Abstract:
WHAT IS KNOWN AND OBJECTIVE:SB5 is a biosimilar to the reference adalimumab (ADL) currently in development. The primary study objective was to demonstrate pharmacokinetic (PK) equivalence of SB5 to European Union-sourced adalimumab (EU-ADL), and United States-sourced adalimumab (US-ADL) in healthy subjects. Safety, tolerability and immunogenicity were also assessed as secondary objectives. METHODS:In this phase I, single-blind trial, 189 healthy volunteers were randomized to a single 40 mg dose of SB5, EU-ADL or US-ADL and PK was evaluated for 71 days afterwards. Serum adalimumab concentrations were measured using an enzyme-linked immunosorbent assay (ELISA) test. PK parameters were calculated based on actual sampling times relative to dosing and non-compartmental analysis methods, and equivalence was determined using predefined margins of 0.8-1.25. RESULTS AND DISCUSSION:Baseline characteristics and demographics were comparable between the three groups. Mean values of area under the concentration-time curve from time zero to infinity (AUCinf ), maximum serum concentration (Cmax ) and AUC from time zero to the last quantifiable concentration (AUClast ) were similar between groups, and 90% confidence interval for these parameters were within the predefined equivalence margins for all pairwise comparisons. No discontinuations due to treatment-emergent adverse events (TEAEs) or deaths were reported. Number and kind of TEAEs were comparable between the three groups and considered mild to moderate. The incidence of subjects with antidrug antibodies (ADA) and the overall incidence of neutralizing antibody (NAb) were comparable across the three groups. WHAT IS NEW AND CONCLUSION:The PK of SB5 was equivalent to that of EU-ADL and US-ADL. SB5 was well tolerated with similar safety and immunogenicity profile to EU-ADL and US-ADL.
journal_name
J Clin Pharm Therjournal_title
Journal of clinical pharmacy and therapeuticsauthors
Shin D,Lee Y,Kim H,Körnicke T,Fuhr Rdoi
10.1111/jcpt.12583subject
Has Abstractpub_date
2017-12-01 00:00:00pages
672-678issue
6eissn
0269-4727issn
1365-2710journal_volume
42pub_type
杂志文章,随机对照试验abstract::Although acetylsalicylic acid is prescribed for a broad range of diseases, it can induce a wide array of clinically recognized hypersensitivity reactions, including aspirin-intolerant asthma (AIA) with rhinitis and aspirin-intolerant urticaria (AIU) with anaphylaxis. Altered eicosanoid metabolism is the generally acce...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2710.2008.00961.x
更新日期:2008-10-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Rituximab, an anti-CD20 monoclonal antibody, is widely used with good response for the treatment of B-cell lymphoma and various refractory autoimmune diseases. Although rituximab is effective, rare but serious pulmonary adverse reactions have been reported. We report on a case of rituximab-i...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12052
更新日期:2013-06-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:The HbA1C marker used in assessing diabetes control quality is not sufficient in diabetes patients with thalassaemia. CASE DESCRIPTION:A male diabetic patient with thalassaemia was hospitalized due to distal neuropathic pain, right toe trophic ulcer, unacceptable five-point glycaemic profil...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,评审
doi:10.1111/jcpt.13073
更新日期:2020-04-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Anti-tuberculosis drug-induced liver injury (ATLI) is one of the most significant adverse reactions for this line of therapy. N-acetyltransferase 2 (NAT2) is an important metabolic enzyme involved in drug metabolism and detoxification. Genetic polymorphism and DNA methylation have been prove...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.13097
更新日期:2020-06-01 00:00:00
abstract::Enalapril was shown to have no effect on the serum potassium of patients (n = 16) already taking Frusemide and Amiloride. Furthermore, there was no difference in serum potassium levels of the group taking a combination of Enalapril, Frusemide and Amiloride when compared to a similar group of patients taking Frusemide ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1987.tb00543.x
更新日期:1987-10-01 00:00:00
abstract:PURPOSE:To estimate the prevalence of potentially severe drug-drug interactions (DDIs) and their relationship with age, sex and number of prescribed drugs. METHODS:We analysed all prescriptions dispensed from 1 January 2003 to 31 December 2003 to individuals aged 65 or more registered under the Local Health Authority ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2009.01021.x
更新日期:2009-08-01 00:00:00
abstract::An imbalance of oxidative-antioxidant defence mechanism has been proposed in systemic lupus erythematosus patients. Co-administration of N-acetylcysteine (NAC) which has a strong antioxidant activity may produce a satisfactory therapeutic outcome when added to standard therapy. We report a case of a 46-year-old lupus ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2710.2009.01108.x
