DOCSLIB.ORG

Rising IBD Rates in Minorities Heighten Need for Awareness

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Rising IBD Rates in Minorities Heighten Need for Awareness mdedge.com/gihepnews December 2020 Volume 14 / Number 12 Start CRC screening INSIDE GI ONCOLOGY at age 45, USPSTF Task force report Best practices noted for managing malignant now suggests colorectal polyps. • 16 LIVER DISEASE BY ROXANNE NELSON, that all adults aged 45-75 RN, BSN years be screened for CRC. Semaglutide shows ARNES This is an “A” recom- promise in NASH study B creening for colo- mendation for adults aged Phase 2 data show rectal cancer (CRC) 50-75 and a “B” recom- resolution TEPHANIE S Sshould begin at age mendation for adults aged in 60%. • 27 45 years instead of 50 45-49. Dr. Barry explained OURTESY IBD AND INTESTINAL C years, as recommended that the reason for this Dr. Edward L. Barnes and his associates noted that disparities in care in the current guideline, difference is that the DISORDERS start with later diagnosis of IBD, followed by issues with continuity. the U.S. Preventive Ser- Tool predicted vices Task Force said in 45- to 49-year age group. vedolizumab a draft recommendation “Butbenefit there’s is smaller not much for the nonresponse that is open for public difference between A and Rising IBD rates in comment. B from a practical stand- Point-based scoring “This is the only change point,” he explained. system uses clinical minorities heighten that was made,” said task For adults aged 76-85, variables. • 30 force member Michael PRACTICE Barry, MD, director of of screening need to be need for awareness the Informed Medical weighedthe benefits against and harmsthe indi- MANAGEMENT Decisions Program in the vidual’s overall health and Delay in Stark reform BY AMY KARON wrote Edward L. Barnes, Health Decision Sciences personal circumstances. stunts value-based care MDedge News MD, MPH, of University of Center at Massachusetts This is a “C” recommenda- CMS dragging North Carolina at Chapel General Hospital, Boston. tion. its feet. • 34 - Hill, with his associates. The recommendation is See USPSTF · page 16 ease (IBD) is rapidly in- However, Blacks with IBD Icreasingnflammatory among bowel racial dis and tend to be diagnosed later ethnic minorities, which than Whites, are less likely makes it important to con- to receive recommended Study IDs microbial signature of sider for patients with com- biologics and immunomod- patible symptoms, experts ulators, and are more likely celiac disease in children wrote in Gastroenterology. to receive care at an emer- Crohn’s disease and ul- gency department, to expe- BY AMY KARON healthy children, accord- regardless of whether cerative colitis are “chronic rience delays in colectomy, MDedge News ing to the findings of a children were newly diag- diseases with intermittent and to miss regular visits to study published in Gastro- nosed or had already mod- - IBD specialists because of leven operational tax- enterology. sion, so access to specialists, Eonomic units (OTUs) This microbial signa- Konstantina Zafeiropoulou appropriateperiods of flare therapies, and remis and barriers, they added. of fecal bacteria were andified Ben their Nichols, diet, reported PhD, of frequent follow-up visits financialThese disparities and transportation are less abundant in children approximately four out of - are vital to good outcomes,” See Minorities · page 28 with celiac disease than in ture correctly identified See Celiac · page 9 the Glasgow Royal Infir five cases of celiac disease, CROHN’S & COLITIS CONGRESS® Connecting Virtually | January 21–24, 2021 Rosemont, IL 60018 IL Rosemont, PERMIT 500 PERMIT Suite 280 Suite HARRISBURG PA HARRISBURG PAID 10255 W Higgins Road, Road, Higgins W 10255 U.S. POSTAGE U.S. REGISTER TODAY. www.crohnscolitiscongress.org GI & Hepatology News Hepatology & GI PRSRT STD PRSRT CHANGE SERVICE REQUESTED SERVICE CHANGE 01_09_to_17_28_31_GIH20_12.indd 1 11/20/2020 3:42:15 PM Not an injection, not an infusion2 • XELJANZ is available in 5 mg or 10 mg twice-daily doses I 2 ORAL • XELJANZ XR is available in 11 mg or 22 mg once-daily doses THE FIRST AND ONLY FDA-APPROVED ORAL JAK INHIBITOR See dosage adjustments in XELJANZ/XELJANZ XR full prescribing information. FOR