Update on systemic therapies and emerging treatments How do I choose a systemic agent?
|
|
- Merry Phillips
- 6 years ago
- Views:
Transcription
1 Update on systemic therapies and emerging treatments How do I choose a systemic agent? Amy S. Paller, M.D. Walter J. Hamlin Professor and Chair of Dermatology Professor of Pediatrics Northwestern University Feinberg School of Medicine Chicago, Illinois Session: F025 Investigator: Abbvie; Celgene; Eli Lilly, Janssen, Leo Foundation; Novartis Consultant with honorarium: Amgen; Celgene; Eli Lilly; Novartis
2 When should a child with pediatric plaque psoriasis advance to a systemic medication? Generally moderate to severe disease Sometimes more limited disease, such as severe, recalcitrant nail involvement/ palmoplantar Not responding or tolerant of topical medications Having an impact on quality of life Highly visible Time of developing of self-esteem, social interactions Feeling control is critical: importance of adherence
3 Systemic interventions for children and adolescents with plaque psoriasis Phototherapy Compliance in kids is difficult Methotrexate [69.2%] Retinoids [14.6%] Cyclosporine [7.7%] Fumaric acid [4.9%; not in N. America] Biologics [27.2%] - Etanercept: Approved by FDA 11/16 - Adalimumab: Not yet FDA-approved - Ustekinumab: Approved by FDA 10/17 [ %] = % using this drug 12/90-9/14 Europe and US; N=390 children Bronckers et al. JAMA Derm 2017;153:1147
4 What about a Retinoid? Usually acetretin: First-line agent for pustular psoriasis in children, but also a favorite agent in some sites for plaque and palmoplantar psoriasis Most effective in study of 154 children in France (PASI 75=33.1% in 3 months) Charbit et al. BJD 2016;174:1118 Study in Turkey of 4 centers/ 61 patients on retinoids: PASI 50 in 65.5% and PASI 75 in 47.5% (no duration given) Ergun et al. J Dermatol Dec [Epub] Study of 18 patients in Italy: 44.4% with PASI 75 at wk 16 Di Lernia et al. Pediatr Dermatol 2016;33:530
5 What about a Retinoid? Dosage: mg/kg/d (max 0.6 mg/kg/d) Maintain at lowest effective level after taper No immunosuppression Can stop and start without loss of efficacy Many potential side effects, but primarily skin and mucosal dryness Higher drug survival than CsA and Mtx (36% 1 yr, 13% 3 year) with mucocutaneous issues tolerated Ergun et al. J Dermatol Dec [Epub] May be used adjunctively w/ photorx, Mtx, CsA or biologics
6 Would you use Cyclosporine? Good responses for plaque, pustular and erythrodermic psoriasis in children Generally well tolerated, but greatest potential toxicity leaves it lower on therapeutic ladder Lowest drug survival at 1 (15%), 2 (5.5%) and 3 (0) years among 80 patients on CsA (vs. Mtx/acetretin): Risk of immunosuppression, renal and liver disease, hypertension Ergun et al. J Dermatol Dec [Epub]; Pereira et al. JEADV 2006;20:651 Ergun et al. J Dermatol Dec [Epub] Dosage 3-5 mg/kg/d; can titrate up based on levels and tolerance Mean 12 weeks to improve; 40-50% with PASI 75
7 Methotrexate is most commonly used Dosage: mg/kg/wk; adjust upwards for increased efficacy; maintain at lowest effective level after taper for safety Decades of experience in children Recent study of 85 children: 34.1% achieved PASI 75 (time course not given) and drug survival 21.1% (1 yr) and 6.8% (2 yrs) Be prepared: update vaccines, warnings, check labs Ergun et al. J Dermatol Dec [Epub] For all immunosuppressants: baseline and annual TB testing; pregnancy counseling
8 Tips on Use of Methotrexate May take many months for best effect Single-site prospective study in 25 children PASI 50 PASI 75 ~40% achieved PASI 50 at 12 wks ~40% and 80% achieved PASI 75 and PASI 50 by 36 wks PASI 90 Van Geel et al. J Derm Treat 2015;26:406
9 Folate during MTX therapy International retrospective chart review of 20 US and European sites = 390 well-characterized patients treated with systemics Methotrexate most common (69.2%) > Biologics (27.2%; 76% etanercept) Daily or 6d/wk folic acid lowers risk of GI issues (nausea, dyspepsia) vs. weekly folic acid (usu. day after Mtx) GI AEs OR = 0.21 (95% CI, ) for daily and OR= 16 (95% CI, ) for 6x/wk Not related to route (eg, po vs sc) or maximum Mtx dose, but increased OR with longer duration on Mtx (p=0.006) Other AEs: Transaminitis 13.3%; fatigue 6.3%, infections (esp skin, airway) 4.4%, leukopenia 3.3% Bronckers et al. JAMA Derm 2017;153:1147
10 Biologics tested and available for children *Th17/ Th17R inhibition not tested in children
