Abstract:
Background:Biosimilars are of growing clinical, regulatory, and commercial importance. Purpose:To summarize evidence about the bioequivalence between biosimilar and reference tumor necrosis factor-α (TNF-α) inhibitors. Data Sources:PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and LILACS from inception through 13 April 2016 and ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform, EU Clinical Trials Register, U.S. Food and Drug Administration, and European Medicines Agency from inception through 30 April 2016. Study Selection:Published English-language studies of any size or design that compared the pharmacokinetics, clinical efficacy, adverse events, or immunogenicity of a biosimilar TNF-α inhibitor with a reference biologic in humans. Data Extraction:Two reviewers independently screened titles and abstracts, extracted data from selected studies, and assessed study quality. Data Synthesis:Of 19 eligible studies, 8 were phase 1 randomized trials, 5 were phase 3 randomized trials, and 6 were observational studies. Most phase 1 trials (n = 7) involved healthy volunteers, phase 3 trials involved patients with rheumatoid arthritis, and observational studies involved those with rheumatoid arthritis or inflammatory bowel disease. All phase 1 trials showed that pharmacokinetic parameters of the biosimilar and respective biologic were within the prespecified equivalence margin of 80% to 125%. Phase 3 trials suggested similar clinical responses and adverse events. Adverse events were usually of mild to moderate severity. Two cross-sectional observational studies showed cross-reactivity between products, whereas 4 cohort studies of patients switched from reference to biosimilar products suggested similar efficacy and safety outcomes. Limitation:Possible publication bias, small sample sizes of many studies, and lack of published studies for several biosimilars. Conclusion:Preliminary evidence supports the biosimilarity and interchangeability of biosimilar and reference TNF-α inhibitors. Primary Funding Source:Johns Hopkins Center of Excellence in Regulatory Science and Innovation. (PROSPERO: CRD42015025262).
journal_name
Ann Intern Medjournal_title
Annals of internal medicineauthors
Chingcuanco F,Segal JB,Kim SC,Alexander GCdoi
10.7326/M16-0428subject
Has Abstractpub_date
2016-10-18 00:00:00pages
565-574issue
8eissn
0003-4819issn
1539-3704pii
2540851journal_volume
165pub_type
杂志文章,评审abstract:OBJECTIVE:To evaluate the incidence and symptoms of and risk factors for biliary sludge and gallstones during pregnancy and to assess the natural history of these conditions in the first year after delivery. DESIGN:Cohort study. PATIENTS:A total of 272 pregnant women recruited in the first trimester. MEASUREMENTS:Bi...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-119-2-199307150-00004
更新日期:1993-07-15 00:00:00
abstract:BACKGROUND:Corticosteroid injections (CSIs) and physical therapy are used to treat patients with the shoulder impingement syndrome (SIS) but have never been directly compared. OBJECTIVE:To compare the effectiveness of 2 common nonsurgical treatments for SIS. DESIGN:Randomized, single-blind, comparative-effectiveness,...
journal_title:Annals of internal medicine
pub_type: 杂志文章,随机对照试验
doi:10.7326/M13-2199
更新日期:2014-08-05 00:00:00
abstract:BACKGROUND:Motor vehicle crashes (MVCs) remain a leading cause of injury-related deaths in the United States. Primary seat belt laws allow vehicle occupants to be ticketed solely for not wearing seat belts, and secondary laws allow ticketing only for failure to wear seat belts in the setting of other violations. OBJEC...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M14-2368
更新日期:2015-08-04 00:00:00
abstract::The question of whether initial treatment is necessary in relatively asymptomatic patients with stage III and IV non-Hodgkin's lymphomas of favorable histologic types was studied by retrospective analysis. Two groups of patients were studied: [1] 44 nonprotocol patients, followed since 1963, in whom initial treatment ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-90-1-10
更新日期:1979-01-01 00:00:00
abstract:OBJECTIVE:To determine whether a cytogenetic response after interferon-alpha therapy in patients with chronic myelogenous leukemia is independently associated with improved survival. DESIGN:Retrospective analysis. PATIENTS:274 patients with a diagnosis of Philadelphia chromosome-positive chronic myelogenous leukemia ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-122-4-199502150-00003