MODERATELY TO SEVERELY ACTIVE UC1,2 XELJANZ/XELJANZ XR In two 8-week induction studies1,2,a • OCTAVE 1: 18% of patients taking XELJANZ 10 mg twice daily achieved remissionb vs 8% on placebo; P<0.01 (primary endpoint) A MARK OF b 1,2 • OCTAVE 2: 17% of patients taking XELJANZ 10 mg twice daily achieved remission vs I RAPID 4% on placebo; P<0.001 (primary endpoint) Reductions in rectal bleeding and stool frequency2 • Decreases in rectal bleeding and stool frequency Mayo subscores were observed as early as Week 2 in patients treated with XELJANZ (exploratory endpoint) RAPID, POWERFUL, AND SUSTAINED RESULTS IN UC1,2 In a 52-week maintenance study1,2,c I POWERFUL • 41% on XELJANZ 10 mg twice daily and 34% on XELJANZ 5 mg twice daily achieved remissionb AND (primary endpoint) vs 11% on placebo; P<0.0001d SUSTAINED1,2 • 47% on XELJANZ 10 mg twice daily and 35% on XELJANZ 5 mg twice daily achieved sustained corticosteroid-free remissione (key secondary endpoint) vs 5% on placebo; P<0.0001f LEARN MORE AT XELJANZRESULTS.COM Not an actual patient. Pill not to scale. INDICATION In the UC population, XELJANZ 10 mg twice daily was associated Study Designs for OCTAVE 1, OCTAVE 2, and OCTAVE Sustain (UC-I, UC-II, and UC-III)2: The OCTAVE clinical program included 3 phase 3, randomized, • XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment with greater risk of serious infections compared to 5 mg twice double-blind, placebo-controlled clinical trials. In OCTAVE 1 and 2, two identical, 8-week induction studies, 1139 patients with moderately to severely active of adult patients with moderately to severely active ulcerative daily. Opportunistic herpes zoster infections (including UC (598 and 541 patients, respectively) were randomized to XELJANZ 10 mg twice daily or placebo (4:1 ratio). Patients were required to have experienced meningoencephalitis, ophthalmologic, and disseminated treatment failure with or intolerance to at least 1 of the following agents: oral or intravenous corticosteroids, azathioprine, 6-MP, or TNF blocker. Patients were colitis (UC), who have had an inadequate response or who are permitted to use stable doses of oral aminosalicylates and corticosteroids (prednisone daily dose up to 25 mg equivalent). Concomitant immunosuppressants intolerant to TNF blockers. cutaneous) were seen in patients who were treated with b XELJANZ 10 mg twice daily. (immunomodulators or biological therapies) were not permitted. The primary endpoint was remission. In OCTAVE Sustain, a 52-week maintenance study, • Limitations of Use: Use of XELJANZ/XELJANZ XR in 593 patients who had completed the induction studies and achieved clinical response were rerandomized to XELJANZ 10 mg twice daily, XELJANZ 5 mg twice combination with biological therapies for UC or with potent The risks and benefi ts of treatment with XELJANZ/XELJANZ XR daily, or placebo (1:1:1 ratio). Patients were permitted to use stable doses of oral aminosalicylates, but initiation of corticosteroid tapering was required upon immunosuppressants such as azathioprine and cyclosporine is should be carefully considered prior to initiating therapy in patients entrance into this study for patients who were receiving corticosteroids at baseline. Concomitant immunosuppressants (immunomodulators or biological not recommended. with chronic or recurrent infection, or those who have lived or therapies) were not permitted. The primary endpoint was remission.b Sustained corticosteroid-free remissione was a key secondary endpoint. XELJANZ 5 mg traveled in areas of endemic TB or mycoses. Viral reactivation twice daily is the recommended dosage for maintenance therapy. For patients with loss of response during maintenance treatment, a dosage of 10 mg IMPORTANT SAFETY INFORMATION including herpes virus and hepatitis B reactivation have been twice daily may be considered and limited to the shortest duration. SERIOUS INFECTIONS reported. Screening for viral hepatitis should be performed in Patients treated with XELJANZ/XELJANZ XR are at increased risk accordance with clinical guidelines before starting therapy. IMPORTANT SAFETY INFORMATION (cont’d) pancreatic cancer. NMSCs have been reported in patients for developing serious infections that may lead to hospitalization