DOCSLIB.ORG

Drug Therapy Advancements in Specialty Pharmacy Michael Mccall, Pharm.D

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Drug Therapy Advancements in Specialty Pharmacy Michael Mccall, Pharm.D Inflammatory Disorders: Drug Therapy Advancements in Specialty Pharmacy Michael McCall, Pharm.D. January 26, 2019 Today’s Speaker Michael McCall, Pharm.D. PGY1 Pharmacy Resident Duquesne University | AllianceRx Walgreens Prime Disclosures No disclosure to report Learning Objectives Upon completion of this activity, participants should be able to: • Explain the inflammatory pathway involved in the pathogenesis of rheumatoid arthritis, psoriasis, and inflammatory bowel disease • Review the current treatment options for the management of patients with rheumatoid arthritis, psoriasis, and inflammatory bowel disease • Describe the advancements in drug therapy and compare their use in treatment to recommend an appropriate regimen based on a patient case • Evaluate the role of specialty pharmacies in the management of patients with rheumatoid arthritis, psoriasis, and inflammatory bowel disease and their impact on patient outcomes Rheumatoid Arthritis Pathogenesis – Rheumatoid Arthritis4,6,7 • Repeated activation of immune system • Auto-immune inflammatory cascade • T and B cells, plasma cells, macrophages, dendritic cells ,synoviocytes • Recognition of self proteins as foreign • Auto-antibody production immune complexes • Synovial joint inflammation • Multiple joints affected • Small joints progressing to larger joints • Erosion of cartilage and bone • Cytokines • Osteoclast stimulation Current Drug Therapy – Rheumatoid Arthritis9,10 • First line • Conventional disease modifying anti-rheumatic drugs (cDMARD) • Methotrexate (MTX), leflunomide, hydroxychloroquine, sulfasalazine • Second line • TNFα-inhibitor alone or in combination with MTX • Adalimumab, certolizumab pegol, etanercept, golimumab, infliximab • Failure on TNFα-inhibitor • IL-6 inhibitor or JAK inhibitor • Guidelines prefer IL-6 inhibitors • Other drug therapies • Abatacept, rituximab • Anakinra • Immunosuppressants IL-6 inhibitors – Rheumatoid Arthritis11-14 • Tocilizumab (Actemra®) • Dosing information • 162 mg subcutaneously (SC) every other week; may increase to weekly • 4 mg/kg intravenously (IV) every 4 weeks; may increase to 8 mg/kg every 4 weeks • Safety • Gastrointestinal perforations • Development of multiple sclerosis • Serious infections – 3.8% of patients (SUMMACTA) • Efficacy – ACR20 (%) • Tocilizumab ± MTX > MTX in naïve and experienced patients • Tocilizumab effective treatment in patents with an inadequate response to TNFα-inhibitors • Tocilizumab > adalimumab in patients intolerant to MTX IL-6 inhibitors – Rheumatoid Arthritis15-18 Sarilumab (Kevzara®) • Dosing Information • 200 mg SC once every two weeks. May decrease to 150 mg SC every two weeks • Safety • Gastrointestinal perforations • Serious infections – 2.6 to 4% of patients (MOBILITY) • Efficacy – ACR20 (%) • Sarilumab > MTX monotherapy when added as combination • Sarilumab + DMARD effective in patients with an inadequate response to TNFα-inhibitors • Sarilumab > adalimumab in patients with an inadequate response to MTX JAK inhibitors – Rheumatoid Arthritis20-23 • Tofacitinib (Xeljanz®) • Dosing information • 5 mg PO twice daily or 11 mg PO once daily (XR) • Safety • Malignancies • Serious infections – 2.5% of patients (ORAL START) • Comparable discontinuation rates due to adverse events • Efficacy – ACR20 (%) • Tofacitinib effective in patients with an inadequate response to non-biologic or biologic • Tofacitinib > MTX in naïve patients • Tofacitinib + MTX non-inferior to adalimumab + MTX JAK inhibitors – Rheumatoid Arthritis24,25 • Baricitinib (Olumiant®) • Dosing information • 2 mg PO once daily • Safety • Malignancies • Serious infections – 2% of patients (RA-BEAM) • Thrombosis – DVT and PE • Efficacy – ACR20 (%) • Baricitinib + MTX > MTX in patients with an inadequate response to MTX or other cDMARD • Baricitinib > adalimumab in patients with an inadequate response to MTX or other cDMARD Case 1 – Rheumatoid Arthritis BT is a 57 year-old