Immunology Lecture Edinburgh
Total Page：16
File Type：pdf, Size：1020Kb
Load more
Recommended publications
-
WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT (51) International Patent Classification: (71) Applicant: JUNO THERAPEUTICS, INC. [US/US]; 400 A 61K 35/1 7 (20 15.0 1) A 61P 35/00 (2006 .0 1) Dexter Ave. N., Suite 1200, Seattle, WA 98109 (US). (21) International Application Number: (72) Inventor: ALBERTSON, Tina; 400 Dexter Ave. N., Suite PCT/US2018/035755 1200, Seattle, WA 98109 (US). (22) International Filing Date: (74) Agent: AHN, Sejin et al; Morrison & Foerster LLP, 1253 1 0 1 June 2018 (01 .06.2018) High Bluff Drive, Suite 100, San Diego, CA 92130-2040 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of national protection available): AE, AG, AL, AM, (30) Priority Data: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 62/5 14,774 02 June 2017 (02.06.2017) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 62/5 15,530 05 June 2017 (05.06.2017) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/521,366 16 June 2017 (16.06.2017) u s HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, 62/527,000 29 June 2017 (29.06.2017) u s KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 62/549,938 24 August 2017 (24.08.2017) u s MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 62/580,425 0 1 November 2017 (01 .11.2017) u s OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 62/593,871 0 1 December 2017 (01 .12.2017) u s SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 62/596,764 08 December 2017 (08.12.2017) u s TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. -
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. -
JAK-Inhibitors for the Treatment of Rheumatoid Arthritis: a Focus on the Present and an Outlook on the Future
biomolecules Review JAK-Inhibitors for the Treatment of Rheumatoid Arthritis: A Focus on the Present and an Outlook on the Future 1, 2, , 3 1,4 Jacopo Angelini y , Rossella Talotta * y , Rossana Roncato , Giulia Fornasier , Giorgia Barbiero 1, Lisa Dal Cin 1, Serena Brancati 1 and Francesco Scaglione 5 1 Postgraduate School of Clinical Pharmacology and Toxicology, University of Milan, 20133 Milan, Italy; [email protected] (J.A.); [email protected] (G.F.); [email protected] (G.B.); [email protected] (L.D.C.); [email protected] (S.B.) 2 Department of Clinical and Experimental Medicine, Rheumatology Unit, AOU “Gaetano Martino”, University of Messina, 98100 Messina, Italy 3 Experimental and Clinical Pharmacology Unit, Centro di Riferimento Oncologico di Aviano (CRO), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Pordenone, 33081 Aviano, Italy; [email protected] 4 Pharmacy Unit, IRCCS-Burlo Garofolo di Trieste, 34137 Trieste, Italy 5 Head of Clinical Pharmacology and Toxicology Unit, Grande Ospedale Metropolitano Niguarda, Department of Oncology and Onco-Hematology, Director of Postgraduate School of Clinical Pharmacology and Toxicology, University of Milan, 20162 Milan, Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-090-2111; Fax: +39-090-293-5162 Co-first authors. y Received: 16 May 2020; Accepted: 1 July 2020; Published: 5 July 2020 Abstract: Janus kinase inhibitors (JAKi) belong to a new class of oral targeted disease-modifying drugs which have recently revolutionized the therapeutic panorama of rheumatoid arthritis (RA) and other immune-mediated diseases, placing alongside or even replacing conventional and biological drugs. -
Clinical Efficacy of New JAK Inhibitors Under Development. Just More of the Same?