Patients should be closely monitored for the development of MALIGNANCIES treated with XELJANZ. In the UC population, treatment with or death. Most patients who developed these infections were signs and symptoms of infection during and after treatment Lymphoma and other malignancies have been observed in XELJANZ 10 mg twice daily was associated with greater risk of taking concomitant immunosuppressants, such as methotrexate with XELJANZ/XELJANZ XR, including the possible development patients treated with XELJANZ. Epstein Barr Virus-associated NMSC. Periodic skin examination is recommended for patients or corticosteroids. of tuberculosis in patients who tested negative for latent post-transplant lymphoproliferative disorder has been observed who are at increased risk for skin cancer. If a serious infection develops, interrupt XELJANZ/XELJANZ XR tuberculosis infection prior to initiating therapy. at an increased rate in renal transplant patients treated with THROMBOSIS until the infection is controlled. Caution is also recommended in patients with a history of chronic XELJANZ and concomitant immunosuppressive medications. Thrombosis, including pulmonary embolism, deep venous Reported infections include: lung
Load more

Recommended publications
  • AK002), an Anti-Siglec-8 Antibody, Depletes Tissue Eosinophils and Improves Dysphagia Symptoms in Patients with Eosinophilic Esophagitis (ENIGMA Study; NCT03496571
    Lirentelimab (AK002), an Anti-Siglec-8 Antibody, Depletes Tissue Eosinophils and Improves Dysphagia Symptoms in Patients with Eosinophilic Esophagitis (ENIGMA Study; NCT03496571) Ikuo Hirano1, Kathryn A. Peterson2, Joseph A. Murray3, Evan S. Dellon4, Gary W. Falk5, Nirmala Gonsalves1, Mirna Chehade6, John Leung7, Robert M. Genta8, Paneez Khoury9, Adam C. Bledsoe3, Camilla Shaw10, Bhupinder Singh10, Alan T. Chang10, Amol P. Kamboj10, Henrik S. Rasmussen10, Marc E. Rothenberg11 1Northwestern University, Chicago, IL; 2University of Utah, Salt Lake City, UT; 3Mayo Clinic Rochester, Rochester, MN; 4University of North Carolina, Chapel Hill, NC; 5University of Pennsylvania, Philadelphia, PA; 6Icahn School of Medicine at Mount Sinai, New York, NY; 7Tufts University, Boston, MA; 8Baylor College of Medicine, Houston, TX; 9NIAID/NIH, Bethesda, MD; 10Allakos, Inc., Redwood City, CA.; 11Cincinnati Children’s Hospital, Cincinnati, OH; AAAAI 2020 Philadelphia, PA March 13th – 16th 2020 Disclosures • Dr. Ikuo Hirano is a principal investigator in ENIGMA • Lirentelimab (AK002) is an investigational drug candidate and is not FDA/EMA approved Eosinophilic Gastrointestinal Diseases (EGIDs) Eosinophilic Esophagitis (EoE) Chronic Eosinophilic Inflammation Eosinophilic Gastritis (EG) of the Stomach, Small Intestine, or Esophagus ESOPHAGUS • Eosinophils and mast cells are important STOMACH drivers of disease • Symptoms: abdominal pain, nausea, early satiety, loss of appetite, bloating, abdominal DUODENUM/ cramping, vomiting, diarrhea, and dysphagia SMALL INTESTINE
    [Show full text]
  • Antibodies to Watch in 2021 Hélène Kaplona and Janice M
    MABS 2021, VOL. 13, NO. 1, e1860476 (34 pages) https://doi.org/10.1080/19420862.2020.1860476 PERSPECTIVE Antibodies to watch in 2021 Hélène Kaplona and Janice M. Reichert b aInstitut De Recherches Internationales Servier, Translational Medicine Department, Suresnes, France; bThe Antibody Society, Inc., Framingham, MA, USA ABSTRACT ARTICLE HISTORY In this 12th annual installment of the Antibodies to Watch article series, we discuss key events in antibody Received 1 December 2020 therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The Accepted 1 December 2020 coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the KEYWORDS healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two Antibody therapeutics; anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were cancer; COVID-19; Food and authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed Drug Administration; antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 European Medicines Agency; in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the immune-mediated disorders; first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may Sars-CoV-2 be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency.