更新日期:1995-02-15 00:00:00
abstract:OBJECTIVE:To describe the prevalence of cognitive impairment among elderly primary care patients and to compare diagnostic evaluations and use of health services among patients with and those without cognitive impairment. DESIGN:Prospective cohort study. SETTING:Academic primary care group practice. PATIENTS:3954 pa...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-122-6-199503150-00004
更新日期:1995-03-15 00:00:00
abstract::The sharp rise in drug abuse in the past decade has led to the development of new sources of information on drug-abuse trends. These include surveys, drug-related emergencies, drug-abuse treatment, hepatitis rates, and various types of law enforcement information. This paper summarizes data currently available for her...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-83-3-402
更新日期:1975-09-01 00:00:00
abstract:BACKGROUND:The risk for hypertension after kidney donation remains uncertain. PURPOSE:To see whether normotensive adults who donate a kidney develop higher blood pressure and risk for hypertension compared with nondonor adults acting as control participants. DATA SOURCES:MEDLINE, EMBASE, and Science Citation Index we...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析,评审
doi:10.7326/0003-4819-145-3-200608010-00006
更新日期:2006-08-01 00:00:00
abstract::Systematic reviewers increasingly must decide whether and how to incorporate existing systematic reviews into complex systematic reviews that are commissioned to support clinical guideline development or for other health policy uses. To date, however, this issue has been largely unexamined. Reviewers seeking to incorp...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-148-10-200805200-00010
更新日期:2008-05-20 00:00:00
abstract::The data from population-based, randomized trials of the mammographic screening of women aged 40 to 49 years are limited by retrospective subgroup analysis, low statistical power, and the use of older mammographic techniques. Nonetheless, meta-analysis involving the most recently reported data from all similarly desig...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-122-7-199504010-00010
更新日期:1995-04-01 00:00:00
abstract::Although the efficacy of hepatitis vaccine is well documented, the duration of immunity of healthy adults after vaccination is unknown. We studied 245 hospital employees 3 years after primary vaccination with hepatitis B vaccine to determine the prevalence of immunity indicated by levels of antibody to hepatitis B sur...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-108-2-185
更新日期:1988-02-01 00:00:00
abstract::Considerable evidence links elevated blood cholesterol levels to the development of atherosclerosis. The National Cholesterol Education Program (NCEP) has recently published revised guidelines for detecting and treating hypercholesterolemia in adults. Included in these guidelines is the recommendation that all adults ...
journal_title:Annals of internal medicine
pub_type: 评论,杂志文章,评审
doi:10.7326/0003-4819-124-5-199603010-00008
更新日期:1996-03-01 00:00:00
abstract:SOURCE CITATION:Ye Z, Rochwerg B, Wang Y, et al. Treatment of patients with nonsevere and severe coronavirus disease 2019: an evidence-based guideline. CMAJ. 2020;192:E536-45. 32350002. ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/ACPJ202007210-004
更新日期:2020-07-21 00:00:00
abstract:BACKGROUND:Introduction of a universal varicella vaccine program for U.S. children in 1996 sparked concern that less-frequent exposure to varicella would decrease external boosting of immunity to varicella zoster virus and thereby increase incidence of herpes zoster (HZ). OBJECTIVE:To determine whether the varicella v...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-159-11-201312030-00006
更新日期:2013-12-03 00:00:00
abstract:STUDY OBJECTIVE:To determine the safety of withholding anticoagulant therapy in pregnant patients with clinically suspected deep-vein thrombosis who have negative results by serial impedance plethysmography. DESIGN:Prospective study evaluating prognosis by long-term follow-up to 3 months postpartum in all patients. S...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-112-9-663
更新日期:1990-05-01 00:00:00
abstract:BACKGROUND:Posttransplantation acute renal failure (ARF) occurs in roughly 25% of recipients of organs from deceased donors. Inflammation in the donor organ is associated with risk for ARF. OBJECTIVE:To determine whether administering corticosteroids to deceased organ donors reduces the incidence and duration of ARF i...