RHEUMATOLOGY Rheumatology 2019;58:i27i33 doi:10.1093/rheumatology/key256 Clinical efficacy of new JAK inhibitors under development. Just more of the same? Rene Westhovens1 Abstract Janus kinase inhibition is promising in the treatment of RA, with already two oral drugs marketed. New compounds are under investigation that are more selective for Janus kinase 1 or Janus kinase 3. Phase II results for filgotinib, upadacitinib, peficitinib and decernotinib are reviewed showing almost consistently a fast dose-dependent clinical improvement similar to already approved drugs tofacitinib and baricitinib. I will reflect on the most frequently reported dose-dependent adverse events and laboratory changes. Some are similar for all drugs of this class, some are more specific for a certain drug, but all may influence future treatment effectiveness in daily practice. This implies the need for a critical evaluation of phase III trials, and eventually trials specifically powered for conclusions on the safety profile and registries once these drugs become marketed. These innovative drugs also need head-to-head trials versus biologics or in-class as well as specific strategy studies to determine their optimal future use. Key words: Janus kinase inhibitor, RA, filgotinib, upadacitinib, peficitinib, decernotinib Rheumatology key messages . Efficacy but also some adverse events of most new Janus kinase inhibitors are dose dependent. Target selectivity of new Janus kinase inhibitors is an interplay between selectivity, dosing, drugdrug interaction, pharmacokinetics and pharmacodynamics. These new Janus kinase inhibitors might alter treatment paradigms by a rapid dose-dependent action, eventually also in monotherapy. Introduction regarding functionality, quality of life and even aspects of participation in daily life. -
Study Protocol
(rJ GI LEAi) Galapagos CLINICAL STUDY PROTOCOL Study Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Sponsor: Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404, USA IND Number: 129646 EudraCT Number: 2016-003179-23 Clinical Trials.gov NCT03046056 Identifier: Indication: Small Bowel Crohn’s Disease Protocol ID: GS-US-419-4015 Contact Information: The medical monitor name and contact information will be provided on the Key Study Team Contact List. Protocol Original: 12 September 2016 Version/Date: Amendment 1: 16 December 2016 Amendment 2: 26 June 2017 Amendment 3: 04 February 2020 CONFIDENTIALITY STATEMENT The information contained in this document, particularly unpublished data, is the property or under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The information is only to be used by you in connection with authorized clinical studies of the investigational drug described in the protocol. You will not disclose any of the information to others without written authorization from Gilead Sciences, Inc., except to the extent necessary to obtain informed consent from those persons to whom the drug may be administered. Filgotinib Protocol GS-US-419-4015 Final Gilead Sciences, lnc. Amendment3 TABLE OF CONTENTS TABLE -
Recommendations from York and Scarborough Medicines
Recommendations from York and Scarborough Medicines Commissioning Committee March 2021 Drug name Indication Recommendation, rationale and place in RAG status Potential full year cost impact therapy CCG commissioned Technology Appraisals 1. TA672: Brolucizumab for Brolucizumab is recommended as an option for treating wet Listed as RED Discussed and approved at Feb 2021 MCC meeting. treating wet age-related age-related macular degeneration in adults, only if, in the eye drug macular degeneration to be treated: the best-corrected visual acuity is between 6/12 and Commissioning: CCG, 6/96 tariff excluded there is no permanent structural damage to the central fovea the lesion size is less than or equal to 12 disc areas in greatest linear dimension and there is recent presumed disease progression (for example, blood vessel growth, as shown by fluorescein angiography, or recent visual acuity changes). It is recommended only if the company provides brolucizumab according to the commercial arrangement. If patients and their clinicians consider brolucizumab to be one of a range of suitable treatments, including aflibercept and ranibizumab, choose the least expensive (taking into account administration costs and commercial arrangements). Only continue brolucizumab in people who maintain an adequate response to therapy. Criteria for stopping should include persistent deterioration in visual acuity and identification of anatomical changes in the retina that indicate inadequate response to therapy. 2. TA675: Vernakalant for NICE is unable to make a recommendation about the Not listed No cost impact to CCGs as appraisal terminated by the rapid conversion of use in the NHS of vernakalant for the rapid conversion NICE and insufficient evidence to approve use. -
