A review of secukinumab in psoriasis treatment

Immunotherapy ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 201-216
Author(s):  
Scott H Berg ◽  
Esther A Balogh ◽  
Rima I Ghamrawi ◽  
Steven R Feldman
Keyword(s):  
Psoriatic Arthritis ◽  
Severity Index ◽  
European Medicines Agency ◽  
Real World Data ◽  
Igg1 Monoclonal Antibody ◽  
Pubmed Database ◽  
The Us ◽  
Human Igg1 ◽  
Us Fda

Psoriasis is a systemic immunologic disorder associated with decreased quality of life and numerous co-morbidities, including psoriatic arthritis and cardiovascular disease. Secukinumab, a fully human IgG1 monoclonal antibody, selectively binds IL-17A and is approved by the US FDA and European Medicines Agency for moderate-to-severe plaque psoriasis and psoriatic arthritis. This review examines the efficacy and safety of secukinumab for the treatment of psoriasis using the literature retrieved from the PubMed database. In clinical trials, treatment with secukinumab led to rapid and sustained improvement in Psoriasis Area and Severity Index (PASI) scores, with PASI 90 response rates up to 68.5% at 5 years. Long-term clinical trial and real-world data have established secukinumab as a safe and effective treatment for psoriasis.

An updated review of infliximab biosimilar, CT-P13, in the treatment of immune-mediated inflammatory diseases

Immunotherapy ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 609-623
Author(s):  
Seung Wook Hong ◽  
Yong-Gil Kim ◽  
Byong Duk Ye
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Real World ◽  
Inflammatory Diseases ◽  
European Medicines Agency ◽  
Immune Mediated ◽  
The Us ◽  
Us Fda ◽  
The Cost

The introduction of anti-TNFs, such as infliximab (IFX), has revolutionized the treatment of immune-mediated inflammatory diseases. Anti-TNF agents have shown outstanding efficacy and long-term improvement of clinical outcomes, but the cost has been relatively high. Out of this concern, several ‘biosimilar’ drugs of anti-TNF agents have been developed. CT-P13, the first biosimilar of reference IFX, was approved by the European Medicines Agency and licensed by the US FDA for use in all indications of IFX. This updated review summarizes all aspects of CT-P13, including pharmacology and pharmacokinetics, and evaluates its efficacy, safety and immunogenicity for all indications based on the results of the latest clinical trials as well as on real-world experiences.

scholarly journals Formaldehyde Reacts with Amino Acids and Peptides with a Potential Role in Acute Methanol Intoxication

2020 ◽  
Vol 44 (8) ◽  
pp. 880-885 ◽  
Author(s):  
David Sýkora ◽  
Jindřich Jindřich ◽  
Vladimír Král ◽  
Milan Jakubek ◽  
Ameneh Tatar ◽  
...  
Keyword(s):  
Amino Acids ◽  
High Resolution ◽  
High Resolution Mass Spectrometry ◽  
Cytotoxic T Lymphocyte ◽  
Mass Shift ◽  
Biologically Relevant ◽  
Igg1 Monoclonal Antibody ◽  
Human Igg1 ◽  
And Function

Abstract Methanol, an aliphatic alcohol widely used in the industry, causes acute and chronic intoxications associated with severe long-term health damage, including permanent visual impairment, brain damage, mainly necrosis of the basal ganglia and high mortality due to cancer. However, the role of formaldehyde, an intermediate metabolite of methanol oxidation, in methanol toxicity remains unclear. Thus, we studied the reactivity of several amino acids and peptides in the presence of formaldehyde by identifying products by direct infusion electrospray high-resolution mass spectrometry (MS) and matrix-assisted laser desorption-ionization MS. Cysteine, homocysteine and two peptides, CG and CGAG, provided cyclic products with a +12 amu mass shift with respect to the original compounds. The proposed structures of the products were confirmed by high-resolution tandem MS. Moreover, the formation of the products with +12 amu mass shift was also shown for two biologically relevant peptides, fragments of ipilimumab, which is a human IgG1 monoclonal antibody against cytotoxic T-lymphocyte-associated protein 4. Overall, our experimental results indicate that formaldehyde reacts with some amino acids and peptides, yielding covalently modified structures. Such chemical modifications may induce undesirable changes in the properties and function of vital biomolecules (e.g., hormones, enzymes) and consequently pathogenesis.

