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https://www.readbyqxmd.com/read/27900937/post-authorization-changes-in-the-safety-and-efficacy-assessment-recommended-indications-and-drug-quality-profile-of-adalimumab-a-chronological-overview
#1
Gergely Iványi, Romána Zelkó
OBJECTIVE: The intention of the present study was to demonstrate the postauthorization changes of adalimumab (European trade name: Humira), evaluating the variations in its safety, efficacy, and quality profile. METHODS: Type-II, major variations of the Summary of Product Characteristics (SmPC) from September 8, 2003 to November 19, 2015, were analyzed, which, according to Commission Regulation (EC) No. 1234/2008, have to reflect changes that may have a significant impact on the safety, efficacy, or quality profile of a medicinal product...
November 30, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27883347/-adalimumab-as-induction-therapy-for-crohn-s-disease-one-center-study
#2
Maciej Gonciarz, Aldona Mularczyk, Dawid Szkudłapski, Iwona Piątek, Marek Kopała
: Adalimumab is a subcutaneously administered recombinant fully human monoclonal antibody targeting tumor necrosis factor alpha. It has been approved for use in Poland to treat patients with Crohn's disease under the program of Polish National Health Found since 2010. AIM: The aim of this study was to evaluate the efficacy of adalimumab monotherapy for inducing clinical remission in patients with active Crohn's disease . The primary outcome assessment was the reduction in score to 150 or below on the Crohn's Disease Activity Index (CDAI) at 12 weeks and the secondary one was the reduction in ΔCDAI of at least 100 points...
November 25, 2016: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#3
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
November 19, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27854156/demonstration-of-physicochemical-and-functional-similarity-between-the-proposed-biosimilar-adalimumab-msb11022-and-humira%C3%A2
#4
Laurent Magnenat, Angelo Palmese, Christèle Fremaux, Fabio D'Amici, Mariagrazia Terlizzese, Mara Rossi, Laurent Chevalet
Biosimilars are biological products that are highly similar to existing products approved by health authorities. Demonstration of similarity starts with the comprehensive analysis of the reference product and its proposed biosimilar at the physicochemical and functional levels. Here, we report the results of a comparative analysis of a proposed biosimilar adalimumab MSB11022 and its reference product, Humira®. Three batches of MSB11022 and up to 23 batches of Humira® were analyzed by a set of state-of-the-art orthogonal methods...
November 17, 2016: MAbs
https://www.readbyqxmd.com/read/27845027/clinical-effectiveness-and-cost-effectiveness-of-use-of-therapeutic-monitoring-of-tumour-necrosis-factor-alpha-tnf-%C3%AE-inhibitors-lisa-tracker%C3%A2-enzyme-linked-immunosorbent-assay-elisa-kits-tnf-%C3%AE-blocker-elisa-kits-and-promonitor%C3%A2-elisa-kits-versus-standard-care
#5
Karoline Freeman, Martin Connock, Peter Auguste, Sian Taylor-Phillips, Hema Mistry, Deepson Shyangdan, Rachel Court, Ramesh Arasaradnam, Paul Sutcliffe, Aileen Clarke
BACKGROUND AND OBJECTIVES: Systematic reviews and economic modelling of clinical effectiveness and cost-effectiveness of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [using LISA-TRACKER(®) enzyme-linked immunosorbent assay (ELISA) kits (Theradiag, Marne La Vallee, France, or Alpha Laboratories, Heriot, UK), TNF-α-Blocker ELISA kits (Immundiagnostik AG, Bensheim, Germany) and Promonitor(®) ELISA kits (Proteomika, Progenika Biopharma, Bizkaia, Spain)] versus standard care for Crohn's disease (CD)...
