DOCSLIB.ORG

Atopic Dermatitis 9

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Atopic Dermatitis 9 An Update on Drugs in Dermatology 2020 – 2021 Charles W. Lynde, MD, FRCPC, DABD Medical Director, The Lynde Institute for Dermatology & Lynderm Research Inc. Associate Professor, University of Toronto, Department of Medicine Dr. Charles W. Lynde has been a speaker, consultant and/or private investigator for: AbbVie, Allergan, Amgen, Aralez, Arcutis, Bausch Health, Bayer, Boehringer Ingelheim, Celgene, Cipher, Dermavant, Eli Lilly, Galderma, Genentech, Glenmark, GSK, Innovaderm, Janssen, Kyowa, L’Oreal, LeoPharma, Merck, Medexus, Mylan, Novartis, Pediapharm, Pfizer, Procter and Gamble, Roche, Sandoz, Sanofi Adventis, Sanofi Genzyme, Stiefel, TEVA, Valeant. Objectives 1.To be familiar with the key dermatological therapeutics of 2020 and what’s in the pipeline 2.To translate this information into changing dermatologic clinical practice Disrupter of 2020: COVID-19 COVID-19 has changed the way we practice medicine, how clinical trials operate and our personal lives Overview 1.Vaccines 8. Skin Cancer 2.Atopic Dermatitis 9. Vitiligo 3.Psoriasis 10. Alopecia 4.Palmoplantar Pustulosis 11. Anesthetic 5.Hidradenitis Suppurativa 12. Urticaria 6.Hand Dermatitis 7.Acne Vaccines Vaccines for COVID-19 As of November 2nd 2020 As of November 2nd 2020 there were there are 254 Active, Upcoming or 1,989 Active, Upcoming or Recruiting Trials Recruiting Trials and 273 Total Trials listed under listed under Vaccines COVID-19 on clinicaltrials.gov on clinicaltrials.gov 12.8% of all active, upcoming or recruiting vaccine trials are for COVID-19 Atopic Dermatitis Atopic Dermatitis As of November 2019 there As of October 30, 2020 there were are 855 trials 961 trials listed under listed under Atopic Dermatitis Atopic Dermatitis on clinicaltrials.gov on clinicaltrials.gov Atopic Dermatitis •New biologics •New small molecules •New topicals Pathogenesis Guttman-Yassky, Emma, et al. “New Era of Biologic Therapeutics in Atopic Dermatitis.” Expert Opinion on Biological Therapy, vol. 13, no. 4, 2013, pp. 549–561., doi:10.1517/14712598.2013.758708. Atopic Dermatitis Marked ….. ? the Barrier most Interpla Defect y important Microbio Immune me Defects Moisturizers • May be sufficient for mild disease • Should be applied liberally and often • Choice depends on individual preference • Should be effective, free of potential sensitizers, inexpensive TikTok Famous Biologics for Atopic Dermatitis • Dupilumab • September 2019: NOC Health Canada for > 12 years • May 2020: FDA Approval for 6-11 years • ANB020 • GBR 830-204 • KHK4083 • Tralokinumab • Lebrikizumab • Nemolizumab • Tezepelumab Dupilumab Phase 3 Trial: (LIBERTY AD PEDS) ≥ 6 to < 12 y/o IGA (0,1) at Week 161 EASI-75 at Week 161 100% †P=0.0004 100% ‡P<0.0001 ‡P<0.0001 80% 80% 67% 70% 60% 60% 40% 40% 33% 30% 27% Percentage of Patients Percentage of Patients 20% 20% 11% 0% 0% Placebo Dupilumab Dupilumab Placebo Dupilumab Dupilumab 100/200 mg 300 mg 100/200 mg 300 mg q2w q4w q2w q4w These data represent interim results from the trial. The efficacy and safety of dupilumab in children below the age of 12 have not currently been reviewed by a regulatory authority. EASI-75, improvement of ≥75% on Eczema Area and Severity Index score; IGA, Investigator’s Global Assessment; q2w, every 2 weeks; q4w, every 4 weeks. 