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Presentation Title Goes Here Evolution of Pediatric Inflammatory Bowel Disease Ashish S. Patel, MD Division Chief, Pediatric Gastroenterology Phoenix Children's Hospital Professor Department of Child Health University of Arizona College of Medicine-Phoenix Disclosure • Abbvie – Consultant and Speaker 2 Goals • Review the current understanding of pediatric IBD • Discuss the current therapeutic options in the treatment and management of pediatric IBD • Understand risks of immunomodulation in pediatric IBD • Monitoring, surveillance and immunizations in your IBD patient 3 Pediatric Inflammatory Bowel Disease (IBD) • Pediatric Inflammatory Bowel Disease (IBD) is a chronic relapsing and remitting disease characterized by inflammation, ulceration and bleeding in the gastrointestinal tract. • It is a systemic disease with the primary site of involvement being the gastrointestinal tract. • Includes the disease spectrum of – Crohn’s Disease – Ulcerative Colitis – IBD Unclassified (formerly indeterminate colitis) • IBD can present with significant phenotypic and genetic variability. Distinguishing IBD • 12 y/o Caucasian male presents to your office with a 6 week history of increased diarrheal consistency stools, no overt evidence of bleeding, but heme-occult positive in your office. • Complains of a 7-8 pound weight loss during that time. • Complains of right lower quadrant tenderness and low grade fever. • Family history: mom has Crohn’s disease • Ethnicity: Jewish • 15 y/o African American male presents to your office with a 4 week history of bright red blood per rectum, going 8-10 times per day. • Patient appears pale and a CBC reveals a hemoglobin of 5, platelets of 750,000 and WBC 18. • Patient has tenderness in the left lower and upper quadrants. • No significant weight loss of growth failure. • No family history. • 6 y/o Asian American female presents with a 4-5 month history of joint pain. • On further questioning, associated vague abdominal cramping and foul smelling flatulence. • Joint pain is typically localized to a single joint, complains of knee swelling and ankle swelling with pain on movement. • Rectal exam reveals heme positive stools and multiple perianal tags. • 14 year old Caucasian female presents with growth failure. • Growth and weight are below the 3%. • Sexual development is Tanner 1 with no evidence of menarche. • Patient has recently developed raised exquisitely tender lesions on the extensor surfaces of her legs, dermatologist diagnosed erythema nodosum. Clinical Variability • The clinical variability is highly dependant on the involved location of diseases. – For example, small bowel disease is more likely to lead to occult bleeding associated with growth failure or weight loss. – On the other hand, large bowel disease often presents with bright red bleeding, anemia, and less likely associated with growth failure or weight loss. – The diagnosis of IBD does not discriminate by age, sex or ethnicity, though there are higher risks groups. Crohn’s vs Ulcerative Colitis • Can involve the gastrointestinal • Localized to the large intestine, tract from mouth to anus, starting distally and extending propensity for the TI proximally • Granulomas • Granulomas uncommon • “Skip” lesions • Continuous inflammation • Rectal sparing • Rectal involvement • Strictures • No strictures (carcinoma) • Fistulas • No fistulas • Growth failure • Growth issues uncommon • No cure • Surgery is curative Ulcerative Colitis vs Crohn’s disease JAMA. 2014;311(19):2034. doi:10.1001/jama.2014.1664. A little bit of history….. In 1932, Dr Burrill Bernard Crohn, a Jewish- American gastroenterologist affiliated with Mt. Sinai Hospital in New York City published a description of 14 cases of terminal ileitis that came to be known as “Crohn’s disease” Crohn BB, Ginzburg L, Oppenheimer GD. Regional ileitis: a pathologic and clinical entity. JAMA 1932; 99:1323 Epidemiology • Several unique features of the disease – A North-South gradient – • Higher incidence in countries within the Northern hemisphere. • Rarely diagnosed in South America and Africa. • Within both Europe and North America, higher incidence of disease in the northern latitudes. – Male to female ratio 1:1 – Two peaks in diagnosis • 15-30 years of age (2nd to 3rd decade of life) • 60 years of age (5th to 6th decade of life) Genetics/Ethnicity • Known risk factor, especially in the pediatric population is a first degree relative with IBD – Relative risk is 15 times the general population • Higher prevalence in the Jewish population, regardless of geographic location – Ashkenazi Jews (eastern Europe) have a two to fourfold higher risk of developing IBD than non-Jews – 67% concordance for Crohn’s in monozygotic twins – 15% concordance for UC in monozygotic twins A total of 200 genes now described Jostens L, et al. Nature. 