11 Percentage of Patients Etanercept trial 211 children (4-17 years) 12 weekly injections of placebo vs. 0.8 mg/kg/wk etanercept (50=max) 24 weeks open-label etanercept Baseline 12 weeks Placebo (n = 105) Etanercept 0.8mg/kg QW (n = 106) PASI 50 PASI 75 PASI 90 spga "clear"/ "Almost clear" wk PASI 75: 68% and 65% No significant safety issues Paller et al. NEJM 2008;358:21
12 5-year safety and efficacy 60-70% 30-40% Open-label extension of dbl-blind trial (4-17 yrs) in patients who achieved at least PASI 50, no AE/SAE Of 181 enrolled, 69 completed 5 years 1 patient with cellulitis No malignancy, deaths Paller et al. JAAD 2016;74: % Etanercept: Approved 2016 for 6 years and above Financial assistance program Home nurse program
13 Adalimumab vs. Methotrexate 114 patients (not US) with moderate-severe psoriasis Ages 4-8 years; mean 13 y/o, 21% obese and 15% overweight Family history psoriasis in 33% Mean duration 5 y/ %BSA 28/ mean PASI 18 Rules: could have been on etanercept >4 wks ago and on Mtx with response and tolerance >1 year ago Randomized to 16 wks Mtx ( mg/kg/wk, max 25 mg) vs. standard dose Ada (0.8 mg/kg qowk, max 40) vs. half-dose Ada (0.4 mg/kg qowk, max 20) Papp et al. Lancet 2017;390:40
14 Weeks 4-16 PASI 75 Comparable incidence of adverse events Papp et al. Lancet 2017;390:40
15 Tips on Use of TNF Inhibitors May require higher dosing for older, obese children Efficacy may be lost over years: do not have durability studies in children Does not prevent psoriatic arthritis, but most are also helpful for arthritis Most common side effect is injection site reaction May be more infections than methotrexate but need more careful data collection/ monitoring - No reported lymphoma; follow long-term
16 Tips on Use of TNF Inhibitors Baseline hx, PE, vaccines, TB testing Annual TB tests; No consensus for other labs Rheum: CBC, LFTs, Cr every 3 6 months - Level of evidence: D Beukelman et al. Arthritis Care Res 2011;63:465 Survey (n=51): 40% of pedi derms do no other labs; no lab abnormalities found Delphi study to gain consensus among pedi derms planned
17 Proportion of Subjects (%) Ustekinumab in 110 adolescents: CADMUS trial 12 wk RDBC, multicenter trial Dosing 1 mo, then open q 3 mo. (total 60 wks) 12 y, moderate to severe disease Primary endpoint: PGA of Clear (0) or Minimal (1) at Week 12 *p< /37 25/37 25/36 Placebo UST Half-Standard UST Standard 0.75 mg/kg/d Landells et al. JAAD 2015;73:
18 Secondary Endpoints: PASI 75 and PASI 90 Responders at Week 12 PASI 75 PASI 90 *p< wk etanercept PASI 75 57% and PASI 90 27% Landells et al. JAAD 2015;73:594
19 Proportion of Subjects (%) Other Secondary Analyses: PGA Clear (0) and PASI 100 at Week 12 PGA clear *p<0.001 PASI100 *p<0.001 **p=0.014 * * * ** 1/37 Placebo 12/37 17/36 UST HStd UST Std 1/37 Placebo 8/37 14/36 UST HStd UST Std Landells et al. JAAD 2015;73:
20 Mean (SD) Change from Baseline Change from Baseline in Children s Dermatology Life Quality Index (CDLQI) Score at Week 12 (3.18) (6.43) (5.63) Placebo p=0.003 UST Half Standard p<0.001 UST Standard No significant side effects Approved in US >12 y/o October, 2017
21 Tip: Ustekinumab may be choice for CARD14 mutation (may present as PRP, plaque psoriasis, erythrodermic psoriasis with pustules) CARD14 IL8 IL36 VEGF
22 Comparison among systemic medications Infrequent dosing with biologics = convenience; fewer labs Significant side effects unusual with biologics Potential issues with anti-drug antibody; no drug holidays Unknown long-term risk of biologics Etanercept use could prevent enrollment in trials Cost and response Mtx < acitretin < CsA << biologics Adjusted PASI-75 response rate (adults): 31.9% apremilast; 52.6% etanercept; 65.9% adalimumab; 68.6% ustekinumab 45mg and 74.0% 90mg* Cost per responder (PASI-75, adults) at 16 wks: $18.9K apremilast; $33.5K etanercept; $29.3K adalimumab; $21.5K and $39.9K 45mg/90mg ustekinumab* May not be covered by insurance; access an issue; biosimilars 20-30% less *Feldman et al. Presented AAD, 2015
23 Future considerations US trial ongoing for apremilast in children: case report in 14 y/o boy Ongoing effort to make adalimumab available for US children US trial ongoing for ustekinumab in children <12 years US trial ongoing for ixekizumab in adolescents and younger children Trials planned for other Th17/IL-23 inhibitors Pathogenesis-based therapy Smith. JAAD Case Rep 2016;2:89 Study using flow analysis of pediatric plaque psoriasis (n=10) suggested increased IL-17A and IL-22 T cells in skin from pediatric psoriasis vs. healthy children and vs adult psoriasis Could IL-22 be a better target in children than adults? Cordoro et al. J Am Acad Dermatol 2017;77:417
