Therapeutic Class Overview Immunomodulators
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Positioning Biologics in the Management of Moderate to Severe Crohn's Disease
REVIEW CURRENT OPINION Positioning biologics in the management of moderate to severe Crohn’s disease Jana G. Hashash and Fadi H. Mourad Purpose of review Since there is a lack of head-to-head randomized controlled trials, little direction is provided from guidelines on the positioning of biologics for the treatment of Crohn’s disease (CD). This review utilizes comparative effectiveness and safety results from real-world data and network meta-analyses to inform clinical practice for positioning of biological therapies in the treatment of moderate-to-severe CD. Recent findings We summarize the results of studies pertaining to the identification of predictors for response to biologics in CD. Recently published studies about the management of moderate-to-severe CD are discussed and a positioning algorithm is proposed for the therapeutic approach of these patients. Summary Different classes of biologics are comparable with regards to safety and almost similar in effectiveness in the management of CD. There are certain clinical scenarios in which one biologic is more effective than another. For instance, patients with a more aggressive disease phenotype such as fistulizing disease would benefit from infliximab over other biologics, whereas in older patients at a higher risk for infectious complications, it may be more appropriate to use ustekinumab or vedolizumab over the anti-tumor necrosis factor (TNF) agents. More data pertaining to identifying predictors of response to the different available therapies and head-to-head comparison trials are needed to personalize our therapeutic approach of CD patients. Keywords biologics, Crohn’s disease, moderate-to-severe, positioning INTRODUCTION The medical management of patients with CD To guide the choice of treatment in patients with has changed over recent years. -
Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution. -
Genentech Tocilizumab Letter of Authority June 24 2021
June 24, 2021 Hoffmann-La Roche, Ltd. C/O Genentech, Inc. Attention: Dhushy Thambipillai Regulatory Project Management 1 DNA Way, Bldg 45-1 South San Francisco, CA 94080 RE: Emergency Use Authorization 099 Dear Ms. Thambipillai: This letter is in response to Genentech, Inc.’s (Genentech) request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of Actemra1 (tocilizumab) for the treatment of coronavirus disease 2019 (COVID-19) in certain hospitalized patients, as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes coronavirus disease 2019 (COVID-19).2 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 3 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section. Actemra is a recombinant humanized monoclonal antibody that selectively binds to both soluble and membrane-bound human IL-6 receptors (sIL-6R and mIL-6R) and subsequently inhibits IL- 6-mediated signaling through these receptors. -
Review Anti-Cytokine Biologic Treatment Beyond Anti-TNF in Behçet's Disease
Review Anti-cytokine biologic treatment beyond anti-TNF in Behçet’s disease A. Arida, P.P. Sfikakis First Department of Propedeutic Internal ABSTRACT and thrombotic complications (1-3). Medicine Laikon Hospital, Athens, Unmet therapeutic needs in Behçet’s Treatment varies according to type and University Medical School, Greece. disease have drawn recent attention to severity of disease manifestations. Cor- Aikaterini Arida, MD biological agents targeting cytokines ticosteroids, interferon-alpha and con- Petros P. Sfikakis, MD other than TNF. The anti-IL-17 anti- ventional immunosuppressive drugs, Please address correspondence to: body secukinumab and the anti-IL-2 such as azathioprine, cyclosporine-A, Petros P. Sfikakis, MD, receptor antibody daclizumab were not cyclophosphamide and methotrexate, First Department of Propedeutic superior to placebo for ocular Behçet’s and Internal Medicine, are used either alone or in combination Laikon Hospital, in randomised controlled trials, com- for vital organ involvement. During the Athens University Medical School, prising 118 and 17 patients, respec- last decade there has been increased use Ag Thoma, 17, tively. The anti-IL-1 agents anakinra of anti-TNF monoclonal antibodies in GR-11527 Athens, Greece. and canakinumab and the anti-IL-6 patients with BD who were refractory E-mail: [email protected] agent tocilizumab were given to iso- to conventional treatment or developed Received on June 7, 2014; accepted in lated refractory disease patients, who life-threatening complications (4, 5). revised form on September 17, 2014. were either anti-TNF naïve (n=9) or Anti-TNF treatment has been shown to Clin Exp Rheumatol 2014; 32 (Suppl. 84): experienced (n=18). -
