Thank you for Connecting with Trellus Elevate™

This Reference Guide was designed to ensure you have everything you need to partner with us in delivering the highest quality of resilience-based integrated support to you and your patients with IBD.

Please do not hesitate to contact us via email [email protected] or by phone at 800.989.5503 with any questions or any additional help we can provide for you and your patients.

Thank you for joining us in reimagining resilience for chronic GI conditions.

Sincerely,

The Trellus Elevate™ Team

 

A. Digital Notification and Alert System Overview

Trellus has designed a digital notification and alert system for your patients to be notified or alerted when they are reporting poor or worsening health trends. Additionally, they will be reminded of what labs require monitoring and when based on the medications they are receiving for their IBD and what health maintenance they are due for. Trellus educates patients on when and how to best communicate with their GI provider, to reduce the burden on you and your staff, and how to safely stay on their therapies and sustain tight control of their disease. Our automated disease monitoring and therapy notification system was designed specifically for GI providers based on best practice quality metrics.

    • Red Flag notifications are triggered when your patient is reporting some poor health trends, including clinical and well-being outcomes, and or unplanned health care utilization which requires attention.

    • Your patient will be advised to connect with you and your team to discuss this change in symptoms and next steps.

 

Risk Reason for Notification
# of Bowel Movements Patient is experiencing worsening of symptoms, with at least 4 bowel movements for 7 days in a row.
Liquid Bowel
Movements
Patient is experiencing worsening of symptoms, reporting liquid stools for 7 days in a row.
Blood in
Bowel Movement
Patient is experiencing worsening of symptoms, reporting blood in bowel movements for 7 days in a row.
Urgency Patient is experiencing worsening of symptoms, reporting urgency for 7 days in a row.
Fecal Incontinence Patient is experiencing worsening of symptoms, reporting leakage of stool, blood, or liquid before reaching the toilet at least 2 days in the past week.
Abdominal Pain Patient is experiencing worsening of symptoms, reporting moderate or severe abdominal pain for 7 days in a row.
Urgent Care Patient visited an urgent care center for their IBD.
ER Visit Patient visited the ER for their IBD.
Hospitalization Patient had an unplanned hospitalization for their IBD.
GI Provider Contact Patient has attempted to contact you but has not been able to reach you.
CT Scan Patient has received an unplanned CT scan.
Prednisone Use Patient has reported taking prednisone recently.
Opioid Use Patient has new report of taking opioid medication outside of
their regular care plan.

 

    • Yellow Flag notifications are triggered when patient is reporting some poor health trends, including clinical and well-being outcomes, as well as key biomarkers of inflammation indicating there is rising risk of health care utilization.

    • Your patient will be advised to connect with you and your team to discuss this change in symptoms and next steps.

 

Trigger Field Reason for Notification
Bowel Movements Patient had at least 4 bowel movements for 7 days in a row, with no worsening of symptoms in last 30 days
Liquid Bowel Movements Patient had liquid stools for 7 days in a row, with no worsening of symptoms in last 30 days
Blood in Bowel Movements Patient has blood in bowel movement 7 days in a row, with no worsening of symptoms in last 30 days
Urgency Patient is experiencing more frequent urgency 7 days in a row, with no worsening of symptoms in last 30 days
Abdominal Pain Patient had new mild pain at least 7 days in a row, with no worsening of symptoms in last 30 days
Abdominal Pain Patient had pain for at least 7 days in a row, more pain than usual, and has had pain at least 3 days per week in past 30 days
General
Physical Health
Patient indicates worsening from previous week, now to “Fair” or “Poor”
Average IBD- related Pain Patient had pain > 4 or has had an increase of at least 3 levels since last report
GI Provider Contact Patient has reached out to you recently and had their concerns addressed.
Fecal Calprotectin Patient has a recent fecal calprotectin lab result greater than the upper limit of normal.
C-Reactive Protein Patient has a recent C-Reactive Protein lab result at least 2x the upper limit of normal.
Hemoglobin Patient has a recent Hemoglobin lab result of less than 11 gm/dL.
Albumin Patient has a recent Albumin lab result of less than 3.5 g/dL.

These include labs, well being and symptom burden triggers that the Trellus Resilience Team will work with your patient to overcome and patients will be directed to their provider if there is a worsening in symptoms or other red or yellow flags are triggered.

Notification Trigger Field Reason for Notification
Bloating Patient reported feeling bloated for 7 days in a row.
Fatigue Patient reported two weeks of increased fatigue or very severe fatigue.
Anxious, Depressed, or Irritable Patient reported two weeks of being more bothered by emotional problems than usual, or often/always being bothered by emotional problems.
Life Satisfaction Patient reported disagreeing or strongly disagreeing with the statement: My life has been going well.
Vitamin D 25-OH Patient has a recent Vitamin D lab result of less than 30
ng/mL.

