1. November Managing Severe Ulcerative Colitis in the Hospital Setting – Salvage Therapy with Cyclosporine Bridge
Author(s)
Jennifer labas, FNP-BC, RN, MSN
reviewed by the Crohn’s & Colitis Foundation’s Nurse & Advanced Practice Committee

2. Instructions
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3. Objectives
Audience will understand the clinical situation of ulcerative colitis, in which salvage therapy is considered.
Audience will understand induction of salvage therapy as a bridge to maintenance medical options.
Audience will understand what it means to achieve remission with salvage therapy, as well as the importance of compliance with follow-up care.

4. Introduction/Background
25 y.o. male diagnosed with UC at age 15 when he developed diarrhea w/blood/urgency
Failure of
Mesalamine
Intermittent IV/PO steroids
Dual therapy w/Azathioprine + Adalimumab (including dose escalation to weekly dosing)
Infliximab (s/p 2 loading doses) →initial improvement after 2nd, then worsened
Admitted May 2017

5. Review of Systems (ROS)
No headaches, or oral ulcers
+Fatigue, no dizziness with standing
No skin rashes
Bilateral knee arthralgias consistent with active disease
10-15 bloody BMs/day, no response to po Prednisone 40mg daily

6. Physical Exam
Blood pressure 110/72, pulse 67, temperature 36.4 °C (97.5 °F), temperature source Tympanic, resp. rate 15, weight 56.8 kg (125 lb 3.5 oz), SpO2 100 %. The patient is alert and oriented x3, in no acute distress. HEENT: Extraocular motion intact. Pupils equal, round and reactive to light. Oropharynx is clear. Sclerae are nonicteric. Neck: There is no lymphadenopathy; the thyroid is not palpable. CARDIAC: RRR, normal S1, S2.No murmurs, rubs or gallops. PULMONARY: Clear bilaterally to auscultation and percussion. BACK: No CVA tenderness. ABDOMEN: Soft, non-tender, non-distended. Bowel sounds are present. No obvious hepatomegaly, splenomegaly, or masses. No hernias or ascites. PERIANAL: Examination is deferred. GENITALS: Examination deferred. LYMPHATICS: No palpable nodes in the neck. MUSCULOSKELETAL: Normal gait and station, digits and nails. Extremities are all normal without edema. SKIN: Anicteric. No rashes NEUROLOGICAL: Cranial nerves intact. PSYCHIATRIC: Appropriate judgement and insight, oriented to time, place and person, has normal recent and remote memory, and appropriate mood and affect.

7. Work Up – Obtain baseline flex sig
Flex sig with moderate inflammation was found from the anus to the sigmoid colon 2nd to pan UC .

8. Previous Workup
BP: Normotensive Lipid Panel: total cholesterol 148 CMP: Magnesium 2.2, Creatinine 0.6 Quantifuron Gold/Hepatitis B serologies: Negative CBC: WBC 6.7, Hgb 12.0 CMV PCR: Negative GI Panel: Negative (initially) CRP: 12

9. Do you have red flags/cause for concern based on physical exam & previous workup?
Is patient hypertensive?
Is patient cholesterol < 100?
Does patient have a baseline leukocytosis?
Does patient have a baseline anemia?
Does patient have normal electrolytes?
Does patient have normal creatinine?
Baseline KUB?

10. Do you have a Differential Diagnosis?
Is this CMV (cytomegalovirus)?
Flex sig for tissue CMV PCR and serum CMV PCR
If +, initially treat with IV Ganciclovir 5mg/kg IV BID x 3 weeks, then change to Valcyte 900 mg po BID until negative tissue/serum
Consult Infectious Disease for duration (likely want negative tissue biopsy and negative serum PCRs prior to cessation of therapy as immunosuppressed)
Assess for improvement if UC needs to be treated separately
Is this c.diff (clostridium difficile)?
GI panel (tests for 22 different GI bacteria/viruses)
If positive for c.diff, initiate Vancomycin 125mg po QID

11. What is your plan of care?
Initiate IV Cyclosporine at 4mg/kg
Goal trough
First trough checked 48 hours post infusion initiation
MUST BE CONTINUOUS INFUSION FOR RELIABLE TROUGH
Cannot be disconnected for shower, or for prolonged time as can drop level
If patient loses IV access, RN must immediately notify team
Given in conjunction with IV Solumedrol
Bactrim PJP prophylaxis (1DS q MWF)
SURGICAL CONSULT – NEVER LEAVE THIS DISCUSSION UNTIL THE LAST MINUTE – PATIENT NEEDS TIME TO PROCESS AND UNDERSTAND IF SALAVGE THERAPY FAILS, COLECTOMY IS ONLY REMAINING OPTION

12. Daily Evaluation
CRP 12 initially → down to < 3 with gradual improvement of symptoms
Day #6, CRP bump to 14→26→34
C.diff rechecked (initially negative)
Now positive
PO Vancomycin initiated
CRP decreased from 34 to 7 in 24 hours
Initiated outpatient Vedolizumab prior authorization
Discharged home on:
BID Cyclosporine dosing (ex: 300mg IV bag = 300mg po BID)
Prednisone 40mg po daily
Bactrim 1 DS q MWF
Azathioprine 150mg daily
Vancomycin 125mg po QID x 14 days (for c.diff)

13. So How Did He Do Post Discharge?
Patient successfully weaned off Prednisone after Vedolizumab initiation in June 2017 (maintenance troughs decrease to )
Azathioprine dose optimized to 200mg po daily, based on metabolite levels
Successfully weaned off Cyclosporine August 2017 (after creatinine bumped from 0.6 to 1.2)
Most recent clinic visit February 2017
Completed college
Relocated to Chicago
Got engaged
Starting a new job in full remission
Due for repeat colonoscopy

14. Summary
Cyclosporine is a very effective salvage therapy, once patient has exhausted all standard induction modalities.
It is only to be used as a bridge therapy, for no longer duration than 3 months, given nephrotoxicity risk.
Follow-up is EXTREMELY important given effects Cyclosporine can have on blood pressure, electrolytes, and kidneys.
Cyclosporine is NOT an option for patients who are noncompliant, given above risks. In this event colectomy would be recommended should no additional medical options be available.