The Treatment Toolbox for Severe Pediatric Psoriasis
The Treatment Toolbox for Severe Pediatric Psoriasis Dr. Kim A. Papp, MD, PhD, FRCPC, FAAD K Papp Clinical Research and Probity Medical Research Objectives: Treating severe pediatric psoriasis 1. Challenges
More informationchemotherapeutic agents in
Use of biologics and chemotherapeutic agents in cutaneous emergencies: Focus on lifethreatening forms of psoriasis Alice Bendix Gottlieb MD, PhD Professor of Dermatology New York Medical College Metropolitan
More informationIncorporating Biologics Into Your Practice
Incorporating Biologics Into Your Practice Jeffrey M. Sobell MD Tufts University School of Medicine SkinCare Physicians Ora Clinical Research Disclosure Of Relationships With Industry Amgen AbbVie Celgene
More informationPsoriasis: Therapeutic goals
Psoriasis: Therapeutic goals I want to die 50 45 impetiginization infliximab 600 40 35 30 400 25 20 15 200 10 5 0 22-ene 21-feb 23-mar 22-abr 22- may Efalizumab 6 doses: flare + REBOUND CSA 3 21-jun 21-jul
More informationBiologics and Psoriasis: The Beat Goes On
Biologics and Psoriasis: The Beat Goes On Mark Lebwohl, MD Waldman Professor And Chairman Kimberly and Eric J. Waldman Department of Dermatology Icahn School of Medicine at Mount Sinai Mark Lebwohl is
More informationBreakthrough Drugs in Dermatology. Mark Lebwohl, MD
Breakthrough Drugs in Dermatology Mark Lebwohl, MD Sol and Clara Kest Professor And Chairman Kimberly and Eric J. Waldman Department of Dermatology Icahn School of Medicine at Mount Sinai LIFE CHANGING
More informationDisclosures. Activity Information. Updates in Psoriasis Therapy. Ustekinumab Guselkumab Tildrakizumab. Secukinumab Ixekizumab Brodalumab
Disclosures Faculty: Teri Greiling, MD, PhD, has disclosed the following conflicts of interest: research funding: Eli Lilly. Updates in Psoriasis Therapy 12 October 2018 St. Charles Medical Center Teri
More informationThe New and Emerging Agents: Dermatology
Psoriasis Treatment 2013: What is New and on the Horizon? Neil J Korman, MD, PhD Professor of Dermatology University Hospitals Case Medical Center Clinical Director Murdough Family Center for Psoriasis
More informationPsoriasis management. A/Prof Amanda Oakley Dermatologist, Waikato
Psoriasis management A/Prof Amanda Oakley Dermatologist, Waikato AbbVie Breakfast Session, 14 June 2014 Disclosure This breakfast session is sponsored by Abbvie Autoimmune skin disorders Psoriasis Eczema
More informationRecalcitrant Warty Erythroderma With Severe Pruritus. Gil Yosipovitch Professor & Chair Department of Dermatology & Itch Center Temple University
Recalcitrant Warty Erythroderma With Severe Pruritus Gil Yosipovitch Professor & Chair Department of Dermatology & Itch Center Temple University DISCLOSURE OF RELEVANT RELATIONSHIPS WITH INDUSTRY Gil Yosipovitch,
More informationCigna Drug and Biologic Coverage Policy
Cigna Drug and Biologic Coverage Policy Subject Apremilast Table of Contents Coverage Policy... 1 General Background... 2 Coding/Billing Information... 4 References... 4 Effective Date... 1/1/2018 Next
More informationPsoriasiform Dermatitis in Children: Calling in the Troops
Psoriasiform Dermatitis in Children: Calling in the Troops Markus Boos, MD PhD Attending Physician, Dermatology Seattle Children s Hospital Assistant Professor of Pediatrics, University of Washington School
More informationAn Update on Topical Therapy for Atopic Dermatitis
An Update on Topical Therapy for Atopic Dermatitis Amy S. Paller, M.D. Professor and Chair of Dermatology Professor of Pediatrics Northwestern University Feinberg School of Medicine Chicago, Illinois Disclosures
More informationCombination Nonbiologic Therapy in Psoriasis. Sushil Tahiliani, MBBS, MD
Combination Nonbiologic Therapy in Psoriasis Sushil Tahiliani, MBBS, MD Agenda Rationale Preferred and less preferred combination Morphology-specific preferred combinations Doses used in combinations Potential
More informationRheumatology journal club October 20, 2017 Presented by: Matthew Stoll MD,PhD,PSCS
Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis (Mease et al., 2017) Rheumatology journal club October 20,
More informationBiologics in Psoriasis. Peter CM van de Kerkhof Department of Dermatology Radboud University Nijmegen Medical Centre
