Celiac Disease: The Latest Follow-up after Diagnosis

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1 Celiac Disease: The Latest Follow-up after Diagnosis DR. CONNIE M SWITZER MD, FRCPC CLINICAL PROFESSOR OF MEDICINE UNIVERSITY OF ALBERTA CHAIR CCA PROFESSIONAL ADVISORY BOARD

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3 Accreditation This event is an accredited (Section1) group learning activity as defined by the Maintenance of Certification program of the Royal College of Physicians and Surgeons of Canada (RCPSC). The program was produced under the RCPSC guidelines for the development of co-developed educational activities between the Canadian Association of Gastroenterology (CAG) and Vertex Pharmaceuticals

4 2013 CDDW/CASL Winter Meeting CanMEDS Roles Covered: Medical Expert (as Medical Experts, physicians integrate all of the CanMEDS Roles, applying medical knowledge, clinical skills, and professional attitudes in their provision of patient-centered care. Medical Expert is the central physician Role in the CanMEDS framework.) Communicator (as Communicators, physicians effectively facilitate the doctor-patient relationship and the dynamic exchanges that occur before, during, and after the medical encounter.) Collaborator (as Collaborators, physicians effectively work within a healthcare team to achieve optimal patient care.) Manager (as Managers, physicians are integral participants in healthcare organizations, organizing sustainable practices, making decisions about allocating resources, and contributing to the effectiveness of the healthcare system.) Health Advocate (as Health Advocates, physicians responsibly use their expertise and influence to advance the health and well-being of individual patients, communities, and populations.) Scholar (as Scholars, physicians demonstrate a lifelong commitment to reflective learning, as well as the creation, dissemination, application and translation of medical knowledge.) Professional (as Professionals, physicians are committed to the health and well-being of individuals and society through ethical practice, profession-led regulation, and high personal standards of behaviour.)

5 Financial Interest Disclosure (over the past 24 months) Name: Dr. Connie M Switzer Commercial Interest Ferring, Takeda Takeda Relationship advisory board speaker Related to this presentation: No relevant financial relationships with any commercial interests No Slides were prepared by an industry partner

6 Is dietary adherence assessment enough? No: But it is a start..

7 Celiac Follow-up Challenges Amongst the many guidelines for Celiac follow up there is a lack of clarity re: what, who and when Management of GFD is critical to successful Celiac Rx The role of serology in follow up is evolving Mucosal healing may be slow and lack of agreement on timing/need for repeat biopsy Micronutrient deficiencies may persist on GFD and require treatment Assessment of bone health is important especially in those at highest risk

8 Treatment of Celiac Disease GFD is the treatment for Celiac disease Aimed at treating and reversing the enteropathy Reduces systemic immune/inflammatory reactivity Improves patients GI/systemic symptoms Reverses micro and macro nutrient deficiencies Improves the QoL Improves bone density Prevents complications of Celiac

9 Status of Guidelines: F/U after Celiac diagnosis Practice guidelines are not consistent with regard to follow-up and timing * There is no consensus among recommendations on whether serology should be used (...to) assess compliance. *..incongruency of guidelines in defining the categories of follow up evaluation.. * Lack of clarity on need/timing of biopsy in follow up Follow up evaluation may suboptimal *Herman M et al; CGH, 2012: 10: 893

10 Guidelines for Celiac Follow-up AGA technical review 2001 AGA position statement 2001 NIH Consensus Conference 2004 Pietzak 2005 NASPGHAN 2005; 2012 WGO 2006 BSG 2006; 2010 PCSGI (UK) 2006 Systematic review long term management CD Canadian Position Statement: Bone health in CD 2012

11 Select summary: Guidelines for Laboratory F/U Measure AGA ( 01) NIH ( 04) BSG ( 10) PCSG ( 06) Haines (08) CBC Folate Ferritin B LFT s + Serology +? + + Ca, VitD, PTH? + + Dexa Adapted from: Silvester J, CJG, 2007;21(9):557; Haines et al APT;2008; 28:1042

12 Systematic review: The evidence for long-term management of Celiac Disease.Given the high number of complications associated with CD several risk factors and ways to assess risks.it appears intuitive that follow up is necessary. * *Haines M et al; APT; 2008; 28: 1042

13 Risk Factors for Complications of Celiac Genetic Gluten exposure Monitoring adherence to GFD Intestinal inflammation Assessing mucosal recovery Nutritional deficiency Monitoring for deficiencies and/or their complications Haines M et al; APT; 2008; 28: 1042

14 Risk Factors for Complications: Gluten Gluten exposure Antigenic drive to maintain intestinal inflammation Some evidence that GFD may alter some associated illnesses Evidence that GFD reduces the risk of developing complications or associated illness very difficult to obtain Malignancy risk higher: untreated or dx at older age Longer duration of untreated Celiac Mortality untreated/undiagnosed Celiac 4X higher GFD treats and prevents bone complications AI disease frequency may be reduced with earlier diagnosis Haines M et al; APT; 2008; 28: 1042