female with a 15 year history of rheumatoid arthritis. Her previous treatments include methotrexate (MTX), adalimumab, and abatacept. She is currently being treated with certolizumab and still experiencing moderate RA symptoms including pain, joint swelling, and morning stiffness. BT’s rheumatologists would like to switch her to another medication to better control her disease activity. What is an appropriate treatment option? A. Golimumab B. Anakinra C. Tocilizumab D. Tofacitinib Psoriasis Epidemiology - Psoriasis26 • Affects approximately 7.5 millions Americans • Men and women equally • Develops between ages 15 and 35 • Beyond a cosmetic concern • Mental health - twice as likely to become depressed • Decreased work productivity – 60% of patients missed work due to condition • Cardiovascular disease – 58% more likely to have an event • Development of psoriatic arthritis • Estimated 10 to 30% of patients • Usually develops 10 years after psoriasis Pathogenesis - Psoriasis27 • Immune stimulation in the epidermal layers of the skin • Microbial invasion and cytokine infiltration • Proliferation and thickening of keratinocytes • Inflammation of the skin • Causes raised, red patches that can be itchy and painful • Commonly appears on elbows, knees, or scalp • Five types of psoriasis • Plaque psoriasis • Guttate psoriasis • Inverse psoriasis • Pustular psoriasis • Erythrodermic psoriasis Current Drug Therapy – Psoriasis28 Topicals • Corticosteroids, vitamin D analogues, retinoids Targeted phototherapy • Excimer laser Phototherapy • UVB • PUVA (psoralen + UVA) Systemic agents • Retinoids, immunosuppressants Biologics • TNFα-inhibitors • Adalimumab, etanercept, certolizumab pegol, infliximab • Interleukin inhibitors IL-23/12 inhibitors - Psoriasis46,47 • Ustekinumab (Stelara®) • Dosing information • Induction dose: 45 mg or 90 mg SC at weeks 0 and 4 • Maintenance dose: 45 mg or 90 mg SC every 12 weeks thereafter, starting at week 16 • Safety • Reversible Posterior Leukoencephalopathy Syndrome • Non-infectious pneumonia • Efficacy – PASI 75 (%) • Ustekinumab > placebo at week 12 and 40 PASI 75 response • Ustekinumab > etanercept at week 12 PASI 75 response IL-17 inhibitors - Psoriasis30-33 • Secukinumab (Cosentyx®) • Dosing information • Induction: 300 mg SC at weeks 0, 1, 2, 3, 4 • Maintenance: 300 mg SC every 4 weeks • Safety • Infections – oral candidiasis • Exacerbation of inflammatory bowel disease • Efficacy • Secukinumab > etanercept in week 12 PASI 75 response • Secukinumab > ustekinumab in week 16 PASI 90 response • Results maintained at 1 year – PASI 90 76% IL-17 inhibitors - Psoriasis34-36 • Ixekizumab (Taltz®) • Dosing information • Induction: 160 mg SC at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10 and 12 • Maintenance: 80 mg SC every 4 weeks • Safety • Infections – oral candidiasis • Exacerbation of inflammatory bowel disease • Efficacy • Ixekizumab > placebo and etanercept in week 12 PASI 75 response • Maintenance of PASI 75 and PASI 90 up to 60 weeks IL-17 inhibitors - Psoriasis37,38 • Brodalumab (Siliq®) • Dosing information • Induction: 210 mg SC at weeks 0, 1, and 2 • Maintenance: 210 mg SC every 2 weeks • Safety • Suicidal behaviors and ideation – REMS • Risk of flares following discontinuation • Efficacy • Brodalumab > placebo in week 12 PASI 75 response • Brodalumab > ustekinumab in week 12 PASI 100 response IL-23 inhibitors – Psoriasis40-43 • Guselkumab (Tremfya®) • Dosing information • Induction: 100 mg SC at weeks 0 and 4 • Maintenance: 100 mg SC every 8 weeks • Safety • Adverse events comparable to adalimumab and ustekinumab • Efficacy • Guselkumab > adalimumab in week 16 and 24 PASI 90 response • Results maintained for up to two years – PASI 90 82% • Guselkumab > ustekinumab in week 52 PASI 90 response • Switch to guselkumab or remain on ustekinumab IL-23 inhibitors – Psoriasis44,45 • Tildrakizumab-asmn (Ilumya®) • Dosing information • Inductions: 100 mg SC at weeks 0 and 4 • Maintenance: 100 mg SC every 12 weeks • Safety • Angioedema and urticarial • Efficacy • Tildrakizumab > etanercept in week 12 and 28 PASI 75 response • Long-term studies showing sustained