Abstract:
INTRODUCTION:Repository corticotropin injection (RCI; H.P. Acthar® Gel; Mallinckrodt Pharmaceuticals Inc., Hampton, NJ) is a highly purified, prolonged-release porcine preparation of adrenocorticotropic hormone (ACTH) analogue that is FDA-approved for treatment of 19 autoimmune and inflammatory disorders. The diverse physiological actions of RCI at the melanocortin receptors (MCRs) affect processes involved in inflammation, pigmentation, steroidogenesis, and immunomodulation. Although RCI has been approved to treat inflammatory and autoimmune diseases for more than 60 years, recent progress in understanding both MCRs and the effects of RCI in modulating immune responses has led to increased interest in RCI as a therapeutic choice. The objective of this narrative literature review is to summarize key clinical and economic data on RCI treatment of seven disorders: infantile spasms (IS), multiple sclerosis (MS) relapses, proteinuria in nephrotic syndrome, rheumatoid arthritis (RA), dermatomyositis/polymyositis (DM/PM), systemic lupus erythematosus (SLE), and symptomatic sarcoidosis based on published literature and product information. An extended report is available as the Academy of Managed Care Pharmacy (AMCP) Formulary dossier for H.P. Acthar® Gel. METHODS:Key studies of clinical efficacy and healthcare utilization and cost from 1956 to 2016 are summarized. RESULTS:The evidence supports the efficacy of RCI across the seven indications. RCI is effective as a first-line therapy for IS. For the other six conditions, RCI may improve clinical outcomes during exacerbations or when the condition is resistant to conventional treatments. Use of RCI is associated with reduced use of biologics, corticosteroids, and disease-modifying antirheumatic drugs. Initiation of RCI therapy in patients with IS, MS, RA, SLE, or DM/PM has been associated with lower post-therapy healthcare utilization and medical costs, including decreases in hospitalizations, hospital length of stay, outpatient visits, and emergency department visits. CONCLUSION:The evidence suggests that RCI may improve inflammatory and autoimmune disease control and patient quality of life, particularly in complex patients, and yield healthcare cost savings that demonstrate the medicine's value. FUNDING:Mallinckrodt Pharmaceuticals Inc.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Philbin M,Niewoehner J,Wan GJdoi
10.1007/s12325-017-0569-9subject
Has Abstractpub_date
2017-08-01 00:00:00pages
1775-1790issue
8eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-017-0569-9journal_volume
34pub_type
杂志文章,评审abstract:INTRODUCTION:To determine patient and rheumatologist preferences for rheumatoid arthritis (RA) treatment attributes in Spain and to evaluate their attitude towards shared decision-making (SDM). METHODS:Observational, descriptive, exploratory and cross-sectional study based on a discrete choice experiment (DCE). To ide...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01258-5
更新日期:2020-04-01 00:00:00
abstract:INTRODUCTION:Acute gastrointestinal bleeding (GIB) is a major cause of death in liver cirrhosis. This multicenter study aims to develop and validate a novel and easy-to-access model for predicting the prognosis of patients with cirrhosis and acute GIB. METHODS:Patients with cirrhosis and acute GIB were enrolled and ra...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-019-01083-5
更新日期:2019-11-01 00:00:00
abstract:INTRODUCTION:The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials. METHODS:Pooled data from 20 trials were analyzed for patients with T2DM treated with emp...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01329-7
更新日期:2020-08-01 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::Coronary heart disease is the major cause of morbidity and mortality in industrialized countries, and its prevalence is predicted to grow as the population ages. Current drugs for chronic stable angina (such as beta-blockers, calcium-channel blockers, long- and short-acting nitrates, and potassium-channel activators) ...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-009-0005-x
更新日期:2009-02-01 00:00:00
abstract:INTRODUCTION:In budesonide/formoterol (Symbicort(R) Turbuhaler(R), AstraZeneca, Lund, Sweden) maintenance and reliever therapy (SMART), patients with asthma take a daily maintenance dose of budesonide/formoterol, with the option of taking additional doses for symptom relief instead of a short-acting beta(2)-agonist (SA...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-009-0063-0
更新日期:2009-09-01 00:00:00
abstract:BACKGROUND:The OPTIMA© (MSD, Courbevoie, France) questionnaire was developed to promote shared decisions and the set-up of specific micro-objectives in clinical practice by optimizing communication between type 2 diabetes (T2DM) patients and their physicians. The present study aimed to assess OPTIMA in clinical practic...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-016-0341-6
更新日期:2016-06-01 00:00:00
abstract:INTRODUCTION:Idiopathic pulmonary fibrosis (IPF) is the classic progressive fibrosing interstitial lung disease (ILD), but some patients with ILDs other than IPF also develop a progressive fibrosing phenotype (PF-ILD). Information on use and cost of healthcare resources in patients with PF-ILD is limited. METHODS:We u...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01380-4
更新日期:2020-07-01 00:00:00
abstract:INTRODUCTION:The purpose of this study was to evaluate the clinical outcomes of patients with anterior segment neovascularization treated with or without intravitreal bevacizumab. METHODS:This was a retrospective, comparative case series of 60 patients with anterior segment neovascularization: 30 consecutive patients ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-009-0001-1
更新日期:2009-02-01 00:00:00
abstract:INTRODUCTION:Benefit and risk of anticoagulation in cirrhotic patients with portal vein thrombosis (PVT) remain controversial, especially in those with asymptomatic PVT and in non-liver transplant candidates. Furthermore, the predictors of portal vein recanalization and bleeding events after anticoagulation are critica...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01550-4
更新日期:2020-11-05 00:00:00
abstract:INTRODUCTION:Vitamin E is one of the most promising agents for nonalcoholic steatohepatitis (NASH) treatment, and its drug responsiveness may be closely associated with haptoglobin (Hp) genotype. However, its efficacy and safety remain unknown in China. This clinical trial of vitamin E versus placebo for the treatment ...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1007/s12325-018-0670-8