Biologics in Psoriasis Peter CM van de Kerkhof Department of Dermatology Radboud University Nijmegen Medical Centre Disclosures Consultancy services for Celgene, Centocor, Almirall, Amgen, Pfizer, Philips,
More informationEconomic Evaluation of Apremilast in the Treatment of Moderate to Severe Psoriasis in the United States
1142 Economic Evaluation of Apremilast in the Treatment of Moderate to Severe Psoriasis in the United States Tom Tencer, PhD 1 ; Zoe Clancy, PharmD, MS 1 ; Vidya Damera, MS 2 ; Frank Zhang MD, MPH 1 ;
More informationPharmacy Accreditation
EASING THE PATIENT BURDEN OF PSORIASIS AND PSORIATIC ARTHRITIS: THE ROLE OF THE SPECIALTY PHARMACIST Claire Lee, PharmD, CSP, CPHQ Clinical Quality Improvement Supervisor Diplomat Flint, Michigan Pharmacy
More informationCost per Responder of Apremilast Versus Etanercept, Adalimumab, and Ustekinumab in Patients With Moderate to Severe Psoriasis
1108 Cost per Responder of Apremilast Versus Etanercept, Adalimumab, and Ustekinumab in Patients With Moderate to Severe Psoriasis Steven R. Feldman, MD, PhD 1 ; Tom Tencer, PhD 2 ; Zoe Clancy, PharmD,
More informationDrugs and Applicable Coding: J-code: Enbrel-J1438; Humira-J0135; Remicade-J1745; Inflectra-Q5102; Cimzia-J0718; Simponi-J1602 Renflexis - pending
Policy Subject: Anti-TNF Agents Policy Number: SHS PBD16 Category: Rheumatology & Autoimmune Policy Type: Medical Pharmacy Department: Pharmacy Product (check all that apply): Group HMO/POS Individual
More informationAdalimumab M Clinical Study Report Final R&D/14/1263. Page:
Synopsis AbbVie Inc. Name of Study Drug: Adalimumab Name of Active Ingredient: Adalimumab Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only) Title of Study:
More information(Poster presented on Sunday 05 March, 08:50 08:55; 2017 AAD Meeting, Orlando, Florida, USA)
Secukinumab in Psoriasis Patients with Concurrent Psoriatic Arthritis: Patient-Reported Outcomes in the Corrona Psoriasis Registry AB Gottlieb, B Strober, 2 AW Armstrong, 3 JD Greenberg, 4,5 C Karki, 4
More informationEvaluating Psoriasis: Patient Reported Outcomes and Impact of Disease
Evaluating Psoriasis: Patient Reported Outcomes and Impact of Disease Bruce E. Strober, MD, PhD Professor and Chair Department of Dermatology University of Connecticut Farmington, Connecticut DISCLOSURE
More informationClinical Policy: Ixekizumab (Taltz) Reference Number: ERX.SPA.122 Effective Date:
Clinical Policy: (Taltz) Reference Number: ERX.SPA.122 Effective Date: 10.01.16 Last Review Date: 11.18 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
More informationFaculty David M. Pariser, MD Professor Eastern Virginia Medical School Norfolk, VA
Disclaimer This slide deck in its original and unaltered format is for educational purposes and is current as of May 2015. The content and views presented in this educational activity are those of the
More informationPediatric Psoriasis Comorbidities. Kelly M. Cordoro, M.D. Associate Professor of Dermatology and Pediatrics University of California, San Francisco
Pediatric Psoriasis Comorbidities Kelly M. Cordoro, M.D. Associate Professor of Dermatology and Pediatrics University of California, San Francisco log2 (Expression/hARP) Th1 CXCL10 Disclosures * *** **
More informationETANERCEPT Generic Brand HICL GCN Exception/Other ETANERCEPT ENBREL GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)
Generic Brand HICL GCN Exception/Other ETANERCEPT ENBREL 18830 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of moderate to severe rheumatoid
More informationWhat's Now, What's Next: Individualizing the Treatment of Patients With Moderate to Severe Psoriasis for the Dermatologist Presentation 1
The following is a transcript from a web-based CME-certified multimedia activity. Interactivity applies only when viewing the activity online. This activity is supported by educational grants from Celgene
More informationBilaga 1.till rapport. Bilaga 1 Tabell över inkluderade studier/ Appendix 1 Description of included studies
Bilaga 1.till rapport Ljusbehandling och systemisk behandling av psoriasis, rapport nr 278 (2018) Bilaga 1 Tabell över inkluderade studier/ Appendix 1 Description of included studies Description of included
More informationPsoriasis: A Cutaneous or Systemic Disease
Psoriasis: A Cutaneous or Systemic Disease Ian D.R. Landells, MD, FRCPC Clinical Chief Dermatology, Eastern Health Clinical Assistant Professor Disciplines of Medicine and Paediatrics Faculty of Medicine
