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Heejin Lim, Sang Hyung Lee, Hyun Tae Lee, Jee Un Lee, Ji Young Son, Woori Shin, Yong-Seok Heo
The binding of the tumor necrosis factor α (TNFα) to its cognate receptor initiates many immune and inflammatory processes. The drugs, etanercept (Enbrel® ), infliximab (Remicade® ), adalimumab (Humira® ), certolizumab-pegol (Cimzia® ), and golimumab (Simponi® ), are anti-TNFα agents. These drugs block TNFα from interacting with its receptors and have enabled the development of breakthrough therapies for the treatment of several autoimmune inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and psoriatic arthritis...
March 7, 2018: International Journal of Molecular Sciences
Stanley B Cohen, Alberto Alonso-Ruiz, Piotr A Klimiuk, Eric C Lee, Nuala Peter, Ivo Sonderegger, Deepak Assudani
OBJECTIVE: To demonstrate clinical equivalence of adalimumab biosimilar candidate BI 695501 with Humira. METHODS: Patients with active rheumatoid arthritis on stable methotrexate were randomised to BI 695501 or Humira in a double-blind, parallel-group, equivalence study. At week 24, patients were rerandomised to continue BI 695501 or Humira, or switch from Humira to BI 695501. The coprimary endpoints were the percentage of patients achieving the American College of Rheumatology 20% response criteria (ACR20) at weeks 12 and 24...
March 7, 2018: Annals of the Rheumatic Diseases
Dawn Aitken, Laura L Laslett, Feng Pan, Ida K Haugen, Petr Otahal, Nicholas Bellamy, Paul Bird, Graeme Jones
OBJECTIVE: To assess the efficacy of adalimumab in patients with erosive hand osteoarthritis (OA). METHOD: Patients >50 years old, meeting the ACR criteria for hand OA, with pain >50 on 100mm VAS, morning stiffness >30 minutes and >1 erosive joint on x-ray with synovitis present on MRI were included in a randomised double-blind placebo-controlled crossover trial. Patients were randomised to adalimumab (40 mg subcutaneous injections every other week) or identical placebo injections for 12 weeks followed by an 8-week washout and then crossed over treatment groups for another 12 weeks...
February 27, 2018: Osteoarthritis and Cartilage
Ulrich Storz
This article is the second part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics. TNFα is the world's most valuable target, with accumulated sales of TNFα biologics of 34 bn USD in 2014. While in the first part of this trilogy, Humira was discussed, this second parts discusses the patent strategies of Enbrel, Remicade, Cimzia and Simponi.
February 5, 2018: Human Antibodies
Qian Dong, Yuxue Liang, Xinjian Yan, Sanford P Markey, Yuri A Mirokhin, Dmitrii V Tchekhovskoi, Tallat H Bukhari, Stephen E Stein
We describe the creation of a mass spectral library composed of all identifiable spectra derived from the tryptic digest of the NISTmAb IgG1κ. The library is a unique reference spectral collection developed from over six million peptide-spectrum matches acquired by liquid chromatography-mass spectrometry (LC-MS) over a wide range of collision energy. Conventional one-dimensional (1D) LC-MS was used for various digestion conditions and 20- and 24-fraction two-dimensional (2D) LC-MS studies permitted in-depth analyses of single digests...
February 9, 2018: MAbs
Jan Hillson, Tim Mant, Molly Rosano, Carolyn Huntenburg, Mehrshid Alai-Safar, Siddhesh Darne, Donna Palmer, Borislava G Pavlova, Jennifer Doralt, Russell Reeve, Niti Goel, Doris Weilert, Paul W Rhyne, Kamali Chance, John Caminis, James Roach, Tanmoy Ganguly
The aims of this randomized, double-blind, three-arm, single-dose study were to demonstrate pharmacokinetic (PK) equivalence of the adalimumab biosimilar M923 (hereafter referred to as "M923") to each of 2 reference products, and to assess M923's safety and immunogenicity. Primary PK endpoints were maximum observed concentration (Cmax ), area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-inf ), and AUC from time 0 to 336 hours (AUC0-336 ). Secondary endpoints included safety and immunogenicity assessments...