B. Best Practices

TrellusElevate™ simplifies medication safety monitoring and preventative care/health maintenance with automated reminders that notify your patients when there are actions to be taken.

When adding new therapies or reviewing current medications, refer to the included Glossary of Medication-Related Monitoring and IBD Vaccine Reference Guide. We also provide these resources to your patients so they can increase their understanding of why these monitoring reminders are important and help to meet national standards.

TrellusElevate™ enables tight control disease monitoring based on clinical disease severity.

Biomarker Tracking

Remote patient monitoring is driven in part by patient’s lab results. Your patient may receive notifications to request a lab order from the provider if the patient is missing or overdue for the laboratory results in TrellusElevate™.

Biomarker High Clinical Severity Lo w Clinical Severity
Fecal Ca lprotectin At least every 4 months At least every 6 months
C-Re active Protein At least every 4 months At least every 6 months

GI Provider – Recommended Touch points

Based on disease severity we recommend the following clinical visit schedule

High Clinical Severity Low Clinical Severity
Every 4-6 months Every 6 – 12 months

C.  Glossary of Medication Related Monitoring

IBD Medications Common Brands Safety Checks
aminosalicylates –
balsalazide, mesalamine
Apriso™
Asacol® HD
Colazal®
Giazo™
Canasa®
Delzicol™ Rowasa®
Lialda™
Pentasa®

Prior to Initiating Therapy
✓  Initial/baseline bloodwork such as complete blood counts, renal function, liver function

While on Therapy
✓ Yearly Renal (kidney) function test. Order yearly urinalysis

aminosalicylates –
sulfasalazine
Azulfidine® Azulfidine® EN- tabs

Prior to Initiating Therapy
✓  Initial/baseline bloodwork such as complete blood count, renal function, liver function

While on Therapy
✓  Routine bloodwork such as complete blood count, renal function, liver function every 3-6 months
✓  Yearly urinalysis
✓ Daily folic acid supplements (1mg /day and up 2 mg/ day if pregnant)

NOTE: More frequent lab monitoring may be necessary during first few months of therapy

biologics – TNF-α (adalimumab, infliximab, certolizumab pegol, golimumab) Humira®
Cyltezo™
Amjevita®
Hyrimoz™
Cimzia®
Simponi® Remicade® Renflexis®
Avsola
Inflectra™
IXIFI™

Prior to Initiating Therapy
✓  Tuberculosis (TB) screening prior to initiating medication (e.g. QuantiFERON- TB Gold or PPD. If high risk or indeterminate results from QuantiFERON-TB Gold or PPD: Chest X-ray)
✓  Check Hepatitis B Immunity Status (preferably before starting therapy but can be done after starting therapy) and re/vaccinate if not immune
✓  Avoid live vaccines within 4 weeks of starting therapy and during therapy
✓  Initial/baseline bloodwork such as complete blood count, renal function, liver function

While on Therapy
✓  Annual TB risk assessment and screening if meeting criteria for high risk
✓ Avoid live vaccines
✓  Routine bloodwork such as complete blood count, renal function, liver function every3-6 months
✓ Consider measuring drug concentrations to ensure there is a therapeutic amount of drug in the system, especially when symptomatic. (This can be considered shorty after starting therapy)

Patient Traveling Soon?
They may be considered high-risk for TB if traveling to certain countries. Check if destination is high-risk for TB here: https://wwwnc.cdc.gov/travel/destinations/list

biologics – α4 integrin
(natalizumab)
Tysabri®

Prior to Initiating Therapy
✓  Enroll patient in TOUCH program
✓  Initial/baseline bloodwork such as complete blood count, renal function, liver function

While on Therapy
✓  Routine bloodwork such as complete blood counts, renal function, liver function every 3-6 months

biologics – IL-12/23 (ustekinumab) and IL-23 (risankizumab) Stelara®
Skyrizi ®

Prior to Initiating Therapy
✓  Tuberculosis (TB) screening prior to initiating medication (e.g. QuantiFERON- TB Gold or PPD. If high risk or indeterminate results from QuantiFERON-TB Gold or PPD: Chest X-ray)
✓  Avoid live vaccines within 4 weeks of starting therapy
✓  Initial/baseline bloodwork such as complete blood count renal function, liver function

While on Therapy
✓  Annual TB risk assessment and screening if meeting criteria for high risk
✓  Avoid live vaccines
✓  Routine bloodwork such as complete blood count, renal function, liver function every 3-6 months (Skyrizi LFT check within 12 weeks of initiating)
✓  Consider measuring drug concentrations to ensure there is a therapeutic amount of drug in the system, especially when symptomatic