    [Show full text]
  • March 30, 2021 | Virtual Awards Program Visit to Register
    March 30, 2021 | Virtual Awards Program Visit www.clinicalresearchforum.org/2021Top10Awards to register. HONORING THE IMPORTANT WORK THAT WE ACCOMPLISH On behalf of the Clinical Research Forum Board of Directors, thank you for supporting and celebrating the achievements of the 2021 Top Ten Clinical Research Achievement Awardees. As researchers around the globe are working around the clock to find ways to stop COVID-19, we are reminded by the great and important clinical and translational research that is done every day. Under tremendous pressure, the pandemic has inspired change, innovation, clinical work and research that has elevated our field. In the midst of this, many of the studies we will honor during the awards program surmounted great time constraints and made impressive discoveries without sacrificing the science and data that legitimizes our profession. In this context, I cannot emphasize enough the pride I feel for the amazing work of all our colleagues and for clinical research as a field. Not only has the nation been dealing with the pandemic, but recent tragic actions have surfaced social justice inadequacies and systemic racism in our culture. As clinical researchers, we are well versed in health disparities and the impact racism has on health. We believe that clinical research can make important contributions to social justice and health equity, as some of our Top Ten Clinical Research Achievement Awardees have shown so brilliantly. To that end, the CR Forum Board of Directors has put together a statement and an action plan to help make a difference. Racism is a disease Americans have failed to address for four hundred years.
    [Show full text]
  • AK002) 2 Lirentelimab (AK002) Clinical Summary
    Targeting Chronic Inflammation Driven by Mast Cells and Eosinophils with Lirentelimab (AK002) 2 Lirentelimab (AK002) Clinical Summary • Lirentelimab, an anti-Siglec-8 mAb, has demonstrated activity in several inflammatory diseases – Eosinophilic Gastrointestinal Disorders: Eosinophilic gastritis (EG), duodenitis (EoD), esophagitis (EoE) – Mast Cell Gastrointestinal Diseases (MGIDs) – Chronic urticaria – Indolent systemic mastocytosis – Severe allergic conjunctivitis/atopic diseases • Strong scientific rationale for development of AK002 in additional indications – Asthma, atopic dermatitis, ulcerative colitis, and other diseases • Studies initiated in 2020 – Phase 3 study in eosinophilic gastritis and/or duodenitis – Phase 2/3 study in eosinophilic esophagitis – EGID/MGID prevalence study – AK002 subcutaneous PK/PD/safety study 3 Confidential Lirentelimab (AK002) Targets Siglec-8 on Mast Cells and Eosinophils 4 Mast Cells and Eosinophils Are Key Drivers of Inflammatory Disease Allergens Epithelium IL-33 CTIVATION AND ECRUITMENT OF THER TSLP A R O IMMUNE CELLS AND TISSUE INFLAMMATION IL- 4 IL-13 NGF, Histamine Histamine IL-5 IL-8 IL-6, TNFa T Cell B Cell Sub P IL- 4 IL-13 Sub P Neuron Smooth Muscle Eosinophil Neutrophil Macrophage Mast Cell ECP, MBP, elastase, MMP, Activated IgE TNFa , IL-1b, TGFb B Cell Histamine, LTC4, PGD2 and Bronchoconstriction, Tissue damage, fibrosis proteases increased GI motility, pain, itch SENSITIZATION ACUTE AND CHRONIC INFLAMMATION 5 Mast Cells and Eosinophils Contribute to Allergic and Non-Allergic Inflammation
    [Show full text]
  • Horizon Scanning Status Report December 2020