Tocilizumab in Hospitalised Adults with Covid-19
This document has been approved for use at [ ] USE OF TOCILIZUMAB IN HOSPITALISED ADULTS WITH COVID-19 INFORMATION FOR PATIENTS, FAMILIES AND CARERS This information leaflet contains important information about the medicine called tocilizumab when used in the treatment of COVID-19. WHAT IS THE POTENTIAL BENEFIT OF It is important you provide your formal consent TOCILIZUMAB FOR COVID-19? before receiving tocilizumab. You can always change your mind about treatment with Tocilizumab belongs to a group of medicines called tocilizumab and withdraw consent at any time. monoclonal antibodies. Monoclonal antibodies are proteins, which specifically recognise and bind to unique proteins in the body to modify the way the WHAT SHOULD THE DOCTOR KNOW immune system works. Tocilizumab has effects on BEFORE TOCILIZUMAB IS USED IN the immune system that may be useful in helping COVID-19? to reduce the effects of severe COVID-19. The doctor should know about: Tocilizumab has been approved in Australia to treat any other conditions including HIV or AIDs, some immune conditions such as arthritis, cytokine tuberculosis, diverticulitis, stomach ulcers, release syndrome and giant cell arteritis. The brand diabetes, cancer, heart problems, raised name is Actemra®. blood pressure or any nerve disease such as Recent clinical trials studying the effectiveness of neuropathy tocilizumab in COVID-19 have been analysed by previous allergic reactions to any medicine Australia’s National COVID-19 Clinical Evidence all medicines including over-the-counter and Taskforce. The Taskforce makes recommendations complementary medicines e.g. vitamins, about when tocilizumab is most likely to be minerals, herbal or naturopathic medicines effective in the treatment of COVID-19. -
B.C. Pharmacare Drug Information Sheet for Vedolizumab (Entyvio)
The drug below is being considered for possible coverage under the B.C. PharmaCare program. PharmaCare is a government-funded drug plan that helps British Columbians with the cost of eligible prescription drugs and specific medical supplies. For more information on PharmaCare, visit Ministry of Health - PharmaCare. PharmaCare reviews each drug for treating a specific illness or medical condition (known as an “indication”). If a decision is made to cover the drug, it will be only for that illness or condition. In some cases, PharmaCare may cover a drug only for people who have the illness or condition and have not responded to other drugs used to treat that illness or condition. For more information on PharmaCare’s drug coverage review process, see the last page of this information sheet. Information about the drug Generic name (scientific name) vedolizumab Brand name Entyvio® Manufacturer Takeda Canada Inc. Indication Entyvio is indicated for the treatment of moderately to severely active Crohn’s disease in adult patients. Has the drug been reviewed by Yes the Common Drug For more information about the CDR’s review of vedolizumab (Entyvio®), you can Review (CDR)? Search the CDR Reports. (see the note below this table.) Public input start date Friday, November 13, 2020 Public input closing date Friday, December 11, 2020 AT MIDNIGHT How is the drug taken? Entyvio is administered by subcutaneous injection (into the skin). How often is the drug taken? Entyvio is administered every two weeks, following at least two intravenous infusions (into the vein). Ministry of Health Pharmaceutical Services Division Page 1 of 4 BC PharmaCare Drug Information — vedolizumab (Entyvio®) continued… Information about the drug General drug and/or drug Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract, which study information most commonly affects the small intestine, beginning of large intestine, and rectum. -
Biological Therapies for Atopic Dermatitis: an Update (Review)
EXPERIMENTAL AND THERAPEUTIC MEDICINE 17: 1061-1067, 2019 Biological therapies for atopic dermatitis: An update (Review) DIANA DELEANU1-3 and IRENA NEDELEA1,2 1Allergology and Immunology Discipline, ‘Iuliu Hatieganu’ University of Medicine and Pharmacy, 400058 Cluj-Napoca; Departments of 2Allergy and 3Internal Medicine, ‘Professor Doctor Octavian Fodor’ Regional Institute of Gastroenterology and Hepatology, 400162 Cluj-Napoca, Romania Received July 6, 2018; Accepted August 22, 2018 DOI: 10.3892/etm.2018.6989 Abstract. Severe atopic dermatitis, which affects both adults in low-income countries (3). Furthermore, the past decades and children, is a debilitating disorder with a significant decline brought a 2-3-fold increase in prevalence in industrialized of patients' quality of life. Although aetiopathogenic factors countries (3). Generally AD onset is in early childhood, as are currently a topic of study and interpretation, the main one of the first steps of