Abstract:
INTRODUCTION:Phase IV post-marketing surveillance studies are needed to evaluate the real-world safety and effectiveness of drug products. This study aimed to evaluate the safety and effectiveness of biosimilar etanercept (Altebrel, AryoGen Co., Iran) in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA). METHODS:In this open-label, multicenter, prospective, observational, post-marketing surveillance study, 583 patients received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly and were followed up to 12 months. The primary objective was to evaluate the safety of biosimilar etanercept by documenting all the adverse events in the case report forms throughout the study period. The secondary objective was to evaluate the effectiveness of biosimilar etanercept in study patients, where longitudinal changes in health assessment questionnaire (HAQ), pain, and disease activity scores were assessed. RESULTS:A total of 583 patients (44.80 ± 13.09 years of age) were included and followed for an average of 8.12 ± 3.96 months. Among all patients, 172 (29.50%) experienced at least one adverse event, and injection site reaction, abdominal pain, and upper respiratory tract infection were the most common. HAQ scores decreased from 1.32 ± 0.77 at baseline to 0.81 ± 0.61 at 12 months in patients with RA/PsA (p < 0.01) and from 0.82 ± 0.58 at baseline to 0.66 ± 0.63 at 12 months in patients with AS (p = 0.18). Pain scores decreased from 6.49 ± 2.41 at baseline to 3.51 ± 2.39 at 12 months (p < 0.01). CONCLUSION:The results demonstrated the real-world safety and effectiveness of biosimilar etanercept in patients with RA, PsA, and AS. TRIAL REGISTRATION:ClinicalTrials.gov identifier NCT04582084.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Gharibdoost F,Salari AH,Salesi M,Ebrahimi Chaharom F,Mottaghi P,Hosseini M,Sahebari M,Nazarinia M,Mirfeizi Z,Shakibi M,Moussavi H,Karimifar M,Mowla K,Karimzadeh H,Anjidani N,Jamshidi Adoi
10.1007/s12325-020-01611-8subject
Has Abstractpub_date
2021-01-11 00:00:00eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-020-01611-8pub_type
杂志文章abstract::Brucellosis remains an important public health problem in Turkey, just as it is in other regions of the world. This study was conducted to determine the types and rates of cutaneous lesions that occur in patients with brucellosis. Brucellosis was diagnosed by standard tube agglutination testing for Brucella antibodies...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02849964
更新日期:2007-07-01 00:00:00
abstract::Unfortunately, the fourteenth author's name was incorrectly published in the Original Article. The correct author name is Cen Hong. ...
journal_title:Advances in therapy
pub_type: 已发布勘误
doi:10.1007/s12325-019-01009-1
更新日期:2019-08-01 00:00:00
abstract:INTRODUCTION:Arteriosclerosis obliterans (ASO) causes ischemic symptoms of the lower limbs, reducing quality of life (QOL), and has a poor prognosis. Early diagnosis and treatment are necessary. In this study, the effects of long-term administration of beraprost sodium (beraprost) to treat ASO were investigated. METHO...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0030-7
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abstract:INTRODUCTION:Data regarding the prevalence of immune thrombocytopenia (ITP) is limited, and is derived from North American population-based analyses. Therefore, the authors conducted the first study outside the United States (US) using the United Kingdom (UK) General Practice Research Database (GPRD) to estimate the ad...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-011-0084-3
更新日期:2011-12-01 00:00:00
abstract::Duodenal self-expandable metal stents (SEMS) are designed for palliation and prompt relief of malignant gastric outlet obstruction (GOO). This mini-invasive endoscopic treatment is preferable to surgery due to its lower morbidity and mortality, shorter hospitalization, and earlier symptoms relief; furthermore endoscop...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0061-2
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abstract:INTRODUCTION:D-Dimer (DD) has been described as a useful predictor of both morphologic changes in acute thoracic aortic dissection (TAD) and of TAD-associated mortality. This study analyzed the use of DD screening to screen patients with chest pain for acute (TAD) to determine if it improves diagnosis and cost effectiv...