    PCORI Health Care Horizon Scanning System Volume 2 Issue 4 Horizon Scanning Status Report December 2020 Prepared for: Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036 Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12 Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 Investigators: Randy Hulshizer, MA, MS Damian Carlson, MS Christian Cuevas, PhD Andrea Druga, MSPAS, PA-C Marcus Lynch, PhD, MBA Misha Mehta, MS Prital Patel, MPH Brian Wilkinson, MA Donna Beales, MLIS Jennifer De Lurio, MS Eloise DeHaan, BS Eileen Erinoff, MSLIS Cassia Hulshizer, BBA Madison Kimball, MS Maria Middleton, MPH Melinda Rossi, BS Diane Robertson, BA Kelley Tipton, MPH Rosemary Walker, MLIS Andrew Furman, MD, MMM, FACEP Statement of Funding and Purpose This report incorporates data collected during implementation of the Patient-Centered Outcomes Research Institute (PCORI) Health Care Horizon Scanning System, operated by ECRI under contract to PCORI, Washington, DC (Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12). The findings and conclusions in this document are those of the authors, who are responsible for its content. No statement in this report should be construed as an official position of PCORI. An intervention that potentially meets inclusion criteria might not appear in this report simply because the Horizon Scanning System has not yet detected it or it does not yet meet the inclusion criteria outlined in the PCORI Health Care Horizon Scanning System: Horizon Scanning Protocol and Operations Manual. Inclusion or absence of interventions in the horizon scanning reports will change over time as new information is collected; therefore, inclusion or absence should not be construed as either an endorsement or a rejection of specific interventions.
    [Show full text]
  • Corporate Presentation I June 2021 Developing Therapeutic Antibodies Targeting Allergic Inflammatory and Proliferative Disease Disclaimer
    Corporate Presentation I June 2021 Developing Therapeutic Antibodies Targeting Allergic Inflammatory and Proliferative Disease Disclaimer This presentation contains forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regarding the financial position of Allakos Inc. (“Allakos,” the “Company,” “we” or “our”); the generation of future value; business strategy; plans and objectives for future operations; our expectations regarding the potential benefits, activity, effectiveness and safety of our product candidates; our expectations with regard to the initiation, design, timing and results of our clinical studies, preclinical studies and research and development programs, including the timing and availability of data from such studies; our preclinical, clinical and regulatory development plans for our product candidates, including the timing or likelihood of regulatory filings and approvals for our product candidates; the size of the market opportunity for our product candidates in the diseases we are targeting; and our expectations with regard to our ability to acquire, discover and develop additional product candidates and advance such product candidates into, and successfully complete, clinical studies, are forward-looking statements. Allakos has based these forward-looking statements on its estimates and assumptions and its current expectations and projections about future events. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements.
    [Show full text]
  • The Role of Eosinophils in Physiology and Disease: Is Complete Depletion of Eosinophils the Goal?