February 2018: Pharmacology Research & Perspectives
Amporn Atsawarungruangkit, Fernando Dominguez, Gustavo Borda, Nikolaos Mavrogiorgos
Listeria monocytogenes is a gram-positive bacterium that causes listeriosis. Brain abscess is a very uncommon manifestation of listeriosis and has not been reported to be associated with adalimumab (humira), one of the approved medications for treating Crohn's disease. A 45-year-old female with Crohn's disease presented with sudden onset of fever, headache, nausea, vomiting, and altered mental status for 1 day. She was on prednisone and 6-mercaptopurine. She had started taking adalimumab 17 days prior to admission...
September 2017: Case Reports in Gastroenterology
Hazel Squires, Edith Poku, Inigo Bermejo, Katy Cooper, John Stevens, Jean Hamilton, Ruth Wong, Alastair Denniston, Ian Pearce, Fahd Quhill
BACKGROUND: Non-infectious intermediate uveitis, posterior uveitis and panuveitis are a heterogeneous group of inflammatory eye disorders. Management includes local and systemic corticosteroids, immunosuppressants and biological drugs. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of subcutaneous adalimumab (Humira® ; AbbVie Ltd, Maidenhead, UK) and a dexamethasone intravitreal implant (Ozurdex® ; Allergan Ltd, Marlow, UK) in adults with non-infectious intermediate uveitis, posterior uveitis or panuveitis...
November 2017: Health Technology Assessment: HTA
Doerte Langemann, Magdalena Trochimiuk, Birgit Appl, Patrick Hundsdoerfer, Konrad Reinshagen, Georg Eschenburg
We demonstrated sensitization for chemotherapy by Smac mimetic (SM) LCL161, a potent antagonist of inhibitor of apoptosis proteins (IAP), in neuroblastoma (NB). Vinca alkaloids, particularly vincristine (VCR), displayed the strongest impact on inhibition of proliferation and apoptosis induction in combination with LCL161. The underlying signaling pathways remain elusive, though. LCL161 induces a quick degradation of cellular IAP 1 (cIAP-1). Combination of LCL161 with VCR had only marginal effects on X-linked IAP (XIAP) protein expression...
October 20, 2017: Oncotarget
Ana Duarte, Teumzghi Mebrahtu, Pedro Saramago Goncalves, Melissa Harden, Ruth Murphy, Stephen Palmer, Nerys Woolacott, Mark Rodgers, Claire Rothery
BACKGROUND: Psoriasis is a chronic inflammatory disease that predominantly affects the skin. Adalimumab (HUMIRA®, AbbVie, Maidenhead, UK), etanercept (Enbrel®, Pfizer, New York, NY, USA) and ustekinumab (STELARA®, Janssen Biotech, Inc., Titusville, NJ, USA) are the three biological treatments currently licensed for psoriasis in children. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of adalimumab, etanercept and ustekinumab within their respective licensed indications for the treatment of plaque psoriasis in children and young people...
November 2017: Health Technology Assessment: HTA
Nefyn H Williams, Alison Jenkins, Nia Goulden, Zoe Hoare, Dyfrig A Hughes, Eifiona Wood, Nadine E Foster, David A Walsh, Dawn Carnes, Valerie Sparkes, Elaine M Hay, John Isaacs, Kika Konstantinou, Dylan Morrissey, Jaro Karppinen, Stephane Genevay, Clare Wilkinson
BACKGROUND: Biological treatments such as adalimumab (Humira®; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. OBJECTIVES: To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica...
October 2017: Health Technology Assessment: HTA
Ashish J Mathew, Arvind Ganapati, Sathish Kumar T, Ruchika Goel, Sandhya P, Debashish Danda
The advent of biologic therapies has brought in significant improvement in the outcome of patients suffering from chronic inflammatory arthritis. High costs and unavailability have however, limited their utility in some parts of the world. These limitations have been overcome to a good extent by the introduction of biosimilar versions of original products, which are gaining momentum, of late. Adalimumab (Humira®), a TNF-α inhibitor has been successfully used in patients with inflammatory arthritis for more than a decade now...
