BAFF-Neutralizing Interaction of Belimumab Related to Its Therapeutic Efficacy for Treating Systemic Lupus Erythematosus
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Old and New Challenges in Uveitis Associated with Behçet's Disease
Journal of Clinical Medicine Review Old and New Challenges in Uveitis Associated with Behçet’s Disease Julie Gueudry 1,* , Mathilde Leclercq 2, David Saadoun 3,4,5 and Bahram Bodaghi 6 1 Department of Ophthalmology, Hôpital Charles Nicolle, F-76000 Rouen, France 2 Department of Internal Medicine, Hôpital Charles Nicolle, F-76000 Rouen, France; [email protected] 3 Department of Internal Medicine and Clinical Immunology, AP-HP, Centre National de Références Maladies Autoimmunes et Systémiques Rares et Maladies Autoinflammatoires Rares, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] 4 Sorbonne Universités, UPMC Univ Paris 06, INSERM, UMR S 959, Immunology-Immunopathology-Immunotherapy (I3), F-75005 Paris, France 5 Biotherapy (CIC-BTi), Hôpital Pitié-Salpêtrière, AP-HP, F-75651 Paris, France 6 Department of Ophthalmology, IHU FOReSIGHT, Sorbonne-AP-HP, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] * Correspondence: [email protected]; Tel.: +33-2-32-88-80-57 Abstract: Behçet’s disease (BD) is a systemic vasculitis disease of unknown origin occurring in young people, which can be venous, arterial or both, classically occlusive. Ocular involvement is particularly frequent and severe; vascular occlusion secondary to retinal vasculitis may lead to rapid and severe loss of vision. Biologics have transformed the management of intraocular inflammation. However, the diagnosis of BD is still a major challenge. In the absence of a reliable biological marker, diagnosis is based on clinical diagnostic criteria and may be delayed after the appearance of the onset sign. However, therapeutic management of BD needs to be introduced early in order to control inflammation, to preserve visual function and to limit irreversible structural damage. -
Ocrevus (Ocrelizumab) Policy Number: C11250-A
Prior Authorization Criteria Ocrevus (ocrelizumab) Policy Number: C11250-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DUE BY OR BEFORE 8/1/2017 2/17/2021 4/26/2022 LAST P&T J CODE TYPE OF CRITERIA APPROVAL/VERSION J2350-injection,ocrelizumab, Q2 2021 RxPA 1mg 20200428C11250-A PRODUCTS AFFECTED: Ocrevus (ocrelizumab) DRUG CLASS: Multiple Sclerosis Agents - Monoclonal Antibodies ROUTE OF ADMINISTRATION: Intravenous PLACE OF SERVICE: Specialty Pharmacy or Buy and Bill The recommendation is that medications in this policy will be for pharmacy benefit coverage and the IV infusion products administered in a place of service that is a non-hospital facility-based location (i.e., home infusion provider, provider’s office, free-standing ambulatory infusion center) AVAILABLE DOSAGE FORMS: Ocrevus SOLN 300MG/10ML FDA-APPROVED USES: Indicated for the treatment of: • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease, in adults • Primary progressive MS, in adults COMPENDIAL APPROVED OFF-LABELED USES: None COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: Multiple Sclerosis REQUIRED MEDICAL INFORMATION: A. RELAPSING FORMS OF MULTIPLE SCLEROSIS: 1. Documentation of a definitive diagnosis of a relapsing form of multiple sclerosis as defined by the McDonald criteria (see Appendix), including: Relapsing- remitting multiple sclerosis [RRMS], secondary-progressive multiple sclerosis [SPMS] with relapses, and progressive- relapsing multiple sclerosis [PRMS] or First clinical episode with MRI features consistent with multiple sclerosis Molina Healthcare, Inc. confidential and proprietary © 2021 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission from Molina Healthcare. -
Tabalumab for Systemic Lupus Erythematosus