1. Sanofi. https://www.sanofi.com/en/media-room/press-releases/2019/2019-08-06-07-05-00. Accessed August 6, 2019. GZCA.DUP.20.05.0158 Dupilumab Other Investigations • Severe Chronic Hepatic • Safety in Pregnancy Pruritus • Eosinophilic Esophagitis • Rhinosinunitis in Sleep Apnea • Localized Scleroderma Patients • Asthma • Severe Chronic Hand Eczema • Bullous Pemphigoid • Aspirin Excerbated Respiratory Disease • Prurigo Nodularis • Peanut Allergy • Atopic keratoconjunctivits ANB020 / Etokimab (Anaptysbio) • Indication: Moderate-to-Severe AD • MoA: IL-33 Inhibitor • Active: • Phase 2: A Study Investigating the Efficacy, Safety, and PK Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe AD (ATLAS) • Other indications being investigated: Eosinophilic Asthma, Peanut Allergy, Chronic Rhinosinusitis ClinicalTrials.gov GBR 830 / GBR 830-204 (Glenmark) • Indication: Atopic Dermatitis • MoA: IgG1 antibody specific for OX40 (CD134) • Active: • Phase 2b: Treatment of Adult Subjects • Administration: Subcutaneous injection • Other indications being investigated: None ClinicalTrials.gov KHK4083 (Kyowa) • Indication: Atopic Dermatitis • MoA: Anti OX40 Monoclonal Antibody • Active: • Phase 2: Treatment of Adult Subjects • Administration: Subcutaneous injection • Other indications being investigated: Ulcerative Colitis ClinicalTrials.gov Tralokinumab (LEOPharma) • Indication: Atopic Dermatitis • Expected Launch: US (FDA) ? Q2 2021 • MoA: IL-13 Inhibitor • Currently Recruiting / Upcoming: • Phase 2: Skin Barrier Function • Phase 3: In Combination with Topical Corticosetoids • Phase 3: Long Term Extension • Administration: subcutaneous injection • Other indications being investigated: alopecia areata, ulcerative colitis, asthma, pulmonary fibrosis COMING SOON ClinicalTrials.gov Lebrikizumab / DRM 06 (Dermira) • Indication: Atopic Dermatitis • MoA: IL-13 Inhibitor • Currently Recruiting: • Phase 3: Long-term Safety and Efficacy • Phase 3: Efficacy and Safety in Adults • Phase 3: Safety and Efficacy of in Adolescents • Phase 3: In Combination with Topical Corticosteroid • Administration: subcutaneous injection loading dose, followed by Q2W or Q4W • Other indications being investigated: Asthma, COPD, Idiopathic Pulmonary Fibrosis ClinicalTrials.gov Nemolizumab / CD14152 • Indication: Atopic Dermatitis • MoA: IL-31 Inhibitor • Currently Recruiting: • Phase 3: Long-term Safety and Efficacy • Phase 3: Efficacy and Safety in Adults • Phase 3: Safety and Efficacy of in Adolescents and Adults • Administration: subcutaneous injection • Other indications being investigated: prurigo nodularis ClinicalTrials.gov Tezepelumab / Amgen 20170755 (AMGEN) • Indication: Atopic Dermatitis • MoA: TSLP (Thymic Stromal Lymphopoietin) Inhibitor • STOPPED JULY 2020 – DID NOT MEET PRIMARY ENDPOINTS • Phase 2b: A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy • Administration: Subcutaneous injection with a treatment period of 52 weeks • Other indications being investigated: Severe Asthma, Asthma, COPD, Bronchial Disease, Respiratory Tract Diseases, and Respiratory Hypersensitivity, Chronic Spontaneous Urticaria ClinicalTrials.gov In 2018 we met JA(C)K (Lynde) Last year JAK was older and wiser This year JAK is in JK… he has matured Small Molecules • Abrocitinib – JAK-1 Inhibitor • Baricitinib – Selective JAK-1 Inhibitor • Brepocitinib – TYK2/JAK1 • LEO LP0190 – H4 Inhibitor • Upadacitinib – Selective JAK-1 Inhibitor • ZPL389 – H4 Inhibitor PF-04965842 / Abrocitinib (Pfizer) • Indication: Moderate-to-Severe AD • MoA: JAK-1 Inhibitor • Recruiting / Active: • Phase 3: Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy • Phase 3: Without Topical Medications in Subjects Aged 12 Years and Older • Other indications being investigated: Hepatic Impairment, Psoriasis • Launch: ? Q2 2021 “Search of: PF-04965842 - List Results.” Search of: PF-04965842 - List Results - ClinicalTrials.gov, clinicaltrials.gov/ct2/results?cond=&term=PF-04965842&cntry=&state=&city=&dist=. Non-head-to-head comparison of various novel treatment efficacy for moderate to severe AD EASI 75 (Week 12*/16) PBO UPA 7.5mg UPA 15mg UPA 30mg Column3 UPA 7.5mg2 UPA 15mg3 UPA 30mg4 Column1 PBO4 Abro 100mg Abro 200mg Column15 PF5842 100mg2 PF5842 200mg23 Column12 PBO2 SOLO 1 Dupi Q2W PBO3 SOLO 2 Dupi Q2W Column4 SOLO 1 Dupi Q2W2 SOLO 2 Dupi Q2W2 Column2 PBO42 Bari 2mg Bari 4mg Column5 Bari 2mg6 Bari 4mg7 100% MONOTHERAPY STUDY MONOTHERAPY STUDY MONOTHERAPY STUDIES COMBO STUDY WITH Phase 2 Phase 3 Phase 2 VARIABLE TCS USE IN PBO & BARI GROUPS Phase 2 75% 50% 25% 0% RAW DATA PLACEBO ADJ RAW DATA PLACEBO ADJ RAW DATA PLACEBO ADJ RAW DATA PLACEBO ADJ RINVOQ ABROCITINIB* DUPILUMAB BARICITINIB For Reference Only: Not From Head to Head Trials. Dupilumab Phase 3 vs Upadacitinib Phase 2 vs Baricitinib Phase 2 vs Abrocitinib Phase 2 Baricitinib / LY3009104 (Eli Lilly) • Indication: Moderate-to-Severe AD • Administration: Oral • MoA: JAK1/2 Inhibitor • Recruiting / Active: • Phase 3: Children and Adolescents With Atopic Dermatitis • Phase 3: With Topical Corticosteroids in Adults That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine • Phase 3: A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis (BREEZE-AD3) • Other indications being investigated: RA, Giant Cell Areritis, Liver Disease, AA • Launch: ? Q4 2020 / 2021 ClinicalTrials.gov Brepocitinib / PF-06700841 (Pfizer) • Indication: Moderate-to-Severe AD • Administration: Oral • MoA: TKY2/JAK1 • Completed: • Phase 2: Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis • Other indications being investigated: SLE, Crohn’s, PsO, PsA, UC, AA ClinicalTrials.gov Upadacitinib / M16-045 (Abbvie) • Indication: Moderate-to-Severe AD • Administration: Oral dose with a treatment period of 16 weeks and a blinded extension period up to 3 years • MoA: JAK-1 Selective Inhibitor • Recruiting / Active: • Phase 3: Open-Label Extension Study • Phase 3: Evaluation of Upadacitinib in Adolescent and Adult Patients • Phase 3: In Combination With Topical Corticosteroids in Adolescent and Adult Participants
Load more

Recommended publications
  • WO 2015/063180 Al 7 May 2015 (07.05.2015) P O P C T
    (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 2015/063180 Al 7 May 2015 (07.05.2015) P O P C T (51) International Patent Classification: (74) Agent: WILLIAMS, Rachel; Novozymes Biopharma UK A61K 39/00 (2006.01) C07K 16/00 (2006.01) Ltd., Castle Court, 59 Castle Boulevard, Nottingham Not A61K 39/395 (2006.01) tinghamshire NG7 1FD (GB). (21) International Application Number: (81) Designated States (unless otherwise indicated, for every PCT/EP2014/073261 kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (22) International Filing Date: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, 29 October 2014 (29.10.2014) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (25) Filing Language: English HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (26) Publication Language: English MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (30) Priority Data: PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 13 190750.3 29 October 2013 (29. 10.2013) EP SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 14166865.7 2 May 2014 (02.05.2014) EP TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (71) Applicant: NOVOZYMES BIOPHARMA DK A S (84) Designated States (unless otherwise indicated, for every [DK/DK]; Krogshoejvej 36, DK-2880 Bagsvaerd (DK).
