COPYRIGHT. Celiac Disease and Non-Celiac Gluten Sensitivity: Where we are and Where we are going
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1 Celiac Disease and Non-Celiac Gluten Sensitivity: Where we are and Where we are going Daniel Leffler MD, MS Research The Celiac Center Beth Israel Deaconess Medical Center Associate Professor of Medicine Harvard Medical School BETH ISRAEL DEACONESS MEDICAL CENTER HARVARD MEDICAL SCHOOL
2 Disclosures Daniel Leffler receives research support/has consulted for the following entities: NIH, Sidney Frank Foundation, Celiac Sprue Association, Prometheus Laboratories, Alvine Pharmaceuticals, Alba Therapeutics, Shire Pharmaceuticals, Ironwood Pharmaceuticals, InovaDiagnostics, Genzyme, GI Supply, Coronado Biosciences
3 Pathophysiology Step 1: Gluten Entry into the Submucosa Step 2: Deamidation of Gluten by Tissue Transglutaminase (ttg) Step 3: Immune Activation Only HLA DQ2 and DQ8 are able to bind gluten! Green, Cellier NEJM 2007 Step 1 Step 2 Step 3 Serologic tests
4 Dermatitis Herpetiformis: Model for Celiac Disease Outside the Gut Antibodies to TG3 or T cells primed to react to TG Antibodies deposit at Dermal-Epidermal junction Dapsone / sulfapyridine Complement activation Cytokine release Neutrophil infiltrate Zone et al. J. Investigative Dermatology, 2009 Murray, et al. Int. J. Derm, 2003
5 Celiac Disease is a Multi-System Autoimmune Disorder Dermatitis Herpetiformis + Hadjivassiliou et al. Lancet, Neuro 2010 Lane Hamilton Syndrome IgA Nephropathy MPGN Cardiomyopathy, IHD Fertility Classic Celiac + Manifestations in: Lung, Liver, Kidney, Blood Vessels, Placenta, etc
6 Changing Prevalence New Diagnoses of Celiac Disease at BIDMC # of Patients What IgA happened TTG serology here? > 95% accurate Year Finland United States Lohi et al. APT 2007, Rubio-Tapia Gastro 2009
7 Current Definitions Celiac disease is a chronic small intestinal immune-mediated enteropathy precipitated by exposure to dietary gluten in genetically predisposed individuals. vs. Non-Celiac Gluten Sensitivity (NCGS) relates to one or more of a variety of immunological, morphological or symptomatic manifestations that are precipitated by the ingestion of gluten in people in whom CD has been excluded. Ludvigsson J. Et al. GUT 2012.
8 What is going on with Gluten? : GF products grew by 28% each year 2015: >$10 billion in the US Sapone A, et al. BMC Medicine. 2012;10:13 Reuters on line, Sept 2012.
9 Current Epidemiology of Celiac Disease in the United States Seroprevalence of celiac disease ~2 million On Gluten Free Diet ~2 million Rubio-Tapia et al. AJG 2012 Diagnosed with celiac disease and on a gluten free diet ~400,000
10 A Short History of NCGS Case reports since the 1970s and the first controlled study published in Interest really begins in last 5 years with increased interest in celiac disease and overflow of the GFD into the general population Cooper BT et al. Gastroenterol. 1980
