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The Use of Biologic Agents in the Treatment of Oral Lesions Due to Pemphigus and Behçet's Disease: a Systematic Review
Davis GE, Sarandev G, Vaughan AT, Al-Eryani K, Enciso R. The Use of Biologic Agents in the Treatment of Oral Lesions due to Pemphigus and Behçet’s Disease: A Systematic Review. J Anesthesiol & Pain Therapy. 2020;1(1):14-23 Systematic Review Open Access The Use of Biologic Agents in the Treatment of Oral Lesions due to Pemphigus and Behçet’s Disease: A Systematic Review Gerald E. Davis II1,2, George Sarandev1, Alexander T. Vaughan1, Kamal Al-Eryani3, Reyes Enciso4* 1Advanced graduate, Master of Science Program in Orofacial Pain and Oral Medicine, Herman Ostrow School of Dentistry of USC, Los Angeles, California, USA 2Assistant Dean of Academic Affairs, Assistant Professor, Restorative Dentistry, Meharry Medical College, School of Dentistry, Nashville, Tennessee, USA 3Assistant Professor of Clinical Dentistry, Division of Periodontology, Dental Hygiene & Diagnostic Sciences, Herman Ostrow School of Dentistry of USC, Los Angeles, California, USA 4Associate Professor (Instructional), Division of Dental Public Health and Pediatric Dentistry, Herman Ostrow School of Dentistry of USC, Los Angeles, California, USA Article Info Abstract Article Notes Background: Current treatments for pemphigus and Behçet’s disease, such Received: : March 11, 2019 as corticosteroids, have long-term serious adverse effects. Accepted: : April 29, 2020 Objective: The objective of this systematic review was to evaluate the *Correspondence: efficacy of biologic agents (biopharmaceuticals manufactured via a biological *Dr. Reyes Enciso, Associate Professor (Instructional), Division source) on the treatment of intraoral lesions associated with pemphigus and of Dental Public Health and Pediatric Dentistry, Herman Ostrow Behçet’s disease compared to glucocorticoids or placebo. School of Dentistry of USC, Los Angeles, California, USA; Email: [email protected]. -
PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects
International Journal of Molecular Sciences Review PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects Rosalin Mishra , Hima Patel, Samar Alanazi , Mary Kate Kilroy and Joan T. Garrett * Department of Pharmaceutical Sciences, College of Pharmacy, University of Cincinnati, Cincinnati, OH 45267-0514, USA; [email protected] (R.M.); [email protected] (H.P.); [email protected] (S.A.); [email protected] (M.K.K.) * Correspondence: [email protected]; Tel.: +1-513-558-0741; Fax: +1-513-558-4372 Abstract: The phospatidylinositol-3 kinase (PI3K) pathway is a crucial intracellular signaling pathway which is mutated or amplified in a wide variety of cancers including breast, gastric, ovarian, colorectal, prostate, glioblastoma and endometrial cancers. PI3K signaling plays an important role in cancer cell survival, angiogenesis and metastasis, making it a promising therapeutic target. There are several ongoing and completed clinical trials involving PI3K inhibitors (pan, isoform-specific and dual PI3K/mTOR) with the goal to find efficient PI3K inhibitors that could overcome resistance to current therapies. This review focuses on the current landscape of various PI3K inhibitors either as monotherapy or in combination therapies and the treatment outcomes involved in various phases of clinical trials in different cancer types. There is a discussion of the drug-related toxicities, challenges associated with these PI3K inhibitors and the adverse events leading to treatment failure. In addition, novel PI3K drugs that have potential to be translated in the clinic are highlighted. Keywords: cancer; PIK3CA; resistance; PI3K inhibitors Citation: Mishra, R.; Patel, H.; Alanazi, S.; Kilroy, M.K.; Garrett, J.T. -
Gy Total Body Irradiation Followed by Allogeneic Hematopoietic St