scholarly journals Extended storage of SARS-CoV-2 nasopharyngeal swabs does not negatively impact results of molecular-based testing across three clinical platforms

2020 ◽  
pp. jclinpath-2020-206738
Author(s):  
Karin A Skalina ◽  
D Y Goldstein ◽  
Jaffar Sulail ◽  
Eunkyu Hahm ◽  
Momka Narlieva ◽  
...  
Keyword(s):  
Real World ◽  
Nasopharyngeal Swab ◽  
Molecular Testing ◽  
Clinical Tests ◽  
Ambient Conditions ◽  
Long Term Stability ◽  
The Us ◽  
Us Fda ◽  
World Environment

With the global outbreak of COVID-19, the demand for testing rapidly increased and quickly exceeded the testing capacities of many laboratories. Clinical tests which receive CE (Conformité Européenne) and Food and Drug Administration (FDA) authorisations cannot always be tested thoroughly in a real-world environment. Here we demonstrate the long-term stability of nasopharyngeal swab specimens for SARS-CoV-2 molecular testing across three assays recently approved by the US FDA under Emergency Use Authorization. This study demonstrates that nasopharyngeal swab specimens can be stored under refrigeration or even ambient conditions for 21 days without clinically impacting the results of the real-time reverse transcriptase-PCR testing.

scholarly journals UHPLC–MS/MS method for iohexol determination in human EDTA and lithium-heparin plasma, human urine and in goat- and pig EDTA plasma

Bioanalysis ◽  
2020 ◽  
Vol 12 (14) ◽  
pp. 981-990
Author(s):  
Jasper Stevens ◽  
Mireille A Wessels ◽  
Jan Roggeveld ◽  
Remco A Koster ◽  
Claire CJ Dekkers ◽  
...  
Keyword(s):  
Human Urine ◽  
Pharmacokinetic Profile ◽  
European Medicines Agency ◽  
Simple Method ◽  
The Us ◽  
Heparin Plasma ◽  
Thermo Fisher Scientific ◽  
Tandem Quadrupole Mass Spectrometer ◽  
Edta Plasma ◽  
Us Fda

Aim: Iohexol plasma clearance is used as an indicator of kidney function in clinical and preclinical settings. To investigate the pharmacokinetic profile of iohexol, a rapid, simple method for measurement of iohexol in different matrices and species was needed. Materials & methods: Iohexol was separated on an Accucore C18 column (Thermo Fisher Scientific, CA, USA). Detection was performed on a Thermo Scientific Quantiva tandem quadrupole mass spectrometer. The method was validated according to the requirements for bioanalytical methods issued by the US FDA and European Medicines Agency. Conclusion: We developed and validated a fast and efficient analytical method, suitable for analyzing iohexol in human EDTA plasma, human lithium-heparin plasma, human urine and goat- and pig EDTA plasma, using only one calibration line prepared in human EDTA plasma.