    The role of eosinophils in physiology and disease: Is complete depletion of eosinophils the goal? Dr Enrico Heffler Humanitas University Milan, Italy Disclaimer • Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions • The presenting faculty have been advised by touchIME® to ensure that they disclose any such references made to unlabelled or unapproved use • No endorsement by touchIME® of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME® activities • touchIME® accepts no responsibility for errors or omissions The role of eosinophils in homeostasis and disease Physiologic roles of eosinophils Immune response • Production of cytotoxic mediators (MBP, EPO, ECP, EDN) • Production of pro-inflammatory cytokines and chemokines • Host defence against parasitic, viral, fungal and bacterial infections Tissue homeostasis Eosinophil • Metabolic homeostasis • Wound healing • Epithelial remodelling in the respiratory tract • Homeostasis in the intestinal environment and microbiota ECP, eosinophil cationic protein; EDN, eosinophil-derived neurotoxin; EPO, eosinophil peroxidase; MBP, major basic protein. Kanda A, et al. Allergol Int. 2021;70:9–18. Pathogenic roles of eosinophils Atopic dermatitis Gastrointestinal diseases Hypereosinophilic syndromes Airway inflammation • Severe eosinophilic asthma • CRSwNP EGPA CRSwNP, chronic rhinosinusitis with nasal polyposis; EGPA,
    [Show full text]
  • The Many Faces of Ige-Mediated Disease – a Symposia Series
    The many faces of IgE-mediated disease – a symposia series EAACI 2021 Congress 10th, 11th & 12th July − lunchtime symposia Chaired by: Professor Marcus Maurer These virtual symposia are organised and funded by Novartis Pharma AG May 2021 | 119204 Disclaimer You are viewing a symposium organised and funded by Novartis Pharma AG intended for an audience of HCPs as defined by local Polish Law within the context of the EAACI Hybrid Congress 2021, July 10-12, 2021. Novartis Pharma AG provides this information to the best of its knowledge at the time of production of this item in May /June 2021 for the aforementioned congress. In line with Local Polish Pharmaceutical Law, this information is intended solely for medical doctors, physicians in training (graduates of medicine, who are authorized to prescribe medicinal products), medical doctor clinical researchers, pharmacists or industry representatives. The information included in this symposium is not intended for Allied Health Professionals, non-medical doctor clinical researchers, dieticians, journalists, lab technicians, medical students, nurses, scientists or social workers. This symposium is organised and funded by Novartis Pharma AG. This event may include data/information on investigational uses of compounds/drugs that have not yet been approved by regulatory authorities. This presentation is intended for non-promotional scientific purposes only and may contain information on products or indications currently under investigation and/or that have not been approved by the regulatory authorities. The opinions and views expressed in this slide deck are those of the presenters and do not necessarily constitute the opinions or recommendations of Novartis. Any data about non-Novartis products are based on publicly available information at the time of presentation.
    [Show full text]
  • Allakos Annual Report 2021
    Allakos Annual Report 2021 Form 10-K (NASDAQ:ALLK) Published: March 1st, 2021 PDF generated by stocklight.com UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38582 Allakos Inc. (Exact name of Registrant as specified in its Charter) Delaware 45-4798831 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 975 Island Drive, Suite 201 Redwood City, California 94065 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (650) 597-5002 Securities registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered Common Stock, par value $0.001 ALLK The Nasdaq Global Select Market Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☒ NO ☐ Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ☐ NO ☒ Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
    [Show full text]
  • Organ-Specific Hypereosinophilic Syndrome Presenting As Eosinophilic Gastroenteritis
    Open Access Case Report DOI: 10.7759/cureus.16021 Organ-Specific Hypereosinophilic Syndrome Presenting as Eosinophilic Gastroenteritis Aneesh Kumar 1 , Asim Haider 2 , Ayesha Siddiqa 2 1. Internal Medicine, BronxCare Hospital Center, Bronx, USA 2. Internal Medicine, BronxCare Health System, Bronx, USA Corresponding author: Asim Haider, [email protected] Abstract Gastrointestinal (GI) diseases have a substantial impact on the population health and healthcare resources of the United States. They constitute billions of dollars in expenditure and millions of office and hospital visits. With advancing diagnostic and treatment modalities, rare diseases are increasingly recognized and managed. However, after close to 80 years since the first description, eosinophilic GI disorders (EGID) are still uncommon, and only around 300 cases have been reported to date. Hypereosinophilic syndrome (HES) is well studied, but there are still no guidelines to direct management. We report the case of a 56-year-old female who presented with gastroenteritis and a persistent eosinophil count above 7 x 109/L. Imaging was suggestive of bowel wall thickening, and endoscopy revealed normal-appearing mucosa. However, histologic examination revealed eosinophilic infiltration of the GI tract. She was diagnosed with HES and treated with oral prednisone with remarkable improvement of her symptoms. Categories: Internal Medicine, Gastroenterology, Hematology Keywords: eosinophilic gastroenteritis, eosinophilia, diagnosis of exclusion, eosinophilic gastrointestinal disorder, hypereosinophilia syndrome Introduction Hypereosinophilic syndrome (HES) is a rare and under-reported group of diseases that are characterized by persistent eosinophilia above 1.5 x 109/L on at least two occasions and eosinophil-mediated organ damage/dysfunction. Other causes of organ damage and secondary causes of hypereosinophilia must be ruled out [1].
