TNF Inhibitors: Lessons From Immunogenicity

Size: px
Start display at page:

Download "TNF Inhibitors: Lessons From Immunogenicity"

Transcription

1 TNF Inhibitors: Lessons From Immunogenicity Edward Keystone, MD, FRCP(C) Professor of Medicine University of Toronto Toronto, Canada Edward Keystone, MD FRCP(C) Disclosures Sources of Funding for Research: Abbott Laboratories; Amgen Inc.; AstraZeneca Pharmaceuticals LP; Baylis Medical; Bristol-Myers Squibb; F. Hoffmann-La Roche Inc; Janssen Inc, Lilly Pharmaceuticals, Novartis Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, UCB. Consulting Agreements/Advisory Board Membership: Abbott Laboratories; AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company; F. Hoffmann-La Roche Inc; Genentech Inc; Jannsen Inc, Lilly Pharmaceuticals; Merck, Nycomed, Pfizer Pharmaceuticals, UCB; Speaker Honoraria Agreements: Abbott Laboratories; Astrazeneca LP; Bristol-Myers Squibb Canada; F. Hoffmann-La Roche Inc.; Janssen Inc.; Pfizer Pharmaceuticals; UCB; Amgen Financial Interests/Stock Ownership: None Discussion of Off-Label, Investigational, or Experimental Drug Use: None Revised May 2013

2 Outline Targets of Immunogenicity Factors Affecting Immunogenicity Clinical Implications Proposed Treatment Algorithm 2007

3 Etanercept (Enbrel ) Three classes of TNF antagonists: Fusion proteins, Antibodies, Pegylated Fab Fragments Receptor Infliximab (Remicade ) Fab Adalimumab (Humira ) Fab Golimumab Certolizumab pegol (Cimzia ) Fab IgG1 Fc IgG1 Fc IgG1 Fc PEG Recombinant receptor/fc fusion protein Monoclon al antibody PEGylated Fab fragment 40 kda PEG (2 20 kda) Weir N, Athwal D, et al. Therapy. 2006;3: Anti-Drug Antibodies Are Increased In All TNFis Managed Healthcare Training Audience Date Company Confidential 2013

4 Antidrug Antibodies (ADAb) to TNF-Specific Neutralising Agents In Chronic Inflammatory Diseases: A Real Issue, A Clinical Perspective Vincent FB et al. Ann Rheum Dis 2012;0:1-9 Managed Healthcare Training Audience Date Company Confidential 2013 INFLIXIMAB: Incidence, Clinical And Biological Associations Of Anti-drug Antibodies = 6-61% Vincent FB et al. Ann Rheum Dis 2012 Managed Healthcare Training Audience Date Company Confidential

5 ADALIMUMAB: Incidence, Clinical And Biological Associations Of Anti-drug Antibodies In The Literature = % Vincent FB et al. Ann Rheum Dis 2012 Managed Healthcare Training Audience Date Company Confidential 2013 ETANERCEPT: Incidence, Clinical And Biological Associations Of Anti-drug Antibodies = 0-18% Vincent FB et al. Ann Rheum Dis 2012 Managed Healthcare Training Audience Date Company Confidential 2013

6 CERTOLIZUMAB: Incidence, Clinical & Biological Associations of anti-drug Antibodies = 3-25% Vincent FB et al. Ann Rheum Dis 2012 Managed Healthcare Training Audience Date Company Confidential 2013 GOLIMUMAB: Incidence, Clinical & Biological Associations of anti-drug Antibodies = 0-7.2% Vincent FB et al. Ann Rheum Dis 2012 Managed Healthcare Training Audience Date Company Confidential 2013

7 Take Home Message Anti-Drug Abs observed with all TNFis: in RA and non-ra disorders variable between TNFis Anti-Drug Abs inversely correlated with: serum trough level clinical response MTX use Anti-Drug Abs correlated with A/Es: mainly infusion reactions Managed Healthcare Training Audience Date Company Confidential 2013 Factors Related to Immunogenicity & Its Detection Factors Contributing to Immunogenicity Dose, frequency, duration and route of administration 1 Concomitant medication 2 Genetics, immune and nutritional status of the patient 1 Antibody isotype 1 IgG1, IgG2, IgG3, IgG4 Function of the therapeutic target 1 Size and complexity of the therapeutic agent 1 Factors Contributing to the Detection of Anti-drug Antibody Clearance rate of the immunecomplex 1 Presence of soluble drug 1 Type of detection assay 1 Timing of antibody determination 1 antibody titer 2 1. Cassinotti A, et al. Inflamm Bowel Dis. 2009;15: Hermeling S, et al. Pharm Res. 2004;21:

8 Positive Interpretation of Results Positive for antibodies regardless of drug levels Negative Negative for antibodies Undetectable drug levels Inconclusive Negative for antibodies Detectable drug levels Important Limitations Regarding Immunogenicity Information Data on antibody development and immunogenicity are highly dependent on the sensitivity and specificity of the assay Interpretation requires information about drug levels at the time of sampling Very few assays in the public domain For these reasons, comparison of the incidence of antibodies between products may be misleading.