Psoriatic Nail Disease: Quality of Life and Treatment

2009 ◽  
Vol 13 (5_suppl) ◽  
pp. S102-S106 ◽  
Author(s):  
Aditya K. Gupta ◽  
Elizabeth A. Cooper
Keyword(s):  
Quality Of Life ◽  
Psoriatic Arthritis ◽  
Plaque Psoriasis ◽  
Large Scale ◽  
Severity Index ◽  
Biologic Therapies ◽  
Nail Psoriasis ◽  
Psoriatic Nail Disease

Nail psoriasis is common among patients with plaque psoriasis or psoriatic arthritis and has a detrimental effect on quality of life. However, there are currently no standardized therapeutic regimens for nail psoriasis. Traditional treatments for nail psoriasis, which include topical, intralesional, and oral therapies, may be time-consuming, painful, or unsafe when administered long term. Biologic therapies have demonstrated efficacy for plaque psoriasis and psoriatic arthritis; these therapies may be particularly promising for the treatment of nail psoriasis as both groups of patients have an elevated incidence of nail dystrophy. The biologic therapies adalimumab, alefacept, efalizumab, etanercept, and infliximab have demonstrated clinically important nail psoriasis improvements using the Nail Psoriasis Severity Index, a helpful tool that, upon validation, will allow comparison across treatments and trials. Large-scale, long-term trials using standardized outcome measures are needed to further evaluate biologic therapies for the treatment of nail psoriasis.

scholarly journals Structural and Functional Characterization of Low-molecular-weight Heparins: Impact on the Development of Guidelines for Generic Products

2009 ◽  
Vol 15 (2) ◽  
pp. 137-144 ◽  
Author(s):  
Cafer Adiguzel ◽  
Walter P. Jeske ◽  
Debra Hoppensteadt ◽  
Jeanine M. Walenga ◽  
Vinod Bansal ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Functional Characterization ◽  
Current Data ◽  
European Medicines Agency ◽  
Low Molecular Weight ◽  
Low Molecular Weight Heparins ◽  
Biological Drugs ◽  
Biologic Drugs ◽  
The Us ◽  
Us Fda

Low-molecular-weight heparins (LMWHs) are poly-pharmacologic drugs used to treat thrombotic and cardiovascular disorders. Recently, several generic versions of branded LMWHs have been introduced. Although generic versions of LMWHs exhibit similar profiles, marked differences in their biological and pharmacologic properties have been demonstrated. Several studies have demonstrated differences in terms of anti-Xa activity and tissue factor pathway inhibitor release. The current data emphasize the need to consider multiple functional parameters when defining bioequivalence of biologic drugs and also underscore the importance of further pharmacologic studies involving animal and human clinical trials. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are currently developing guidelines for the acceptance of complex biological drugs including LMWHs. The US FDA considers these drugs as follow-on agents whereas the EMEA classifies these drugs as biosimilar agents. Until clear guidelines are developed, generic interchange of LMWHs may not be feasible.

scholarly journals Estimated Cancer Risks Associated with Nitrosamine Contamination in Commonly Used Medications

2021 ◽  
Vol 18 (18) ◽  
pp. 9465
Author(s):  
Kate Li ◽  
Karin Ricker ◽  
Feng C. Tsai ◽  
ChingYi J. Hsieh ◽  
Gwendolyn Osborne ◽  
...  
Keyword(s):  
Environmental Protection Agency ◽  
Animal Species ◽  
Protection Agency ◽  
Cancer Risks ◽  
The Us ◽  
Treatment Of Hypertension ◽  
Us Fda

Many nitrosamines are potent carcinogens, with more than 30 listed under California’s Proposition 65. Recently, nitrosamine contamination of commonly used drugs for treatment of hypertension, heartburn, and type 2 diabetes has prompted numerous Food and Drug Administration (FDA) recalls in the US. These contaminants include the carcinogens NDMA (N-nitrosodimethylamine) and NDEA (N-nitrosodiethylamine) and the animal tumorigen NMBA (N-nitroso-N-methyl-4-aminobutyric acid). NMBA and NDEA are metabolically and/or structurally related to NDMA, an N-nitrosomethyl-n-alkylamine (NMA), and 12 other carcinogenic NMAs. These nitrosamines exhibit common genotoxic and tumorigenic activities, with shared target tumor sites amongst chemicals and within a given laboratory animal species. We use the drug valsartan as a case study to estimate the additional cancer risks associated with NDMA and NDEA contamination, based on nitrosamine levels reported by the US FDA, cancer potencies developed by California’s Proposition 65 program and the US Environmental Protection Agency (EPA), and specific exposure scenarios. These estimates suggest that nitrosamine contamination in drugs that are used long-term can increase cancer risks and pose a serious concern to public health.