Horizon Scanning Centre May 2014 Tabalumab for systemic lupus erythematosus SUMMARY NIHR HSC ID: 5581 Tabalumab (LY-2127399) is intended to be used as second line therapy for the treatment of systemic lupus erythematosus (SLE). If licensed, it would offer an additional treatment option for patients who have active moderate to severe SLE despite treatment with glucocorticoids, anti-malarials, and/or immunosuppressants; a group who currently have few effective therapies This briefing is available. Tabalumab is a human anti-B-cell activating factor (BAFF or B based on lymphocyte stimulator [BLyS]) monoclonal antibody. It is administered information subcutaneously, in contrast to the only existing licensed BAFF antagonist, which is administered via IV infusion. available at the time of research and a The annual incidence of SLE in the UK is between 3 and 4 cases per limited literature 100,000 population, which equates to approximately 1,600 and 2,100 new search. It is not cases in England per year. The estimated prevalence of SLE is 25-28 per intended to be a 100,000 population, commensurate with around 15,000 people in England definitive statement with the disease. SLE is associated with considerable morbidity and on the safety, mortality, with 10-year survival rates ranging from 70% to 92%. Around 40– efficacy or 70% of SLE patients develop renal involvement which confers a worse effectiveness of the prognosis for survival; and approximately 10% of patients with lupus nephritis health technology develop end-stage renal failure requiring dialysis or transplantation. covered and should Neuropsychiatric involvement occurs in 27% of people with SLE, and SLE is not be used for also characterised by haematological features and cardiovascular commercial complications. -
Xolair/Omalizumab
Therapeutic/Humanized Antibodies ELISA Kits ‘Humanized antibodies” are ‘Animal Antibodies’ that have been modified by recombinant DNA-technology to reduce the overall content of the animal- portion of immunoglobulin so as to increase acceptance by humans or minimize ‘rejection’. By analogy, if the hands of a mouse is actually responsible for grabbing things then ‘humanized-mouse’ will only contain the ‘mouse hands’ and the rest of the body will be human. Since the size of the IgGs is similar in mouse and human, the size of the native mouse IgG and the ‘humanized IgG’ does not significantly change. Antigen recognition property of an antibody actually resides in small portion of the IgG molecule called the ‘antigen binding site or Fab’. Therefore, humanized antibodies contain the minimal portion from the Fab or the epitopes necessary for antigen binding. The process of "humanization of antibodies" is usually applied to animal (mouse) derived monoclonal antibodies for therapeutic use in humans (for example, antibodies developed as anti-cancer drugs). Xolair (Anti-IgE) is an example of humanized IgG. The portion of the mouse IgG that remains in the ‘humanized IgG’ may be recognized as foreign by humans and may result into the generation of “Human Anti-Drug Antibodies (HADA). The presence of anti-Drug antibody (e.g., Human Anti-Rituximab IgG) that may limit the long-term usage the humanized antibody (Rituximab). Not all monoclonal antibodies designed for human therapeutic use need be humanized since many therapies are short-term. The International Nonproprietary Names of humanized antibodies end in “-zumab”, as in “omalizumab”. Humanized antibodies are distinct from chimeric or fusion antibodies. -
Exploring the Association Between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: a Vigibase Study
Drug Safety https://doi.org/10.1007/s40264-018-00789-9 ORIGINAL RESEARCH ARTICLE Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study Lotte A. Minnema1,2 · Thijs J. Giezen2,3 · Patrick C. Souverein1 · Toine C. G. Egberts1,4 · Hubert G. M. Leufkens1 · Helga Gardarsdottir1,4,5 © The Author(s) 2019 Abstract Introduction Several monoclonal antibodies (mAbs) have been linked to neuropsychiatric adverse efects in patients, includ- ing depression and suicidal ideation and behavior. Objective The aim of this study was to quantify and characterize spontaneously reported adverse drug reactions (ADRs) of depression