November 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/27813422/bioequivalence-safety-and-immunogenicity-of-bi-695501-an-adalimumab-biosimilar-candidate-compared-with-the-reference-biologic-in-a-randomized-double-blind-active-comparator-phase-i-clinical-study-voltaire%C3%A2-pk-in-healthy-subjects
#6
Christopher Wynne, Mario Altendorfer, Ivo Sonderegger, Lien Gheyle, Rod Ellis-Pegler, Susanne Buschke, Benjamin Lang, Deepak Assudani, Sandeep Athalye, Niklas Czeloth
Background This Phase I study (VOLTAIRE™-PK) aimed to evaluate three-way pharmacokinetic similarity (bioequivalence), safety and immunogenicity of BI 695501 (a Humira® [adalimumab] biosimilar candidate) compared with US- and EU-approved Humira in healthy male subjects. Methods Subjects (N = 327) were randomized 1:1:1 to receive one 40 mg subcutaneous dose of BI 695501, US- or EU-approved Humira; safety was assessed for 70 days. Bioequivalence was evaluated using the average bioequivalence method to test if the 90% confidence intervals (CIs) of the geometric means (BI 695501 versus US- and EU-approved Humira) for the primary endpoints were within pre-specified acceptance ranges (80-125%)...
November 4, 2016: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/27792008/of-patents-and-patent-disputes-the-tnf%C3%AE-patent-files-part-1-humira
#7
Ulrich Storz
This article discusses the patent strategy underlying the world's best selling drug, AbbVie's Humira®. Despite a non-optiimal starting position, AbbVie has established an extensive portfolio to fend off biosimilar competition. This article is the first part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics.
October 21, 2016: Human Antibodies
https://www.readbyqxmd.com/read/27784520/adalimumab-humira-%C3%A2-for-hidradenitis-suppurativa
#8
Aditya K Gupta, Maria Cernea, William Abramovits, Kimberly Dawn Vincent
No abstract text is available yet for this article.
2016: Skinmed
https://www.readbyqxmd.com/read/27665300/adalimumab-a-review-in-hidradenitis-suppurativa
#9
Esther S Kim, Karly P Garnock-Jones, Susan J Keam
Subcutaneous adalimumab (Humira(®)) is a tumour necrosis factor-α blocker that is the only approved agent for the treatment of moderate to severe hidradenitis suppurativa (HS) in several countries worldwide. This article reviews the clinical efficacy and safety of subcutaneous adalimumab in patients with moderate to severe HS. In clinical trials (PIONEER I and II), a greater proportion of adalimumab than placebo recipients reached HS clinical response (HiSCR) at week 12. The main secondary endpoints, such as the proportion of patients with an abscess and inflammatory nodule count of ≤2 at week 12, were significantly greater with adalimumab than with placebo in PIONEER II, but not in PIONEER I...
October 2016: American Journal of Clinical Dermatology
https://www.readbyqxmd.com/read/27598372/utility-of-immunodeficient-mouse-models-for-characterizing-the-preclinical-pharmacokinetics-of-immunogenic-antibody-therapeutics
#10
Maria Myzithras, Tammy Bigwarfe, Hua Li, Erica Waltz, Jennifer Ahlberg, Craig Giragossian, Simon Roberts
Prior to clinical studies, the pharmacokinetics (PK) of antibody-based therapeutics are characterized in preclinical species; however, those species can elicit immunogenic responses that can lead to an inaccurate estimation of PK parameters. Immunodeficient (SCID) transgenic hFcRn and C57BL/6 mice were used to characterize the PK of three antibodies that were previously shown to be immunogenic in mice and cynomolgus monkeys. Four mouse strains, Tg32 hFcRn SCID, Tg32 hFcRn, SCID and C57BL/6, were administered adalimumab (Humira®), mAbX and mAbX-YTE at 1 mg/kg, and in SCID strains there was no incidence of immunogenicity...
September 6, 2016: MAbs
https://www.readbyqxmd.com/read/27476973/comparative-efficacy-and-incremental-cost-per-responder-of-methotrexate-versus-apremilast-for-methotrexate-na%C3%A3-ve-patients-with-psoriasis
#11
April W Armstrong, Keith A Betts, Murali Sundaram, Darren Thomason, James E Signorovitch
BACKGROUND: To our knowledge, no clinical trials directly compare apremilast with methotrexate (the standard of care for initial systemic treatment of psoriasis). OBJECTIVE: We sought to compare apremilast's relative efficacy with that of methotrexate for moderate to severe psoriasis. METHODS: An anchor-based indirect comparison was conducted for 75% improvement in Psoriasis Area and Severity Index score from baseline to week 16 (PASI 75) rates for systemic-naïve patients from Efficacy and Safety Trial Evaluating the Effects of apreMilast in psoriasis (ESTEEM) 1 and 2 (apremilast vs placebo) and Comparative study of HumirA vs...