15 Monitoring Adherence to GFD Dietary history Skilled dietitian trained in GFD adherence/interview One of the best markers of adherence: low cost, non-invasive, correlation with intestinal damage Validated surveys/questionnaires Clinical assessment: Lack of strict adherence to GFD is the MOST common cause of persistent symptoms Resolution of symptoms is NOT an accurate assessment of GFD adherence or mucosal healing (as far back as 1982) Persistent symptoms may have causes other than gluten ingestion Haines M et al; APT; 2008; 28: 1042

16 Monitoring Adherence to GFD Celiac serology: Levels of attg and EMA fall with gluten restriction attg: 7/8 normalize within ONE year on strict GFD healing Rate of fall or normalization adherence to GFD EMA: 87% normalize at one year mucosal healing Serial serology may be useful in following on-going adherence to GFD Haines M et al; APT; 2008; 28: 1042

17 Monitoring Adherence to GFD Duodenal biopsy: Biopsy is the gold standard for assessing strict adherence to GFD This is a strong argument for performing a follow up bx after 12 months or so on strict GFD * Remember: <50mg gluten/day cause mucosal damage for some as little as 10 mg/day *Haines M et al; APT; 2008; 28: 1042

18 Assessing Mucosal Healing in Celiac disease Clinical assessment: Not a reliable method to determine healing Serology: normalization healing 50-66% pts normalized serology have persistent VA 66% pts who healed mucosa have a normalized serology Persistently +ve or raising titers MAY indicate development of RCD Markers of systemic inflammation Utility of ESR, CRP have not been reported Markers of absorptive surface area and function Intestinal permeability further study required Haines M et al; APT; 2008; 28: 1042; Rubio-Tapia et al, AJG, 2010; 105(6): 1412

19 Assessing Mucosal Healing in Celiac Histologic recovery may be slow even on strict GFD Many adult studies have demonstrated: slow or incomplete healing over time 10% persistent VA over 5 years (Wahab 02) 62% (of 57) persistent VA over 13 mo (Shepherd 08) 40% incomplete healing over 24 mo (Tursi 06) Complete mucosal healing may be slow: 34% complete mucosal recovery at TWO yrs; 66% complete recovery at FIVE yrs (Rubio-Tapia 10) 1/3 continue to have enteropathy 5 years on GFD Haines M et al; APT; 2008; 28: 1042; Rubio-Tapia et al, AJG, 2010; 105(6): 1412

20 What are the causes of delayed healing? Delayed diagnosis: Poor awareness and education about CD High rate of undetected CD; Late intervention Complexity and cost of GFD (242% more expensive) Access to GFF; texture, taste, availability North American lifestyle eating out & travel Hidden sources of gluten Cross contamination with gluten; Inadvertent gluten ingestion Intentional gluten ingestion Social issues: GFF: difference in appearance Food labelling issues

21 Canada s New Labelling Law Bill 1220 Effective August 4 th, 2012 In process for >20 yrs Collaboration by patient advocacy groups Allergen groups & CCA Exemption for the Beer industry All food/beverage are REQUIRED to label for: Almonds, peanuts, sesame seeds, wheat/gluten & triticale, eggs, milk, soybeans, crustasceans, fish, shellfish, mustard seed 2012: Acceptance of end product must have <20ppm of gluten to be GF

22 Risk Factors for Complications: Nutrients Nutritional deficiency: impact on likelihood of complications and can be readily treated Macronutrient deficiency: Celiac: peds developmental delay and growth retardation Micronutrient deficiency: Iron: anemia and cognitive impairment Folate: anemia B def: homocysteine levels ( s thrombosis, miscarriage, LBMD) Calcium, Vitamin D deficiency Vit E:?neurological esp cerebellar disease Selenium: impair thyroid hormone activity?evidence Haines M et al; APT; 2008; 28: 1042

23 Nutritional Deficiency Assessment At diagnosis: Many micronutrient deficiencies Iron, folate, B12, Ca, Zn, Se, Cu, etc Long term F/U on GFD (Sweden; Hallert 2002) 50% adult CD pts have continued abnormal vitamin status including: Low levels B6/12; homocysteine levels B replacement correct folate Calcium, vitamind Others of concern: copper (neurologic), selenium, zinc Causes:???multiple May include intake on strict GFD (GFF are not vitamin fortified) Haines M et al; APT; 2008; 28: 1042; Hallert et al APT; 2009: 811

24 What should be followed and when? Screening blood tests: CBC, Celiac serology, electrolytes, LFT`s, thyroid function, iron studies, calcium, phosphate, vitamin D, folate, B12, fasting glucose, ± zinc, Mg When: At diagnosis At 6 months At one year and annually Duodenal biopsy: At diagnosis At 1-2 yrs; then as indicated on clinical grounds Bone density see new Canadian recommendations At diagnosis At 3-5 years in high risk groups; yearly if osteoporosis on Rx Haines M et al; APT; 2008; 28: 1042

25 Recommendations for Celiac Follow Up (EB) Recommendations on frequency of follow up and who should do the follow up cannot be made based on evidence However: Initial consultation 1-2 weeks after endoscopy Review consultation 3-6 months Subsequent review annually* *Haines M et al; APT; 2008; 28: 1042

