Michael D. Kreines, M.D.

Transcription

1 Michael D. Kreines, M.D. Gastroenterology Section Chief Medical Director, IBD Program The Christ Hospital of Cincinnati Ohio GI and Liver Institute

2 This Year s Story How to figure out how severe each case of IBD is? What are some of the important questions to ask? What is a reasonable schedule of follow up visits/labs/scopes? What s the latest medical IBD news?

3 How Severe is My IBD? Guides treatment decisions Prognostic Comprehensive focus on disease complications/implications Guides testing and follow up Insurance documentation for appropriate meds

4 UC Severity Score Mild disease <4 BM per day with or without blood, no fever Moderate disease >4 BM per day mild systemic systems. Ex low grade fever Severe disease >6 bloody BM per day with fever, anemia, tachycardia

5 CROHN'S DISEASE SEVERITY LOW RISK: onset age >30 limited anatomic involvement no perianal or severe rectal disease superficial ulceration no prior resection no stricturing/penetrating disease MODERATE/HIGH RISK onset age <30 extensive involvement perianal or severe rectal disease deep ulcers prior resection stricture/penetrating disease

6 IBD DISEASE ACTIVITY PROVIDER ASSESSMENT IBD type and location Historical disease severity Bowel frequency compared to baseline Abdominal Pain Abdominal mass/bowel thickening Nutritional status Anemia Medication compliance, reported as: [default value]. Treatment related monitoring Treatment risks and side effects Steroid sparing therapy? Bone health education provided Smoking status Vaccinations: flu recommended to take yearly, pneumovac once with a 5 yr booster, avoid live virus vaccines Dysplasia/Cancer Surveillance:

7 IBD Patient Synopsis OCCUPATION etc: IBD TYPE: YEAR DIAGNOSED: FIRST APPT c MK: IBD Hx: COMORBITIES: IBD SURGERY: EXTRAINTESTINAL MANIFESTATIONS: PERIANAL DZ: IBD ASSESSMENTS: ENDOSCOPY: RADIOLOGY: [default value] SEROLOGY ETC: MEDICATION HX: [default value] CURRENT IBD MEDS: MEDICATION COMPLIANCE ASSESSMENT: SMOKING STATUS: BONE HEALTH: DEXA FAMILY HX of IBD or CRC: VACCINATIONS: Crohn's and Colitis Foundation (CCF):

8 Disease Severity Based Care Plan Guideline Historically mild UC currently in remission Office visit every 6-12 months CBC, CRP, comprehensive metabolic profile every 6-12 months Surveillance colonoscopy timing based on disease length and location, typically begin 8 years after disease onset and then every 1-2 years thereafter for extensive disease, every 5 years for limited disease

9 Disease Severity Based Care Plan Guideline Historically Moderate UC currently in remission Office visit every 4-6 months CBC, CRP, comprehensive metabolic profile every 6-12 months Disease evaluation every 1-2 years (CRP and/or colonoscopy and/or therapeutic drug monitoring) Surveillance colonoscopy timing based on disease length and location, typically begin 8 years after disease onset and then every 1-2 years thereafter for extensive disease, every 5 years for limited disease

10 Disease Severity Based Care Plan Guideline Historically severe UC currently in remission Office visit every 4 months CBC, CRP, comprehensive metabolic profile every 4 months Disease evaluation every 1-2 years (CRP, and/or colonoscopy and/or therapeutic drug monitoring) Surveillance colonoscopy timing based on disease length and location, typically begin 8 years after disease onset and then every 1-2 years thereafter for extensive disease, every 5 years for limited disease

11 Disease Severity Based Care Plan Guideline Historically mild CD currently in remission Office visit every 6 months CBC, CRP, comprehensive metabolic profile every 6-12 months Disease evaluation every 1-2 years (CRP, and/or colonoscopy, and/or MRE and/or therapeutic drug monitoring)