scholarly journals Long-term effectiveness and safety of infliximab, golimumab and ustekinumab in patients with psoriatic arthritis from a Canadian prospective observational registry

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e036245 ◽  
Author(s):  
Proton Rahman ◽  
Regan Arendse ◽  
Majed Khraishi ◽  
Dalton Sholter ◽  
Maqbool Sheriff ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Survival Rates ◽  
Severity Index ◽  
Biologic Treatment ◽  
Psoriasis Area Severity Index ◽  
Link Type ◽  
Over Time ◽  
Disease Parameters

ObjectivesThe objectives of this study were to describe the demographic profile and baseline disease characteristics of patients with psoriatic arthritis (PsA) treated with either infliximab (IFX), subcutaneous golimumab (GLM) or ustekinumab (UST) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety.MethodsPatients with PsA were enrolled into the Biologic Treatment Registry Across Canada registry (ClinicalTrials.gov Identifier: NCT00741793) from 2005 to 2017. The study visits occurred at study enrolment (baseline) and every 6 months thereafter. Effectiveness was assessed by changes in disease parameters (joint counts, Psoriasis Area Severity Index (PASI), Health Assessment Questionnaire, patient/physician global, minimal disease activity, enthesitis, dactylitis, erythrocyte sedimentation rate, C reactive protein). Improvements from baseline were explored with the paired t-test and the McNemar’s test. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates.ResultsA total of 111 IFX-treated, 281 GLM-treated and 70 UST-treated patients were enrolled. Most baseline disease parameters remained similar over time in all three cohorts. UST-treated patients had lower mean baseline Disease Activity Score in 28 joints CRP, swollen joint based on 28 joints and higher PASI compared with patients treated with GLM. Treatment with IFX, GLM and UST was associated with significant improvements in all disease parameters over time (p<0.001) from baseline up to 84, 84 and 40 months, respectively.AEs were reported for 74.8%, 69.8% and 52.9% (138, 114 and 115 events/100 patient-years (PYs)) covering 325, 567 and 87 years of exposure for IFX-treated, GLM-treated and UST-treated patients, respectively. Severe AEs were reported in 19.8%, 8.5% and 5.7% (8.8, 7.2 and 8.0 events/100 PYs) in IFX-treated, GLM-treated and UST-treated patients, respectively. The proportion of patients who discontinued treatment were 63.1%, 50.9% and 50.0%, respectively.ConclusionsIFX, GLM and UST treatment significantly reduced disease activity and improved functionality in patients with PsA followed by routine clinical practice and had a safety profile similar to that previously reported in the literature.Trial registration numberNCT00741793.

3D printing in spine surgery: current and future applications

2021 ◽  
Author(s):  
Umar F Samdani ◽  
Steven W Hwang
Keyword(s):  
3D Printing ◽  
Spine Surgery ◽  
3D Models ◽  
Patient Specific ◽  
Spine Deformity ◽  
Medical Field ◽  
The Us ◽  
Us Fda ◽  
Term Data

The revolutionary technology of 3D printing has gained traction in the medical field in recent years; spine surgery has in particular seen major advances in 3D printing. The applications of this technology have grown from utilizing 3D models to enhance patient education to patient specific, highly detailed intraoperative anatomical molds. However, obstacles remain that prevent the widespread utilization of 3D printing in spine surgery such as cost, time consumption, lack of long-term data, and regulation by the US FDA. Despite these obstacles, it is evident that 3D printing will be utilized to optimize preoperative, intraoperative, and postoperative care of patients with spine deformity. The purpose of this review is to establish the applications of 3D printing for spine surgery.

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