DOCSLIB.ORG

Utah Medicaid Pharmacy and Therapeutics Committee Drug

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Utah Medicaid Pharmacy and Therapeutics Committee Drug Utah Medicaid Pharmacy and Therapeutics Committee Drug Class Review Cytokine Modulators Abatacept (Orencia) Adalimumab (Humira) Anakinra (Kineret) Apremilast (Otezla) Baricitinib (Olumiant) Brodalumab (Siliq) Canakinumab (Ilaris) Certolizumab Pegol (Cimzia) Etanercept (Enbrel) Golimumab (Simponi) Guselkumab (Tremfya) Ixekizumab (Taltz) Risankizumab-rzaa (Skyrizi) Sarilumab (Kevzara) Secukinumab (Cosentyx) Tildrakizumab-asmn (Ilumya) Tocilizumab (Actemra) Tofacitinib (Xeljanz, Xeljanz XR) Upadacitinib (Rinvoq) Ustekinumab (Stelara) Report finalized: August 2019 Report Presented September 2019 Review prepared by: Valerie Gonzales, Pharm.D., Clinical Pharmacist Elena Martinez Alonso, B.Pharm., Medical Writer Vicki Frydrych, B.Pharm., Pharm.D., Clinical Pharmacist Joanita Lake, B.Pharm., MSc EBHC (Oxon), Research Assistant Professor, Clinical Pharmacist Joanne LaFleur, PharmD, MSPH, Associate Professor University of Utah College of Pharmacy University of Utah College of Pharmacy, Drug Regimen Review Center Copyright © 2019 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved Contents Executive Summary ....................................................................................................................................... 4 Introduction .................................................................................................................................................. 9 Table 1. Disease States Covered by Cytokine Inhibitor Indications ............................................... 10 Table 2. Orphan Disease Approvals ............................................................................................... 12 Methods ...................................................................................................................................................... 13 Disease Overview and Guideline Recommendations ................................................................................. 14 A. Psoriasis ......................................................................................................................................... 14 Table 3. Proposed Definitions for Psoriasis Severity and Treatment Options in Plaque Psoriasis 16 Table 4. FDA-Approved Cytokine Inhibitors for Plaque Psoriasis .................................................. 17 Table 5. Guideline Recommendations for Cytokine Inhibitors in the Treatment of Moderate to Severe Psoriasis .............................................................................................................................. 19 Table 6. Summary of Recommended Options and Strength of Evidence for Monotherapy Treatment of Moderate-to-Severe Psoriasis in Adults (as Reported by the 2019 AAD/NPF Guideline) ....................................................................................................................................... 20 B. Psoriatic Arthritis ........................................................................................................................... 21 Table 7. FDA-Approved Cytokine Inhibitors for Psoriatic Arthritis ................................................ 22 Table 8. Guideline Recommendations for Cytokine Inhibitors in the Treatment of Psoriatic Arthritis .......................................................................................................................................... 25 C. Rheumatoid Arthritis ..................................................................................................................... 28 Table 9. FDA-Approved Cytokine Inhibitors for Rheumatoid Arthritis .......................................... 29 Table 10. Guideline Recommendations for Biologics in the Treatment of Rheumatoid Arthritis . 31 D. Ankylosing Spondylitis ................................................................................................................... 33 Table 11. Cytokine Inhibitors FDA-Approved for Axial Spondyloarthritis...................................... 33 Table 12. Guideline Recommendations for Biologics in the Treatment of Ankylosing Spondylitis and Spondyloarthritis..................................................................................................................... 35 E. Juvenile Idiopathic Arthritis ........................................................................................................... 36 Table 13. FDA-Approved Cytokine Inhibitors for the Treatment of Juvenile Idiopathic Arthritis . 36 Table 14. Guideline Recommendations for Cytokine Inhibitors in the Treatment of Juvenile Idiopathic Arthritis ......................................................................................................................... 38 F. Inflammatory Bowel Disease ......................................................................................................... 39 Table 15. Cytokine Inhibitors Approved for Inflammatory Bowel Disease .................................... 40 F.1 Crohn’s Disease ............................................................................................................................ 41 Table 16. Disease Status Descriptions For Crohn’s Disease ........................................................... 42 Table 17. Treatment Guidelines for the Use of Biologics in Crohn’s Disease ................................ 43 F.2 Ulcerative Colitis ........................................................................................................................... 45 2 Table 18. Treatment Guidelines for the Use of Biologics in Ulcerative Colitis .............................. 46 Pharmacology & Special Populations ......................................................................................................... 48 Table 19. Mechanism of Action for Interleukin Inhibitors ............................................................. 50 Table 20. Pharmacokinetic Parameters ......................................................................................... 51 Table 21. Special Population Considerations for Cytokine Inhibitors ............................................ 52 Direct Comparative Evidence for Cytokine Modulators ............................................................................. 56 Figure 1. PRISMA Flow Chart for Publication Screening ................................................................ 56 Section 1. Overview of Key Findings from Head-to-Head Evidence ....................................................... 