12 Disease Severity Based Care Plan Guideline Historically Moderate CD currently in remission Office visit every 4-6 months CBC, CRP, comprehensive metabolic profile every 6-12 months Disease evaluation every 1-2 years (CRP, and/or colonoscopy, and/or MRE and/or therapeutic drug monitoring)

13 Disease Severity Based Care Plan Guideline Historically severe CD currently in remission Office visit every 4 months CBC, CRP, comprehensive metabolic profile every 4-6 months Disease evaluation every 1-2 years (CRP, and/or colonoscopy, and/or MRE and/or therapeutic drug monitoring)

14 Disease Severity Based Care Plan Guideline Mildly active CD Stool C diff and possibly other stool microbiology CBC, comprehensive metabolic profile Therapeutic drug monitoring Possible colonoscopy and/or MRE Appropriate medication changes Office visit 1-3 months

15 Disease Severity Based Care Plan Guideline Moderately active CD Stool C diff and possibly other stool microbiology CBC, comprehensive metabolic profile Therapeutic drug monitoring Possible colonoscopy and/or MRE Appropriate medication changes Office visit 1-2 months

16 Disease Severity Based Care Plan Guideline Severely active CD Stool C diff and possibly other stool microbiology CBC, comprehensive metabolic profile Therapeutic drug monitoring Possible colonoscopy and/or MRE Appropriate medication changes Office visit 1 week to 1 month vs hospitalization

17 Disease Severity Based Care Plan Guideline Mildly active UC Stool C diff and possibly other stool microbiology CBC, comprehensive metabolic profile Therapeutic drug monitoring Appropriate medication changes Possible colonoscopy Office visit 1-3 months

18 Disease Severity Based Care Plan Guideline Moderately active UC Stool C diff and possibly other stool microbiology CBC, comprehensive metabolic profile Therapeutic drug monitoring Possible colonoscopy Appropriate medication changes Office visit 1-2 months

19 Disease Severity Based Care Plan Guideline Severely active UC Stool C diff and possibly other stool microbiology CBC, comprehensive metabolic profile Therapeutic drug monitoring Possible colonoscopy Hospitalization? Appropriate medication changes Office visit 1 week to 1 month vs hospitalization

20 TRANSITIONING TO ADULT GI Understands condition and can describes it to others? Feels comfortable discussing the disease with providers, family, and friends? Able to talk about concerns with us and with others? Can make decisions about treatment? Can make transportation arrangements for visits? Knows who and how to call for medical advice? Can refill prescriptions? Knows medications and possible side effects?

21 TRANSITIONING TO ADULT GI Eating IBD healthy foods? Knows importance of physical activity? Dealing with stress or needs help? Addressing issues of relationships and sex? Using alcohol, marijuana, or anything else not prescribed? Feel comfortable taking care of your disease yourself?

22 THE IBD PROGRAM MULTIDISCIPLINARY TEAM 22

23 AntiTNF during preganancy 4.8% vs 4.2% birth defects for women with any inflammatory disorder compared to no inflammation 683 women received antitnf during pregnancy There was a somewhat higher overall number of birth defects but statistically was not significant Mainly cardiovascular and urologic defects

24 Paternal anti TNF and Birth Outcome Preconception antitnf No increased congenital abnormalities

25 Thiopurines and Babies 309 women 108 on thiopurines during pregnancy No difference in spontaneous abortions No different in birth outcomes At one year old, no difference in the health of the babies (no increased infections or diseases, no difference in response to vaccinations)

26 Delivery Consider C section if active perianal Crohn s Consider C section if prior ileoanal pouch surgery

27 MEN Slight decrease in semen quality in men with Crohn s No impact of antitnf on semen quality In remission, normal sexual function

28 Statins and risk of IBD Compared 9617 cases of IBD with 46,665 non- IBD cases Looked at statin use (lipitor, zocor etc) The use of any statin was associated with a statistically significant lower rate of both UC and CD.

