1. Medical therapy decisions for the difficult to treat IBD patient and the nursing role.
Case Study Advances 2014
Betty White C-NP
Manager Center for Crohn’s and Colitis
Digestive Health Specialists
Tacoma, WA

2. Disclosures
Speaker for Abbvie, UCB, Salix, Janssen, Takeda

3. Objectives
Discuss presenting factors that may predict a difficult to treat patient
Review treatment choices and be able to discuss the nursing role associated with each.
List important health maintenance recommendations for patients on immune- suppressing therapies

4. Initial presentation 23 y/o male
2 months intermittent abdominal pain and loose stools
Weight loss 20lbs
FHX aunt with Crohn’s
Social hx drinks 6-8 drinks on weekends smokes ½ pk cig a day recently started smoking marijuana to increase appetite
Single
Started a new job with frequent travel

5. labs Hgb 7.3 Albumin 2.6 WBC 14 Stool negative for c-difficile
Stool positive for lactoferrin
Positive for ASCA, C-BIR

6. Index colonoscopy

7. MR enterography
Several loops of small bowel thickened, 8cm terminal ileum thickened with proximal small bowel dilatation, colon with thickening in the sigmoid, possible perianal fistula , no abscess

8. What do we know already?

9. Markers of aggressive Disease
Age <30
Smoker
Severity of disease on index colonoscopy
Positive ASCA
Low albumin, anemia

10. Nursing considerations at first visit
Update vaccinations at first visit
Dietician consult
Social work
Cost of medications-copay assistance
Psychologist
CCFA educational materials

11. Minimize Risk for Drug-Related Complications in Patients With IBD
Immunize patients who require immunosuppressive therapy against vaccine-preventable infections
Limit exposure to corticosteroids
<50% of patients with IBD require corticosteroids
Corticosteroid dependency and need for surgery are common—even among patients who initially respond to corticosteroid therapy
Long-term corticosteroid therapy is associated with adverse effects, including bone loss
Reduce risks for drug-related complications by immunizing patients against vaccine-preventable infections and limiting corticosteroid use
Faubion WA Jr, et al. Gastroenterology. 2001;121: ; Melmed GY, et al. Am J Gastroenterol. 2006;101: ; Sands BE, et al. Inflamm Bowel Dis. 2004;10:

12. Follow up
After colonoscopy he was started on prednisone 40 mg po daily
Ciprofloxacin 500 mg po bid x 7 days
Biopsy’s show active colitis with chronic changes at 30 cm and TI shows chronic active colitis with ulceration
Patient is having less abd pain since starting prednisone but now having 7-8 loose stools daily, some nausea and poor appetite

13. What do you want to tell the patient?

14. Nursing implications Calcium 1400 mg vitamin d 800-2000iu daily
Baseline DEXA
Patient education on disease
Teach the basics
Smoking cessation

15. Nursing Implications TPMT Quantiferon gold for TB
Chronic hepatitis panel
Vaccination review
Nutritional review
Authorization for biologic

16. How to help with cost of treatment
Pharmaceutical patient assistance programs, reimbursement of out of pocket expense
Foundations-CCFA.org over 20 listings
Medical VS Pharmaceutical benefit
Change of insurance or individual writer
Crohn’s Advocate

17. Immunmodulator VS biologic
D’Haens et al 2008 Lancet
Suggest improved outcomes with earlier use of biologics
SONIC
Combination therapy was superior to IFX or AZA alone
COMMIT
No difference between patients on IFX, steroids and MTX versus IFX and steroids
Azathioprine
2013 meta analysis showed it took up to 17 weeks for response

18. SONIC trial
169 pts receiving combination therapy (Infliximab and AZA)
96 were steroid week 26.
169 pts receiving monotherapy
With infliximab alone - 75 were steroid free
With AZA alone - 51 were steroid free.
ACT 1&2
728 patients with moderate to severe steroid resistant UC.
Clinical response at 8weeks
ACT1-69.4%
ACT2-64.5%
Infliximab was also associated with improved health related quality of life scores ( HRQOL).
Reference: A review of Infliximab use in ulcerative colitis. Wilhelm SM, McKenney KA, Rivait KN, Kale-Pradhab PB. Clin ther Feb 2008
Colombel JF et al Infliximab, azathioprine, or Combination therapy for Crohn’s Disease. NEJM April 15, 2010.

19. Combination therapy
Patient agrees to start certolizumab and azathioprine
Certolizumab 200mg prefilled syringe
Inject 400mg SQ q 2 weeks x 3 doses then q 4 weeks
Azathioprine 1.5mg/kg daily

20. When should the patient expect to feel better
When should the patient expect to feel better? What do you want to make sure to tell the patient?

21. Nursing implications Labs CBC q 2weeks x2 , q 4 weeks x2 then q 3 mo
CMP, CRP, Sed Rate q 3-6 mo
Educate patient on symptoms to report, infection risk
Monitor adherence to treatment

22. Follow up 2 mo later
Patient’s weight has stabilized but still 10 lbs down from previous normal
Reports only occasional cramping and 3 loose stools daily associated with meals
Hgb 9
Albumin 3.2

23. Follow up MR abd/pelvis 6mo after initiating combination therapy
Small bowel thickened areas show improvement but continued stricture at TI with proximal bowel dilation, continued thickening sigmoid colon with small fluid collection

24. Is the patient under good control
Is the patient under good control? What do you want the patient to know now?

25. Biologic VS surgery Surgical referral early in process
Proximal bowel dilatation not acute process
Worsening perianal disease

26. Follow up Patient elects to continue medical therapy
Considerations for switching biologics
Adherence, cost, drug levels
Continue azathioprine, consider levels to maximize therapy
Patient elects to try a second biologic

27. Follow up Remains on azathioprine check 6tgn/6mmp levels
Doing well after induction of Infliximab 5/mg/kg 0,2,6 weeks
Some cramping, 1-2 loose stools daily
Weight stable
Albumin 3
Hgb 8

28. Colonoscopy

29. Discussion
Patient symptoms have improved but stricture has not improved
Perianal disease
When is the right time to consider surgery?
What can improve outcomes?

30. Nursing Consideration for nutritional support TPN?
Social support in place
FMLA
Online resources, CCFA, UOAA`

31. Patient decides to consider surgery Referral to Colorectal surgeon
When should the patient return to Gastroenterologist?
What to expect after surgery?

32. Thank you