Pathological Mechanisms and Modern Pharmacologic Therapies
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by espace@Curtin Bone Research www.nature.com/boneres REVIEW ARTICLE OPEN Rheumatoid arthritis: pathological mechanisms and modern pharmacologic therapies Qiang Guo1,2, Yuxiang Wang1, Dan Xu2,3, Johannes Nossent3,4, Nathan J. Pavlos2 and Jiake Xu2 Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease that primarily affects the lining of the synovial joints and is associated with progressive disability, premature death, and socioeconomic burdens. A better understanding of how the pathological mechanisms drive the deterioration of RA progress in individuals is urgently required in order to develop therapies that will effectively treat patients at each stage of the disease progress. Here we dissect the etiology and pathology at specific stages: (i) triggering, (ii) maturation, (iii) targeting, and (iv) fulminant stage, concomitant with hyperplastic synovium, cartilage damage, bone erosion, and systemic consequences. Modern pharmacologic therapies (including conventional, biological, and novel potential small molecule disease-modifying anti-rheumatic drugs) remain the mainstay of RA treatment and there has been significant progress toward achieving disease remission without joint deformity. Despite this, a significant proportion of RA patients do not effectively respond to the current therapies and thus new drugs are urgently required. This review discusses recent advances of our understanding of RA pathogenesis, disease modifying drugs, and provides perspectives on next generation therapeutics for RA. Bone Research (2018) 6:15 ; https://doi.org/10.1038/s41413-018-0016-9 INTRODUCTION manifestations such as keratitis, pulmonary granulomas (rheuma- Rheumatoid arthritis (RA) is a chronic systemic autoimmune toid nodules), pericarditis/pleuritis, small vessel vasculitis, and disease that arises more frequently in females than males, being other non-specific extra-articular symptoms will develop. -
Promising Therapeutic Targets for Treatment of Rheumatoid Arthritis
REVIEW published: 09 July 2021 doi: 10.3389/fimmu.2021.686155 Promising Therapeutic Targets for Treatment of Rheumatoid Arthritis † † Jie Huang 1 , Xuekun Fu 1 , Xinxin Chen 1, Zheng Li 1, Yuhong Huang 1 and Chao Liang 1,2* 1 Department of Biology, Southern University of Science and Technology, Shenzhen, China, 2 Institute of Integrated Bioinfomedicine and Translational Science (IBTS), School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China Rheumatoid arthritis (RA) is a systemic poly-articular chronic autoimmune joint disease that mainly damages the hands and feet, which affects 0.5% to 1.0% of the population worldwide. With the sustained development of disease-modifying antirheumatic drugs (DMARDs), significant success has been achieved for preventing and relieving disease activity in RA patients. Unfortunately, some patients still show limited response to DMARDs, which puts forward new requirements for special targets and novel therapies. Understanding the pathogenetic roles of the various molecules in RA could facilitate discovery of potential therapeutic targets and approaches. In this review, both Edited by: existing and emerging targets, including the proteins, small molecular metabolites, and Trine N. Jorgensen, epigenetic regulators related to RA, are discussed, with a focus on the mechanisms that Case Western Reserve University, result in inflammation and the development of new drugs for blocking the various United States modulators in RA. Reviewed by: Åsa Andersson, Keywords: rheumatoid arthritis, targets, proteins, small molecular metabolites, epigenetic regulators Halmstad University, Sweden Abdurrahman Tufan, Gazi University, Turkey *Correspondence: INTRODUCTION Chao Liang [email protected] Rheumatoid arthritis (RA) is classified as a systemic poly-articular chronic autoimmune joint † disease that primarily affects hands and feet. -
A Closer Look at JAK/STAT Signaling Pathway Emira Bousoik Chapman University