results into 2 years – 80% PASI 75 Case 2 – Psoriasis AH is a 34 year-old female with a 10 year history of plaque psoriasis. Her condition is extensive, effecting areas of her face, scalp, and palms. She has tried multiple topical treatments and suffers from depression and anxiety due to disease persistence. Other past treatments include etanercept, adalimumab, and ustekinumab. AH’s dermatologist would like to switch her to another medication to better control her condition. What is an appropriate treatment option? A. Certolizumab B. Brodalumab C. Sarilumab D. Tildrakizumab E. Secukinumab Case 2 – Psoriasis (cont.) A few days later you receive the following prescription for AH Secukinumab (Cosentyx) 150 mg/mL pen device QTY: 1 box (2 pens) SIG: Inject 300 mg (2 pens) subcutaneously every 4 weeks What clinical intervention should be made to the prescriber? Inflammatory Bowel Disease Epidemiology – Inflammatory Bowel Disease48,49 • Affects over 1.6 million adults in the United States • Ulcerative colitis – 900,000 • More common in males • Typically diagnosed in mid-30s • Crohn’s disease – 780,000 • Males and females equally • Develops between 15 to 35 years old • Disease burdens • Over 100,000 hospitalizations each year • 119,000 cases of disability each year • Surgery • CD – 70% of patients with a 30% recurrence rate • UC – 33% of patients Pathogenesis49,50 • Inappropriate immune response in GI tract • Impaired epithelial barrier function • Infiltration of gut microbes
Load more

Recommended publications
  • Kyntheum, INN-Brodalumab
    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 Kyntheum 210 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution. 1 ml solution contains 140 mg brodalumab. Brodalumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) The solution is clear to slightly opalescent, colourless to slightly yellow and free from particles. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. 4.2 Posology and method of administration Kyntheum is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. Posology The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks. Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Special populations Elderly (aged 65 years and over) No dose adjustment is recommended in elderly patients (see section 5.2).
    [Show full text]
  • Astra Makes Quiet Progress with Respiratory Pipeline
    June 18, 2014 Astra makes quiet progress with respiratory pipeline Jonathan Gardner In defending AstraZeneca against acquisition by Pfizer its executives pointed to oncology candidates such as the checkpoint inhibitor Medi4736 and lung cancer project AZD9291 as assets not fully valued by the American pursuer. Less well appreciated is Astra's portfolio of clinical-stage respiratory programmes, one of which appears to be the only project of its class to be tested in the clinic. Given Astra's relative position in each therapy area, one might think that respiratory disease would draw more attention, even though oncology remains the hottest area of drug development. A focus on novel classes and severe disease – demonstrated by a licensing deal last week for an inhalable interferon for asthma – could allow Astra to expand even as growth in respiratory therapies flattens through the rest of the decade. Ordinary and unusual Astra executives themselves have made less of the respiratory disease pipeline, forecasting sales that are in line with consensus figures even as they pumped up the group’s collective R&D (Don’t blame Soriot, he’s just doing his job, May 7, 2014). In some respects, it is somewhat ordinary: the phase III pipeline features some candidates in well-established classes like long-acting beta-2 agonists (LABAs) in the form of assets brought on board with the acquisition of Pearl Therapeutics (Astra’s Soriot finds hidden value in private assets, June 10, 2013). James Ward-Lilley, the UK group’s vice-president of respiratory, inflammation and autoimmune disease, acknowledged that the respiratory group had not received the attention of the investor community in part because the potential payoff of a clinical gamble is not valued as highly.