More informationCriteria Inclusion criteria Exclusion criteria. despite treatment with csdmards, NSAIDs, and/or previous anti-tnf therapy and/or
Supplementary Material Table S1 Eligibility criteria (PICOS) for the SLR Criteria Inclusion criteria Exclusion criteria Population Adults (aged 18 years) with active PsA despite treatment with csdmards,
More informationAnti-TNF biologic agents Dr Lluís Puig
Department of Dermatology Hospital de la Santa Creu i Sant Pau IPC NOVARTIS PSORIASIS PRECEPTORSHIP Anti-TNF biologic agents Dr Lluís Puig Barcelona, July 9th-10th, 2013 Anti-TNF therapy in the pathophysiology
More informationPsoriasis Pearls. Mark Lebwohl, MD
Psoriasis Pearls Mark Lebwohl, MD Waldman Professor And Chairman Kimberly and Eric J. Waldman Department of Dermatology Icahn School of Medicine at Mount Sinai Psoriasis Pearls Pearl #1 Patients who can
More informationEfficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis (UNVEIL Phase IV Study)
4892 Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis ( Phase IV Study) Bruce Strober, MD 1 ; Jerry Bagel, MD 2 ; Mark Lebwohl, MD 3 ; Linda Stein Gold, MD 4 ; J. Mark Jackson,
More informationClinical Policy: Ixekizumab (Taltz) Reference Number: CP.PHAR.257 Effective Date: Last Review Date: 11.18
Clinical Policy: (Taltz) Reference Number: CP.PHAR.257 Effective Date: 08.01.16 Last Review Date: 11.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationMichael P. Heffernan, M.D San Luis Dermatology & Laser Clinic Director, US Probity Medical Research
Michael P. Heffernan, M.D San Luis Dermatology & Laser Clinic Director, US Probity Medical Research mpheffernanmd@gmail.com DISCLOSURES Consultant, Speaker, Investigator: Abbvie, Amgen, Brickell Biotech,
More informationPediatric Psoriasis:
Pediatric Psoriasis: What s New, What s True? Kelly M. Cordoro, M.D. Associate Professor of Dermatology and Pediatrics University of California, San Francisco Kelly.cordoro@ucsf.edu Disclosures Consultant
More informationDISCLOSURES WHAT S NEW AND EXCITING FROM JAAD
WHAT S NEW AND EXCITING FROM JAAD Bruce H. Thiers, MD, Editor, JAAD Professor, Medical University of South Carolina Department of Dermatology and Dermatologic Surgery DISCLOSURES PFIZER VALEANT EFFECT
More informationTargeted Immunomodulators for the Treatment of Moderate-to- Severe Plaque Psoriasis: Effectiveness and Value
Targeted Immunomodulators for the Treatment of Moderate-to- Severe Plaque Psoriasis: Effectiveness and Value Condition Update Final Background and Scope January 9, 2018 Background Psoriasis is a common
More informationBackground AN UPDATED LOOK AT TREATMENTS FOR PLAQUE PSORIASIS JULY 2018 PLAQUE PSORIASIS TARGETED IMMUNOMODULATORS AS A TREATMENT OPTION
JULY 2018 Background PLAQUE PSORIASIS Plaque psoriasis is a common disease affecting 3% of the US population that causes itchy, red, scaly, raised lesions on the skin, most commonly on the elbows, knees,
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE 1 Guideline title SCOPE Psoriasis: the management of psoriasis 1.1 Short title Psoriasis 2 The remit The Department of Health has asked NICE: 'to produce
More informationHorizon Scanning Centre January Apremilast for psoriasis SUMMARY NIHR HSC ID: 2652
Horizon Scanning Centre January 2013 Apremilast for psoriasis SUMMARY NIHR HSC ID: 2652 This briefing is based on information available at the time of research and a limited literature search. It is not
More informationBruce Strober 1, 2, Chitra Karki 3, Marc Mason 3, Ning Guo 3, Jeffrey D Greenberg 3,4, Mark Lebwohl 5
Characterization of Disease Burden, Comorbidities and Use of Patients with Psoriasis at Enrollment: Results from the Corrona Psoriasis Registry Bruce Strober 1, 2, Chitra Karki 3, Marc Mason 3, Ning Guo
More informationPhototherapy for Psoriasis. Henry W. Lim, MD Chairman and C.S. Livingood Chair Department of Dermatology Henry Ford Hospital, Detroit, MI, USA
Phototherapy for Psoriasis Henry W. Lim, MD Chairman and C.S. Livingood Chair Department of Dermatology Henry Ford Hospital, Detroit, MI, USA Disclosure Investigator: Clinuvel Estée Lauder Ferndale Incyte
More informationClinical Policy: Apremilast (Otezla) Reference Number: CP.PHAR.245 Effective Date: Last Review Date: Line of Business: HIM, Medicaid
Clinical Policy: (Otezla) Reference Number: CP.PHAR.245 Effective Date: 08.16 Last Review Date: 11.18 Line of Business: HIM, Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationIs Apremilast (Otezla) Effective in Reducing Pruritus in Adults over 18 Years Old with Plaque Psoriasis?