Bone Marrow Transplantation (2009) 44, 785–792 & 2009 Macmillan Publishers Limited All rights reserved 0268-3369/09 $32.00 www.nature.com/bmt ORIGINAL ARTICLE Fludarabine, amsacrine, high-dose cytarabine and 12 Gy total body irradiation followed by allogeneic hematopoietic stem cell transplantation is effective in patients with relapsed or high-risk acute lymphoblastic leukemia F Zohren, A Czibere, I Bruns, R Fenk, T Schroeder, T Gra¨f, R Haas and G Kobbe Department of Haematology, Oncology and Clinical Immunology, Heinrich Heine-University, Du¨sseldorf, Germany In this prospective study, we examined the toxicity and Introduction efficacy of an intensified conditioning regimen for treatment of patients with relapsed or high-risk acute The use of intensified conventional induction chemothera- lymphoblastic leukemia who undergo allogeneic hemato- pies in the treatment of newly diagnosed ALL in adult poietic stem cell transplantation. Fifteen patients received patients has led to initial CR rates of up to 90%. But, as fludarabine 30 mg/m2, cytarabine 2000 mg/m2, amsacrine some patients are even refractory to first-line therapy, the 100 mg/m2 on days -10, -9, -8 and -7, anti-thymocyte majority of the responding patients unfortunately suffer globulin (ATG-Fresenius) 20 mg/kg body weight on days from relapse. Therefore, the probability of long-term -6, -5 and -4 and fractionated total body irradiation disease-free survival is o30%.1–5 Risk stratification based 2 Â 2 Gy on days -3, -2 and -1 (FLAMSA-ATG-TBI) on prognostic factors allows identification of high-risk before allogeneic hematopoietic stem cell transplantation. ALL patients with poor prognosis.6–12 Myeloablative At the time of hematopoietic stem cell transplantation, 10 conditioning therapy followed by allogeneic hematopoietic patients were in complete remission (8 CR1; 2 CR2), 3 stem cell transplantation (HSCT) is currently the treatment with primary refractory and 2 suffered from refractory of choice for these high-risk patients.13–15 A combination of relapse. -
AHFS Pharmacologic-Therapeutic Classification System
AHFS Pharmacologic-Therapeutic Classification System Abacavir 48:24 - Mucolytic Agents - 382638 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Acitretin 84:92 - Skin and Mucous Membrane Agents, Abaloparatide 68:24.08 - Parathyroid Agents - 317036 Aclidinium Abatacept 12:08.08 - Antimuscarinics/Antispasmodics - 313022 92:36 - Disease-modifying Antirheumatic Drugs - Acrivastine 92:20 - Immunomodulatory Agents - 306003 4:08 - Second Generation Antihistamines - 394040 Abciximab 48:04.08 - Second Generation Antihistamines - 394040 20:12.18 - Platelet-aggregation Inhibitors - 395014 Acyclovir Abemaciclib 8:18.32 - Nucleosides and Nucleotides - 381045 10:00 - Antineoplastic Agents - 317058 84:04.06 - Antivirals - 381036 Abiraterone Adalimumab; -adaz 10:00 - Antineoplastic Agents - 311027 92:36 - Disease-modifying Antirheumatic Drugs - AbobotulinumtoxinA 56:92 - GI Drugs, Miscellaneous - 302046 92:20 - Immunomodulatory Agents - 302046 92:92 - Other Miscellaneous Therapeutic Agents - 12:20.92 - Skeletal Muscle Relaxants, Miscellaneous - Adapalene 84:92 - Skin and Mucous Membrane Agents, Acalabrutinib 10:00 - Antineoplastic Agents - 317059 Adefovir Acamprosate 8:18.32 - Nucleosides and Nucleotides - 302036 28:92 - Central Nervous System Agents, Adenosine 24:04.04.24 - Class IV Antiarrhythmics - 304010 Acarbose Adenovirus Vaccine Live Oral 68:20.02 - alpha-Glucosidase Inhibitors - 396015 80:12 - Vaccines - 315016 Acebutolol Ado-Trastuzumab 24:24 - beta-Adrenergic Blocking Agents - 387003 10:00 - Antineoplastic Agents - 313041 12:16.08.08 - Selective -
Vorinostat—An Overview Aditya Kumar Bubna
E-IJD RESIDENTS' PAGE Vorinostat—An Overview Aditya Kumar Bubna Abstract From the Consultant Vorinostat is a new drug used in the management of cutaneous T cell lymphoma when the Dermatologist, Kedar Hospital, disease persists, gets worse or comes back during or after treatment with other medicines. It is Chennai, Tamil Nadu, India an efficacious and well tolerated drug and has been considered a novel drug in the treatment of this condition. Currently apart from cutaneous T cell lymphoma the role of Vorinostat for Address for correspondence: other types of cancers is being investigated both as mono-therapy and combination therapy. Dr. Aditya Kumar Bubna, Kedar Hospital, Mugalivakkam Key Words: Cutaneous T cell lymphoma, histone deacytelase inhibitor, Vorinostat Main Road, Porur, Chennai - 600 125, Tamil Nadu, India. E-mail: [email protected] What was known? • Vorinostat is a histone deacetylase inhibitor. • It is an FDA approved drug for the treatment of cutaneous T cell lymphoma. Introduction of Vorinostat is approximately 9. Vorinostat is slightly Vorinostat is a histone deacetylase (HDAC) inhibitor, soluble in water, alcohol, isopropanol and acetone and is structurally belonging to the hydroxymate group. Other completely soluble in dimethyl sulfoxide. drugs in this group include Givinostat, Abexinostat, Mechanism of action Panobinostat, Belinostat and Trichostatin A. These Vorinostat is a broad inhibitor of HDAC activity and inhibits are an emergency class of drugs with potential anti- class I and class II HDAC enzymes.