the ‘atopic march’, which describes the features of atopic eczema are skin barrier disturbance and natural history of atopic manifestations, and it is character- immune dysregulation. Severe refractory disease that fails to ized by xerotic skin and acute flare-ups of intensely pruritic improve with conventional therapy may benefit from biologic eczematous lesions (4). Recent studies recognize a predilection therapy. Progress in understanding immunopathology of atopic of AD for persistence in adulthood, with a lifetime prevalence dermatitis have allowed identification of therapeutic molecular accounting for 34.1% (5). Early onset, allergic rhinitis and targets in the field of biological therapy. We reviewed the hand eczema in childhood are high-risk factors for persistent different biological treatments with a focus on novel targeted AD (5). -
Risk Assessment and Risk Mitigation Review(S)
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125476Orig1s000 RISK ASSESSMENT and RISK MITIGATION REVIEW(S) Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Office of Medication Error Prevention and Risk Management Final Risk Evaluation and Mitigation Strategy (REMS) Review Date: May 7, 2014 Reviewer(s): George Neyarapally, Pharm.D., M.P.H. Division of Risk Management (DRISK) Team Leader: Reema Mehta, Pharm.D., M.P.H. DRISK Division Director: Claudia Manzo, Pharm.D. DRISK Drug Name(s): Entyvio (vedolizumab) Therapeutic Class: Lymphocyte α4β7 integrin receptor antagonist Dosage and Route: Solution for infusion Application Type/Number: BLA 125476, BLA 125507 Applicant/Sponsor: Takeda Pharmaceuticals OSE RCM #: 2013-1641 *** This document contains proprietary and confidential information that should not be released to the public. *** 1 Reference ID: 3502774 CONTENTS 1 INTRODUCTION ....................................................................................................... 1 1.1 Product Background............................................................................................ 1 1.2 Disease Background............................................................................................ 2 1.3 Regulatory History .............................................................................................. 2 2 MATERIALS REVIEWED ....................................................................................... -
Tocilizumab in the Treatment of Severe and Refractory Parenchymal Neuro
TAB0010.1177/1759720X20971908Therapeutic Advances in Musculoskeletal DiseaseJ Liu, D Yan 971908research-article20202020 Therapeutic Advances in Musculoskeletal Disease Case Series Ther Adv Musculoskel Dis Tocilizumab in the treatment of severe and 2020, Vol. 12: 1–8 DOI:https://doi.org/10.1177/1759720X20971908 10.1177/ refractory parenchymal neuro-Behçet’s 1759720X20971908https://doi.org/10.1177/1759720X20971908 © The Author(s), 2020. Article reuse guidelines: syndrome: case series and literature review sagepub.com/journals- permissions Jinjing Liu* , Dong Yan*, Zhimian Wang, Yunjiao Yang, Shangzhu Zhang, Di Wu, Lingyi Peng, Zhichun Liu and Wenjie Zheng Abstract Correspondence to: Objectives: This study aimed to investigate the efficacy and safety of tocilizumab (TCZ) in Wenjie Zheng severe and refractory parenchymal neuro-Behçet’s syndrome (p-NBS). Department of Rheumatology and Clinical Methods: We retrospectively analyzed five patients with p-NBS treated with TCZ in our center Immunology, Peking Union between 2013 and 2020, and six cases from literature research with the index terms “neuro- Medical College Hospital, Chinese Academy of Behçet’s syndrome” and “tocilizumab” on PubMed NCBI. Medical Sciences & Peking Union Medical Results: A total of 11 patients with p-NBS were enrolled (5 males, 6 females), with a mean College, Key Laboratory of age of 34.5 ± 8.0 years at the onset. All the patients had parenchymal neurological lesions, Rheumatology and Clinical Rheumatology, Ministry six patients (54.5%) suffered from multiple lesions, and nine patients (81.8%) were disabled. of Education, National Clinical Research Center Before TCZ administration, all the patients had failed conventional therapy, eight patients for Dermatologic and (72.7%) received two or more immunosuppressants, and five patients showed insufficient Immunologic Diseases, No. -
Anticorps FR-EN 110X90.Indd