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Scholarship Student Dissertations, Theses and Papers 3-2017 Is Apremilast (Otezla) Effective in
More informationAbstract Background: Methods: Results: Conclusion:
1131 Efficacy of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, for Palmoplantar Psoriasis in Patients With Moderate to Severe Plaque Psoriasis in Phase 2 and Phase 3 (ESTEEM) Trials Robert Bissonnette,
More informationPsoriasis. Jessica Kaffenberger, M.D. Assistant Professor of Dermatology Division of Dermatology The Ohio State University Wexner Medical Center
Psoriasis Jessica Kaffenberger, M.D. Assistant Professor of Dermatology Division of Dermatology The Ohio State University Wexner Medical Center Learning objectives Recognize the different types of psoriasis
More informationPsoriasis. Andrei Metelitsa, MD, FRCPC, FAAD Clinical Associate Professor, Dermatology, U of C Co-Director, Institute for Skin Advancement
Psoriasis Andrei Metelitsa, MD, FRCPC, FAAD Clinical Associate Professor, Dermatology, U of C Co-Director, Institute for Skin Advancement Copyright 2017 by Sea Courses Inc. All rights reserved. No part
More informationClinical Policy: Ixekizumab (Taltz) Reference Number: CP.PHAR.257 Effective Date: Last Review Date: 05.18
Clinical Policy: (Taltz) Reference Number: CP.PHAR.257 Effective Date: 08.01.16 Last Review Date: 05.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More information2.0 Synopsis. Adalimumab R&D/04/118. (For National Authority Use Only) Referring to Part of Dossier: Volume:
2.0 Synopsis Abbott Laboratories Name of Study Drug: Adalimumab Name of Active Ingredient: Adalimumab Title of Study: Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority
More informationClinical Policy: Brodalumab (Siliq) Reference Number: CP.PHAR.375 Effective Date: Last Review Date: 05.18
Clinical Policy: (Siliq) Reference Number: CP.PHAR.375 Effective Date: 06.01.18 Last Review Date: 05.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationWhat s New in the Treatment of Psoriasis
What s New in the Treatment of Psoriasis Mark Lebwohl, MD Waldman Professor And Chairman Kimberly and Eric J. Waldman Department of Dermatology Icahn School of Medicine at Mount Sinai Mark Lebwohl is an
More informationThe Natural History of Psoriasis and Treatment Goals
The Natural History of Psoriasis and Treatment Goals Psoriasis Epidemiology Prevalence Affects 2 3% of adult population (>7 million in US) Caucasians: 25% 2.5% African Americans: 1.3% (more likely to have
More informationJ. Gelfand 1, A. Joshi 2, D. Shin 1, A. Dey 2, D. Torigian 1, D. Rader 1, M. Playford 2, M. Ahlman 2, A. Alavi 1, N. Mehta 2.
A Trial to Determine the Effect of Psoriasis Treatment (Adalimumab, Phototherapy, and placebo) on Cardiometabolic Disease: The Vascular Inflammation in Psoriasis (VIP) Trial Abstract 393 J. Gelfand 1,
More informationTremfya (guselkumab) NEW PRODUCT SLIDESHOW
Tremfya (guselkumab) NEW PRODUCT SLIDESHOW Introduction Brand name: Tremfya Generic name: Guselkumab Pharmacological class: Interleukin-23 antagonist Strength and Formulation: 100mg/mL; soln for SC inj;
More informationGaps in the Treatment of Psoriasis and PsA for Systemic Therapy
Gaps in the Treatment of Psoriasis and PsA for Systemic Therapy Mark Lebwohl, MD Sol and Clara Kest Professor And Chairman Department of Dermatology Icahn School of Medicine at Mount Sinai Disclosure Mark
More informationDimethyl Fumarate in Psoriasis Therapy
Dimethyl Fumarate in Psoriasis Therapy This meeting took place on 12 th October 2018, as part of the 2 nd European Workshop on Skin Immune Mediated Inflammatory Diseases (SIMID) in Verona, Italy Speakers:
More informationHorizon Scanning Centre March Ixekizumab for moderate to severe chronic plaque psoriasis SUMMARY NIHR HSC ID: 5209
Horizon Scanning Centre March 2015 Ixekizumab for moderate to severe chronic plaque psoriasis SUMMARY NIHR HSC ID: 5209 This briefing is based on information available at the time of research and a limited
More informationElements of Successful PBS Applications. Barbara Radulski RN. Copyright
Elements of Successful PBS Applications Barbara Radulski RN PBS Requirements April 1 2006 THE RULES PBS Requirements 18 years and over Psoriasis x 6 months Failed to achieve an adequate response to 3 systemic
More informationDo Psoriasis Therapies Increase the Risk of Skin Cancer? Mark Lebwohl, MD
Do Psoriasis Therapies Increase the Risk of Skin Cancer? Mark Lebwohl, MD Sol and Clara Kest Professor And Chairman Department of Dermatology The Mount Sinai School of Medicine Disclosure Mark Lebwohl
More informationDLQI (ESTEEM
192 Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Moderate to Severe Plaque Psoriasis: Pruritus and DLQI Correlations at Week 16 (ESTEEM 1 and 2) Steven R. Feldman, MD, PhD 1 ; Diamant
More informationCertolizumab pegol (Cimzia) for chronic plaque psoriasis in adults