journal_title:Advances in therapy
pub_type: 杂志文章
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abstract::Patients with severe gastrointestinal motility disorders are often found to have intravenous access clots or deep venous thrombosis. It has previously been reported that many patients who have intravenous access thrombosis have concomitant thrombotic risk factors. In this study, the goal was to determine the underlyin...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850315
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abstract:INTRODUCTION:Alcohol dependence represents a severe pathological disorder associated with a significant rate of morbidity and mortality. To date, limited pharmacological agents exist to treat this disorder, and there is a growing interest for new therapies. In this context, pregabalin represents a promising strategy. P...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-012-0061-5
更新日期:2012-11-01 00:00:00
abstract:INTRODUCTION:Nivolumab has been approved in patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection, in the adjuvant setting. A pivotal trial compared nivolumab with ipilimumab; however, no head-to-head trial exists comparing nivolumab to observation, a common comp...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-01060-y
更新日期:2019-10-01 00:00:00
abstract::Data from the Framingham Heart Study and risk-appraisal models were used to develop a Coronary Heart Disease (CHD) Risk Factor Calculator for early identification of high-risk individuals. The Calculator was tested at an employee health fair for a large northeastern US corporation. Of the 590 employees who registered ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850248
更新日期:2001-01-01 00:00:00
abstract:INTRODUCTION:This Phase 2 clinical trial assessed the efficacy and safety of the novel antioxidative, renewable compound SkQ1 for topical treatment of dry eye signs and symptoms. METHODS:In a single-center, randomized, double-masked, placebo-controlled, 29-day study, 91 subjects with mild to moderate dry eye instilled...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/s12325-015-0274-5
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVE:Examine outcomes and costs of patients with persistent asthma who initiated treatment with beclomethasone dipropionate hydrofluoroalkane (BDP-HFA) or fluticasone propionate (FP). METHODS:MedStat's Commercial Claims and Encounters database (July 1, 2002-June 30, 2007) was utilized. Patients (n=13,968) were in...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-009-0056-z
更新日期:2009-08-01 00:00:00
abstract::In the past 15 years, improvements in the treatment of HIV infection have dramatically reduced morbidity and mortality. Nucleoside reverse transcriptase inhibitors are the backbone of combination antiretroviral therapy for the treatment of HIV. One of the recommended and commonly used therapies in this class is the on...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0006-9
更新日期:2010-01-01 00:00:00
abstract:INTRODUCTION:The present study aimed to identify preoperative factors that predispose the development of subretinal fluid (SRF) following successful macular hole (MH) surgery. METHODS:Thirty-four eyes of 33 consecutive patients that underwent pars plana vitrectomy for idiopathic full-thickness MH surgery were included...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-015-0227-z
更新日期:2015-07-01 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::Subretinal hemorrhage secondary to age-related macular degeneration (AMD) has a poor visual prognosis. Surgical drainage of the blood improves visual acuity only in selected patients. We report on two elderly patients with spontaneous subretinal hemorrhage from AMD. In one eye, recombinant tissue plasminogen activator...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:
更新日期:1997-09-01 00:00:00
abstract:INTRODUCTION:Asthma is associated with significant economic burden. Inhaled corticosteroid and long-acting beta2-agonist (ICS/LABA) combination therapies are considered mainstays of treatment. We describe real-world use of ICS/LABAs by comparing treatment persistence and adherence among patients with asthma in the Unit...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01344-8
更新日期:2020-06-01 00:00:00
abstract::Venous leg ulcers (VLUs) are the most severe manifestation of chronic venous disease (CVD). Due to their chronic nature, high recurrence rate and slow healing time, VLUs account for 80% of all leg ulcers seen in patients with CVD. VLUs impose a heavy burden on patients that reduces their quality of life; VLUs also rep...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01219-y
更新日期:2020-02-01 00:00:00
abstract::Endocrine therapy (ET) is integral to the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). Aromatase inhibitors (AIs; e.g., anastrozole, letrozole, exemestane), selective estrogen receptor modulators (e.g., tamoxifen), and the selec...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01552-2
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journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0653-1
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abstract:BACKGROUND:There have been few large studies that have analyzed the effect of professional (masked) continuous glucose monitoring (P-CGM) on glycemic control in patients with type 2 diabetes (T2DM) who were on a broad spectrum of baseline therapies. METHODS:We performed a retrospective, blinded evaluation of glycemic ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0576-x
更新日期:2017-08-01 00:00:00
abstract::Angio-immunoblastic T-cell lymphoma (AITL), a rare disease that constitutes 1% to 2% of non-Hodgkin's lymphomas, presents in middle-aged and elderly individuals. This report describes a patient with high-grade fever and lymphadenopathy. An extensive in-hospital work-up that included lymph node biopsy yielded negative ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02849974
更新日期:2007-07-01 00:00:00
abstract::Endophthalmitis is an intraocular inflammatory condition which may or may not be caused by infective agents. Noninfectious (sterile) endophthalmitis may be attributable to various causes including postoperative retained soft lens matter or toxicity following introduction of other agents into the eye. Infectious endoph...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-016-0307-8
更新日期:2016-05-01 00:00:00
abstract::Recently, immunotherapy has been shown to be an effective and helpful therapeutic option for the treatment of advanced non-small-cell lung cancer (NSCLC). The activity of antitumor T cells may be restored through the checkpoint blockade using anti-programmed death 1 or anti-programmed death ligand 1 (PD-L1) antibodies...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
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更新日期:2019-10-01 00:00:00
abstract:INTRODUCTION:Glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) approved to date are administered by injection; therefore, patient perceptions of an oral GLP-1 RA are unknown. This discrete choice experiment explored preferences for (unbranded) oral and injectable GLP-1 RA profiles among Japanese patients with typ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01561-1
更新日期:2020-11-27 00:00:00
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...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1007/s12325-018-0751-8
更新日期:2018-08-01 00:00:00
abstract:INTRODUCTION:This retrospective study used data from a primary care database to compare two insulin products in routine clinical practice for the treatment of type 2 diabetes in the UK. PATIENTS AND METHODS:Records were analyzed for patients with type 2 diabetes who had been initiated on biphasic insulin aspart 30 (BI...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-010-0079-5
更新日期:2010-11-01 00:00:00
abstract::In order for the global healthcare system to remain sustainable, healthcare spending needs to be reduced, and self-treating certain conditions under the guidance of a pharmacist provides a means of accomplishing this goal. This article was developed to describe global healthcare trends affecting self-care with a speci...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-016-0395-5
更新日期:2016-10-01 00:00:00
abstract:INTRODUCTION:New biosimilars of monoclonal antibodies are anticipated to bring significant cost savings and increase access to treatment. The rituximab biosimilar CT-P10 has recently been approved in Europe in all indications held by reference rituximab (RTX), including rheumatoid arthritis, non-Hodgkin's lymphoma, and...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-017-0522-y
更新日期:2017-05-01 00:00:00
abstract:INTRODUCTION:The aim of this study was to assess the efficacy and safety of esomeprazole 40 mg once daily (q.d.) in healing reflux oesophagitis at 4 and 8 weeks, and the efficacy of esomeprazole 20 mg q.d. for 12 weeks in the maintenance of remission. METHODS:A total of 235 patients with endoscopically proven reflux o...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1007/s12325-008-0071-5
更新日期:2008-06-01 00:00:00