26 Recommendations for Celiac Follow Up (EB) Follow up should address: Compliance with the GFD Include assessment of dietary adherence Encouragement of self management strategies (include CCA) Symptoms Duodenal biopsy Appropriate timing has not been established Earlier bx is repeated the higher the likelihood that healing will be incomplete Repeat biopsy NO earlier than 1-2 years *Haines M et al; APT; 2008; 28: 1042

27 Recommendations for Celiac Follow Up (EB) Follow up should address: Nutritional assessment Micronutrient deficiency: CBC, iron studies, Vitamin D, Calcium, phosphate, folate, B12 Homocysteine levels (especial in pts with thromboembolic) PTH level: indicator of 2ndry hyperparathroidism Magnesium (reported low in 13% of pts)( Bode, 1996) Zinc (low in 30% Celiac pts) (Bode, 1996) Vit E & Selenium optional Screening for complications & associated disease Thyroid, glucose, LFT s, electrolytes, platelets Haines M et al; APT; 2008; 28: 1042

28 Canadian Position Statement on Bone Health in Celiac disease At Celiac diagnosis: Only 30% have normal bone mass 30% have osteoporosis;30% osteopenia Risk factors for LBMD Classical presentation, LBMI, postmenopausal, older age at diagnosis, men >age 50, non adherence to GFD, highly elevated attg, 2ndry hyperparathyroidism, RCD Increased fracture risk: adults and children Classical presentation OR 5.2 Overall fracture risk Many have their fractures before diagnosis Fouda MA et al; CJG, 2012; 26 (11): 819

29 Canadian Position Statement on Bone Health in Celiac disease - Adults Indications for BMD testing in Adult Celiac: Classic Celiac disease: BMD done at diagnosis (Level 1) Asymptomatic/silent Celiac disease: BMD should be evaluated after one year on GFD (Level 1) Fouda MA et al; CJG, 2012; 26 (11): 819

30 Canadian Position Statement on Bone Health in Adult Celiac disease Asymptomatic Celiac with other risk factors: BMD (<1 yr after dx): Peri or post menopausal women (Level 1) Men older than 50 (Level 1) History of fragility fracture (Level 1) Unexplained iron deficiency anemia (Level III) Vitamin D deficiency (Level II) High titers for CD serological markers (Level I) Repeat or 1 st time DEXA in all groups at menopause and men over 50 (Level II) The FRAX tool will be useful to estimate # risk (Level II) Fouda MA et al; CJG, 2012; 26 (11): 819

31 Canadian Position Statement on Bone Health in Celiac disease Indications for BMD follow up Osteoporosis & osteopenia at diagnosis: follow up BMD at one year GFD (Level I) Normal BMD at diagnosis Follow up BMD: after TWO years GFD (Level II) Fouda MA et al; CJG, 2012; 26 (11): 819

32 Canadian Position Statement on Bone Health in Celiac disease Treatment: Gluten free diet adherence is the treatment of choice for normalization of BMD in CD patients (Level I) Pharmacological intervention with antiresorptive medications can be used to treat osteoporosis in postmenopausal adult CD patients after ensuring adequate calcium and vit D supplementation (Level III) Fouda MA et al; CJG, 2012; 26 (11): 819

33 Canadian GI s and Celiac follow up Canada: Survey of 585 GI s (response rate: 43%) 76% GI s routinely provide Celiac f/u care 56% almost always order f/u serology Timing of f/u serology: 16% first 3 months 57% at 6 mo 26% at one yr Routine biopsy performed after GFD initiation 38% Always, 36% Never Most common indication for f/u biopsy 76% for on-going symptoms or concern re: GFD adherence 25% to confirm normal histology Silvester J & Rashid M; CJG, 2010;24(8):499

34 USA: What f/u do Celiac patients get? 122 biopsy proven Celiac patients Assessed: what follow up was done from 6mo-5 yrs after dx according to the health records 93% followed for 4 or more years ONLY 35% follow up met AGA recommendations % Clinic visit % GFD compliance Dietitian visit % % Biopsy % Serology 1 year year Herman M et al; CGH, 2012; 10: 893

35 Increasing BMI with GFD Concern regarding BMI following GFD therapy 679 pts with at least 2 BMI s recorded during 39.5 mo f/u Celiac cohort was less likely to be overweight or obese 32% vs 59% p BMI d significantly with introduction of GFD 24.0 to 24.6 p, % with normal or high BMI at start d BMI > 2 points 15.8% moved from a normal/low BMI into an overwt BMI 22% who were overwt at dx continued to gain weight Weight management should be an integral part of Celiac dietary education Kabbani T et al; APT 2012; 35:

36 What have we learned? Follow up strategy is essential for Celiac pts Clinical assessment Important in overall clinical care (includes BMI) Is not an effective measure of mucosal response GFD review essential for successful therapy Serology: indicates response but normalization healing Biopsy is the gold standard for healing Healing may be slow (biopsy recheck 1-2 yrs) Monitoring/treatment of nutritional deficiencies Fe, B6, B12, Vit D, Ca, Se, Cu, Zn Bone Density management important Encourage patient in their self-management

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