May 2017: Journal of the Association of Physicians of India
V V Kaushik
A first fully humanized monoclonal antibody approved by US Food and Drug Administration (FDA) in 2002 was Adalimumab. Clinical efficacy and safety of adalimumab has been assessed in various trials in rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn's Disease, and ulcerative colitis. It is one of the major sales success among biological and still one of the greatest blockbuster amongst monoclonal antibodies. With the advent of patent expiry of the parent drug HUMIRA, several potential biosimilars have debuted in various markets worldwide...
May 2017: Journal of the Association of Physicians of India
Sandro Donato, Serena Pacilè, Federico Colombo, Chiara Garrovo, Simeone Dal Monego, Paolo Macor, Giuliana Tromba, Stefania Biffi
It is increasingly recognized that early detection of bone erosion plays an important role in the overall evaluation of rheumatoid arthritis and in the choice of the correct treatment approach. Since an appropriate use of imaging biomarkers in preclinical settings offers the prospect of smaller and optimized sample size, in the present study we define an anatomical imaging biomarker that could be objectively measured from micro-CT imaging data as an indicator of bone erosion in arthritis process. The well-characterized antigen-induced arthritis (AIA) model in rats was used...
August 8, 2017: Scientific Reports
Ahmadreza Jamshidi, Farhad Gharibdoost, Mahdi Vojdanian, Soosan G Soroosh, Mohsen Soroush, Arman Ahmadzadeh, Mohammad Ali Nazarinia, Mohammad Mousavi, Hadi Karimzadeh, Mohammad Reza Shakibi, Zahra Rezaieyazdi, Maryam Sahebari, Asghar Hajiabbasi, Ali Asghar Ebrahimi, Najmeh Mahjourian, Amin Mohammadinejad Rashti
BACKGROUND: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). METHODS: In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7...
July 20, 2017: Arthritis Research & Therapy
N Zerbinati, E D'Este, L Ini, A Baruffato, V Premoli, A Calligaro, M Paulli
Hidradenitis Suppurativa (HS) is recently attracting much attention and awareness, often because it is misdiagnosed for years, restricting the therapeutic options. Moreover, this pathology arises in areas such as the inguinal region, that may cause embarrassment in young patients. Wrong diagnosis and delay in appropriate treatments lead to an exacerbation of the symptoms and a progression of the disease, which at the last stage can only be managed through extensive surgical excisions, ablation and vaporization of nodules with CO2 laser systems or aggressive chemotherapies such as anti-TNF-alpha like adalimumab (Humira®-AbbVie Inc...
April 2017: Journal of Biological Regulators and Homeostatic Agents
Sultan Gulce Iz, Muge Anil Inevi, Pelin Saglam Metiner, Duygu Ayyildiz Tamis, Nazli Kisbet
Recent developments in medical biotechnology have facilitated to enhance the production of monoclonal antibodies (mAbs) and recombinant proteins in mammalian cells. Human mAbs for clinical applications have focused on three areas, particularly cancer, immunological disorders, and infectious diseases. Tumor necrosis factor alpha (TNF-α), which has both proinflammatory and immunoregulatory functions, is an important target in biopharmaceutical industry. In this study, a humanized anti-TNF-α mAb producing stable CHO cell line which produces a biosimilar of Humira (adalimumab) was used...
July 6, 2017: Applied Biochemistry and Biotechnology
Humira Sonah, Rupesh K Deshmukh, Caroline Labbé, Richard R Bélanger
Aquaporins (AQPs) are of vital importance in the cellular transport system of all living organisms. In this study, genome-wide identification, distribution, and characterization of AQPs were determined in Arabidopsis lyrata, Capsella grandiflora, C. rubella, Eutrema salsugineum, Brassica rapa, B. oleracea, and B. napus (canola). Classification and phylogeny of AQPs revealed the loss of XIPs and NIP-IIIs in all species. Characterization of distinctive AQP features showed a high level of conservation in spacing between NPA-domains, and selectivity filters...
June 5, 2017: Scientific Reports
Peter Norman
No abstract text is available yet for this article.
May 9, 2017: Pharmaceutical Patent Analyst
Filip Van den Bosch, Andrew J K Ostor, Siegfried Wassenberg, Naijun Chen, Chen Wang, Vishvas Garg, Jasmina Kalabic
No abstract text is available yet for this article.
June 2017: Rheumatology and Therapy
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