October 2016: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/27388530/adalimumab-humira-for-the-treatment-of-hidradenitis-suppurativa
#12
A K Gupta, C Studholme
Adalimumab (Humira®) is a novel therapy approved by the US Food and Drug Administration, Health Canada, and the European Commission for the treatment of hidradenitis suppurativa (HS). Results of two Phase III trials of adalimumab demonstrate significantly higher efficacies compared to placebo. Primary efficacy outcome of 50% reduction in abscess and inflammatory nodule count was seen in 41.8% and 58.9% of participants receiving adalimumab in PIONEER I and PIONEER II studies, respectively, showing substantial improvement compared with placebo groups in both trials (26...
July 2016: Skin Therapy Letter
https://www.readbyqxmd.com/read/27285856/comparison-of-the-pharmacokinetics-safety-and-immunogenicity-of-msb11022-a-biosimilar-of-adalimumab-with-humira-%C3%A2-in-healthy-subjects
#13
Elizabeth Hyland, Tim Mant, Pantelis Vlachos, Neil Attkins, Martin Ullmann, Sanjeev Roy, Volker Wagner
AIMS: The aim of the study was to compare the pharmacokinetics (PK), safety and tolerability of the proposed adalimumab biosimilar MSB11022 (Merck) with Humira(®) (AbbVie), sourced from both the US (US reference product [US-RP]) and Europe (European reference medicinal product [EU-RMP]). METHODS: In this phase 1 double-blind, parallel group trial (EMR200588-001), 213 healthy volunteers were randomized 1 : 1 : 1 to receive a single dose (40 mg) of MSB11022, US-RP or EU-RMP in order to achieve 80% power assuming a 5% difference among groups and a 10% dropout rate...
October 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27220829/infliximab-adalimumab-and-golimumab-for-treating-moderately-to-severely-active-ulcerative-colitis-after-the-failure-of-conventional-therapy-including-a-review-of-ta140-and-ta262-clinical-effectiveness-systematic-review-and-economic-model
#14
Rachel Archer, Paul Tappenden, Shijie Ren, Marrissa Martyn-St James, Rebecca Harvey, Hasan Basarir, John Stevens, Christopher Carroll, Anna Cantrell, Alan Lobo, Sami Hoque
BACKGROUND: Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients' quality of life. The burden for the NHS is substantial. OBJECTIVES: To evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities...
May 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/27168265/reduction-in-c-reactive-protein-levels-with-adalimumab-therapy-in-patients-with-moderate-to-severe-hand-and-or-foot-psoriasis
#15
Craig L Leonardi, Kristina Unnebrink, Wendell C Valdecantos
INTRODUCTION: We evaluated post hoc the relationship between Humira<sup>®</sup> (adalimumab) therapy and high-sensitivity C-reactive protein (hs-CRP) levels in patients with moderate-to-severe hand and/or foot psoriasis from the 16-week placebo-controlled period of REACH.<br/> METHODS: REACH was a phase 4, multicenter, randomized, double-blind trial, evaluating adalimumab treatment for patients with psoriasis of the hands and/or feet. Adults were randomized 2:1 to adalimumab 40 mg every other week (following 80 mg at week 0) or matching placebo from weeks 1 to 16, followed by a 12-week, open-label extension...