NIHR Innovation Observatory Evidence Briefing: April 2017 Certolizumab pegol (Cimzia) for chronic plaque psoriasis in adults NIHRIO (HSRIC) ID: 2406 NICE ID: 9112 LAY SUMMARY Plaque psoriasis is the most
More informationustekinumab (Stelara )
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationSingle Technology Appraisal (STA) Tildrakizumab for treating moderate to severe plaque psoriasis
Single Technology Appraisal (STA) Tildrakizumab for treating moderate to severe plaque psoriasis Response to consultee and commentator comments on the draft remit and draft scope (pre-referral) Please
More informationPGA x BSA as a PASI Surrogate
PGA x BSA as a PASI Surrogate Alice Bendix Gottlieb MD, PhD Professor of Dermatology New York Medical College Metropolitan Hospital New York, NY, USA DISCLOSURE OF RELEVANT RELATIONSHIPS WITH INDUSTRY
More informationUSTEKINUMAB Generic Brand HICL GCN Exception/Other USTEKINUMAB STELARA GUIDELINES FOR USE
Generic Brand HICL GCN Exception/Other USTEKINUMAB STELARA 36187 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of psoriatic arthritis (PsA)
More informationBiologics in Psoriasis: 2018 and Beyond. Jeffrey M. Sobell MD Tufts University School of Medicine SkinCare Physicians Ora Clinical Research
Biologics in Psoriasis: 218 and Beyond Jeffrey M. Sobell MD Tufts University School of Medicine SkinCare Physicians Ora Clinical Research Biologics in Psoriasis FDA approved TNF inhibitors Etanercept Adalimumab
More informationPsoriasis. Dr. Pablo de la Cueva Hospital Universitario Infanta Leonor Madrid
Psoriasis Dr. Pablo de la Cueva Hospital Universitario Infanta Leonor Madrid PSORIASIS Psoriasis News. Topical treatment Calcipotriene/Betamethasone Dipropionate (Cal/BD) foam: In the real-world, Cal/BD
More informationJEADV SHORT REPORT. Abstract
DOI: 1.1111/jdv.14738 JEADV SHORT REPORT Safety and efficacy of through 14 weeks in patients with moderate to severe psoriasis who continued on or switched from etanercept treatment: findings from the
More informationSTELARA (USTEKINUMAB)
Oxford STELARA (USTEKINUMAB) UnitedHealthcare Oxford Clinical Policy Policy Number: PHARMACY 218.13 T2 Effective Date: February 1, 2017 Table of Contents Page INSTRUCTIONS FOR USE... 1 CONDITIONS OF COVERAGE...
More information1 Introduction. Kim A. Papp 1 April W. Armstrong. Wendell Valdecantos 4
Am J Clin Dermatol (216) 17:79 86 DOI 1.17/s4257-15-161-5 ORIGINAL RESEARCH ARTICLE Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis
More informationTRANSPARENCY COMMITTEE OPINION. 26 April 2006
TRANSPARENCY COMMITTEE OPINION 26 April 2006 REMICADE 100 mg powder for concentrate for solution for infusion Box of 1 (CIP code: 562 070.1) Applicant : laboratoires Schering Plough List I Drug for hospital
More informationU059 Hidradeni-s Suppura-va and Pityriasis Rubra Pilaris: Updates on Treatment
U059 Hidradeni-s Suppura-va and Pityriasis Rubra Pilaris: Updates on Treatment DISCLOSURES I do not have any relevant relationships with industry. Scott Worswick UCLA Dermatology Director of Inpatient
More informationEfficacy and Survival of Systemic Psoriasis Treatments: An Analysis of the Swiss Registry SDNTT
Original Paper Received: March 7, 2016 Accepted after revision: October 3, 2016 Published online: January 12, 2017 Efficacy and Survival of Systemic Psoriasis Treatments: An Analysis of the Swiss Registry
More informationSource: American Academy of Dermatology Annual Meeting held February 16 20, 2018, in San Diego, California
Source: American Academy of Dermatology Annual Meeting held February 16 20, 2018, in San Diego, California OVERVIEW Steven R. Feldman, MD, PhD, and Alan Menter, MD, as well as principal investigators,
More informationJashin J Wu, 1 Alexander Egeberg, 2 James A Solomon, 3,4,5 Olawale Osuntokun, 6 Orin Goldblum, 6 Susan R Moriarty, 6 Fangyi Zhao, 6 Neil Korman 7
4662 Ixekizumab Treatment Shows a Neutral Impact on the Glucose and Lipid Profile of Patients with Moderate-to-Severe Psoriasis: Results from UNCOVER-1, -2, and -3 Jashin J Wu, 1 Alexander Egeberg, 2 James
More informationClinical Policy: Apremilast (Otezla) Reference Number: CP.PHAR.245 Effective Date: 08/16 Last Review Date 08/17
Clinical Policy: (Otezla) Reference Number: CP.PHAR.245 Effective Date: 08/16 Last Review Date 08/17 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationPsoriasis Patients with: Integrating New Psoriasis Therapies Into Your Practice
Integrating New Psoriasis Therapies Into Your Practice Mark Lebwohl, MD Sol and Clara Kest Professor And Chairman Department of Dermatology The Mount Sinai School of Medicine Psoriasis Patients with: Psoriatic
More informationThe role of current biologic therapies in psoriasis
: An Update on and IL-17 Inhibitors Joanna Dong, BA; Gary Goldenberg, MD PRACTICE POINTS The newest biologics for treatment of moderate to severe plaque psoriasis are and IL-17 inhibitors with unprecedented
More informationC. Assess clinical response after the first three months of treatment.