    [Show full text]
  • Summary of Late-Stage Clinical Trials
    Summary of late-stage clinical trials As of Dec. 31, 2017 The document contains information available on the date indicated in its cover page. The public information of clinicaltrials.gov is continuously updated as the trials make progress. See the current information on our ongoing trials at the Website. https://clinicaltrials.gov/ The whole picture of our pipeline is available on the following website: http://www.kyowa-kirin.com/research_and_development/pipeline/index.html List of abbreviations AE Adverse Events DLT Dose Limiting Toxicity iv Intravenous MTD Maximum Tolerated Dose ORR Overall Response Rate OS Overall Survival PD Pharmacodynamics PFS Progression Free Survival PK Phamacokinetics po Peroral PPK Population Pharmacokinetics Q2W Every Two Weeks Q3W Every Three Weeks Q4W Every Four Weeks QD Once Daily QW Once Weekly sc Subcutaneous TID Three Times a Day Late-stage pipeline summary Phase II Phase III AMG531 (romiplostim) AMG531 (romiplostim) KW-0761 (mogamulizumab) Aplastic Anemia Aplastic Anemia HAM ASKP1240 (bleselumab) Recurrence of focal segmental KHK4563 (benralizumab) glomerulosclerosis in de novo kidney Asthma transplant recipients KHK2375 (entinostat) KHK4563 (benralizumab) Breast cancer COPD KHK4083 KHK4827 (brodalumab) Ulcerative colitis Psoriasis KHK4563 (benralizumab) KHK4827 (brodalumab) Eosinophilic chronic rhinosinusitis axSpA KRN23 (burosumab) KHK7580 (evocalcet) TIO/ENS Primary hyperparathyroidism KRN23 (burosumab) KRN23 (burosumab) XLH (pediatric) XLH (adult) KW-0761 (mogamulizumab) KRN23 (burosumab) ATL XLH
    [Show full text]
  • Paradoxical Psoriatic Arthritis with the Initiation of Brodalumab and Guselkumab
    Henry Ford Health System Henry Ford Health System Scholarly Commons Case Reports Medical Education Research Forum 2020 5-2020 Paradoxical Psoriatic Arthritis with the Initiation of Brodalumab and Guselkumab Reem Kashlan Henry Ford Health System, [email protected] Kristin Slater Henry Ford Health System Francisca Kartono Henry Ford Health System Follow this and additional works at: https://scholarlycommons.henryford.com/merf2020caserpt Recommended Citation Kashlan, Reem; Slater, Kristin; and Kartono, Francisca, "Paradoxical Psoriatic Arthritis with the Initiation of Brodalumab and Guselkumab" (2020). Case Reports. 68. https://scholarlycommons.henryford.com/merf2020caserpt/68 This Poster is brought to you for free and open access by the Medical Education Research Forum 2020 at Henry Ford Health System Scholarly Commons. It has been accepted for inclusion in Case Reports by an authorized administrator of Henry Ford Health System Scholarly Commons. Paradoxical Psoriatic Arthritis with the Initiation of Brodalumab and Guselkumab Reem Kashlan MPH, Kristin Slater MS, Francisca Kartono DO Henry Ford Health System, Detroit, Michigan Background Timeline Discussion • Paradoxical reactions have been described in the literature Paradoxical plaque psoriasis reactions have been reported with for biologics such as anti-tumor Necrosis Factor Alpha the usage of biologics, primarily with the use of anti-TNF One week later, Patient Agents, ustekinumab, secukinumab, ixekizumab1 agents. Brodalumab, a human monoclonal antibody against Patient prescribed Siliq 210 called with joint pain after starting Siliq. Severe pain interleukin-17 receptor A (IL17RA), has been proven to be mg/1.5mL subcutanous • It has been hypothesized that paradoxical reactions occur injection over the weekend in knees effective against psoriasis and psoriatic arthritis.1 A newer and shoulders.
    [Show full text]
  • Inflammatory Conditions – Kevzara™ (Sarilumab for Subcutaneous Injection)
    Cigna National Formulary Coverage Policy Prior Authorization Inflammatory Conditions – Kevzara® (sarilumab for subcutaneous injection) Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 59231 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 3 Revision History ................................................... 3 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.
    [Show full text]
  • New Biologics in Psoriasis: an Update on IL-23 and IL-17 Inhibitors
    New Biologics in Psoriasis: An Update on IL-23 and IL-17 Inhibitors Joanna Dong, BA; Gary Goldenberg, MD PRACTICE POINTS • The newest biologics for treatment of moderate to severe plaque psoriasis are IL-23 and IL-17 inhibitors with unprecedented efficacy of complete skin clearance compared to older biologics. • Risankizumab, guselkumab, and tildrakizumab are new IL-23 inhibitors currently in phase 3 trials with promising early efficacy and safety results. • Ixekizumab, which recently was approved, and brodalumab, which is pending US Food and Drug Administration review, are new IL-17 inhibitors that achieved total skin clearance in more than one-quarter of phase 3 participants after 12 weeks of treatment. copy not As immune-related pathways involved in the he role of current biologic therapies in pso- pathogenesis of psoriasis are elucidated, new riasis predicates on the pathogenic role of biologic treatments targeting these steps of the Tupregulated, immune-related mechanisms psoriatic immune cascade are developed. In Dothis that result in the activation of myeloid dendritic article, we review the literature on IL-23 and IL-17 cells, which release IL-17, IL-23, and other cytokines inhibitors in the pipeline for use in moderate to to activate T cells, including helper T cell TH17. severe psoriasis. Numerous pipeline biologic Along with other immune cells, TH17 produces therapies, including risankizumab, guselkumab, IL-17. This proinflammatory cascade results in kera- tildrakizumab, ixekizumab, and brodalumab, are tinocyte proliferation, angiogenesis, and migration being investigated in phase 2 and 3 studies to of immune cells toward psoriatic lesions.1 Thus, the establish the efficacy and safety of these new newest classes of biologics target IL-12, IL-23, and agents.