May 1, 2016: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/27150018/convergent-transcription-of-interferon-stimulated-genes-by-tnf-%C3%AE-and-ifn-%C3%AE-augments-antiviral-activity-against-hcv-and-hev
#16
Wenshi Wang, Lei Xu, Johannes H Brandsma, Yijin Wang, Mohamad S Hakim, Xinying Zhou, Yuebang Yin, Gwenny M Fuhler, Luc J W van der Laan, C Janneke van der Woude, Dave Sprengers, Herold J Metselaar, Ron Smits, Raymond A Poot, Maikel P Peppelenbosch, Qiuwei Pan
IFN-α has been used for decades to treat chronic hepatitis B and C, and as an off-label treatment for some cases of hepatitis E virus (HEV) infection. TNF-α is another important cytokine involved in inflammatory disease, which can interact with interferon signaling. Because interferon-stimulated genes (ISGs) are the ultimate antiviral effectors of the interferon signaling, this study aimed to understand the regulation of ISG transcription and the antiviral activity by IFN-α and TNF-α. In this study, treatment of TNF-α inhibited replication of HCV by 71 ± 2...
2016: Scientific Reports
https://www.readbyqxmd.com/read/27136625/molluscum-contagiosum-of-the-eyelid-case-report-in-a-man-receiving-methotrexate-and-literature-review-of-molluscum-contagiosum-in-patients-who-are-immunosuppressed-secondary-to-methotrexate-or-hiv-infection
#17
Bryce David Beutler, Philip R Cohen
BACKGROUND: Molluscum contagiosum is a benign viral infection of the skin. Lesions typically present as dome-shaped, flesh-colored, umbilicated papules that range in size from 1 to 5 millimeters in diameter. They are usually asymptomatic, but can become tender or pruritic. Children and immunocompromised adults, including individuals being treated with immunosuppressive drugs, are most susceptible to infection. Single or multiple lesions most commonly appear on the extremities, face, genitals, and trunk...
2016: Dermatology Online Journal
https://www.readbyqxmd.com/read/27135404/the-clinical-effectiveness-and-cost-effectiveness-of-abatacept-adalimumab-etanercept-and-tocilizumab-for-treating-juvenile-idiopathic-arthritis-a-systematic-review-and-economic-evaluation
#18
Jonathan Shepherd, Keith Cooper, Petra Harris, Joanna Picot, Micah Rose
BACKGROUND: Juvenile idiopathic arthritis (JIA) is characterised by joint pain, swelling and a limitation of movement caused by inflammation. Subsequent joint damage can lead to disability and growth restriction. Treatment commonly includes disease-modifying antirheumatic drugs (DMARDs), such as methotrexate. Clinical practice now favours newer drugs termed biologic DMARDs where indicated. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of four biologic DMARDs [etanercept (Enbrel(®), Pfizer), abatacept (Orencia(®), Bristol-Myers Squibb), adalimumab (Humira(®), AbbVie) and tocilizumab (RoActemra(®), Roche) - with or without methotrexate where indicated] for the treatment of JIA (systemic or oligoarticular JIA are excluded)...
April 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/27087201/humira-the-impending-patent-battles-over-adalimumab-biosimilars
#19
Peter Norman
The world's top selling drug, adalimumab (AbbVie's Humira), generated sales in excess of US$13 billion in 2015. The primary product patent expires in 2016 in the USA and 2018 in Europe. This has resulted in a rush by companies to develop adalimumab biosimilars and Amgen submitted regulatory filings for its product ABP-501 in late 2015 in both the USA and Europe. AbbVie has claimed its patent portfolio provides product protection until 2022, but an increasing number of patent challenges are being made and the filings for approval of biosimilars will see more challenges made over the next few years...
May 2016: Pharmaceutical Patent Analyst
https://www.readbyqxmd.com/read/27026296/a-systematic-characterization-of-aquaporin-9-expression-in-human-normal-and-pathological-tissues
#20
Cecilia Lindskog, Anna Asplund, Anca Catrina, Søren Nielsen, Michael Rützler
AQP9 is known to facilitate hepatocyte glycerol uptake. Murine AQP9 protein expression has been verified in liver, skin, epididymis, epidermis and neuronal cells using knockout mice. Further expression sites have been reported in humans. We aimed to verify AQP9 expression in a large set of human normal organs, different cancer types, rheumatoid arthritis synovial biopsies as well as in cell lines and primary cells. Combining standardized immunohistochemistry with high-throughput mRNA sequencing, we found that AQP9 expression in normal tissues was limited, with high membranous expression only in hepatocytes...
May 2016: Journal of Histochemistry and Cytochemistry: Official Journal of the Histochemistry Society
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