11 Initial Studies Suggest an Immune Mechanism for NCGS Wahnschaffe U, et al. CGH 2007.
12 Gluten Exposure in Individuals without Celiac Disease reporting Gluten Responsive GI symptoms VAS (0-100 mm) VAS (0-100 mm) VAS, visual analog scale. P=.047 Mean Change in Symptoms Over 6 Weeks 16g Gluten vs. Placebo Overall Symptoms Week Pain P=.02* VAS (0-100 mm) VAS (0-100 mm) P=.031 Bloating Week Tiredness Week P=.001* Week Gluten (n=19) Placebo (n=15) *P-value for analyses at Week 1 and entire study period Biesiekierski JR, et al. Am J Gastroenterol. 2011;106:
13 The Gluten Free Diet for IBS? Camilleri; Gastro 2013
14 Huge Effect of the Low FODMAP Run-In Biesiekieski; Gastro 2013
15 What are FODMAPs? Fermentable oligo-, di-, monosaccharides and polyols Excess Fructose Fructans Sorbitol Honey, apples, pears, peaches, mangos, fruit juice, dried fruit Wheat (large amounts), rye (large amounts), onions, leeks, zucchini Apricots, peaches, artificial sweeteners, artificially sweetened gums Lactose Alcohols Milk, Cheese, Dairy Cider, some wines Shepherd SJ, et al. Clin Gastroenterol Hepatol.2008;6:765. Shepherd SJ, Gibson PR. J Am Diet Assoc. 2006;106:
16 No Effect of Gluten on Symptoms Biesiekieski; Gastro 2013
17 FODMAP Diet Reduces Symptoms: Randomized Trial in IBS Proportion of Patients (%) * Control * * Intervention * 10 0 Bloating Abdominal pain Flatulence Borborygmi Urgency Diarrhea Constipation Tiredness Overall symptoms Symptoms Saudacher HM, et al. J Nutr. 2012;142(8):
18 Role of alpha amylase/ trypsin inhibitors (ATIs) Junker Y, et al. J EX Med, 2013
19 Current Paradigm NCGS Celiac Disease GFD Responsive IBS Motility Sensitivity Non-Gluten Immune Activation Intestinal permeability Inflammation Innate immune activation Anti-gliadin antibodies Innate and adaptive immune activation Auto-antibodies Destructive mucosal inflammation Celiac Lite
20 High tolerance to visceral sensation Immune-tolerant Food (In)Tolerance Visceral sensitivity Immune response to food/food products Immune-reactive Low tolerance to visceral sensation
21 Current Epidemiology of Celiac Disease in the United States Seroprevalence of celiac disease ~2 million On Gluten Free Diet ~2 million Rubio-Tapia et al. AJG 2012 Diagnosed with celiac disease and on a gluten free diet ~400,000
22 Percent of CD Patients Diagnosed NHANES Finland Choung RS AJG 2015
23 Test Sensitivity (Range) Specificity (Range) PPV* IgA AGA 85 (57-100) 90 (47-94) IgG AGA 85 (42-100) 80 (50-94) EMA 95 (86-100) 99 (97-100) IgA anti-ttg 98 (78-100) 98 (90-100) IgG anti-ttg 70 (45-95) 95 (94-100) IgA anti-dgp 88 (74-100) 95 (90-99) IgG anti-dgp 80 (63-95) 98 (90-99) IgA/IgG anti- DGP Celiac Test Performance 97 (75-99) 95 (87-100) NPV* * pretest probability of 5% Leffler, Schuppan AJG 2010
24 Celiac Disease Diagnosis Necessary: Duodenal biopsy compatible with celiac AND one or both of the following: Positive CD-specific serology (ttg, EMA or DGP) Clinical or histological response to gluten-free diet Supportive: HLA DQ2 or DQ8 (absence excludes CD) Biopsy proven dermatitis herpetiformis Family history of celiac disease Rostom A et al, Gastroenterology 2006;131:1981 ( Amsterdam criteria ). Eur J Gastroenterol Hepatol 2001;13:1123
25 The 3 Myths of Celiac Disease 1. Celiac disease is rare 2. Celiac disease is not a serious condition 3. The gluten free diet is a perfect treatment
26 Celiac Disease: A Myopic Impression The classic presentation of celiac disease: Rare White, preferably of Irish or Italian decent Early childhood onset Symptoms of diarrhea, abdominal pain, weight loss and failure to thrive
27 An Expanded Perspective Common in many ethnic backgrounds Average age of diagnosis is ~40 Onset at any age when there is exposure to gluten Highly diverse presentation Average of 10 years of symptoms prior to diagnosis Celiac Disease Foundation Green AJG 2001, Cranney DDS 2007