    [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]
  • The Two Tontti Tudiul Lui Hi Ha Unit
    THETWO TONTTI USTUDIUL 20170267753A1 LUI HI HA UNIT ( 19) United States (12 ) Patent Application Publication (10 ) Pub. No. : US 2017 /0267753 A1 Ehrenpreis (43 ) Pub . Date : Sep . 21 , 2017 ( 54 ) COMBINATION THERAPY FOR (52 ) U .S . CI. CO - ADMINISTRATION OF MONOCLONAL CPC .. .. CO7K 16 / 241 ( 2013 .01 ) ; A61K 39 / 3955 ANTIBODIES ( 2013 .01 ) ; A61K 31 /4706 ( 2013 .01 ) ; A61K 31 / 165 ( 2013 .01 ) ; CO7K 2317 /21 (2013 . 01 ) ; (71 ) Applicant: Eli D Ehrenpreis , Skokie , IL (US ) CO7K 2317/ 24 ( 2013. 01 ) ; A61K 2039/ 505 ( 2013 .01 ) (72 ) Inventor : Eli D Ehrenpreis, Skokie , IL (US ) (57 ) ABSTRACT Disclosed are methods for enhancing the efficacy of mono (21 ) Appl. No. : 15 /605 ,212 clonal antibody therapy , which entails co - administering a therapeutic monoclonal antibody , or a functional fragment (22 ) Filed : May 25 , 2017 thereof, and an effective amount of colchicine or hydroxy chloroquine , or a combination thereof, to a patient in need Related U . S . Application Data thereof . Also disclosed are methods of prolonging or increasing the time a monoclonal antibody remains in the (63 ) Continuation - in - part of application No . 14 / 947 , 193 , circulation of a patient, which entails co - administering a filed on Nov. 20 , 2015 . therapeutic monoclonal antibody , or a functional fragment ( 60 ) Provisional application No . 62/ 082, 682 , filed on Nov . of the monoclonal antibody , and an effective amount of 21 , 2014 . colchicine or hydroxychloroquine , or a combination thereof, to a patient in need thereof, wherein the time themonoclonal antibody remains in the circulation ( e . g . , blood serum ) of the Publication Classification patient is increased relative to the same regimen of admin (51 ) Int .
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub
    US 20170172932A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0172932 A1 Peyman (43) Pub. Date: Jun. 22, 2017 (54) EARLY CANCER DETECTION AND A 6LX 39/395 (2006.01) ENHANCED IMMUNOTHERAPY A61R 4I/00 (2006.01) (52) U.S. Cl. (71) Applicant: Gholam A. Peyman, Sun City, AZ CPC .......... A61K 9/50 (2013.01); A61K 39/39558 (US) (2013.01); A61K 4I/0052 (2013.01); A61 K 48/00 (2013.01); A61K 35/17 (2013.01); A61 K (72) Inventor: sham A. Peyman, Sun City, AZ 35/15 (2013.01); A61K 2035/124 (2013.01) (21) Appl. No.: 15/143,981 (57) ABSTRACT (22) Filed: May 2, 2016 A method of therapy for a tumor or other pathology by administering a combination of thermotherapy and immu Related U.S. Application Data notherapy optionally combined with gene delivery. The combination therapy beneficially treats the tumor and pre (63) Continuation-in-part of application No. 14/976,321, vents tumor recurrence, either locally or at a different site, by filed on Dec. 21, 2015. boosting the patient’s immune response both at the time or original therapy and/or for later therapy. With respect to Publication Classification gene delivery, the inventive method may be used in cancer (51) Int. Cl. therapy, but is not limited to such use; it will be appreciated A 6LX 9/50 (2006.01) that the inventive method may be used for gene delivery in A6 IK 35/5 (2006.01) general. The controlled and precise application of thermal A6 IK 4.8/00 (2006.01) energy enhances gene transfer to any cell, whether the cell A 6LX 35/7 (2006.01) is a neoplastic cell, a pre-neoplastic cell, or a normal cell.