9 Practical Clinical Implications of Anti-Drug Abs Impact on safety Impact on efficacy Impact on TNFi dose escalation Impact on switching strategies Impact on Safety

10 Proportion of Infusions with Infusion Reactions Proportion of Infusions with Infusion Reactions Safety - Infusions with Infusion Reactions by Antibody-to-Infliximab (ATI) Status ATTRACT through week ACCENT I through week Positive* 37 / 329 Inconclusive* 93 / 3092 Negative* 35 / 1224 Positive* 42 / 254 Inconclusive* 47 / 1470 Negative* 55 / 656 Antibody-to-Infliximab Status Antibody-to-Infliximab Status *patients with evaluable samples 2 Lancet 2002; 359: Take Home Message Anti-drug Ab increase the risk of infusion reactions with TNFi s

11 Impact on Efficacy The Immunogenicity Of anti-tnf Therapy : A Systemic Review Of The Literature With A Meta-analysis Garces S, Demenegeot J and Benito-Garcia E. Ann Rheum Dis 2012; 0:1-9. doi: /annrheumdis

12 Effect of Anti-Drug Ab Positivity on a TNF Response Garces S et al. Ann Rheum Dis 2012; 0:1-9. doi: /annrheumdis Clinical Characteristics To Address Effect Of Anti-Drug Abs On Drug Response & The Effect Of Immunosuppression On Anti-Drug Ab Detection Garces S et al. Ann Rheum Dis 2012; 0:1-9. doi: /annrheumdis

13 Take Home Message The Effect Of Anti-drug Abs On The TNFi Response Is Influenced By. MTX Rheumatoid Arthritis vs other diseases Initiation of higher biologic dose? Antidrug Antibodies : Association With Disease Activity and Treatment Failure During Long-term Follow-up Bartelds et al, JAMA, April 2013, Vol 305, No. 4, pp

14 Effect of anti-adalimumab Abs on Overall Pt Dropout & Dropout Due to Rx Failure Bartelds, Geertje et al, JAMA, April 2013, Vol 305, No. 4, pp Effect of anti-adalimumab Abs on Sustained Disease Activity & Remission Bartelds, Geertje et al, JAMA, April 2013, Vol 305, No. 4, pp

15 Take Home Message Anti- Drug Abs increased dropout rate as a consequence of loss of efficacy. Anti- Drug Abs reduced sustainability of LDAS and remission Effect of Serum TNFi Levels on Clinical Outcomes

16 CRP < 5mg/dL (% of patients) Complete Endoscopic Remission (% of patients) Remisssion (% of patients) Endoscopic Improvement >75% (% of patients) Effect of SerumTrough Levels of Infliximab in Crohn s 52 wks MSH, Toronto Remission CRP P< P< Trough Serum Infliximab Detectable 0 P< Endoscopic improvement 47 P= Complete endoscopic remission Undetectable Maser EA et al. Clin Gastroenterol Hepatol 2006;4: Anti-adalimumab Antibodies & Serum Adalimumab Concentrations In RA Bartelds GM et al., Ann Rheum Dis 2007; 66:

17 Serum Trough Levels Of Adalimumab In Psoriasis Adalimumab Trough Concentrations per PASI Response Level P < P = P = * 4* Lecluse LLA, et al. Arch Dermatol. 2010;146(2): Serum Trough Levels of Infliximab In Ankylosing Spondylitis Serum Trough Infliximab Level for Responders and Non-Responders P=0.018 De Vries MK, et al. Ann Rheum Dis. 2007;66:

18 Levels Of Etanercept In Ankylosing Spondylitis Etanercept Levels for ASAS Responders and Non-Responders De Vries MK, et al. Ann Rheum Dis. 2009;68: Take Home Message Serum trough levels of inflixmab & adalimumab affect clinical outcomes in RA and non-ra conditions. Trough levels of etanercept do not affect clinical outcomes in AS.

19 Subjects with a response Impact of Anti-Drug Abs On TNFi Dose Escalation Clinical Outcomes in Crohn s Disease Mayo Clinic 100 Detectable ATI 100 Subtherapeutic IFX 75 p< p< n=17 n=12 n=29 n=6 0 Increase IFX Change Anti- TNF Response to test Increase IFX Change Anti- TNF Response to test Afif et al. Am J Gastroenterol. 2010; 105(5):

20 Take Home Message Dose escalation is useful in patients with a subtherapeutic dose of a TNFi Dose escalation unhelpful in patients with detectable anti-drug Abs and therapeutic trough levels BUT.. Some reports show dose escalation can boost immune response with increased infusion reactions While other reports show decrease in anti-dug Abs and improved drug response More studies warranted. Impact of Anti-Drug Abs on TNFi Switching

21 Anti-Infliximab and Anti-Adalimumab Antibodies in Relation to Response to Adalimumab in Infliximab Switchers and Anti-TNF Naïve Patients Study Design Observational cohort study of 235 patients all treated with adalimumab 22% had previously been treated with infliximab switchers 78% were anti-tnf naive Bartelds GM, et al. Ann Rheum Dis. 2010;69: Anti-ADA status, n (%) Total populati on (N=235) Δ DAS28* all 1.6 ± 1.5 Δ DAS28* anti-ada (-) Δ DAS28* anti-ada (+) Anti-TNF naïve patients (n=183) INF switcher s (n=52) INF switcher s with anti-inf (n=33) INF switcher s w/out anti-inf (n=19) 46 (20) 32 (18) 14 (27) 11 (33) 3 (16) 1.8 ± 1.4* 0.6 ± 1.3 Results Frequency of Anti-Adalimumab (a-ada) Antibodies and Clinical Response After 28 Weeks of Adalimumab Treatment 1.7 ± ± 1.4* 0.6 ± ± ± 1.3* 0.5 ± ± ± 1.1* 0.4 ± ± ± 1.4 NS 0.7 ± 1.4 Bartelds GM, et al. Ann Rheum Dis. 2010;69:

22 Results & Conclusion Increased likelihood of anti-ada Ab in patients with anti-inf Ab (rapid metabolizers with low serum drug concentrations?) ADA switchers after INF without a-inf Abs had a reduced response. ADA switchers after INF with a-inf Ab had a good response These results have implications for choice of biologic in TNFi-IRs The Presence Or Absence Of Antibodies To Infliximab Or Adalimumab Determines The Outcome Of Switching To Etanercept Jamnitski Anna et al Ann Rheum Dis 2011; 70: doi:

23 Results Improvement in DAS28 in TNF Naïve Patients vs Switchers P=0.001 P=0.743 P=0.017 Jamnitski A, et al. Ann Rheum Dis. 2011;70(2): Implications of anti-drug Abs to Biologic Switching If anti-drug Abs present to first TNFi consider a second TNFi But possible increase in anti-drug Abs to second TNFi (Bartelds et al) If no anti-drug Ab to first TNFi. consider a biologic with a different MOA (i.e. a non-tnfi)

24 Nice Thought, But There is no comparative data on the response of a second TNFi to that of a biologic with a different MOA in the presence or absence of anti-drug Abs to the first TNFi!