    [Show full text]
  • Rising IBD Rates in Minorities Heighten Need for Awareness
    mdedge.com/gihepnews December 2020 Volume 14 / Number 12 Start CRC screening INSIDE GI ONCOLOGY at age 45, USPSTF Task force report Best practices noted for managing malignant now suggests colorectal polyps. • 16 LIVER DISEASE BY ROXANNE NELSON, that all adults aged 45-75 RN, BSN years be screened for CRC. Semaglutide shows ARNES This is an “A” recom- promise in NASH study B creening for colo- mendation for adults aged Phase 2 data show rectal cancer (CRC) 50-75 and a “B” recom- resolution TEPHANIE S Sshould begin at age mendation for adults aged in 60%. • 27 45 years instead of 50 45-49. Dr. Barry explained OURTESY IBD AND INTESTINAL C years, as recommended that the reason for this Dr. Edward L. Barnes and his associates noted that disparities in care in the current guideline, difference is that the DISORDERS start with later diagnosis of IBD, followed by issues with continuity. the U.S. Preventive Ser- Tool predicted vices Task Force said in 45- to 49-year age group. vedolizumab a draft recommendation “Butbenefit there’s is smaller not much for the nonresponse that is open for public difference between A and Rising IBD rates in comment. B from a practical stand- Point-based scoring “This is the only change point,” he explained. system uses clinical minorities heighten that was made,” said task For adults aged 76-85, variables. • 30 force member Michael PRACTICE Barry, MD, director of of screening need to be need for awareness the Informed Medical weighedthe benefits against and harmsthe indi- MANAGEMENT Decisions Program in the vidual’s overall health and Delay in Stark reform BY AMY KARON wrote Edward L.
    [Show full text]
  • Fecal Microbiota Potentiate Checkpoint Inhibitors, Unleash Microbiome
    news DGEATA PA Drug pipeline 1Q21—the old and the new The US Food and Drug Administration (FDA) continues to approve products at a rapid clip, with 17 new molecular entity (NME) and biologic approvals in the quarter. Over 40 years after the first monoclonal antibody (mAb) was approved—muromonab (Ortho Kung/ OKT3), an anti-CD3 murine mAb for use in graft-versus-host disease—FDA will consider a humanized version of the drug for type 1 diabetes. Elsewhere, CRISPR Therapeutics published promising one-year results on its CRISPR–Cas9 therapy against the BCL111A erythroid-specific enhancer in transfusion-dependent β-thalassemia and sickle cell disease. Bristol Myers Squibb (BMS) and bluebird bio’s Abecma (idecabtagene vicleucel) became the first chimeric antigen receptor (CAR)-T cell therapy to be approved for multiple myeloma and the first directed against an antigen other than CD19. Regeneron’s Evkeeza (evinacumab-dgnb) is the first mAb approved for familial hypercholesterolemia that targets the angiopoietin-like 3 protein. A double dose of bad news came in Huntington’s disease, with clinical setbacks for two antisense oligonucleotide (ASO) therapies: Ionis/Roche’s tominersen and Wave’s WVE-120102. Lilly reported positive trial results for its Alzheimer’s disease therapy mAb donanemab; by next quarter’s end, Biogen might finally get an answer from regulators on its controversial anti–Alzheimer’s disease mAb, aducanumab. Historic US regulatory approvals by drug class Notable clinical trials for COVID-19 products A healthy crop of new approvals in quarter 1, skewed toward small Drug/company Indication Drug information molecules. Immcetz/Creative Medical COVID-19 acute 1/7/2021 In a double-blind, Holdings respiratory distress placebo-controlled phase 2a 70 Vaccine syndrome (ARDS) trial for COVID-19 with ARDS, patients treated with two infusions Cell therapy of umbilical-cord-derived 60 New molecular entity* mesenchymal stem cells had a Biologic significant decrease in cytokines 50 and improved survival (91% versus 42%) Stem Cells Transl.
    [Show full text]