Case Study

Mrs. Z is a 34-year-old female who come in with a complaint of diarrhea accompanied by abdominal pain.  Onset of the symptom was about 4 days ago.  She reports thinking she is running a fever but has not taken her temperature.  She concerned that she is starting to feel weak.

When asked how about the characteristics and the number of bowel movements a day, she reports increased number of BMs over the last few months.  In the last few days she reports averaging about 10 small volume watery stools with varying amounts of blood daily.

She denies recent travel and reportedly has not been on any antibiotics in the past few weeks.

In reviewing her record, you notice that her health history is positive for history of ulcerative colitis.  She has not been on any medications for this over the last few years as she had not been symptomatic.

Mrs. Z is on an oral contraceptive.  She takes slippery elm capsules and has for the last several years.  She reports that she has been taking 2 to 3 doses of Benefiber prebiotic fiber for the last couple days.

Objective data:

BP 116/70 sitting, 100/66 standing; P 92; Temp 100.1

Abdomen – active bowel sounds all 4 quadrants, mild tenderness with palpation

Otherwise her exam is unremarkable for pertinent positives or negatives.

Labs – WBC 14,000; Hgb 11.9; Hct 35.7; Sodium 133; Potassium 3.3

· What pharmacologic therapy would you prescribe for Mrs. Z?

· How will you evaluate the effectiveness of this therapy?

· What patient education would you provide for Mrs. Z relative to the pharmacologic agent you prescribed?

· Are there any pharmacogenetic considerations related to what you prescribed for the patient?

· Are there any alternative therapies or over-the-counter agents that might be of value to Mrs. Z?

· What, if any, lifestyle changes would you recommend?

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Case Summary:

· Mrs X, 34, F

· Chief complaint: (+) diarrhea, (+) abdominal pain, fatigue

· watery stools with streaks of blood

· (-) antibiotic use, (-) travel

· PMH: (+) ulcerative colitis, no maintenance meds

· Recent probiotic intake

· Abdominal examination: active bowel sounds all 4 quadrants, mild tenderness with palpation

Diagnosis

· To consider ulcerative colitis flare – severe

· To consider intestinal amebiasis

What pharmacologic therapy would you prescribe for Mrs. Z?

Anti-TNF induction therapy with adalimumab, golimumab, or infliximab is recommended for moderate-to-severe disease

Infliximab

· induction is 5 mg/kg IV over at least 2 hours at weeks 0, 2, and 6 followed by maintenance therapy; premedication with antihistamines, acetaminophen, and corticosteroids may be considered

· alternate infusion rate: 1-hour infusions significantly reduced the risk of infusion reactions and of delayed infusion reactions compared with standard 2- to 3-hour infusions in patients who previously tolerated at least 3 standard infusion

Adalimumab (Humira)

· 160 mg subcutaneously (given in 1 day or split over 2 consecutive days), followed by 80 mg subcutaneously on day 15, and then 40 mg subcutaneously every other week starting on day 29

· only continue treatment if clinical remission occurs by day 57

Golimumab (Simponi)

· 200 mg subcutaneously at week 0, followed by 100 mg subcutaneously at week 2

How will you evaluate the effectiveness of this therapy?

· Therapeutic drug monitoring is suggested to guide changes in treatment

· Comprehensively evaluate and review disease status and severity prior to considering withdrawal or reduction of any maintenance therapy for IBD including re-evaluating disease activity with clinical, biochemical, endoscopic/histologic, and/or imaging tests; also consider disease history, severity, and extent

· Patient preference should inform decisions on treatment withdrawal

· No current guidelines on monitoring patients withdrawn from maintenance therapy, but a reasonable strategy is monitoring symptoms, inflammatory markers such as C-reactive protein or fecal calprotectin, and/or endoscopy/imaging assessments

What patient education would you provide for Mrs. Z relative to the pharmacologic agent you prescribed?

· Anti-TNF therapy associated with increased risk of serious infection, including tuberculosis, invasive fungal infections, bacterial infections, viral infections, and infections due to opportunistic pathogens

· Compared to the general population, patients taking anti-TNF therapy appear to have low or no increased risk for malignancy, but the risk appears increased when anti-TNF agents are taken in combination with an immunomodulator (thiopurines or methotrexate).

· Both the American College (ACG) and American Gastroenterological Association (AGA) find insufficient evidence to make recommendations on probiotics in the management of mild-to-moderate ulcerative colitis.

Are there any pharmacogenetics considerations related to what you prescribed for the patient?

· None. Oral contraceptive use is not associated with increased rates of steroids prescription or use of anti-TNF therapy in patients with established ulcerative colitis. The effect does not appear to differ according to the type of oral contraceptives.

Are there any alternative therapies or over-the-counter agents that might be of value to Mrs. Z?

· Antidiarrheals, such as loperamide (imodium), may be used for symptomatic relief of diarrhea if needed and colitis is not fulminant

· Consider antispasmodics, neuropathic-directed agents, and antidepressants for functional pain

What, if any, lifestyle changes would you recommend?

· Patients should be advised to maintain a varied and healthy diet, but if functional symptoms persist despite remission specific dietary patterns such as a low-FODMAP diet (reduced dietary fermentable oligo-, di-, and monosaccharides and polyols) may be advised

· Screen for coexisting anxiety or depressive disorders which are reported to be common, and provide resources to address them if present; consider psychological therapies such as cognitive behavioral therapy to improve symptom control and quality of life or in presence of pain without identifiable physical source

· Provide surveillance for colorectal dysplasia and neoplasia with frequency tailored to individual risk factors and history

· Screen for osteoporosis risk factors and correct if possible

· Preventing opportunistic infection is important, particularly in patients receiving immunosuppressive therapies, and involves recommended screening and vaccinations for patients with inflammatory bowel disease

Rubric

NU634 Case Study Rubric (30 pts) (1)