Chapman University Chapman University Digital Commons Pharmacy Faculty Articles and Research School of Pharmacy 7-31-2018 “Do We Know Jack” About JAK? A Closer Look at JAK/STAT Signaling Pathway Emira Bousoik Chapman University Hamidreza Montazeri Aliabadi Chapman University, [email protected] Follow this and additional works at: https://digitalcommons.chapman.edu/pharmacy_articles Part of the Amino Acids, Peptides, and Proteins Commons, Cancer Biology Commons, Cell Anatomy Commons, Cell Biology Commons, Enzymes and Coenzymes Commons, Oncology Commons, and the Other Pharmacy and Pharmaceutical Sciences Commons Recommended Citation Bousoik E, Montazeri Aliabadi H. “Do we know jack” about JAK? A closer look at JAK/STAT signaling pathway. Front. Oncol. 2018;8:287. doi: 10.3389/fonc.2018.00287 This Article is brought to you for free and open access by the School of Pharmacy at Chapman University Digital Commons. It has been accepted for inclusion in Pharmacy Faculty Articles and Research by an authorized administrator of Chapman University Digital Commons. For more information, please contact [email protected]. “Do We Know Jack” About JAK? A Closer Look at JAK/STAT Signaling Pathway Comments This article was originally published in Frontiers in Oncology, volume 8, in 2018. DOI: 10.3389/ fonc.2018.00287 Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 License. Copyright The uthora s This article is available at Chapman University Digital Commons: https://digitalcommons.chapman.edu/pharmacy_articles/590 -
Jyseleca, INN-Filgotinib
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Jyseleca 100 mg film-coated tablets Jyseleca 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Jyseleca 100 mg film-coated tablets Each film-coated tablet contains filgotinib maleate equivalent to 100 mg of filgotinib. Excipient with known effect Each 100 mg film-coated tablet contains 76 mg of lactose (as monohydrate). Jyseleca 200 mg film-coated tablets Each film-coated tablet contains filgotinib maleate equivalent to 200 mg of filgotinib. Excipient with known effect Each 200 mg film-coated tablet contains 152 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Jyseleca 100 mg film-coated tablets Beige 12 × 7 mm, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “100” on the other side. Jyseleca 200 mg film-coated tablets Beige 17 × 8 mm, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “200” on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). -
Study Protocol
~ GILEAU CLINICAL STUDY PROTOCOL Study Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Althritis on Background Therapy with Methotrexate Sponsor: Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 INDNumber: IND 123903 EudraCT Number: 2016-001496-75 Clinical Trials.gov Identifier: TBD Indication: Rheumatoid Arthritis Protocol ID: GS-US-379-1582 Gilead Clinical Name: TomDoan Program Manager: Telephone: PPD Gilead Medical Name: Franziska Matzkies Monitor: Telephone: PPD Fax: PPD Mobile: PPD Protocol Version/Date: Original: 08 April 2016 Amendment 1: 27 Jlme 2016 CONFIDENTIALITY STATEMENT The infonnation contained in this document, pruticularly unpublished data, is the prope1ty or under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The infmmation is only to be used by you in connection with authorized clinical studies of the investigational dmg described in the protocol. You will not disclose any of the infmmation to others without written authorization from Gilead Sciences, Inc., except to the extent necessa1y to obtain inf01med consent from those persons to whom the dmg may be administered. GS-9876 Protocol GS-US-379-1582 Gilead Sciences, Inc. Amendment 1 TABLE OF CONTENTS TABLE OF CONTENTS ..............................................................................................................................................2 -
CHMP Agenda of the 19-22 April 2021 Meeting
28 July 2021 EMA/CHMP/220334/2021 Corr.11 Human Medicines Division Committee for medicinal products for human use (CHMP) Agenda for the meeting on 19-22 April 2021 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes 19 April 2021, 09:00 – 19:30, virtual meeting/ room 1C 20 April 2021, 08:30 – 19:30, virtual meeting/ room 1C 21 April 2021, 08:30 – 19:30, virtual meeting/ room 1D 22 April 2021, 08:30 – 19:00, virtual meeting/ room 1C Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). 1 Correction in section 8.1.1 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021.