25 Take Home Message Serum trough levels of TNFi may be helpful in treatment decisions to dose escalate or switch TNFis Anti-drug levels may be helpful in treatment decisions to switch to another TNFi or a non- TNFi biologic. Can one construct an algorithm for monitoring serum &/or anti-drug Ab in TNFi failures? Of Course

26 Algorithm For Monitoring Serum TNFi Levels & Anti-Drug Abs & in Patients with Failure of a-tnf Therapy Vincent, Fabien et al., Ann Rheum Dis 2012; 0: 1-14.doi: /annrheumdis Although Immunogenicity May Help Explain Clinical Outcomes, Its Role In Clinical Practice Remains Unclear. More Prospective Data Is Needed!

27 Thank You! Results & Conclusions Response to etanercept did not differ between patients who were anti-tnf naïve and switchers with anti-biologic antibodies to the previous TNFi However, switchers without anti-biologic antibodies to the previous TNFi had a diminished response;? Non TNF-dependent Jamnitski A, et al. Ann Rheum Dis. 2011;70(2):

28 Effect of Serum Trough Levels of Adalimumab in Plaque Psoriasis Study Design Prospective observational study cohort of 29 patients with psoriasis starting a regimen of adalimumab 40mg every other week after an initial dose of 80 mg Patients who had inadequate response could be dosed weekly Lecluse LLA, et al. Arch Dermatol. 2010;146(2): Serum Trough Levels of Infliximab in Ankylosing Spondylitis Study Design Prospective clinical trial of 38 patients with AS treated with infliximab 5mg/kg every 6 weeks De Vries MK, et al. Ann Rheum Dis. 2007;66:

29 Effect of Serum Trough Levels of Etanercept in Ankylosing Spondylitis Study Design 53 consecutive patients with AS treated with etanercept 25 mg twice weekly Sera collected at baseline, 3 and 6 months De Vries MK, et al. Ann Rheum Dis. 2009;68: Results Percentage of Patients With and Without ATI Fulfilling ASAS-20 Response Criteria De Vries MK, et al. Ann Rheum Dis. 2007;66:

30 But. Before Routine Screening International consensus for further studies of impact of a-drug Abs and drug concentration Standardization of drug concentration detection methods Definition of cut-off values for defining presence of anti- Drug Abs Definition of therapeutic range of concentration for each TNFi

What I Have Learned Over the Years - Keystone s Top 10 -

What I Have Learned Over the Years - Keystone s Top 10 - What I Have Learned Over the Years - Keystone s Top 10 - Edward Keystone, MD FRCP(C) Professor of Medicine University of Toronto, CANADA Ontario Rheumatology Association Meeting Muskoka, Canada Sunday,

More information

Association Between Plasma Concentrations of Certolizumab Pegol and Endoscopic Outcomes of Patients With Crohn's Disease

Association Between Plasma Concentrations of Certolizumab Pegol and Endoscopic Outcomes of Patients With Crohn's Disease Association Between Plasma Concentrations of Certolizumab Pegol and Endoscopic Outcomes of Patients With Crohn's Disease Jean Frédéric Colombel, William J. Sandborn, Matthieu Allez, Jean Louis Dupas, Olivier

More information

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare Pharmacy Clinical Pharmacy Programs UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2018 P 1017-7 Program Prior Authorization/Notification Medication Cimzia (certolizumab) P&T Approval Date 1/2007, 6/2008, 4/2009, 6/2009,

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy Measurement of Serum Antibodies to Infliximab, Adalimumab and File Name: Origination: Last CAP Review: Next CAP Review: Last Review: measurement_of_serum_antibodies_to_infliximab_and_adalimumab

More information

Immunogenicity of Biologic Agents and How to Prevent Sensitization

Immunogenicity of Biologic Agents and How to Prevent Sensitization Immunogenicity of Biologic Agents and How to Prevent Sensitization William J. Sandborn, MD Professor and Chief, Division of Gastroenterology Director, UCSD IBD Center La Jolla, California, USA Learning

More information

Positioning New Therapies

Positioning New Therapies Positioning New Therapies Stephen Hanauer, MD Professor of Medicine Medical Director, Digestive Disease Center Northwestern Medicine Chicago, Illinois Speaker Disclosure Stephen Hanauer, MD has disclosed

More information

MEDICAL POLICY II. III. SUBJECT: MEASUREMENT OF SERUM ANTIBODIES TO INFLIXIMAB, ADALIMUMAB, AND VEDOLIZUMAB

MEDICAL POLICY II. III. SUBJECT: MEASUREMENT OF SERUM ANTIBODIES TO INFLIXIMAB, ADALIMUMAB, AND VEDOLIZUMAB MEDICAL POLICY SUBJECT: MEASUREMENT OF SERUM ANTIBODIES TO INFLIXIMAB, ADALIMUMAB, AND PAGE: 1 OF: 6 If a product excludes coverage for a service, it is not covered, and medical policy criteria do not

More information

Treatment failure with antagonists of TNF-α: mechanisms and implications for the care of patients

Treatment failure with antagonists of TNF-α: mechanisms and implications for the care of patients 226 Eur. Cytokine Netw., Vol. 21 n 4, December 2010, 226-31 REVIEW ARTICLE Treatment failure with antagonists of TNF-α: mechanisms and implications for the care of patients Marine Desroches, Gauthier Louis,