and suicidal ideation and behavior related to mAb users, and to explore a possible association with their mecha- nism of action. Methods We included mAb ADRs that were reported in VigiBase, and identifed those related to depression and suicidal ideation and behavior. Reporting odds ratios (RORs) were estimated for each mAb (bevacizumab as the reference) and according to their infuence on the immune system (not directly targeting [reference], stimulating, or suppressing). Those suppressing the immune system were further divided into their intended indication (auto-immune diseases, cancer). Results Overall, 2,924,319 ADRs for 44 mAbs were included; 9455 ADRs were related to depression and 1770 were related to suicidal ideation and behavior. The association was strongest for natalizumab and belimumab, both for depression (ROR 5.7, 95% confdence interval [CI] 5.0–6.4; and ROR 5.1, 95% CI 4.2–6.2) and suicidal ideation and behavior (ROR 12.0, 95% CI 7.9–18.3; and ROR 20.2, 95% CI 12.4–33.0). -
Infliximab, Adalimumab and Golimumab for Treating Moderately
HEALTH TECHNOLOGY ASSESSMENT VOLUME 20 ISSUE 39 MAY 2016 ISSN 1366-5278 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 Rachel Archer, Paul Tappenden, Shijie Ren, Marrissa Martyn-St James, Rebecca Harvey, Hasan Basarir, John Stevens, Christopher Carroll, Anna Cantrell, Alan Lobo and Sami Hoque DOI 10.3310/hta20390 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 Rachel Archer,1* Paul Tappenden,1 Shijie Ren,1 Marrissa Martyn-St James,1 Rebecca Harvey,1 Hasan Basarir,1 John Stevens,1 Christopher Carroll,1 Anna Cantrell,1 Alan Lobo2 and Sami Hoque3 1Health Economics and Decision Science, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK 2Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK 3Barts Health NHS Trust, London, UK *Corresponding author Declared competing interests of authors: none Published May 2016 DOI: 10.3310/hta20390 This report should be referenced as follows: Archer R, Tappenden P, Ren S, Martyn-St James M, Harvey R, Basarir H, et al. 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. Health Technol Assess 2016;20(39). Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE, Excerpta Medica/EMBASE, Science Citation Index Expanded (SciSearch®) and Current Contents®/ Clinical Medicine. -
Benlysta® (Belimumab)
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2021 P 1227-6 Program Prior Authorization/Notification Medication Benlysta® (belimumab)* *This program applies to the subcutaneous formulation of belimumab P&T Approval Date 9/2017, 9/2018, 9/2019, 9/2020, 2/2021, 7/2021 Effective Date 10/1/2021; Oxford only: 10/1/2021 1. Background: Benlysta® is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy and adult patients with active lupus nephritis who are receiving standard therapy. Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics. Use of Benlysta is not recommended in these situations. 2. Coverage Criteria: A. Systemic Lupus Erythematosus 1. Initial Authorization a. Benlysta will be approved based on all of the following criteria: (1) Diagnosis of systemic lupus erythematosus -AND- (2) Laboratory testing has documented the presence of autoantibodies [e.g., ANA, Anti-dsDNA, Anti-Sm, Anti-Ro/SSA, Anti-La/SSB] -AND- (3) Patient is currently receiving standard immunosuppressive therapy [e.g., hydroxychloroquine, chloroquine, prednisone, azathioprine, methotrexate] -AND- (4) Patient does not have severe active central nervous system lupus -AND- (5) Patient is not receiving Benlysta in combination with either of the following: (a) Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Kineret (anakinra)] © 2021 UnitedHealthcare Services, Inc. 1 (b) Lupkynis (voclosporin) Authorization will be issued for 12 months. -
Cutaneous Adverse Effects of Biologic Medications
