01-01 00:00:00
abstract:INTRODUCTION:This study aimed to demonstrate the clinical utility of non-invasive multigene Cxbladder urine tests in reducing the overall number of diagnostic tests and invasive procedures used in the clinical evaluation of patients presenting with microhematuria, a key symptom of urothelial carcinoma (UC). There is a ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0518-7
更新日期:2017-05-01 00:00:00
abstract::Hypertension is recognized as a major risk factor for cardiovascular and renal diseases and represents the leading cause of mortality worldwide. In spite of proven benefits of hypertension treatment, blood pressure control rates are poor, even in high-income countries with virtually full-access to therapies. Nearly 75...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-013-0020-9
更新日期:2013-04-01 00:00:00
abstract::The aims of this study were to determine whether the nursing costs of functional disability could be assessed retrospectively and, if so, whether this method was sensitive enough to show the influence of a treatment on economic costs. Four studies were available for this purpose: three randomized, double-blind, place...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:
更新日期:1993-09-01 00:00:00