    [Show full text]
  • Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
    Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models.
    [Show full text]
  • Novartis R&D and Investor Update
    Novartis AG Investor Relations Novartis R&D and investor update November 5, 2018 Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” “agreement to acquire,” or similar expressions, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this presentation, or regarding potential future revenues from such products, or regarding the proposed acquisition of Endocyte, Inc. (Endocyte) by Novartis including the potential outcome and expected timing for completion of the proposed acquisition, and the potential impact on Novartis of the proposed acquisition, including express or implied discussions regarding potential future sales or earnings of Novartis, and any potential strategic benefits, synergies or opportunities expected as a result of the proposed acquisition. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this presentation will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future.
    [Show full text]
  • New Drug Evaluation Monograph Template
    © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-2596 OHSU Drug Effectiveness Review Project Summary Report – Targeted Immune Modulators for Autoimmune Conditions Date of Review: October 2020 Date of Last Review: February 2020 Literature Search: 1/1/20 – 6/28/20 Current Status of PDL Class: See Appendix 1. Purpose: New comparative evidence for existing biologics for autoimmune conditions will be reviewed as presented in 3 Drug Effectiveness Review Project (DERP) systematic reviews focused on safety and efficacy of targeted immune modulators (TIMS) to treat ankylosing spondylitis (AS), rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), Crohn’s disease (CD), and ulcerative colitis (UC). Research Questions: 1. What is the comparative effectiveness of TIMs for alleviating symptoms and stabilizing disease in patients with RA, AS, PsO, PsA, CD and UC? 2. What are the comparative harms of TIMs when used to treat RA, AS, PsO, PsA, CD, and UC? 3. Do the included drugs differ in their effectiveness or harms in the following subgroups: age and racial groups, gender, patients with comorbidities, patients taking other commonly prescribed drugs, or in patients with early vs. established disease? Conclusions: Targeted Immune Modulators for Rheumatoid Arthritis and Ankylosing Spondylitis Most comparisons for the safety and efficacy of TIMs in RA are limited to single trials.1 Moderate- or high-quality of evidence (QoE) indicates that baricitinib, sarilumab, and upadacitinib are more effective than adalimumab as first-line treatments for RA.1 In a fair-quality, multi-center, double-blind randomized clinical trial (RCT) comparing adalimimumab with baricitinib (n=1,305), adalimumab was less effective than baricitinib for achieving response American College of Rheumatology (ACR) response (ACR20, 61% vs.
    [Show full text]
  • PDCO Minutes of Meeting 18-21 May 2021
    21 May 2021 EMA/PDCO/298607/2021 Human Medicines Division Paediatric Committee (PDCO) Minutes for the meeting on 18-21 May 2021 Chair: Koenraad Norga – Vice-Chair: Sabine Scherer Virtual Meeting Disclaimers Some of the information contained in this set of minutes 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 PDCO Committee meeting reports (after the PDCO Opinion is adopted), and on the Opinions and decisions on paediatric investigation plans webpage (after the EMA Decision is issued). Of note, this set of minutes is a working document primarily designed for PDCO members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes 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). 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.
    [Show full text]
  • Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
    CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products.