28 Mortality Risk in Celiac Disease S M 1.5 R 1.0 Finland UK Scotland N. Ireland Sweden Denmark Italy Ludvigsson JAMA. 2009, Grainge AJG 2011, Logan Gastro 1989, Nielsen Scand J Gastro 1985, Cottone DDS 1999, Corrao Lancet 2001, Peters Arch Int Med 2003, West BMJ 2004, Viljamaa DLD 2006, Anderson WJG 2007, Solaymani AJG 2007
29 Just Some of the Conditions Associated with Untreated Celiac Disease Lymphomas and small intestinal cancers Infections Osteoporosis Liver disease Irritable Bowel Syndrome* Anemia Chronic Fatigue Nerve damage/ataxia Recurrent aphthous ulcerations Fertility abnormalities Microscopic colitis Dental enamel defects
30 Celiac Disease in Patients with IBS like Celiac testing in IBS YES! Sanders 2001 Sanders 2003 Catassi 2007 Christofori 2014 Mahmoodi 2014 Sharma 2015 SanchezVargas 2016 Symptoms Celiac testing in IBS, Don t Bother Agreus 2000 Locke GR 2004 Van der Wouden 2007 Cash 2011 Choung 2015 Sanders Lancet 2001, Ford AC JAMA IM 2009, Sanchez Vargas LA Neurogastro 2016, Choung RS CGH 2015, Sharma H J Dig Dis 2015, Mahmoodi A J Clin Dag Res 2014, Christofori JAMA Peds 2014, Cash BD Gastro 2011, Catassi AJG 2007
31 Celiac Disease in Patients with IBS like Celiac testing in IBS YES! Sanders 2001 Sanders 2003 Catassi 2007 Christofori 2014 Mahmoodi 2014 Sharma 2015 Sanchez Vargas 2016 Symptoms UK UK USA Italy Iran India Mexico Celiac testing in IBS, Don t Bother Agreus 2000 Locke GR 2004 Van der Wouden 2007 Cash 2011 Choung 2015 Sweden USA Netherlands USA USA Sanders Lancet 2001, Ford AC JAMA IM 2009, Sanchez Vargas LA Neurogastro 2016, Choung RS CGH 2015, Sharma H J Dig Dis 2015, Mahmoodi A J Clin Dag Res 2014, Christofori JAMA Peds 2014, Cash BD Gastro 2011, Catassi AJG 2007
32 Celiac Disease in Patients with IBS like Celiac testing in IBS YES! Sanders 2001 Sanders 2003 Catassi2007 Christofori 2014 Mahmoodi 2014 Sharma 2015 Sanchez Vargas 2016 UK UK USA Italy Iran India Mexico Symptoms PCP PCP PCP GI* GI PCP Mix Celiac testingin IBS, Don t Bother Agreus 2000 Locke GR 2004 Van der Wouden 2007 Cash 2011 Choung 2015 Sweden USA Netherl ands USA USA PCP OC GI GI OC Sanders Lancet 2001, Ford AC JAMA IM 2009, Sanchez Vargas LA Neurogastro 2016, Choung RS CGH 2015, Sharma H J Dig Dis 2015, Mahmoodi A J Clin Dag Res 2014, Christofori JAMA Peds 2014, Cash BD Gastro 2011, Catassi AJG 2007
33 Forget statistics, what s in it for me? IBS type symptoms improve in patients diagnosed with celiac disease Symptom Before CD n (%) After CD n (%) Diarrhea 163 (75) 73 (34) Constipation 83 (39) 64 (30) Abdominal pain 171 (79) 6 (3) Abdominal bloating 157 (73) 9 (4) Nausea or vomiting 96 (44) 19 (9) Rome Dx Before CD n=81 (%) After CD n=81 (%) IBS 52% 21% Dyspepsia 26% 7% Any Rome dx 67% 46% Murray JA Am J Clin Nut 2004, Silvester J, DDW 2016
34 Should Family Members Be Tested? Children and adolescents with 1 st degree relatives with celiac disease should undergo serologic testing every 2-3 years and at new onset of symptoms All 1 st and 2 nd degree relatives should be informed that they are at risk of celiac disease and encouraged to seek testing if they have symptoms/unexplained medical issues NASPGHAN 2005
35 Celiac Disease and Type 1 Diabetes 5-10% of adults with T1D have celiac disease but <50% are diagnosed American Diabetes Association and the International Society for Pediatric and Adolescent Diabetes recommend celiac testing in children with T1D at diagnosis and consideration of retesting q1 to 2 years In adults, consider celiac testing once at diagnosis of T1D or if symptoms consistant with celiac disease develop. Limited data suggest worse glycemic control and higher rates of retinopathy and nephropathy in patients with T1D and undiagnosed celiac disease
36 Reproductive consequences make celiac diagnosis in women vital Celiac disease can have nutritional and direct inflammatory effects on reproduction Typical newly diagnosed patient is a woman age ~40 who has been symptomatic but undiagnosed for 10 years Ludvigsson JF Gastroenterology 2005, Shah & Leffler Women s Health 2010, Warren R Real Life with Celiac Disease 2010