更新日期:2010-08-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:6-Cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone (ciclopirox) and specifically its olamine salt 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone 2-aminoethanol salt (ciclopirox olamine) are anti-fungal agents currently used for the treatment of mild to moderate cutaneous fungal infection. Our ob...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2010.01172.x
更新日期:2011-04-01 00:00:00
abstract::The effects of age and co-medication on steady-state phenobarbital (PB) level-dose (L/D) ratios were evaluated retrospectively in 539 paediatric patients. The PB L/D ratio increased significantly with age up to 15 years. Associated anti-epileptic therapy affected the PB L/D ratio, which was significantly increased in ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1992.tb01301.x
更新日期:1992-08-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Patients suffering from renal dysfunction often have multiple medical conditions either as a cause or as a consequence of their renal disease. These patients receive an average of 10-12 medications daily leading to complex dosing schedules and are more likely to develop medication-related pr...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2011.01266.x
更新日期:2011-08-01 00:00:00
abstract:OBJECTIVE:The quality of 33 formulations of essential antimicrobial and antimalarial drugs (amoxicillin capsules, metronidazole tablets, sulfamethoxazole/trimethoprim tablets, quinine tablets and sulphadoxine/pyrimethamine tablets) marketed in Rwanda and Tanzania was assessed and the influence of tropical storage condi...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2004.00568.x
更新日期:2004-08-01 00:00:00
abstract::A number of drugs have been reported to cause neuromuscular blockade and/or to increase weakness in myasthenia gravis. We report on two patients, treated with felodipine and nifedipine for arterial hypertension, who presented with an exacerbation of their myasthenia gravis and a myasthenic syndrome or exacerbation of ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1046/j.1365-2710.1998.00172.x
更新日期:1998-10-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:With the ageing of the population also comes increasing comorbidities and the use of multiple medications and administration methods, along with greater susceptibility to adverse drug reactions. Dosage form modification to facilitate drug administration in older adults can be potentially pro...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12822
更新日期:2019-08-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Linezolid, a member of the oxazolidinone class of antibacterial drugs, is approved by the US Food and Drug Administration (FDA) for the treatment of vancomycin-resistant Enterococcus faecium infections, nosocomial and community-acquired pneumonia, as a part of anti tubercular regimen and com...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type:
doi:10.1111/jcpt.13069
更新日期:2020-04-01 00:00:00
abstract::Midazolam concentration curves versus time were analysed in 10 otherwise healthy patients (ASA I-II) with inferior limb pathologies. The benzodiazepine was used as an adjuvant agent to epidural anaesthesia in view of its lower residual effect compared with other intravenous benzodiazepines. Midazolam pharmacokinetics...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1991.tb00306.x
更新日期:1991-06-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Drug prescribing is an essential part of inpatient care, and prescription errors/omissions have the potential to lead to disastrous consequences. Paediatric inpatient prescribing is particularly sensitive to error due to the weight-adjusted dosing of many medications prescribed in the acute ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12114
更新日期:2014-02-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Pulmonary sarcomatoid carcinoma (PSC) is characterized by dismal prognosis and resistance to platinum-based chemotherapy. The immune checkpoint inhibitors showed promising efficacy in the treatment of PSC. Camrelizumab is a programmed cell death protein 1 inhibitor; however, current evidence...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type:
doi:10.1111/jcpt.13234
更新日期:2020-12-01 00:00:00
abstract::The bioequivalence of a 600-mg methocel tablet containing buflomedil hydrochloride in sustained-release form was determined relative to a 300-mg CAP/carbovax-coated tablet of buflomedil hydrochloride in immediate-release form. The tablets were given to 20 patients in a double-blind placebo-controlled clinical study wi...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1365-2710.1994.tb01121.x
更新日期:1994-04-01 00:00:00