    [Show full text]
  • Atopic Dermatitis (AD)
    This activity is provided by PRIME Education. There is no fee to participate. This activity is supported by education grants from AbbVie, Inc., Sanofi Genzyme and Regeneron Pharmaceuticals. © 2019 PRIME® Education, LLC. All Rights Reserved.. Overview This downloadable fact‐sheet provides an easy‐to‐follow collection of the latest evidence shaping the treatment and management of psoriasis (PsO) and atopic dermatitis (AD). Learn about validated tools, evidence‐based strategies, and new and emerging targeted therapies that can be incorporated in daily practice to improve outcomes for patients with these conditions. © 2019 PRIME® Education, LLC. All Rights Reserved.. 2 1 Learning Objectives • Identify major barriers to evidence‐based treatment and management in federal and public sectors • Implement appropriate methods for diagnosis and assessment of disease activity • Assess current evidence on targeted biologic and small‐molecule therapies to guide treatment decisions for patients with moderate to severe disease • Monitor treatment responses according to treat‐to‐target principles and methods • Apply current evidence and guidelines to inform treatment decisions for patients with inadequate responses to initial therapies • Incorporate patient‐reported outcomes and shared decision‐making into clinical practice • Apply effective strategies for multidisciplinary care coordination and shared patient management © 2019 PRIME® Education, LLC. All Rights Reserved.. 3 Accreditation In support of improving patient care, PRIME® is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team, and learners will receive 2.25 Interprofessional Continuing Education (IPCE) credits for learning and change.
    [Show full text]
  • Investor Presentation
    Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Q1 2021 Results Investor presentation 1 Investor Relations │ Q1 2021 Results Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on certain therapeutic areas including dermatology, ophthalmology, our breast cancer portfolio, some newly launched brands and the Sandoz retail and anti-infectives business, and on drug development operations; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our collaboration with Molecular Partners to develop, manufacture and commercialize potential medicines for the prevention and treatment of COVID- 19 and our joining of the industry-wide efforts to meet global demand for COVID-19 vaccines and therapeutics by leveraging our manufacturing capacity and capabilities to support the production of the Pfizer-BioNTech vaccine and to manufacture the mRNA and bulk drug product for the vaccine candidate CVnCoV from CureVac.
    [Show full text]
  • Conference Reportpeer-Reviewed
    Medicom International Conference Series in Dermatology 28th EADV Congress European Academy of Dermatology and Venereology 9-13 october 2019 • Madrid • Spain EVIEWED R PEER- CONFERENCE CONFERENCE REPORT Late-Breaking News Emerging Therapies Spotlight on Psoriasis JAK inhibitors are a fascinating The IL-4/IL-13 blocker dupilumab Ten-year data from the ESPRIT novel drug class entering the der- leads to rapid itch reduction in registry shows the importance of matologic arena. The JAK1 and adolescents. The safety profile is achieving good control of moderate- JAK2 inhibitor baricitinib showed similar to that in adults. to-severe psoriasis. to be effective in patients with moderate-to-severe atopic derma- titis in a phase 3 trial. read more on PAGE 5 read more on PAGE 10 read more on PAGE 13 Editor Peter van de Kerkhof, Radboud University Medical Center, the Netherlands MEDIC AL PUBLISHERS Contents Letter from the Editor 3 Late-Breaking News 3 IL-17A blocker effective in paediatric psoriasis patients 3 Rituximab beats mycophenolate mofetil in pemphigus vulgaris COLOPHON 4 Novel JAK1/2 inhibitor shows remarkable efficacy in alopecia areata Editor Prof. Peter van de Kerkhof Radboud University Medical Center, 5 Acne highly influenced by climate, pollutants, and unhealthy diet the Netherlands 5 JAK inhibition plus TCS lead to high clearance rates in AD Advisory Board Prof. Margarida Gonçalo 6 No cancer risk with long-term use of calcineurin inhibitor in Coimbra University Hospital, Portugal children with AD Dr Tom Hillary UZ Leuven, Belgium 7 Green
    [Show full text]
  • Smoldering Inflammation in Cardio-Immune-Metabolic Disorders