REVIEW CME MOC Selena R. Pasadyn, BA Daniel Knabel, MD Anthony P. Fernandez, MD, PhD Christine B. Warren, MD, MS Cleveland Clinic Lerner College Department of Pathology Co-Medical Director of Continuing Medical Education; Department of Dermatology, Cleveland Clinic; of Medicine of Case Western and Department of Dermatology, W.D. Steck Chair of Clinical Dermatology; Director of Clinical Assistant Professor, Cleveland Clinic Reserve University, Cleveland, OH Cleveland Clinic Medical and Inpatient Dermatology; Departments of Lerner College of Medicine of Case Western Dermatology and Pathology, Cleveland Clinic; Assistant Reserve University, Cleveland, OH Clinical Professor, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH Cutaneous adverse effects of biologic medications ABSTRACT iologic therapy encompasses an expo- B nentially expanding arena of medicine. Biologic therapies have become widely used but often As the name implies, biologic therapies are de- cause cutaneous adverse effects. The authors discuss the rived from living organisms and consist largely cutaneous adverse effects of tumor necrosis factor (TNF) of proteins, sugars, and nucleic acids. A clas- alpha inhibitors, epidermal growth factor receptor (EGFR) sic example of an early biologic medication is inhibitors, small-molecule tyrosine kinase inhibitors insulin. These therapies have revolutionized (TKIs), and cell surface-targeted monoclonal antibodies, medicine and offer targeted therapy for an including how to manage these reactions -
Curriculum Vitae: Daniel J
CURRICULUM VITAE: DANIEL J. WALLACE, M.D., F.A.C.P., M.A.C.R. Up to date as of January 1, 2019 Personal: Address: 8750 Wilshire Blvd, Suite 350 Beverly Hills, CA 90211 Phone: (310) 652-0010 FAX: (310) 360-6219 E mail: [email protected] Education: University of Southern California, 2/67-6/70, BA Medicine, 1971. University of Southern California, 9/70-6/74, M.D, 1974. Postgraduate Training: 7/74-6/75 Medical Intern, Rhode Island (Brown University) Hospital, Providence, RI. 7/75-6/77 Medical Resident, Cedars-Sinai Medical Center, Los Angeles, CA. 7/77-6/79 Rheumatology Fellow, UCLA School of Medicine, Los Angeles, CA. Medical Boards and Licensure: Diplomate, National Board of Medical Examiners, 1975. Board Certified, American Board of Internal Medicine, 1978. Board Certified, Rheumatology subspecialty, 1982. California License: #G-30533. Present Appointments: Medical Director, Wallace Rheumatic Study Center Attune Health Affiliate, Beverly Hills, CA 90211 Attending Physician, Cedars-Sinai Medical Center, Los Angeles, 1979- Clinical Professor of Medicine, David Geffen School of Medicine at UCLA, 1995- Professor of Medicine, Cedars-Sinai Medical Center, 2012- Expert Reviewer, Medical Board of California, 2007- Associate Director, Rheumatology Fellowship Program, Cedars-Sinai Medical Center, 2010- Board of Governors, Cedars-Sinai Medical Center, 2016- Member, Medical Policy Committee, United Rheumatology, 2017- Honorary Appointments: Fellow, American College of Physicians (FACP) Fellow, American College of Rheumatology (FACR) -
Study Protocol
PROTOCOL SYNOPSIS A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus International Coordinating Investigator Study site(s) and number of subjects planned Approximately 450 subjects are planned at approximately 173 sites. Study period Phase of development Estimated date of first subject enrolled Q2 2015 3 Estimated date of last subject completed Q2 2018 Study design This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab (150 mg or 300 mg) versus placebo in subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. The study will be performed in adult subjects aged 18 to 70 years of age. Approximately 450 subjects receiving SOC treatment will be randomised in a 1:2:2 ratio to receive a fixed intravenous dose of 150 mg anifrolumab, 300 mg anifrolumab, or placebo every 4 weeks (Q4W) for a total of 13 doses (Week 0 to Week 48), with the primary endpoint evaluated at the Week 52 visit. Investigational product will be administered as an intravenous (IV) infusion via an infusion pump over a minimum of 30 minutes, Q4W. Subjects must be taking either 1 or any combination of the following: oral corticosteroids (OCS), antimalarial, and/or immunosuppressants. Randomisation will be stratified using the following factors: SLE Disease Activity Index 2000 (SLEDAI-2K) score at screening (<10 points versus ≥10 points); Week 0 (Day 1) OCS dose 2(125) Revised Clinical Study Protocol Drug Substance Anifrolumab (MEDI-546) Study Code D3461C00005 Edition Number 5 Date 18 May 2016 (<10 mg/day versus ≥10 mg/day prednisone or equivalent); and results of a type 1 interferon (IFN) test (high versus low). -