abstract:PURPOSE:Empirical use of intravenous (IV) itraconazole (ITZ) for febrile neutropenic patients has recently been introduced in Korea. This study was designed to investigate the population pharmacokinetics (PK) of IV-ITZ. METHODS:Sparse PK data were collected from febrile neutropenic patients undergoing empirical ITZ th...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2008.00999.x
更新日期:2009-06-01 00:00:00
abstract::The extent and factors that influence drug use were studied in two rural cohorts of Finnish men. The men aged between 65 and 84 years belonged to the Finnish study population of the 25-year follow-up of the 'Seven Countries Study'. Of the original 1,711 men in 1959, 766 were still alive in 1984. The participation rate...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1990.tb00365.x
更新日期:1990-04-01 00:00:00
abstract::Mean values and standard deviations are reported for theophylline plasma clearance in 45 hospitalized geriatric patients (age greater than 65 years), distributed into two groups: Group I (n = 24) included critically ill patients admitted to the ICU on total parenteral nutrition (TPN). Group II (n = 21) included patien...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1990.tb00385.x
更新日期:1990-08-01 00:00:00
abstract::The stability and compatibility of anakinra (recombinant human interleukin-1 receptor antagonist) with ceftriaxone sodium in 0.9% sodium chloride or 5% dextrose injection was determined during a 4-h period at ambient room temperature and light. Anakinra was diluted in 0.9% sodium chloride or 5% dextrose to the concent...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1046/j.1365-2710.1997.95275952.x
更新日期:1997-06-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Massive acute arsenic poisoning is rare yet potentially life-threatening. 2,3-dimercaptopropane-1-sulphonate (DMPS) appears to have the appropriate chelating property. However, clinical experience on the use of DMPS in massive arsenic poisoning is limited. CASE DESCRIPTION:A 37-year-old wom...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type:
doi:10.1111/jcpt.12538
更新日期:2017-08-01 00:00:00
abstract::Drug-induced parotitis is a relatively uncommon adverse drug reaction. Most of the data on drug-induced parotitis consist of isolated case reports with few attempts at rechallenge to confirm the aetiology. Phenylbutazone and oxyphenbutazone have a significant number of reports suggesting that these drugs may be implic...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2710.1993.tb00584.x
更新日期:1993-08-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Antiviral medications cost-effectively reduce influenza-related morbidity and potentially mortality. We sought to assess the appropriateness of antiviral prescribing for influenza. METHOD:We performed a retrospective analysis of visits by adults to primary care clinics during influenza seasons...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2006.00731.x
更新日期:2006-06-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Antituberculosis drug-induced liver injury (ATLI) is a serious adverse drug reaction, and its pathogenic mechanism is still largely unknown. Rifampin (RIF) has been reported to cause haemolysis due to the production of drug-dependent antibodies, and haemolysis results in an increased level o...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.13139
更新日期:2020-08-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Based on extrapolation, biosimilar infliximab (IFX) was approved to treat inflammatory bowel disease (IBD). The first studies in adults have shown similar efficacy and safety in comparison with reference drug. The aim of this review was to collect and evaluate all the literature data regardi...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,评审
doi:10.1111/jcpt.13239
更新日期:2020-12-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Nephrotoxicity is a recognized side effect of cisplatin chemotherapy. However, the optimal strategy for preventing cisplatin-induced nephrotoxicity, if any, remains unclear. The primary objective for this study was to determine whether mannitol or furosemide provides better nephroprotection ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12509
更新日期:2017-06-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:In order to improve public health, it is necessary to facilitate patients' easy access to affordable high-quality primary health care, and one enhanced approach to do so may be to provide primary healthcare services in the community pharmacy setting. Discrete choice experiments to evaluate p...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12574
更新日期:2017-12-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Colchicine is an anti-inflammatory agent used primarily in treatment of gout and familial Mediterranean fever. Toxicity is uncommon, and depends on dose, hepatic or renal impairment, co-administration with P-glycoprotein or CYP3A4 inhibitors and route of administration. In patients taking p-...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12047
更新日期:2013-06-01 00:00:00