    [Show full text]
  • WO 2016/176089 Al 3 November 2016 (03.11.2016) 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 2016/176089 Al 3 November 2016 (03.11.2016) P O P C T (51) International Patent Classification: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, A01N 43/00 (2006.01) A61K 31/33 (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, KN, KP, KR, (21) International Application Number: KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, PCT/US2016/028383 MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (22) International Filing Date: PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 20 April 2016 (20.04.2016) SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 62/154,426 29 April 2015 (29.04.2015) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, (71) Applicant: KARDIATONOS, INC. [US/US]; 4909 DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, Lapeer Road, Metamora, Michigan 48455 (US).
    [Show full text]
  • Biologics in Asthma
    Biologics in Asthma: Present andPresenter Future of Flavia Hoyte,Reproduction MD Associate Professorfor of Medicine FellowshipProperty Training Program Director DivisionNot of Allergy and Immunology National Jewish Health and University of Colorado Disclosures Clinical investigator for GSK, TEVA, and Astra‐ Zeneca. Presenter of Reproduction for Property Not Learning objectives 1. Discuss current approaches to the management of moderate to severe asthma in adult patients. Presenter of 2. Describe new and emergingReproduction biologics for for the managementProperty of moderate to severe asthma. Not Asthma: A Highly Prevalent and Often Inadequately Controlled Disease 24+ million people in the US have asthma.1 17.72 million adults have asthma.Presenter1 of Reproduction 8.86 million adults havefor inadequately 39% of adults with Propertycontrolled asthma.2 1.33 million adults active asthma use Not have inadequately long‐term control controlled asthma medications.3 with eosinophilia.4 1. Centers for Disease Control and Prevention (CDC). Most Recent Asthma Data (2014 data). Accessed June 2016. 2. CDC. Uncontrolled asthma among persons with current asthma. Accessed June 2016. 3. CDC. Use of long‐term control medication among persons with active asthma. Accessed June 2016. 4. McGrath KW et al. Am J Respir Crit Care Med. 2012;185:612‐619. Paradigm Shift to a More Personalized Approach to Asthma Therapy Presenter of Reproduction for Property Not Dunn RM and Wechsler ME. Clinical Pharmacology and Therapeutics 2015; 97(1): 55‐65. Immunopathology of Asthma Presenter of Reproduction for Property Not Pelaia G, et al. Mediators Inflamm 2015:879783. doi: 10.1155/2015/879783. Epub 2015 Mar 23. Presenter of Reproduction for Property Not Katial et al.
    [Show full text]
  • All Reviews for Use of Kevzara for COVID-19 And/Or Cytokine Release Syndrome Associated with COVID-19 Will Be Forwarded to the Medical Director
    Policy: Kevzara™ (sarilumab) Annual Review Date: 08/20/2020 Last Revised Date: 08/20/2020 OVERVIEW Kevzara for subcutaneous (SC) injection is a recombinant humanized interleukin-6 (IL-6) receptor inhibitor.1 IL-6 is a pro- inflammatory cytokine that is involved in various physiologic processes. Kevzara has demonstrated efficacy and is indicated for the treatment of rheumatoid arthritis (RA) in adults with moderate to severe active RA who have had an inadequate response or intolerance to one or more disease-modifying anti-rheumatic drugs (DMARDs).1-2 Kevzara + conventional synthetic (cs)DMARD has demonstrated superior efficacy over placebo + csDMARD as assessed by American College of Rheumatology (ACR) responses, physical function, and radiographic progression. POLICY STATEMENT This policy involves the use of Kevzara. Prior authorization is recommended for pharmacy benefit coverage of Kevzara Approval is recommended for those who meet the conditions of coverage in the Criteria and Initial/Extended Approval for the diagnosis provided. Conditions Not Recommended for Approval are listed following the recommended authorization criteria. Requests for uses not listed in this policy will be reviewed for evidence of efficacy and for medical necessity on a case-by-case basis. Because of the specialized skills required for evaluation and diagnosis of patients treated with Kevzara as well as the monitoring required for adverse events and long-term efficacy, initial approval requires Kevzara be prescribed by or in consultation with a physician who specializes in the condition being treated. All approvals for initial therapy are provided for the initial approval duration noted below; if reauthorization is allowed, a response to therapy is required for continuation of therapy unless otherwise noted below.
    [Show full text]