journal_title:Annals of internal medicine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.7326/0003-4819-153-4-201008170-00003
更新日期:2010-08-17 00:00:00
abstract::Folate deficiency is a frequent cause of anemia in alcoholics, but little attention has been paid to its prevention. Folic acid was readily soluble in wines of high ethanol content at concentrations of 10 microgram/ml. Lactobacillus casei folate activity of folic acid added to wines was well maintained during a month'...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.7326/0003-4819-87-5-542
更新日期:1977-11-01 00:00:00
abstract:OBJECTIVE:To assess the effectiveness of housestaff physician reporting as a method for identifying adverse events on a medical service and to compare the physician reporting mechanism with a retrospective record review mechanism. SETTING:Medical service of an urban, university-affiliated teaching hospital. DESIGN:Co...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-119-5-199309010-00004
更新日期:1993-09-01 00:00:00
abstract:PURPOSE:To develop a clinical perspective on bilateral massive adrenal hemorrhage and an algorithm for its diagnosis and treatment. DATA IDENTIFICATION:Case reports were identified through a computer search using MEDLIN (1976 to 1987), and from bibliographies in review articles (up to 1978). STUDY SELECTION:Twelve re...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-110-3-227
更新日期:1989-02-01 00:00:00
abstract:BACKGROUND:Hyperuricemia is associated with risk for cardiovascular disease and death. However, the role of uric acid independent of established risk factors is uncertain. OBJECTIVE:To examine the relation of serum uric acid level to incident coronary heart disease, death from cardiovascular disease, and death from al...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-131-1-199907060-00003
更新日期:1999-07-06 00:00:00
abstract:BACKGROUND:Tobacco use is the leading cause of preventable death in the United States. PURPOSE:To review the effectiveness and safety of pharmacotherapy and behavioral interventions for tobacco cessation. DATA SOURCES:5 databases and 8 organizational Web sites were searched through 1 August 2014 for systematic review...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/M15-0171
更新日期:2015-10-20 00:00:00
abstract:BACKGROUND:Injection insulin therapy is not readily accepted by patients and many health care providers; therefore, less invasive options for insulin therapy are desirable. PURPOSE:To examine the efficacy, safety, and patient acceptability of inhaled insulin therapy in nonpregnant adults with diabetes mellitus. DATA ...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析
doi:10.7326/0003-4819-145-9-200611070-00009
更新日期:2006-11-07 00:00:00
abstract:OBJECTIVE:To evaluate the amount of variation in in-hospital mortality and length of intensive care unit (ICU) stay that can be accounted for by clinical data available at ICU admission. DESIGN:Inception cohort study. SETTING:Forty-two ICUs in 40 hospitals, including 26 hospitals that were randomly selected and 14 la...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章
doi:10.7326/0003-4819-118-10-199305150-00001
更新日期:1993-05-15 00:00:00
abstract::In addition to gonorrhea and syphilis, both of which may develop primarily at anorectal or pharyngeal sites, a number of conditions, including Neisseria meningitidis urethritis, nonspecific urethritis, anorectal herpes, condyloma acuminatum, amebiasis, giardiasis, shigellosis, typhoid fever, enterobiasis, and hepatiti...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-92-6-805
更新日期:1980-06-01 00:00:00
abstract::Under the current system of disability determination and workers' compensation for occupational lung disease, disabled workers or their survivors can reasonably count on being compensated. However, by rejecting established scientific truth in order to pay workers' compensation in circumstances where disability or deat...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-97-6-908
更新日期:1982-12-01 00:00:00
abstract:OBJECTIVE:To evaluate the 6-month change in cardiovascular (coronary heart disease) risk as a function of diet and drug therapy for mild hypertension. DESIGN:Collaborative randomized, controlled clinical trial to assess the efficacy of alternative regimens in treating mild hypertension. SETTING:Three university-based...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.7326/0003-4819-112-2-89
更新日期:1990-01-15 00:00:00
abstract:PURPOSE:To review the clinical use of noninvasive positive pressure ventilation, including its efficacy with acute and chronic forms of respiratory failure, its mechanism of action, and its implementation. DATA SOURCES:Studies were identified through a MEDLINE search using the key words respiratory failure and mechani...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-120-9-199405010-00008
更新日期:1994-05-01 00:00:00
abstract::Type 2 diabetes mellitus is a metabolic disease of carbohydrate metabolism. However, it should also be considered a vascular disease because diabetic patients have a strong predilection for atherosclerosis. With the increasing prevalence and earlier age at onset of diabetes, the projected effect of diabetes on cardiov...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-139-10-200311180-00010
更新日期:2003-11-18 00:00:00
abstract::With the renewed interest in esophageal motility disorders, diffuse esophageal spasm is being diagnosed more frequently. In many clinical settings, however, the term is used as a synonym for noncardiac chest pain. Our review of the literature and broad clinical experience in studying the motility patterns of healthy s...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-100-2-242
更新日期:1984-02-01 00:00:00
abstract:BACKGROUND:Many constituents of fruits and vegetables may reduce the risk for coronary heart disease, but data on the relationship between fruit and vegetable consumption and risk for coronary heart disease are sparse. OBJECTIVE:To evaluate the association of fruit and vegetable consumption with risk for coronary hear...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-134-12-200106190-00010
更新日期:2001-06-19 00:00:00