2012;491:119-124. Worldwide Incidence Molodecky, Natalie A., et al. "Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review."Gastroenterology 142.1 (2012): 46-54. Cosnes, Jacques, et al. "Epidemiology and natural history of inflammatory bowel diseases." Gastroenterology 140.6 (2011): 1785-1794. Worldwide Incidence Rates of Crohn’s Disease 12- Olmstead County, MN Aberdeen, Scotland Cardiff, Wales Helsinki, Finland Rochester, NY Florence, Italy 10- Iceland years - 8- 6- 4- 2- Incidence/100,000 Incidence/100,000 person 0- 1955 1960 1965 1970 1975 1980 1985 1990 1995 Year Loftus EV. Gastroenterology. 2004;126:1504. Worldwide Incidence Rates of Ulcerative Colitis 20- Olmstead County, MN Malmo, Sweden Rochester, NY Heraklion, Crete 18- Iceland Seoul, South Korea 16- Florence, Italy years - 14- 12- 10- 8- 6- 4- 2- Incidence/100,000 person Incidence/100,000 0- 1955 1960 1965 1970 1975 1980 1985 1990 1995 Year Loftus EV. Gastroenterology. 2004;126:1504. Pathophysiology Pediatric IBD therapeutics • Classically, therapeutics have focused on anti- inflammatory and immunomodulating drugs which decrease the abnormal host response. • The “biologic” era, approximately the last two decades, has redefined our approach to this challenging disease. 21 Studies like RISK lead by Current state Dr Kugathasan will help further define best therapies in children Immunomodulator • Azathioprine / 6MP / Imuran – Oral – Decreases WBC, particularly lymphocytes – Check TPMT Phenotype prior to induction of therapy – Monitor CBC and LFTs – Risk of lymphoma, Hepatosplenic T-cell Lymphoma (HSTL) – Emerging long term risk of dermatological cancers • Methotrexate – Oral or injectable – Decreases WBC – Monitor CBC and LFTs Biologics – Anti-TNF • Antibody that targets TNF alpha, a potent modulator of inflammation in the human body • Prior to therapy – TB, Coccidioidomycosis and Hepatitis B status • During therapy – Monitor labs – Exam – focused on liver, spleen and lymph nodes • Major risks – Lymphoma including HSTL – Infection Biologics – Anti-TNF • Infliximab – First in class – Chimeric antibody – Infusion • Adalimumab – Fully human antibody – Injectable • Certolizumab – Pegolated human antibody – Injectable • Golimumab – Injectable Drug Monitoring – Anti-TNF • Therapeutic drug monitoring available to optimize dosing in pediatrics – Increased drug clearance seen in: • Male • High CRP • Low Albumin • Obesity • Infliximab levels = target 3-10 • Adalimumab levels = target greater than 5 Biosimilars • Next phase of anti TNF therapies • A biosimilar product is a biological product that is approved based on showing that it is highly similar to an already-approved biological product, known as a reference product • Pro – cost • Cons – no formal testing, utilizes data from reference product • USA – currently 4 approved TNF biosimilars – Infliximab-DYYB (Inflectra) – Infliximab-ABDA (Renflexis) – Adalimumab-ATTO (Amjevita) – Adalimumab-BWWD (Hadlima) Biologics – Integrin blockers • Natalizumab (Tysabri) – α4 integrin blocker – blocks recruitment of WBC – PML risks (in patients positive for JC virus) • Vedolizumab (Entyvio) – Α4β7 integrin blocker – blocks recruitment of WBC – Gut specific – Indicated for adult CD and UC – 300mg given at week 0,2,6,14 and then every 8 weeks – No lymphoma signal – Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease Biologics – IL12/IL23 inhibitors • Ustekinumab (Stelara) – Human monoclonal antibody – Blocks cytokines IL12 and IL23 – Given as a loading dose IV and then subq • Loading dose - IV – 6mg/kg dose below 40kg – 40 kg to 55 kg 260mg – 55 kg to 85 kg 390 mg – Greater than 85 kg 520 mg • Maintenance dose – 90mg subq every 8 weeks – Currently approved for adult Crohn’s disease and psoriasis • UNITI Trials Janus Kinase Inhibitor • Tofacitinib – inhibitor of JAK 1 and JAK 3 pathways which regulate inflammatory mediators – Approved for rheumatoid arthritis – Being evaluated for IBD and psoriasis – Unique because of its ORAL delivery Pipeline Dietary Therapy • Exclusive Enteral Nutrition – 12 weeks consume formula only • Elemental, semi-elemental or polymeric – After 12 weeks, maintain 70% total calories from formula – Shown to decrease variability of gut microbiotia • Specific Carbohydrate Diet – Shown positive results in small studies – Dr. David Suskind, Seattle Children’s – Increase variability of gut microbiota – PRODUCE trial – Diet focused on eliminating refined and processed sugars from the diet Remission • The gold standard for therapeutic success is clinical symptom resolution and mucosal healing without
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