Government Health Plan (GHP) of Puerto Rico Authorization Criteria Tumor Necrosis Factor Alpha (TNFα) Adalimumab (Humira ) Managed by MCO Section I. Prior Authorization Criteria A. Physician must submit
More informationScottish Medicines Consortium
Scottish Medicines Consortium ustekinumab, 45mg solution for injection (Stelara ) No. (572/09) Janssen-Cilag Ltd 15 January 2010 The Scottish Medicines Consortium (SMC) has completed its assessment of
More informationSYSTEMIC THERAPY OF MODERATE AND SEVERE PSORIASIS WITH METHOTREXATE
Bulletin of the Transilvania University of Braşov Series VI: Medical Sciences Vol. 5 (54) No. 2-2012 SYSTEMIC THERAPY OF MODERATE AND SEVERE PSORIASIS WITH METHOTREXATE M. FRÎNCU 1 A. OANŢĂ 1 Abstract:
More informationClinical Policy: Ustekinumab (Stelara) Reference Number: ERX.SPA.01 Effective Date:
Clinical Policy: (Stelara) Reference Number: ERX.SPA.01 Effective Date: 04.01.17 Last Review Date: 11.17 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION IXEKIZUMAB (Taltz Eli Lilly Canada Inc.) Indication: Moderate to Severe Plaque Psoriasis Recommendation: The CADTH Canadian Drug Expert Committee
More informationOff-Label Biologic Regimens in Psoriasis: A Systematic Review of Efficacy and Safety of Dose Escalation, Reduction, and Interrupted Biologic Therapy
: A Systematic Review of Efficacy and Safety of Dose Escalation, Reduction, and Interrupted Biologic Therapy Elizabeth A. Brezinski 2, April W. Armstrong 1 * 1 Department of Dermatology, University of
More informationInsights from the Kaiser Permanente database
Insights from the Kaiser Permanente database Jashin J. Wu, M.D. Founding Director of Dermatology Research Director, Psoriasis Clinic Department of Dermatology Kaiser Permanente Los Angeles Medical Center
More informationThe implication of an immunologic
Evidence-Based Review of Biologic Therapy for Psoriasis: Infliximab, Etanercept, Adalimumab, Efalizumab, and Alefacept Jeffrey M. Weinberg, MD; Robin Buchholz, MD; Noah Scheinfeld, MD DERMATOLOGY ABSTRACT
More informationThe Cosentyx clinical trial programme 1-11
The Cosentyx clinical trial programme 1-11 There are eight pivotal trials (four in psoriasis, two in psoriatic arthritis, two in ankylosing spondylitis) There are two head-to-head trials in psoriasis showing
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Otezla (apremilast) Page 1 of 7 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Otezla (apremilast) Prime Therapeutics will review Prior Authorization requests Prior
More informationSTELARA (USTEKINUMAB)
STELARA (USTEKINUMAB) UnitedHealthcare Commercial Medical Benefit Drug Policy Policy Number: 2017D0045J Effective Date: July 1, 2017 Table of Contents Page INSTRUCTIONS FOR USE... 1 BENEFIT CONSIDERATIONS...
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 13 May 2009
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 13 May 2009 STELARA 45 mg, solution for injection B/1 x 0.5 ml vial (CIP code: 392 586-2) JANSSEN-CILAG Ustekinumab
More informationDetails of UNCOVER-2 and UNCOVER-3 Study Results Published in The Lancet
June 10, 2015 Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 U.S.A. +1.317.276.2000 www.lilly.com For Release: Refer to: Immediately Tim Coulom; tim.coulom@lilly.com; 317-771-2241
More informationResearch Developments in Psoriasis Treatment A CME Activity
Overview Research Developments in Psoriasis Treatment A CME Activity Mark Lebwohl, MD, Waldman Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York, provides his perspectives
More informationKim A. Papp, MD PhD Probity Medical Research, Waterloo, ON, Canada
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Moderate to Severe Plaque Psoriasis: Pooled Efficacy Results from the Subgroup of Canadian Patients in Two Phase III Randomized Controlled
More informationSystemic Medications for the Dermatology Toolbox: Azathioprine
Systemic Medications for the Dermatology Toolbox: Azathioprine Wynnis Tom, M.D. Associate Clinical Professor University of California, San Diego and Rady Children s Hospital Faculty Disclosure Information
More informationAmjevita (adalimumab-atto)
*- Florida Healthy Kids Amjevita (adalimumab-atto) Override(s) Prior Authorization Quantity Limit Medications Amjevita 20 mg/0.4 ml prefilled syringe Amjevita (adalimumab-atto) 40 mg/0.8 ml 2 #* ^ prefilled
More information2.0 Synopsis. Adalimumab M Clinical Study Report R&D/04/900. (For National Authority Use Only) Referring to Part of Dossier: Volume:
2. Synopsis Abbott Laboratories Name of Study Drug: Name of Active Ingredient: Title of Study: Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only) Phase
More informationClinical Policy: Secukinumab (Cosentyx) Reference Number: CP.PHAR.261 Effective Date: 08/16 Last Review Date: 08/17
Clinical Policy: (Cosentyx) Reference Number: CP.PHAR.261 Effective Date: 08/16 Last Review Date: 08/17 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationEvaluating Biologic Therapies for Psoriasis Strategies to Reduce Cost and Improve Patient Access and Outcomes
Evaluating Biologic Therapies for Psoriasis Strategies to Reduce Cost and Improve Patient Access and Outcomes Faculty William J. Cardarelli, PharmD Director of Pharmacy Revenue and Supply Atrius Health
More information