37 Two Testing Strategies for High Risk Groups IgA ttg + total IgA is easy and cost effective in most adults and all symptomatic relatives In children and asymptomatic relatives celiac HLA DQ2/DQ8 testing should be considered Negative ttg/biopsy is diet dependent and rules out celiac disease today Negative HLA DQ2/DQ8 is diet independent and rules out celiac disease forever
38 Percent of CD Patients Diagnosed NHANES Finland Choung RS AJG 2015
39 Percent of CD Patients Diagnosed NHANES NHANES Finland Choung RS AJG 2015
40 More Testing = More Diagnosis ttg/year
41 More Testing = More Diagnosis ttg/year Positive ttg
42 Let Thy Food Be Thy Medicine Hippocrates, 400 AD Strict gluten free diet is the only accepted treatment for celiac disease The GFD is one of the more challenging treatments we assign patients Until recently this has been unrecognized by the medical/scientific community GFD
43 The GFD is not Easy Perceived Treatment Burden CD HTN GERD ESRD DM CHF IBD IBS *VAS: 0=Very Easy 100=Very Difficult Sanders JGLD 2011 Shah S, Leffler DA, AJG 2014
44 Spectrum of NRCD in Children and Adults Other 8% RCD 11% IBS 18% SIBO 6% Eating Disorder 6% Disacchari dase Deficiency 9% Gluten Exposure 35% Microsco pic Colitis 7% Leffler et al, CGH 2007; Veeraraghavan ACG 2015
45 Spectrum of NRCD in Children and Adults Other 8% RCD 11% IBS 18% SIBO 6% Eating Disorder 6% Disacchari dase Deficiency 9% Gluten Exposure 35% Microsco pic Colitis 7% Leffler et al, CGH 2007; Veeraraghavan ACG 2015
46 Histologic Recovery is Partial and Age Related Average Age of Celiac Diagnosis l/3 of people have a healthy intestine after 2 years 2/3 of people have a healthy intestine after 5 years Lebwohl et al. APT 2014, Rubio-Tapia AJG 2010, Leffler DA Gut 2012, Maki Gastro 2014
47 Three Main Therapeutic Classes Class Intraluminal Therapies Immunosuppressants Immunotherapies Examples ALV003: oral protease combination of cysteine endoprotease B-soform 2 and prolyl endopeptidase Lazarotide Acetate: 8 polymer peptide and tight junction regulator KumaMax: Synthetic oral protease BL-7010: non-absorbable, co-polymer with high affinity for gliadins CCX282-B: Anti-CCR9 Blockade Hu-MiK-Beta-1: Humanized IL-15 specific antibody Nexvax2: Vaccine COUR-NP-GLI: nanoparticle therapy
48 Phase 2a Larazotide Acetate: Prevention of Signs & Symptoms of Gluten Exposure During Two Week Gluten Challenge Total GSRS Score Change from Day 0 to Day Symptoms Score (GSRS) p = p = Disease Control Negative Control Active Treatment % Subjects with Gluten Toxicity Gluten-Related Adverse Events p = p = Disease Control Negative Control Active Treatment No differences in primary endpoint of LA:MA Prevention of immunologic changes in PBMc (B cells) Daily diary: Reduction in frequency of bowel movements, abdominal discomfort & pain Safety comparable to placebo Daniel A Leffler, C P Kelly, H Z Abdallah, et al., A Randomized, Double-Blind Study of Larazotide Acetate to Prevent the Activation of Celiac Disease during Gluten Challenge, The American Journal of Gastroenterology doi: /ajg
49 Larazotide Phase 2c: 12 week trial in patients with persistent symptoms Leffler DA et al. Gastro 2015
50 Phase 2a ALV-003: Prevention of Gluten Induced Mucosal Injury Exposure During 6 Week Gluten Challenge Lahdeaho ML, Kaukinen K, et al., Gastro 2014
51 Immunotherapies Courtesy of Tobias Frietag
52 Conclusions Celiac disease is a serious and common autoimmune condition Gluten sensitivity is real, but we have a lot to learn about how it works and who it affects ttg is an accurate and cost-effective test, yet 80% of patients with celiac disease are undiagnosed Signs and symptoms of celiac disease can vary greatly and few symptoms few consequences The GFD is an imperfect therapy but novel therapies have the potential to increase diagnosis, encourage monitoring and improve outcomes
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