More information

CADTH Therapeutic Review Panel

CADTH Therapeutic Review Panel Therapeutic Review Panel Final Recommendations Biological Response Modifier Agents for Adults with Rheumatoid Arthritis July 2010 RECOMMENDATIONS The Therapeutic Review Panel (TRP) recommends that in adult

More information

CLINICAL BRIEFS. Tumor Necrosis Factor Inhibitors In the Treatment of Chronic Inflammatory Diseases

CLINICAL BRIEFS. Tumor Necrosis Factor Inhibitors In the Treatment of Chronic Inflammatory Diseases CLINICAL BRIEFS Tumor Necrosis Factor Inhibitors In the Treatment of Chronic Inflammatory Diseases A review of immunogenicity and potential implications By Joseph Flood, MD, FACR President, Musculoskeletal

More information

DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC)

DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) DERBYSHIRE JOINT AREA PRERIBING COMMITTEE (JAPC) Derbyshire commissioning guidance on biologic drugs f the treatment of Rheumatoid arthritis with methotrexate This algithm is a tool to aid the implementation

More information

An Update on the Biologic Treatment for Patients with Inflammatory Bowel Disease. David A. Schwartz, MD

An Update on the Biologic Treatment for Patients with Inflammatory Bowel Disease. David A. Schwartz, MD An Update on the Biologic Treatment for Patients with Inflammatory Bowel Disease David A. Schwartz, MD Director, Inflammatory Bowel Disease Center Associate Professor of Medicine Vanderbilt University

More information

Available Data on Pediatric Exposure Response a Clinician s Perspective

Available Data on Pediatric Exposure Response a Clinician s Perspective Available Data on Pediatric Exposure Response a Clinician s Perspective Marla Dubinsky, MD Professor of Pediatrics and Medicine Chief Pediatric GI and Nutrition Co-Director Susan and Leonard Feinstein

More information

Drugs and Applicable Coding: J-code: Enbrel-J1438; Humira-J0135; Remicade-J1745; Inflectra-Q5102; Cimzia-J0718; Simponi-J1602 Renflexis - pending

Drugs 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 information

Severe IBD: What to Do When Anti- TNFs Don t Work?

Severe IBD: What to Do When Anti- TNFs Don t Work? Severe IBD: What to Do When Anti- TNFs Don t Work? David T. Rubin, MD, FACG Professor of Medicine Co-Director, Inflammatory Bowel Disease Center Interim Chief, Section of Gastroenterology, Hepatology and

More information

Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC

Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC Update on the Treatment of Rheumatoid Arthritis Sabrina Fallavollita MDCM McGill University Canadian Society of Internal Medicine

More information

Update on Biologics in Ulcerative Colitis. Scott Plevy, MD University of North Carolina Chapel Hill, NC

Update on Biologics in Ulcerative Colitis. Scott Plevy, MD University of North Carolina Chapel Hill, NC Update on Biologics in Ulcerative Colitis Scott Plevy, MD University of North Carolina Chapel Hill, NC Objectives Discuss the latest advances in the pharmacologic management of ulcerative colitis Describe

More information

Medical Management of Inflammatory Bowel Disease

Medical Management of Inflammatory Bowel Disease Medical Management of Inflammatory Bowel Disease John K. Marshall MD MSc FRCPC AGAF Division of Gastroenterology McMaster University John K. Marshall: Conflicts of Interest Speaker: AbbVie, Allergan, Ferring,

More information

Drug Class Review Targeted Immune Modulators

Drug Class Review Targeted Immune Modulators Drug Class Review Targeted Immune Modulators Final Update 5 Report June 2016 The purpose of reports is to make available information regarding the comparative clinical effectiveness and harms of different

More information

Common Questions in Crohn s Disease Therapy. Case

Common Questions in Crohn s Disease Therapy. Case Common Questions in Crohn s Disease Therapy Jean-Paul Achkar, MD, FACG Kenneth Rainin Chair for IBD Research Cleveland Clinic Case 23 yo male with 1 year history of diarrhea, abdominal pain and 15 pound

More information

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

Medical Policy An independent licensee of the Blue Cross Blue Shield Association Measurement of Serum Antibodies to Page 1 of 20 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Measurement of Serum Antibodies to Infliximab and Adalimumab Professional

More information

Clinical Policy Title: Measurement of serum antibodies to infliximab and adalimumab

Clinical Policy Title: Measurement of serum antibodies to infliximab and adalimumab Clinical Policy Title: Measurement of serum antibodies to infliximab and adalimumab Clinical Policy Number: 01.01.03 Effective Date: January 1, 2016 Initial Review Date: September 16, 2015 Most Recent

More information

Drug Class Review Targeted Immune Modulators

Drug Class Review Targeted Immune Modulators Drug Class Review Targeted Immune Modulators Final Update 3 Report March 2012 The Agency for Healthcare Research and Quality has not yet seen or approved this report The purpose of the is to summarize

More information

Medical Policy. MP Measurement of Serum Antibodies to Infliximab and Adalimumab

Medical Policy. MP Measurement of Serum Antibodies to Infliximab and Adalimumab Medical Policy BCBSA Ref. policy: 2.04.84 Last Review: 11/15/2018 Effective Date: 11/15/2018 Section: Medicine Related Policies 9.01.502 Experimental / Investigational Services DISCLAIMER Our medical policies

More information

Medical Policy An Independent Licensee of the Blue Cross and Blue Shield Association

Medical Policy An Independent Licensee of the Blue Cross and Blue Shield Association Measurement of Serum Antibodies to Infliximab Page 1 of 8 Medical Policy An Independent Licensee of the Blue Cross and Blue Shield Association Title: Measurement of Serum Antibodies to Infliximab Professional

More information

September 12, 2015 Millie D. Long MD, MPH, FACG

September 12, 2015 Millie D. Long MD, MPH, FACG Update on Biologic Therapy in 2015 September 12, 2015 Millie D. Long MD, MPH, FACG Assistant Professor of Medicine Inflammatory Bowel Disease Center University of North Carolina-Chapel Hill Outline Crohn