MONOCLONAL ANTIBODIES and Fc fusion proteins for therapeutic use DISTRIBUTION OF INTERNATIONAL NONPROPRIETARY NAMES BY INDICATION SOLID TUMORS RHUMATOLOGY PNEUMOLOGY Lung cancer bevacizumab Rheumatoid arthritis etanercept Allergic asthma omalizumab nivolumab infliximab Severe eosinophilic asthma mepolizumab necitumumab adalimumab reslizumab atezolizumab rituximab Colorectal cancer bevacizumab abatacept TRANSPLANTATION cetuximab tocilizumab Transplant rejection basiliximab panitumumab certolizumab pegol belatacept aflibercept golimumab Graft versus host disease inolimomab Bladder cancer atezolizumab Psoriatic arthritis etanercept Breast cancer trastuzumab adalimumab OPHTALMOLOGY bevacizumab infliximab Age related macular ranibizumab pertuzumab golimumab degeneration aflibercept trastuzumab entansine ustekinumab bevacizumab Gastric cancer trastuzumab certolizumab pegol Macular edema ranibizumab ramucirumab secukinumab aflibercept Head and neck cancer cetuximab Ankylosing spondylitis infliximab Myopic choroidal ranibizumab Ovarian cancer bevacizumab etanercept neovascularization aflibercept Fallopian tube cancer bevacizumab adalimumab Cervical cancer bevacizumab golimumab HAEMOSTASIS AND THROMBOSIS Kidney cancer bevacizumab certolizumab pegol nivolumab secukinumab Haemophilia A efmoroctocog α Melanoma ipilimumab Juvenile arthritis etanercept Haemophilia B eftrenonacog α nivolumab adalimumab Reversal of dabigatran idarucizumab Idiopathic thrombocytopenic pembrolizumab abatacept romiplostim Neuroblastoma dinutuximab tocilizumab purpura Malignant -
Tocilizumab Preparation Risk Assessment
OUH General Risk Assessment Form Tocilizumab Preparation Risk Assessment It is recommended that all Trusts have in place a policy for the handling of mAbs. This should describe the responsibility of the Chief Pharmacist in defining the requirements needed for mAbs prepared outside the pharmacy, the resources available for handling of mAbs within the organisation, the mechanisms in place for the risk assessment of MAB handling and the clinical areas where mAbs may be used. This should be endorsed at Board level within the Trust and include a commitment to provide the resources necessary to allow the safe preparation of mAbs within the Trust in line with the guidance included within this document. It should also address the subject of the cost of provision of the resources required and how these are linked to the costs passed on to commissioners. Site JR Oxford University Hosptials NHS Trust Division CSS Directorate Covid wards/Pharmacy/ICU Department Pharmacy Location Exact N/A Date 21/04/2020 Assessors(s) 1 Clinical Divisional Pharmacist 2 Medicines Safety Pharmacist 3 Preparative Services Pharmacist 4 Senior Pharmacist Manager The Hazard or perceived risk Risks: 1. Risks of exposure to tocilizumab for staff handling the product due to the nature of or mode of action of the agent 2. Risks to patient receiving tocilizumab due to the potential for errors or contamination during the preparation of the product Cause: Need to determine the most appropriate area to prepare tocilizumab based on agreed MAB risk categories Affect: Staff could develop a reaction or adverse effect from tocilizumab. Patients may receive inaccurate product, with risk of microbiological contamination Impact: Minimise potential occupational exposure to staff and risk to patients receiving a dose Description (Identify who will be affected and how; include the context e.g. -
Successful Usage of Combination Biologic Therapy with Etanercept
Case Report Nov Tech Arthritis Bone Res Volume 2 Issue 4 - Febeuary 2018 Copyright © All rights are reserved by Yoon Kam Hon DOI: 10.19080/NTAB.2017.02.555592 Successful Usage of Combination Biologic Therapy with Etanercept and Actemra for the Treatment of TNF Inhibitor Failure Patients with Rheumatoid Arthritis: A Report of 2 Cases Yoon Kam Hon Department of Arthritis and Rheumatism Specialist Medical Centre, Singapore Submission: January 15, 2018; Published: February 02, 2018 *Corresponding author: Yoon Kam Hon, Consultant Physician And Rheumatologist, El Shaddai Arthritis and Rheumatism Specialist Medical Centre, Block 102 #01-258 Towner Road, Singapore 322102, Tel: +6581258239; Email: Abstract In the treatment of patients with rheumatoid arthritis with anti-tumour necrosis factor therapy, it is not uncommon for some patients to be unresponsive or relapse with treatment. We report the successful usage of combination biologic therapy with etanercept and tocilizumab in two factor and anti-interleukin 6 cytokine therapy in the treatment of rheumatoid arthritis. patients with moderately severe rheumatoid arthritis who failed etanercept therapy. This is the first report of combination anti-tumour necrosis Keywords: Rheumatoid arthritis; Combination biologic therapy; Etanercept; Tocilizumab Introduction therapy inadequate response (IR) RA patients in the RADIATE Rheumatoid arthritis (RA) is a complex chronic autoimmune trial. 50% of patients achieved ACR20 response at week 24, arthritis where many cytokines and chemokines including but only 20% achieved ACR50 response [5]. In the SUMMACTA Tumour Necrosis Factor (TNF), and Interleukin-6 (IL-6) play trial, it was shown that the intravenous (IV) form given at 8mg/ important roles in the pathophysiology of RA.