[2,3] However, Vorinostat neoplastic activity. These drugs were developed with the does not inhibit HDACs belonging to class III. Based on realization that apart from genetic mutation, alteration crystallographic studies, it has been seen that Vorinostat of HDAC enzymes affected the phenotypic and genotypic binds to the zinc atom of the catalytic site of the HDAC expression in cells, which in turn lead to disturbed enzyme with the phenyl ring of Vorinostat projecting out of homeostasis and neoplastic growth. -
RECENT MAJOR CHANGES------ Age
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ---------------------DOSAGE FORMS AND STRENGTHS--------------------- CRYSVITA safely and effectively. See full prescribing information Injection: 10 mg/mL, 20 mg/mL, or 30 mg/mL in a single-dose vial (3) for CRYSVITA. -------------------------------CONTRAINDICATIONS----------------------------- ® CRYSVITA (burosumab-twza) injection, for subcutaneous use • With oral phosphate and/or active vitamin D analogs. (4) Initial U.S. Approval: 2018 • When serum phosphorus is within or above the normal range for -------------------------RECENT MAJOR CHANGES----------------- age. (4) Indications and Usage (1) 6/2020 • In patients with severe renal impairment or end stage renal Dosage and Administration, disease. (4) Tumor-induced Osteomalacia (2.4) 6/2020 ------------------------WARNINGS AND PRECAUTIONS---------------------- Dosage and Administration, 25-Hydroxy Vitamin D • Hypersensitivity: Discontinue CRYSVITA if serious hypersensitivity Supplementation (2.7) 9/2019 reactions occur and initiate appropriate medical treatment. (5.1) • Hyperphosphatemia and Risk of Nephrocalcinosis: For patients -----------------------------INDICATIONS AND USAGE------------------------- already taking CRYSVITA, dose interruption and/or dose reduction CRYSIVTA is a fibroblast growth factor 23 (FGF23) blocking antibody may be required based on a patient’s serum phosphorus levels. indicated for: (5.2, 6.1) • The treatment of X-linked hypophosphatemia (XLH) in adult and • Injection Site Reactions: Administration of CRYSVITA may result in pediatric patients 6 months of age and older. (1.1) local injection site reactions. Discontinue CRYSVITA if severe • The treatment of FGF23-related hypophosphatemia in tumor- injection site reactions occur and administer appropriate medical induced osteomalacia (TIO) associated with phosphaturic treatment. (5.3, 6.1) mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older. -
CK0403, a 9‑Aminoacridine, Is a Potent Anti‑Cancer Agent in Human Breast Cancer Cells
MOLECULAR MEDICINE REPORTS 13: 933-938, 2016 CK0403, a 9‑aminoacridine, is a potent anti‑cancer agent in human breast cancer cells YUAN-WAN SUN1, KUEN-YUAN CHEN2, CHUL-HOON KWON3 and KUN-MING CHEN1 1Department of Biochemistry and Molecular Biology, College of Medicine, Pennsylvania State University, Hershey, PA 17033, USA; 2Department of Surgery, National Taiwan University Hospital, Taipei 8862, Taiwan, R.O.C.; 3Department of Pharmaceutical Sciences, College of Pharmacy and Allied Health Professions, St. John's University, New York, NY 11439, USA Received November 11, 2014; Accepted October 22, 2015 DOI: 10.3892/mmr.2015.4604 Abstract. 3-({4-[4-(Acridin-9-ylamino)phenylthio]phenyl} reduced growth inhibitory activity under hypoxic conditions, (3-hydroxypropyl)amino)propan-1-ol (CK0403) is a which can induce autophagy. Collectively, the present results sulfur-containing 9-anilinoacridine analogue of amsacrine and supported that CK0403 is highly potent and more effective than was found to be more potent than its analogue 2-({4-[4-(acridin- CK0402 against estrogen receptor-negative and 9-ylamino)phenylthio]phenyl}(2-hydroxyethyl)amino) HER2-overexpressing breast cancer cell lines, suggesting its ethan-1-ol (CK0402) and amsacrine in the inhibition of the future application for chemotherapy in breast cancer. topoisomerase II-catalyzed decatenation reaction. A previous study by our group reported that CK0402 was effective against Introduction numerous breast cancer cell lines, and the combination of CK0402 with herceptin enhanced its activity in HER2(+) Breast cancer is the most common type of cancer diagnosed SKBR-3 cells. In order to identify novel chemotherapeutic agents in American women and is the second most common cause with enhanced potency, the present study explored the potential of cancer-associated mortality. -