More information

Optimizing the effectiveness of anti-tnf therapy in paediatric IBD

Optimizing the effectiveness of anti-tnf therapy in paediatric IBD Optimizing the effectiveness of anti-tnf therapy in paediatric IBD Anne Griffiths MD, FRCPC Co-Lead, Inflammatory Bowel Disease Center Northbridge Chair in IBD Hospital for Sick Children, Professor of

More information

Optimal Use of Immunomodulators and Biologics

Optimal Use of Immunomodulators and Biologics 3/17/214 Optimal Use of Immunomodulators and Biologics Edward V. Loftus, Jr., M.D. Professor of Medicine Division of Gastroenterology and Hepatology Mayo Clinic Rochester, Minnesota, U.S.A. Loftus Disclosures

More information

How to use infliximab?

How to use infliximab? How to use infliximab? Séverine Vermeire, MD, PhD Division of Gastroenterology University Hospital Gasthuisberg Leuven The how to use infliximab rules Before starting IFX: try optimizing chances for response!

More information

RHEUMATOID ARTHRITIS DRUGS

RHEUMATOID ARTHRITIS DRUGS Rheumatology Biologics Criteria from the Exceptional Access Program RHEUMATOID ARTHRITIS DRUGS DRUG NAME BRS REIMBURSED DOSAGE FORM/ STRENGTH Adalimumab Humira 40 mg/0.8 syringe and 40mg/0.8 pen for Anakinra

More information

Certolizumab pegol (Cimzia) for the treatment of ankylosing spondylitis second or third line

Certolizumab pegol (Cimzia) for the treatment of ankylosing spondylitis second or third line Certolizumab pegol (Cimzia) for the treatment of ankylosing spondylitis second or third line August 2011 This technology summary is based on information available at the time of research and a limited

More information

TUBERCULOSIS AND THE TNF-α INHIBITORS. Lloyd Friedman, M.D. Yale University Milford Hospital

TUBERCULOSIS AND THE TNF-α INHIBITORS. Lloyd Friedman, M.D. Yale University Milford Hospital TUBERCULOSIS AND THE TNF-α INHIBITORS Lloyd Friedman, M.D. Yale University Milford Hospital Outline TNF-α Anti-TNF-α medications Rates of tuberculosis Lower rates with etanercept Screening for latent tuberculosis

More information

ISSN: (Print) (Online) Journal homepage:

ISSN: (Print) (Online) Journal homepage: mabs ISSN: 1942-0862 (Print) 1942-0870 (Online) Journal homepage: https://www.tandfonline.com/loi/kmab20 Certolizumab Pegol Niti Goel & Sue Stephens To cite this article: Niti Goel & Sue Stephens (2010)

More information

Commercial Products. Medical Coverage Policy Measurement of Serum. Antibodies to Infliximab and Adalimumab

Commercial Products. Medical Coverage Policy Measurement of Serum. Antibodies to Infliximab and Adalimumab Medical Coverage Policy Measurement of Serum Antibodies to Infliximab and Adalimumab EFFECTIVE DATE: 10 02 2012 POLICY LAST UPDATED: 09 18 2018 OVERVIEW This policy documents secondary loss of response

More information

Disclosures. What Do I Do When Anti-TNF Therapy Is Not Working Anymore? Fadi Hamid, M.D. Saint Luke s GI Specialists

Disclosures. What Do I Do When Anti-TNF Therapy Is Not Working Anymore? Fadi Hamid, M.D. Saint Luke s GI Specialists What Do I Do When Anti-TNF Therapy Is Not Working Anymore? Fadi Hamid, M.D. Saint Luke s GI Specialists Disclosures No financial relationships to disclose. 1 Learning Objectives Case 24M with ileocolonic

More information

Drug Level Monitoring in IBD. Objectives

Drug Level Monitoring in IBD. Objectives Drug Level Monitoring in IBD Corey A. Siegel, MD, MS Director, Dartmouth-Hitchcock IBD Center Associate Professor of Medicine, Geisel School of Medicine at Dartmouth Objectives Review non-biologic drug

More information

chemotherapeutic agents in

chemotherapeutic 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 information

Center for Evidence-based Policy

Center for Evidence-based Policy P&T Committee Brief Targeted Immune Modulators: Comparative Drug Class Review Alison Little, MD Center for Evidence-based Policy Oregon Health & Science University 3455 SW US Veterans Hospital Road, SN-4N

More information

IBD Updates. Themes in IBD IBD management journey. New tools for therapeutic monitoring. First-line treatment in IBD

IBD Updates. Themes in IBD IBD management journey. New tools for therapeutic monitoring. First-line treatment in IBD IBD Updates Maria T. Abreu, MD University of Miami Miller School of Medicine Miami, Florida Themes in IBD 213 First-line treatment in IBD New tools for therapeutic monitoring Biologic therapy for CD and

More information

Certolizumab pegol (Cimzia) for psoriatic arthritis second line

Certolizumab pegol (Cimzia) for psoriatic arthritis second line Certolizumab pegol (Cimzia) for psoriatic arthritis second line This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

The prevalence and clinical effect of immunogenicity of TNF-α blockers in patients with axial spondyloarthritis

The prevalence and clinical effect of immunogenicity of TNF-α blockers in patients with axial spondyloarthritis The prevalence and clinical effect of immunogenicity of TNF-α blockers in patients with axial spondyloarthritis G. Bornstein 1,2, M. Lidar 3, P. Langevitz 3, A. Fardman 2, I. Ben-Zvi 4, C. Grossman 4 1

More information

Mono or Combination Therapy with. Individualized Approach

Mono or Combination Therapy with. Individualized Approach Mono Combination Therapy with Biologics i in IBD: Developing an Individualized Approach David T. Rubin, MD, FACG Co-Direct, Inflammaty Bowel Disease Center Fellowship Program Direct University of Chicago