57 Table 22. Head-to-Head Evidence Identified in the Literature Search .......................................... 58 Section 2. Detailed Information Regarding Head-to-Head Evidence ..................................................... 61 A. Plaque Psoriasis .............................................................................................................................. 61 B. Psoriatic Arthritis ............................................................................................................................ 62 C. Rheumatoid Arthritis ...................................................................................................................... 63 Safety .......................................................................................................................................................... 65 Direct Comparative Evidence ................................................................................................................. 65 Warnings and Precautions ...................................................................................................................... 65 Table 23. Warnings and Precautions for TNF-alpha Inhibitors ...................................................... 68 Table 24. Warnings and Precautions for Interleukin Antagonists ................................................. 69 Table 25. Warnings and Precautions for Selective T Cell Co-stimulator, PDE-4 Inhibitor, and Janus Kinase Inhibitors , ........................................................................................................................... 70 Table 26. Adverse Effects for Cytokine Inhibitors .......................................................................... 71 References .................................................................................................................................................. 73 Appendix A – Additional Product Information for Cytokine Modulators ................................................... 83 Appendix B - Literature Search Strategies .................................................................................................. 86 Appendix C - Excluded References .............................................................................................................. 92 Appendix D - Systematic Reviews and Randomized Controlled Trials ...................................................... 105 3 Executive Summary Background: Multiple cytokine inhibitors are currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic, inflammatory, autoimmune conditions including plaque psoriasis (PsO), psoriatic arthritis (PsA), rheumatoid arthritis (RA), axial spondyloarthritis (ankylosing spondylitis [AS] and non-radiographic axial spondyloarthritis), juvenile idiopathic arthritis (JIA), Crohn’s disease (CD), and ulcerative colitis (UC). This report will review the cytokine inhibitors available as self-administered formulations (oral or subcutaneous). These include 11 interleukin (IL) antagonists
Load more

Recommended publications
  • Old and New Challenges in Uveitis Associated with Behçet's Disease
    Journal of Clinical Medicine Review Old and New Challenges in Uveitis Associated with Behçet’s Disease Julie Gueudry 1,* , Mathilde Leclercq 2, David Saadoun 3,4,5 and Bahram Bodaghi 6 1 Department of Ophthalmology, Hôpital Charles Nicolle, F-76000 Rouen, France 2 Department of Internal Medicine, Hôpital Charles Nicolle, F-76000 Rouen, France; [email protected] 3 Department of Internal Medicine and Clinical Immunology, AP-HP, Centre National de Références Maladies Autoimmunes et Systémiques Rares et Maladies Autoinflammatoires Rares, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] 4 Sorbonne Universités, UPMC Univ Paris 06, INSERM, UMR S 959, Immunology-Immunopathology-Immunotherapy (I3), F-75005 Paris, France 5 Biotherapy (CIC-BTi), Hôpital Pitié-Salpêtrière, AP-HP, F-75651 Paris, France 6 Department of Ophthalmology, IHU FOReSIGHT, Sorbonne-AP-HP, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] * Correspondence: [email protected]; Tel.: +33-2-32-88-80-57 Abstract: Behçet’s disease (BD) is a systemic vasculitis disease of unknown origin occurring in young people, which can be venous, arterial or both, classically occlusive. Ocular involvement is particularly frequent and severe; vascular occlusion secondary to retinal vasculitis may lead to rapid and severe loss of vision. Biologics have transformed the management of intraocular inflammation. However, the diagnosis of BD is still a major challenge. In the absence of a reliable biological marker, diagnosis is based on clinical diagnostic criteria and may be delayed after the appearance of the onset sign. However, therapeutic management of BD needs to be introduced early in order to control inflammation, to preserve visual function and to limit irreversible structural damage.
    [Show full text]
  • WHO Drug Information Vol
    WHO Drug Information Vol. 31, No. 3, 2017 WHO Drug Information Contents Medicines regulation 420 Post-market monitoring EMA platform gains trade mark; Automated 387 Regulatory systems in India FDA field alert reports 421 GMP compliance Indian manufacturers to submit self- WHO prequalification certification 421 Collaboration 402 Prequalification process quality China Food and Drug Administration improvement initiatives: 2010–2016 joins ICH; U.S.-EU cooperation in inspections; IGDRP, IPRF initiatives to join 422 Medicines labels Safety news Improved labelling in Australia 423 Under discussion 409 Safety warnings 425 Approved Brimonidine gel ; Lactose-containing L-glutamine ; Betrixaban ; C1 esterase injectable methylprednisolone inhibitor (human) ; Meropenem and ; Amoxicillin; Azithromycin ; Fluconazole, vaborbactam ; Delafloxacin ; Glecaprevir fosfluconazole ; DAAs and warfarin and pibrentasvir ; Sofosbuvir, velpatasvir ; Bendamustine ; Nivolumab ; Nivolumab, and voxilaprevir ; Cladribine ; Daunorubicin pembrolizumab ; Atezolizumab ; Ibrutinib and cytarabine ; Gemtuzumab ozogamicin ; Daclizumab ; Loxoprofen topical ; Enasidenib ; Neratinib ; Tivozanib ; preparations ; Denosumab ; Gabapentin Guselkumab ; Benznidazole ; Ciclosporin ; Hydroxocobalamine antidote kit paediatric eye drops ; Lutetium oxodotreotide 414 Diagnostics Gene cell therapy Hightop HIV home testing kits Tisagenlecleucel 414 Known risks Biosimilars Warfarin ; Local corticosteroids Bevacizumab; Adalimumab ; Hydroquinone skin lighteners Early access 415 Review outcomes Idebenone
    [Show full text]
  • Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
    antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution.