Interleukins in Therapeutics
67 ISSN: 2347 - 7881 Review Article Interleukins in Therapeutics Anjan Khadka Department of Pharmacology, AFMC, Pune, India [email protected] ABSTRACT Interleukins are a subset of a larger group of cellular messenger molecules called cytokines, which are modulators of cellular behaviour. On the basis of their respective cytokine profiles, responses to chemokines, and interactions with other cells, these T-cell subsets can promote different types of inflammatory responses. During the development of allergic disease, effector TH2 cells produce IL-4, IL- 5, IL-9, and IL-32. IL-25, IL- 31, and IL-33 contributes to TH2 responses and inflammation. These cytokines have roles in production of allergen-specific IgE, eosinophilia, and mucus. ILs have role in therapeutics as well as diagnosis and prognosis as biomarker in various conditions. Therapeutic targeting of the IL considered to be rational treatment strategy and promising biologic therapy. Keywords: Interleukins, cytokines, Interleukin Inhibitors, Advances INTRODUCTION meaning ‘hormones’. It was Stanley Cohen in Interleukins are group of cytokines that were 1974 who for the first time introduced the term first seen to be expressed by leucocytes and ‘‘cytokine’’. It includes lymphokines, they interact between cells of the immune monokines, interleukins, and colony stimulating systems. It is termed by Dr. Vern Paetkau factors (CSFs), interferons (IFNs), tumor (University of Victoria) in1979.Interleukins (IL) necrosis factor (TNF) and chemokines. The are able to promote cell growth, differentiation, majority of interleukins are synthesized by and functional activation. The question of how helper CD4 T lymphocytes as well as through diverse cell types communicate with each monocytes, macrophages, and endothelial cells. -
Review Anti-Cytokine Biologic Treatment Beyond Anti-TNF in Behçet's Disease
Review Anti-cytokine biologic treatment beyond anti-TNF in Behçet’s disease A. Arida, P.P. Sfikakis First Department of Propedeutic Internal ABSTRACT and thrombotic complications (1-3). Medicine Laikon Hospital, Athens, Unmet therapeutic needs in Behçet’s Treatment varies according to type and University Medical School, Greece. disease have drawn recent attention to severity of disease manifestations. Cor- Aikaterini Arida, MD biological agents targeting cytokines ticosteroids, interferon-alpha and con- Petros P. Sfikakis, MD other than TNF. The anti-IL-17 anti- ventional immunosuppressive drugs, Please address correspondence to: body secukinumab and the anti-IL-2 such as azathioprine, cyclosporine-A, Petros P. Sfikakis, MD, receptor antibody daclizumab were not cyclophosphamide and methotrexate, First Department of Propedeutic superior to placebo for ocular Behçet’s and Internal Medicine, are used either alone or in combination Laikon Hospital, in randomised controlled trials, com- for vital organ involvement. During the Athens University Medical School, prising 118 and 17 patients, respec- last decade there has been increased use Ag Thoma, 17, tively. The anti-IL-1 agents anakinra of anti-TNF monoclonal antibodies in GR-11527 Athens, Greece. and canakinumab and the anti-IL-6 patients with BD who were refractory E-mail: [email protected] agent tocilizumab were given to iso- to conventional treatment or developed Received on June 7, 2014; accepted in lated refractory disease patients, who life-threatening complications (4, 5). revised form on September 17, 2014. were either anti-TNF naïve (n=9) or Anti-TNF treatment has been shown to Clin Exp Rheumatol 2014; 32 (Suppl. 84): experienced (n=18). -
Eptifibatide Is Noninferior to Abciximab: Implications for Clinical Practice