More information

Incorporating Biologics Into Your Practice

Incorporating 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 information

Emerging g therapies for IBD: A practical approach to positioning. Sequential Therapies for IBD

Emerging g therapies for IBD: A practical approach to positioning. Sequential Therapies for IBD Emerging g therapies for IBD: A practical approach to positioning Stephen B. Hanauer, MD Sequential Therapies for IBD Disease Severity at Presentation Severe Anti-TNF +/IS Cyclosporine (UC) Colectomy (UC)

More information

Therapeutic Drug Monitoring και ΙΦΝΕ το 2018

Therapeutic Drug Monitoring και ΙΦΝΕ το 2018 Therapeutic Drug Monitoring και ΙΦΝΕ το 2018 TDM: Ναι το χρειαζόμαστε, σε όλους και πάντοτε Κωνσταντίνος Κατσάνος Conflict of interest By means of this, the speaker confirms that he receives honoraria

More information

Annual Rheumatology & Therapeutics Review for Organizations & Societies

Annual Rheumatology & Therapeutics Review for Organizations & Societies Annual Rheumatology & Therapeutics Review for Organizations & Societies Comparative Effectiveness Studies of Biologics Learning Objectives Understand the motivation for comparative effectiveness research

More information

Economic Evaluation of Apremilast in the Treatment of Moderate to Severe Psoriasis in the United States

Economic 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 information

John F. Valentine, MD Inflammatory Bowel Disease Program University of Utah

John F. Valentine, MD Inflammatory Bowel Disease Program University of Utah John F. Valentine, MD Inflammatory Bowel Disease Program University of Utah Hawaii 1/20/2017 DISCLOSURES Research Support: NIH, Pfizer, Celgene, AbbVie, Roche/Genentech, Takeda, CCFA OBJECTIVES Review

More information

STUDY. Extent and Clinical Consequences of Antibody Formation Against Adalimumab in Patients With Plaque Psoriasis

STUDY. Extent and Clinical Consequences of Antibody Formation Against Adalimumab in Patients With Plaque Psoriasis STUDY Extent and Clinical Consequences of Antibody Formation Against Adalimumab in Patients With Plaque Psoriasis Lidian L. A. Lecluse, MD; Rieke J. B. Driessen, MD; Phyllis I. Spuls, MD, PhD; Elke M.

More information

Highlights of DDW 2015: Crohn s disease

Highlights of DDW 2015: Crohn s disease Highlights of DDW 2015: Crohn s disease Mark S. Silverberg, MD, PhD, FRCPC Associate Professor of Medicine, University of Toronto Staff Gastroenterologist, Mount Sinai Hospital Senior Investigator, Lunenfeld-Tanenbaum

More information

Measurement of Serum Antibodies to Infliximab and Adalimumab

Measurement of Serum Antibodies to Infliximab and Adalimumab Measurement of Serum Antibodies to Infliximab and Adalimumab Policy Number: 2.04.84 Last Review: 12/2013 Origination: 2/1/2013 Next Review: 12/2014 Policy Blue Cross and Blue Shield of Kansas City (Blue

More information

Protocol. Measurement of Serum Antibodies to Infliximab and Adalimumab

Protocol. Measurement of Serum Antibodies to Infliximab and Adalimumab Protocol Measurement of Serum Antibodies to Infliximab and Adalimumab (20484) Medical Benefit Effective Date: 04/01/15 Next Review Date: 03/19 Preauthorization No Review Dates: 11/14, 11/15, 11/16, 03/17,

More information

Ali Keshavarzian MD Rush University Medical Center

Ali Keshavarzian MD Rush University Medical Center Treatment: Step Up or Top Down? Ali Keshavarzian MD Rush University Medical Center Questions What medication should IBD be treated with? Can we predict which patients with IBD are high risk? Is starting

More information

Il ruolo degli anticorpi anti farmaco nella pratica clinica

Il ruolo degli anticorpi anti farmaco nella pratica clinica Il ruolo degli anticorpi anti farmaco nella pratica clinica Daniela Pugliese, MD IBD Unit Complesso Integrato Columbus Gemelli Hospital Catholic University Foundation, Rome - Italy Therapeutic Drug monitoring

More information

C. Assess clinical response after the first three months of treatment.

C. 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 information

ETANERCEPT Generic Brand HICL GCN Exception/Other ETANERCEPT ENBREL GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

ETANERCEPT 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 information

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 3041-8 Program Step Therapy Medications UnitedHealthcare Pharmacy Clinical Pharmacy Programs *Orencia (abatacept) *This step criteria refers to the subcutaneous formulation of abatacept

More information

Regulatory Status FDA-approved indication: Humira and Amjevita are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3)

Regulatory Status FDA-approved indication: Humira and Amjevita are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.29 Subject: Humira Page: 1 of 10 Last Review Date: June 22, 2017 Humira Description Humira (adalimumab),

More information

6 ADRs, 2 LOE. 2 ADRs, 4 LOE. Ineffectiveness 24 ADRs 7, 1 pt for convenience. 48% had antibodies against Infliximab at baseline

6 ADRs, 2 LOE. 2 ADRs, 4 LOE. Ineffectiveness 24 ADRs 7, 1 pt for convenience. 48% had antibodies against Infliximab at baseline Summary of Published Switch data Table 1. Information Patients Switch from (n) Reason for switch Switch to: (n) Results Numbers Presse Med. 2002 (1) 14 Infliximab (8) (6) 6 ADRs, 2 LOE 2 ADRs, 4 LOE (8)

More information

TNF-α antagonists improve arterial stiffness in patients with rheumatoid arthritis: a meta-analysis

TNF-α antagonists improve arterial stiffness in patients with rheumatoid arthritis: a meta-analysis TNF-α antagonists improve arterial stiffness in patients with rheumatoid arthritis: a meta-analysis G.Georgiopoulos 1, D.Terentes-Printzios 1, C.Vlachopoulos 1, A.Gravos 1, P.Pietri 1, C.Georgakopoulos

More information

PsA. SIMPONI (golimumab) Rheumatoid arthritis. Psoriatic arthritis. Ankylosing spondylitis EFFICACY EFFICACY EFFICACY. QoL. QoL.