    [Show full text]
  • 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]
  • 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).
    [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]
  • Ilaris Canakinumab for Systemic Juvenile Idiopathic Arthritis SJIA
    Subject: Ilaris (canakinumab) for Systemic Juvenile Original Effective Date: 4/24/2015 Idiopathic Arthritis (SJIA) Policy Number: MCP-246 Revision Date(s): Review Date(s): 12/15/2016; 6/22/2017 DISCLAIMER This Medical Policy is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusion(s) or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the CMS website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination (LCD) will supersede the contents of this Molina medical coverage policy (MCP) document and provide the directive for all Medicare members. SUMMARY This policy addresses the coverage of Ilaris (canakinumab) for the treatment of Systemic Juvenile Idiopathic Arthritis (SJIA) when appropriate criteria are met.
    [Show full text]
  • BCBSVT Specialty Drug List Effective 2021.07.01.Xlsx
    Effective Date: 07/01/2021 SPECIALTY DRUG LIST Revised Date: 05/07/2021 DOSAGE EXCLUDED ON NATIONAL DRUG CLASS DRUG NAME GENERIC NAME FORM PERFORMANCE FORMULARY ANEMIA ARANESP SOLN DARBEPOETIN ALFA SOLN INJ ANEMIA ARANESP SOSY DARBEPOETIN ALFA SOLN PREFILLED SYRINGE ANEMIA EPOGEN SOLN EPOETIN ALFA INJ X ANEMIA PROCRIT SOLN EPOETIN ALFA INJ X ANEMIA REBLOZYL SOLR LUSPATERCEPT-AAMT FOR SUBCUTANEOUS INJ ANEMIA RETACRIT SOLN EPOETIN ALFA-EPBX INJ ANTI-GOUT AGENT KRYSTEXXA SOLN PEGLOTICASE INJ (FOR IV INFUSION) ANTI-INFECTIVE PREVYMIS SOLN LETERMOVIR IV SOLN ANTI-INFECTIVE PREVYMIS TABS LETERMOVIR TAB ASTHMA CINQAIR SOLN RESLIZUMAB IV INFUSION SOLN ASTHMA FASENRA SOSY BENRALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE ASTHMA FASENRA PEN SOAJ BENRALIZUMAB SUBCUTANEOUS SOLN AUTO-INJECTOR ASTHMA NUCALA SOAJ MEPOLIZUMAB SUBCUTANEOUS SOLUTION AUTO-INJECTOR ASTHMA NUCALA SOLR MEPOLIZUMAB FOR INJ ASTHMA NUCALA SOSY MEPOLIZUMAB SUBCUTANEOUS SOLUTION PREF SYRINGE ASTHMA XOLAIR SOLR OMALIZUMAB FOR INJ ASTHMA XOLAIR SOSY OMALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE CARDIOVASCULAR VYNDAMAX CAPS TAFAMIDIS CAP CARDIOVASCULAR VYNDAQEL CAPS TAFAMIDIS MEGLUMINE (CARDIAC) CAP CENTRAL NERVOUS SYSTEM AGENTS AUSTEDO TABS DEUTETRABENAZINE TAB CENTRAL NERVOUS SYSTEM AGENTS ENSPRYNG SOSY SATRALIZUMAB-MWGE SUBCUTANEOUS SOLN PREF SYRINGE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ CAPS TASIMELTEON CAPSULE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ LQ SUSP TASIMELTEON ORAL SUSP CHEMOTHERAPY PROTECTANT AMIFOSTINE SOLR AMIFOSTINE CRYSTALLINE FOR INJ CHEMOTHERAPY PROTECTANT ELITEK
    [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]
  • 761037Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 761037Orig1s000 OTHER REVIEW(S) --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- CHRISTINE H FORD 05/19/2017 Reference ID: 4100987 Continuation of Question 4 Additional data or analysis required for a previously submitted or expected study/clinical trial (provide explanation) Meta-analysis or pooled analysis of previous studies/clinical trials Immunogenicity as a marker of safety Other (provide explanation) Agreed upon: Quality study without a safety endpoint (e.g., manufacturing, stability) Pharmacoepidemiologic study not related to safe drug use (e.g., natural history of disease, background rates of adverse events) Clinical trials primarily designed to further define efficacy (e.g., in another condition, different disease severity, or subgroup) that are NOT required under Subpart H/E Dose-response study or clinical trial performed for effectiveness Nonclinical study, not safety-related (specify) Other 5. Is the PMR/PMC clear, feasible, and appropriate? Does the study/clinical trial meet criteria for PMRs or PMCs? Are the objectives clear from the description of the PMR/PMC? Has the applicant adequately justified the choice
    [Show full text]