RESEARCH HIGHLIGHTS ANTIPLATELET THERAPY Eptifibatide is noninferior to abciximab: implications for clinical practice he glycoprotein IIb/IIIa (GPIIb/ randomized, open, parallel-group January 2004 and December 2007, IIIa) inhibitors eptifibatide and comparison of eptifibatide and abciximab and eptifibatide was used in 2,355 Tabciximab have comparable efficacy in 427 patients presenting within 12 h such procedures over this time frame. and safety in patients with ST-segment of STEMI onset and who underwent During the 1-year follow-up period, elevation myocardial infarction (STEMI) primary PCI. Enrolled patients were from no significant difference was reported undergoing primary percutaneous 22 centers in France and Germany. The for the incidence of death (8.0% and coronary intervention (PCI). These two study drugs were administered in 7.6%), myocardial infarction (9.0% and findings, from a randomized trial and a combination with background therapy 8.4%), or bleeding (2.7% and 3.2%) registry study, are reported in two papers comprising clopidogrel, aspirin, and between abciximab and eptifibatide, published in the Journal of the American heparin or enoxaparin. This study used respectively. Multivariable analysis College of Cardiology (JACC). the surrogate primary end point of showed that eptifibatide was noninferior Platelet aggregation and thrombus complete electrocardiographic ST-segment to abciximab for the prevention of death formation can be inhibited by blocking resolution (STR) 60 min after completion or myocardial infarction (odds ratio 0.94, the GPIIb/IIIa receptor on the platelet of PCI. 95% CI 0.82–1.09). membrane, thereby preventing the binding In the intention-to-treat analysis, These findings “fuel an already much of fibrinogen. -
Challenges and Approaches for the Development of Safer Immunomodulatory Biologics
REVIEWS Challenges and approaches for the development of safer immunomodulatory biologics Jean G. Sathish1*, Swaminathan Sethu1*, Marie-Christine Bielsky2, Lolke de Haan3, Neil S. French1, Karthik Govindappa1, James Green4, Christopher E. M. Griffiths5, Stephen Holgate6, David Jones2, Ian Kimber7, Jonathan Moggs8, Dean J. Naisbitt1, Munir Pirmohamed1, Gabriele Reichmann9, Jennifer Sims10, Meena Subramanyam11, Marque D. Todd12, Jan Willem Van Der Laan13, Richard J. Weaver14 and B. Kevin Park1 Abstract | Immunomodulatory biologics, which render their therapeutic effects by modulating or harnessing immune responses, have proven their therapeutic utility in several complex conditions including cancer and autoimmune diseases. However, unwanted adverse reactions — including serious infections, malignancy, cytokine release syndrome, anaphylaxis and hypersensitivity as well as immunogenicity — pose a challenge to the development of new (and safer) immunomodulatory biologics. In this article, we assess the safety issues associated with immunomodulatory biologics and discuss the current approaches for predicting and mitigating adverse reactions associated with their use. We also outline how these approaches can inform the development of safer immunomodulatory biologics. Immunomodulatory Biologics currently represent more than 30% of licensed The high specificity of the interactions of immu- biologics pharmaceutical products and have expanded the thera- nomodulatory biologics with their relevant immune Biotechnology-derived peutic options available -
WO 2017/173059 Al 5 October 2017 (05.10.2017) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization I International Bureau (10) International Publication Number (43) International Publication Date WO 2017/173059 Al 5 October 2017 (05.10.2017) P O P C T (51) International Patent Classification: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, C12N 9/26 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, (21) International Application Number: KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, PCT/US20 17/024981 MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, (22) International Filing Date: NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, 30 March 2017 (30.03.2017) RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, (25) Filing Language: English ZA, ZM, ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 62/3 15,400 30 March 2016 (30.03.2016) US GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 62/457,584 10 February 2017 (10.02.2017) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 15/473,994 30 March 2017 (30.03.2017) US TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (71) Applicant: AMICUS THERAPEUTICS, INC.