PsA. SIMPONI (golimumab) Rheumatoid arthritis. Psoriatic arthritis. Ankylosing spondylitis EFFICACY EFFICACY EFFICACY. QoL. QoL. RA Rheumatoid arthritis PsA Psoriatic arthritis AS Ankylosing spondylitis EFFICACY EFFICACY EFFICACY QoL QoL QoL SAFETY SAFETY SAFETY EXPERIENCE EXPERIENCE EXPERIENCE SUMMARY SUMMARY SUMMARY Copyright

More information

Biologics and Psoriasis: The Beat Goes On

Biologics 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 information

Beyond Anti TNFs: positioning of other biologics for Crohn s disease. Christina Ha, MD Cedars Sinai Inflammatory Bowel Disease Center

Beyond Anti TNFs: positioning of other biologics for Crohn s disease. Christina Ha, MD Cedars Sinai Inflammatory Bowel Disease Center Beyond Anti TNFs: positioning of other biologics for Crohn s disease Christina Ha, MD Cedars Sinai Inflammatory Bowel Disease Center Objectives: To define high and low risk patient and disease features

More information

ADALIMUMAB Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

ADALIMUMAB Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA 24800 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of moderate to severe rheumatoid

More information

Monitoring of the patients treated by Anti-TNFα : a step towards the personalized medicine.

Monitoring of the patients treated by Anti-TNFα : a step towards the personalized medicine. 10 th World Congress on Inflammation Paris (France) Satellite Symposium June 27 th 2011 Monitoring of the patients treated by Anti-TNFα : a step towards the personalized medicine. 1 Introduction Pr. Xavier

More information

The future of IBD therapeutic research

The future of IBD therapeutic research The future of IBD therapeutic research Jean-Frederic Colombel, MD Director Susan and Leonard Feinstein IBD Clinical Center Icahn School of Medicine, Mount Sinai Hospital New York J-F Colombel has served

More information

Join the conversation at #GIFORUMCCFA

Join the conversation at #GIFORUMCCFA 1 Join the conversation at #GIFORUMCCFA 2 Disclosures In accordance with the ACCME Standards for Commercial Support of CME, the speakers for this course have been asked to disclose to participants the

More information

Technology appraisal guidance Published: 26 January 2016 nice.org.uk/guidance/ta375

Technology appraisal guidance Published: 26 January 2016 nice.org.uk/guidance/ta375 Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed Technology

More information

TRANSPARENCY COMMITTEE OPINION. 26 April 2006

TRANSPARENCY 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 information

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 3 October 2012

The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 3 October 2012 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 3 October 2012 REMICADE 100 mg, powder for concentrate for solution for infusion B/1 vial (CIP code: 562 070-1) Applicant:

More information

Treating Rheumatologic Disease in Arizona: Good News, Bad News

Treating Rheumatologic Disease in Arizona: Good News, Bad News Treating Rheumatologic Disease in Arizona: Good News, Bad News Jeffrey R. Lisse, M.D. Ethel P. McChesney Bilby Professor of Medicine Chief, Section of Rheumatology University of Arizona School of Medicine

More information

(Poster presented on Sunday 05 March, 08:50 08:55; 2017 AAD Meeting, Orlando, Florida, USA)

(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 information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: golimumab_simponi 8/2013 2/2018 2/2019 3/2018 Description of Procedure or Service Golimumab (Simponi and

More information

Horizon Scanning Centre November Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330

Horizon Scanning Centre November Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330 Horizon Scanning Centre November 2012 Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330 Secukinumab is a high-affinity fully human monoclonal antibody that antagonises

More information

Charité - University Hospital, Free University and Humboldt University of Berlin, Berlin, Germany; 2 Sanofi Genzyme, Bridgewater, NJ, USA; 3

Charité - University Hospital, Free University and Humboldt University of Berlin, Berlin, Germany; 2 Sanofi Genzyme, Bridgewater, NJ, USA; 3 Efficacy and Safety of Sarilumab Versus Adalimumab in a Phase 3, Randomized, Double-blind, Monotherapy Study in Patients With Active Rheumatoid Arthritis With Intolerance or Inadequate Response to Methotrexate

More information

For Rheumatoid Arthritis

For Rheumatoid Arthritis For Rheumatoid Arthritis APRIL 2017 NOTICE: On April 14, 2017 the FDA issued a complete response letter for baricitinib indicating that the FDA is unable to approve the application in its current form

More information

of TNF inhibitors. Theo Rispens

of TNF inhibitors. Theo Rispens 22-09-08 Clinical implications of immunogenicity of TNF inhibitors Theo Rispens Disclosure In relation to this presentation, I declare the following, real or perceived conflicts of interest: - received

More information

Psoriatic Arthritis: New and Emergent Therapies

Psoriatic Arthritis: New and Emergent Therapies Psoriatic Arthritis: New and Emergent Therapies Alice Bendix Gottlieb MD, PhD Professor of Dermatology New York Medical College Metropolitan Hospital New York, NY, USA DISCLOSURE OF RELEVANT RELATIONSHIPS

More information

How do I choose amongst medicines for inflammatory bowel disease. Maria T. Abreu, MD

How do I choose amongst medicines for inflammatory bowel disease. Maria T. Abreu, MD How do I choose amongst medicines for inflammatory bowel disease Maria T. Abreu, MD Overview of IBD Pathogenesis Bacterial Products Moderately Acutely Inflamed Chronic Inflammation = IBD Normal Gut Mildly