更新日期:2018-02-01 00:00:00
abstract:INTRODUCTION:To evaluate the short-term efficacy and safety of intravitreal dexamethasone implant (IDI) in patients with macular oedema associated with diabetic retinopathy (DR) and retinal vein occlusion (RVO) using enhanced-depth image optical coherence tomography (EDI-OCT) and to estimate the effect of dexamethasone...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0848-0
更新日期:2019-02-01 00:00:00
abstract::Patients with acute myeloid leukemia (AML) with the t(8;21) karyotype generally have a favorable clinical course, but key prognostic factors remain poorly defined. This study was conducted to determine the prognoses and treatment outcomes of patients with AML with this unique cytogenetic change. A total of 22 patients...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02849984
更新日期:2007-07-01 00:00:00
abstract::The improvement of glycemic control in patients with type 2 diabetes (T2D) is an urgent need in Asia. East Asian T2D patients have distinct characteristics, including relatively low body weight, early impairment of islet beta cell function with reduced insulin secretion and a marked increase in postprandial blood gluc...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-019-00914-9
更新日期:2019-04-01 00:00:00
abstract::Polycystic ovary syndrome (PCOS) affects 6-10% of women and could be considered one of the most common endocrine alterations in women of reproductive age. The syndrome is characterized by several hormonal and metabolic alterations, including insulin resistance and hyperandrogenism, which play a severe detrimental role...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-018-0810-1
更新日期:2018-11-01 00:00:00
abstract::Bacterial translocation is the passage of bacteria or endotoxins from the gastrointestinal tract to extraintestinal sites, such as mesenteric lymph nodes, liver, spleen, and bloodstream. In this study, the investigators examined the effects of various enteral nutrients on bacterial translocation and intestinal morphol...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02849991
更新日期:2007-01-01 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
abstract:INTRODUCTION:The traditional model of evaluating treatments based primarily on primary outcome measures has stumbled in its application to rare disease. Rare disease clinical trials face the methodological challenges of small, heterogeneous patient populations and relatively few validated, disease-specific outcome meas...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-019-00920-x
更新日期:2019-05-01 00:00:00
abstract:INTRODUCTION:This study of UK patients examines clinical, health-related quality of life (HRQOL) and economic outcomes associated with iron chelation therapy (ICT). Desferrioxamine (DFO) (Desferal; Novartis, Switzerland) and Deferiprone (Ferriprox; Apotex, Canada) are ICTs used to treat iron overload. DFO requires 8-to...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-008-0085-z
更新日期:2008-08-01 00:00:00
abstract:INTRODUCTION:This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with chronic osteoarthritis hip or knee pain or low back pain evaluated t...
journal_title:Advances in therapy
pub_type: 杂志文章,meta分析
doi:10.1007/s12325-014-0128-6
更新日期:2014-06-01 00:00:00
abstract:INTRODUCTION:Tumor necrosis factor (TNF-alpha) inhibitors, such as adalimumab, have shown success in treating autoimmune inflammatory diseases but are associated with substantial financial burdens to the healthcare system. Biosimilars, which are highly similar to biologic agents, offer the potential to reduce the finan...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0851-5
更新日期:2019-02-01 00:00:00
abstract:INTRODUCTION:Anti-vascular endothelial growth factor therapy is the standard of care for neovascular age-related macular degeneration (nAMD). The dosage of two licensed agents, ranibizumab and aflibercept, was established through clinical trials; however, it is unclear if either agent is administered as recommended in ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0624-6
更新日期:2017-12-01 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::Tumor necrosis factor (TNF) inhibitors are widely used biologics for the treatment of several chronic inflammatory diseases. The launch of anti-TNF biosimilars has introduced the possibility of non-medical switching between originator biologics and their biosimilars. However, the potential clinical and patient-reporte...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0742-9
更新日期:2018-09-01 00:00:00
abstract:INTRODUCTION:Little has been published on respiratory syncytial virus (RSV) among Medicare patients at high risk (HR) of RSV complications due to age or comorbidity. METHODS:Adult patients (at least 18 years of age) with at least 1 diagnostic code for RSV were identified using the 5% US Medicare database from 2011 thr...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01230-3
更新日期:2020-03-01 00:00:00
abstract:INTRODUCTION:To evaluate, from the patient's perspective, the burden of pain associated with hip/knee osteoarthritis (OA) in the USA and selected European Union (EU) countries. METHODS:Data were drawn from the 2017 global Adelphi OA Disease Specific Programme™ (DSP). Patients with hip/knee OA were stratified based on ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01445-4
更新日期:2020-09-01 00:00:00
abstract::Diabetic foot ulcers (DFUs) are one of the most common and serious complications of diabetes mellitus, as wound healing is impaired in the diabetic foot. Wound healing is a dynamic and complex biological process that can be divided into four partly overlapping phases: hemostasis, inflammation, proliferative and remode...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-014-0140-x
更新日期:2014-08-01 00:00:00
abstract::Pregnancy in adolescence has been and continues to be a problem in public health. The purpose of this study was to investigate obstetric outcomes of adolescent pregnancies in Samsun, Turkey. A cross-sectional study was conducted between January 1 and December 31, 2004, at 3 hospitals in Samsun, Turkey. Of the 10,100 w...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02849957
更新日期:2005-11-01 00:00:00
abstract:INTRODUCTION:Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01352-8
更新日期:2020-06-01 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