29 Biosimilars Poised to Save Big Bucks For all diseases Estimates range from $24 to $150 billion Between 2017 and 2026 Infliximab biosimilar showed similar effectiveness to historical infliximab studies

30 Biologics and Surgery Vedolizumab preoperatively did not increase postoperative complications in UC and Crohn s AntiTNF after surgery is effective even if not effective pre-surgery

31 Drug Level Monitoring is Good Adalimumab drug levels associated with more remission Infliximab drug monitoring and dose adjustment associated with better outcomes Ustekimumab trough level >4.5 associated with lower CRP and improved colonoscopy Thiopurine dosed to a therapeutic level combined with adalimumab was better than low dose thiopurine or adalimumab alone for induction and maintenance of Crohn s

32 Biologic Therapy Risks 14,590 patients Moderate increase risk of any infection Significant risk of opportunistic infection (TB, histoplasmosis) No increased risk of serious infections No increased rate of cancer seen

33 Probiotics are good for UC VSL#3 led to more remission in UC (in China)

34 Investigational Drugs Antibody to Interleukin-23 was effective in Crohn s Tofacitinib (Xeljans), an oral JAK inhibitor was more effective than placebo in Crohn s. At one year, 34-40% vs 11% Microbiome Drug for pediatric patients

35 CCR Studies Ulcerative Colitis: Abbvie M (Adalimumab) Abbvie M (Upadacitinib) Abbvie M (Upadacitinib) Gilead GS-US (Filbotinib) Gilead GS-US (Filbotinib) Gilead GS-US (Filbotinib) Protagonist PTG (PTG-100 Oral Peptide) Roche GA29102 (Etrolizumab) Shire SHP (SHP-647 IgG₂k antihuman MAdCAM monoclonal antibody) Shire SHP (SHP-647 IgG₂k antihuman MAdCAM monoclonal antibody) Shire SHP (SHP-647 IgG₂k antihuman MAdCAM monoclonal antibody) Vivelix IMUC1002 (IMO-9200 TLR Antagonist) 2. Crohn s Disease: Abbvie M (Adalimumab) Abbvie M (Upadacitinib) Abbvie M (Upadacitinib) Abbvie M (Upadacitinib) Gilead GS-US (Filbotinib) Gilead GS-US (Filbotinib) Lilly I6T-MC-AMAG (Mirikizumab) Roche GA29145 (Etrolizumab) Shire SHP (SHP-647 IgG₂k antihuman MAdCAM monoclonal antibody) Shire SHP (SHP-647 IgG₂k antihuman MAdCAM monoclonal antibody) Vivelix IMCD1003 (IMO-9200 TLR Antagonist)

36 Rock n Roll? Factors associated with ER and hospitalizations. Steroids, narcotics, significant anemia

37 FMT benefits UC Review of studies of fecal microbiota transplant for active UC was associated with more clinical and endoscopic remission without serious side effects Number needed to treat was 5

38 IBD and C diff In one study 27% of IBD patients tested for symptoms had an infection C diff the most common IBD patients are 33% more likely to experience C diff than the general population Rectal swab photo

39 Fiber and Flares 1629 patients who were in remission Survey of 26 dietary items Grouped by fiber intake (low 10gm to high around 24 gm/dy) Patients with a long history of IBD and those who have had surgery ate less fiber High fiber intake, fewer Crohn s flares 40% less likely No association with UC

40 Progress in Crohn s Disease? Comparison between time period and period. Use of immuneomodulators - from 30% to 70% Use of biologics from 3% to 40% Rate of hospitalizations from 65% to 44% Rate of surgery from 42% to 17%

41 Economic future for IBD Patients Here is some good news

42 Economic future for IBD Patients 112 IBD patients diagnosed during childhood or adolescence Followed for 14 years Compared to age matched non-ibd citizens IBD patients as adults, on average, had higher level of education and Higher Incomes!

43 HyGIeaCare Colonoscopy prep No drinking, just relaxing

44 Thank You! Cincinnati Children s Hospital CCF Event organizers YOU!