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

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

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

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

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

Index colonoscopy

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

What do we know already?

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

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

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;121:255-260; Melmed GY, et al. Am J Gastroenterol. 2006;101:1834-1840; Sands BE, et al. Inflamm Bowel Dis. 2004;10:677-692.

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

What do you want to tell the patient?

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

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

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

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

SONIC trial 169 pts receiving combination therapy (Infliximab and AZA) 96 were steroid free @ 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.

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

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?

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

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

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

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

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

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

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

Colonoscopy

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

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

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

Thank you