BCMA-Targeted Immunotherapy for Multiple Myeloma Bo Yu1, Tianbo Jiang2 and Delong Liu2*
Yu et al. Journal of Hematology & Oncology (2020) 13:125 https://doi.org/10.1186/s13045-020-00962-7 REVIEW Open Access BCMA-targeted immunotherapy for multiple myeloma Bo Yu1, Tianbo Jiang2 and Delong Liu2* Abstract B cell maturation antigen (BCMA) is a novel treatment target for multiple myeloma (MM) due to its highly selective expression in malignant plasma cells (PCs). Multiple BCMA-targeted therapeutics, including antibody-drug conjugates (ADC), chimeric antigen receptor (CAR)-T cells, and bispecific T cell engagers (BiTE), have achieved remarkable clinical response in patients with relapsed and refractory MM. Belantamab mafodotin-blmf (GSK2857916), a BCMA-targeted ADC, has just been approved for highly refractory MM. In this article, we summarized the molecular and physiological properties of BCMA as well as BCMA-targeted immunotherapeutic agents in different stages of clinical development. Keywords: B cell maturation antigen, BCMA, Belantamab mafodotin, CAR-T, Antibody-drug conjugate, Bispecific T cell engager Introduction B cell maturation antigen (BCMA) Recent advances in novel therapeutics such as prote- BCMA is encoded by a 2.92-kb TNFRSF17 gene located asome inhibitors (PI) and immunomodulatory drugs on the short arm of chromosome 16 (16p13.13) and (IMiD) have significantly improved the treatment out- composed of 3 exons separated by 2 introns (Fig. 1). comes in patients with multiple myeloma (MM) [1–8]. BCMA is a 184 amino acid and 20.2-kDa type III trans- However, most MM patients eventually relapse due to membrane glycoprotein, with the extracellular N the development of drug resistance [9]. In addition, terminus containing a conserved motif of 6 cysteines many of the current popular target antigens, such as [18–21]. -
Rheumatology and CTD
Section 16 Section Editor: G Narsimulu Rheumatology and CTD 206. Refractory Rheumatoid Arthritis 214. Treatment of SLE beyond Steroids Rohini Handa Rathindra Nath Sarkar, Rudrajit Paul 207. Difficulties in Rheumatoid Arthritis 215. Gout Is the Only Enemy That I Do Not Rajan Kumar Wish to Have at My Feet Anjana Pandey, Ajay Maurya, PK Maheshwari 208. Monoarthritis—A Clinical Dilemma to Internists Arup Kumar Kundu, Abhishek Kundu 216. Liver Dysfunction and NAFLD in RA: 209. Oral Targeted Treatments in RA—Update 2021 Is MTX Really a Culprit? Ramakrishna Rao Uppuluri, Sripurna Deepti Challa Kartik Nikhil Balankhe, Rishabh Ramu Nayak, Pulin Kumar Gupta 210. Biosimilars: Bane or Boon for India 217. Sexual Dysfunction in Rheumatic Diseases Durga Prasanna Misra, Pallavi Patro, Vikas Agarwal Vinod Ravindran 211. An Approach to Vasculitis 218. Interpretation of Common Investigations Packiamary Jerome in Rheumatology 212. How to Manage DMARDs Failure in RA? Renu Saigal, Amit Kansal, Vikram Raj Jain N Subramanian 213. IgG4-related Disease Harpreet Singh, Somdatta Giri, Anju Arya MU-206 (Sec-16).indd 1321 29-01-2021 15:25:29 MU-206 (Sec-16).indd 1322 29-01-2021 15:25:30 CHAPTER 206 Refractory Rheumatoid Arthritis Rohini Handa Abstract A sizeable number of patients with rheumatoid arthritis (RA) are unable to attain low disease activity or remission despite treatment. These difficult to treat (D2T) patients are labeled as refractory RA. The troika of D2T RA, as outlined by the European League against Rheumatism, comprises of treatment failure history, presence of active/symptomatic disease, and clinical perception. The approach to refractory RA is evolving.