    EDITORIAL published: 19 March 2021 doi: 10.3389/fphys.2021.651946 Editorial: Smoldering Inflammation in Cardio-Immune-Metabolic Disorders Gilda Varricchi 1,2,3*, Nazareno Paolocci 4,5, Felice Rivellese 6 and Giuseppe Rengo 1,7 1 Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy, 2 Center for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, Italy, 3 Institute of Experimental Endocrinology and Oncology (IEOS), National Research Council, Naples, Italy, 4 Division of Cardiology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States, 5 Department of Biomedical Sciences, University of Padova, Padova, Italy, 6 Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom, 7 Istituti Clinici Scientifici Maugeri SpA Società Benefit, Telese Terme, Italy Keywords: allergic disorders, diabetes, obesity, low grade inflammation, sinovitis, IL-5, mast cells, Alzheimer’s disease Editorial on the Research Topic Smoldering Inflammation in Cardio-Immune-Metabolic Disorders “If many remedies are prescribed for an illness, you may be certain that the illness has no cure.” Anton Chekhov - The Cherry Orchard - Smoldering or low-grade inflammation plays a pivotal role in both physiological and pathological conditions (Calder et al., 2017; Zelechowska et al., 2018; Ronnback and Hansson, 2019). Aging is accompanied by
    [Show full text]
  • Downloaded Here
    Antibodies to Watch in a Pandemic Dr. Janice M. Reichert, Executive Director, The Antibody Society August 27, 2020 (updated slides) Agenda • US or EU approvals in 2020 • Granted as of late July 2020 • Anticipated by the end of 2020 • Overview of antibody-based COVID-19 interventions in development • Repurposed antibody-based therapeutics that treat symptoms • Newly developed anti-SARS-CoV-2 antibodies • Q&A 2 Number of first approvals for mAbs 10 12 14 16 18 20 Annual first approvals in either the US or EU or US the either in approvals first Annual 0 2 4 6 8 *Estimate based on the number actually approved and those in review as of July 15, with assumption of approval on the first c first the on of approval assumption 15, with as July of review in those and approved actually number the on based *Estimate Tables of approved mAbs and antibodies in review available at at mAbs ofand available in antibodies approved review Tables 1997 98 99 2000 01 02 03 Year of first US or EU approval or EU US of first Year 04 05 06 https://www.antibodysociety.org/resources/approved 07 08 09 10 11 12 13 14 15 Non-cancer Cancer 16 - antibodies/ 17 ycl 18 e. 19 2020* First approvals US or EU in 2020 • Teprotumumab (Tepezza): anti-IGF-1R mAb for thyroid eye disease • FDA approved on January 21 • Eptinezumab (Vyepti): anti-CGRP IgG1 for migraine prevention • FDA approved on February 21 • Isatuximab (Sarclisa): anti-CD38 IgG1 for multiple myeloma • FDA approved on March 2, also approved in the EU on June 2 • Sacituzumab govitecan (Trodelvy): anti-TROP-2 ADC for triple-neg.
    [Show full text]
  • Emerging Therapies in Psoriasis: a Systematic Review
    CLINICAL REVIEW Emerging Therapies In Psoriasis: A Systematic Review Erica B. Lee, BS; Mina Amin, BS; Tina Bhutani, MD; Jashin J. Wu, MD soriasis is a chronic, autoimmune-mediated disease PRACTICE POINTS estimated to affect 2.8% of the US population.1 The pathogenesis of psoriasis is thought to involve a • Tumor necrosis factor α, I L-23, and IL-17A are key P targets for psoriasis therapy based on an under- complex process triggered by a combination of genetic standing of the key role that these cytokines play and environmental factors that induce tumor necrosis in the pathophysiology of disease. factor (TNF) α secretion by keratinocytes, which in turn • The biologic agents secukinumab and ixekizumab activates dendritic cells. Activated dendritic cells produce 2,3 are approved for use in the management of pso- IL-23, leading to helper T cell (TH17) differentiation. riasis. Other biologics—brodalumab, bimekizumab, TH17 cells secrete IL-17A, which has been shown to pro- guselkumab, tildrakizumab, risankizumab, and cer- mote psoriatic skincopy changes.4 Therefore, TNF-α, IL-23, tolizumab pegol—have been (and some continue to and IL-17A have been recognized as key targets for pso- be) the focus of phase 2 and phase 3 clinical trials. riasis therapy. • Findings of several of those trials support the idea that The newest biologic agents targeting IL-17– therapies targeting IL-23, specifically its p19 subunit, mediated pathways include ixekizumab, brodalumab, but that spare IL-12 are effective against psoriasis. andnot bimekizumab. Secukinumab, the first US Food and • Longer-term studies are needed to determine whether Drug Administration (FDA)–approved IL-17 inhibitor, the agents reviewed here, including those approved for has been available since 2015 and therefore is not clinical use, are suitable for prolonged administration.
    [Show full text]