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: abatacept_orencia 4/2008 2/2018 2/2019 2/2018 Description of Procedure or Service Abatacept (Orencia ), a

More information

Pharmacy Medical Necessity Guidelines: Orencia (abatacept)

Pharmacy Medical Necessity Guidelines: Orencia (abatacept) Pharmacy Medical Necessity Guidelines: Effective: October 23, 2017 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review SQ: RXUM/ RX / Pharmacy (RX) or

More information

Clinical Policy: Certolizumab (Cimzia) Reference Number: PA.CP.PHAR.247 Effective Date: 01/18 Last Review Date: 08/17 Line of Business: Medicaid

Clinical Policy: Certolizumab (Cimzia) Reference Number: PA.CP.PHAR.247 Effective Date: 01/18 Last Review Date: 08/17 Line of Business: Medicaid Clinical Policy: (Cimzia) Reference Number: PA.CP.PHAR.247 Effective Date: 01/18 Last Review Date: 08/17 Line of Business: Medicaid Coding Implications Revision Log Description (Cimzia ) is a tumor necrosis

More information

Biologics in IBD. Brian P. Bosworth, MD, NYSGEF Associate Professor of Medicine Weill Cornell Medical College

Biologics in IBD. Brian P. Bosworth, MD, NYSGEF Associate Professor of Medicine Weill Cornell Medical College Biologics in IBD Brian P. Bosworth, MD, NYSGEF Associate Professor of Medicine Weill Cornell Medical College Case 30 year old man diagnosed with ulcerative proctitis diagnosed in 2003 Had been maintained

More information

Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs)

Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs) Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs) January 2010 This technology summary is based on information available at the time of research

More information

Optimal care during pregnancy and delivery

Optimal care during pregnancy and delivery Oxford Inflammatory Bowel Disease MasterClass Optimal care during pregnancy and delivery Professor Catherine Nelson-Piercy, London, UK Oxford Inflammatory Bowel Disease MasterClass Therapeutic goals in

More information

Optimizing the treatment of IBD through use of therapeutic drug monitoring

Optimizing the treatment of IBD through use of therapeutic drug monitoring Optimizing the treatment of IBD through use of therapeutic drug monitoring Adam S. Cheifetz Director, Center for Inflammatory Bowel Disease, Beth Israel Deaconess Medical Center Associate Professor of

More information

Biologics in 2016: How Do We Select the Most Appropriate Agent? Gary R. Lichtenstein, MD, FACG University of PA School of Medicine Philadelphia, PA

Biologics in 2016: How Do We Select the Most Appropriate Agent? Gary R. Lichtenstein, MD, FACG University of PA School of Medicine Philadelphia, PA Biologics in 2016: How Do We Select the Most Appropriate Agent? Gary R. Lichtenstein, MD, FACG University of PA School of Medicine Philadelphia, PA Overview Indications and Drug Selection Contraindications

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium etanercept 25mg vial of powder for subcutaneous injection (Enbrel ) (No. 212/05) Wyeth New indication: severe active ankylosing spondylitis inadequately controlled by conventional

More information

Cost per Responder of Apremilast Versus Etanercept, Adalimumab, and Ustekinumab in Patients With Moderate to Severe Psoriasis

Cost 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 information

The effect of two golimumab doses on radiographic progression in ankylosing spondylitis: results through 4 years of the GO-RAISE trial

The effect of two golimumab doses on radiographic progression in ankylosing spondylitis: results through 4 years of the GO-RAISE trial Handling editor Tore K Kvien 1 Department of Rheumatology, Rheumazentrum Ruhrgebiet, Herne, Germany 2 Department of Radiology, Charité Medical School, Berlin, Germany 3 Division of Arthritis & Rheumatic

More information

The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases

The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases RHEUMATOLOGY Rheumatology 2014;53:213 222 doi:10.1093/rheumatology/ket260 Advance Access publication 14 August 2013 Review The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic

More information

(tofacitinib) are met.

(tofacitinib) are met. Xeljanz (tofacitinib) Policy Number: 5.01. 560 Origination: 3/2014 Last Review: 3/2014 Next Review: 3/2015 Policy BCBSKC will provide coverage for Xeljanz (tofacitinib) when it is determined to be medically

More information

Clinical Utility of Measuring Infliximab and Human Anti-Chimeric Antibody Concentrations in Patients With Inflammatory Bowel Disease

Clinical Utility of Measuring Infliximab and Human Anti-Chimeric Antibody Concentrations in Patients With Inflammatory Bowel Disease nature publishing group ORIGINAL CONTRIBUTIONS 1133 see related editorial on page 1140 Clinical Utility of Measuring Infliximab and Human Anti-Chimeric Antibody Concentrations in Patients With Inflammatory

More information

A Clinical Context Report

A Clinical Context Report Rheumatoid Arthritis in Practice An Expert Commentary with Diane Horowitz, MD A Clinical Context Report Rheumatoid Arthritis in Practice Jointly Sponsored by: and Rheumatoid Arthritis in Practice Expert

More information

The Refractory Crohn s Disease

The Refractory Crohn s Disease The Refractory Crohn s Disease Patient David T. Rubin, MD, FACG Professor of Medicine Co-Director, Inflammatory Bowel Disease Center Interim Chief, Section of Gastroenterology, Hepatology and Nutrition

More information

Key findings towards optimising adalimumab treatment: the concentration-effect curve

Key findings towards optimising adalimumab treatment: the concentration-effect curve 4 Key findings towards optimising adalimumab treatment: the concentration-effect curve Mieke Pouw* Charlotte Krieckaert* Mike Nurmohamed Theo Rispens Desiree van der Kleij Lucien Aarden Gertjan Wolbink

More information

Supplementary appendix

Supplementary appendix Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Ruperto N, Martini A. Current and future perspectives

More information