Patient Traveling Soon?
They may be considered high-risk for TB if traveling to certain countries. Check if destination is high-risk for TB here: https://wwwnc.cdc.gov/travel/destinations/list

biologics – α4β7 integrin (vedolizumab) Entyvio®

Prior to Initiating Therapy
Consideration: Patients at high risk for tuberculosis (TB) may be screened, at your discretion
✓  Initial/baseline bloodwork such as complete blood count, renal function, liver function
✓  Avoid live vaccines within 4 weeks of starting therapy

While on Therapy
✓  Avoid live vaccines
✓  Routine bloodwork such as complete blood count, renal function, liver function every 3-6 months
✓  Consider measuring drug concentrations to ensure there is a therapeutic amount of drug in the system, especially when symptomatic

corticosteroids – budesonide

corticosteroids – prednisone

Entocort® EC
Uceris™

A-Methapred® Depo-Medrol® Medrol Dosepak® Solu-Medrol® Deltasone® Oraped® Prelone® Pediapred®

✓  Daily Calcium (1200-1500 mg) and Vitamin D supplements (1000-2000 IU)
✓  Recommend an ophthalmology exam to monitor for ocular side effects
✓  Consider a bone density exam*

* Generally, a bone density exam may be considered if patient has used oral corticosteroids lasting > 3 months, or if patient has used oral corticosteroids lasting 1 year within the past 2 years.

*Women 65 or older should receive a bone density for preventative screening every 2 years regardless of steroid exposure.

immunosuppressant –
cyclosporine
Neoral® Sandimmune® Gengraf®

Prior to Initiating Therapy
✓  Review all medications, including herbal supplements
✓  Iitial/Baseline bloodwork such as complete blood count, renal function, liver function, potassium, cholesterol, and magnesium levels.

While on Therapy
✓  Avoid grapefruit juice
✓  Routine monitoring of drug concentrations and bloodwork such as complete blood count, renal function, liver function, potassium, cholesterol, and magnesium levels every 3-6 months
✓  Recommend consistency of taking medication, either always with food or always without food

NOTE: More frequent lab monitoring may be necessary during first few months of therapy

immunosuppressant –
methotrexate
Rheumatrex® MTX®
Mexate®
Trexall®

Prior to Initiating Therapy
✓  Initial/baseline bloodwork such as complete blood count, renal function, liver function

While on Therapy
✓  Routine bloodwork such as complete blood count, renal function, liver function every 3-6 months
✓  Daily folic acid supplements (1 mg/day)

NOTE: More frequent lab monitoring may be necessary during first few months of therapy

Patient Considering Pregnancy?
It is recommended to stop this therapy 3-6 months prior to getting pregnant. Remind patient to include you in discussions when family-planning so you can support them in having a
healthy pregnancy while keeping their IBD under control.

immunosuppressant –
tacrolimus
Prograf®
Astagraf XL® Envarsus® XR Hecoria®

Prior to Initiating Therapy
✓  Review all medications, including herbal supplements, with care team prior to starting Order initial/baseline bloodwork such as complete blood count, renal function, liver function, potassium, cholesterol, and magnesium levels.

While on Therapy
✓  Avoid grapefruit juice
✓  Recommend consistency of taking medication, either always with food or always without food
✓  Routine monitoring of drug concentrations Order routine bloodwork such as complete blood count, renal function, liver function, potassium, cholesterol, and magnesium levels every 3-6 months

NOTE: More frequent lab monitoring may be necessary during first few months of therapy

immunosuppressant – thiopurine, azathioprine, 6- Mercaptopurine (6-MP) Imuran® Azasan® Purinethol® Purixan

Prior to Initiating Therapy
✓  Thiopurine methyltransferase (TPMT) enzyme blood test to ensure a safe start to the medication. Results will impact starting dose.
✓  Initial/baseline bloodwork such as complete blood count, renal function, liver function

While on Therapy
✓  Routine bloodwork such as complete blood count, renal function, liver function every 3-6 months
✓  Consider measuring drug concentrations to ensure there is a therapeutic amount of drug in the system (Thiopurine Metabolites)

NOTE: More frequent lab monitoring may be necessary during first few months of therapy

small molecules – JAK- inhibitor (tofacitinib, upadacitinib) Xeljanz®
Rinvoq®

Prior to Initiating Therapy
✓  Tuberculosis (TB) screening must be completed prior to initiating medication (e.g. QuantiFERON- TB Gold or PPD. If high risk or indeterminate results from QuantiFERON-TB Gold or PPD: Chest X-ray)
✓  Avoid live vaccines within 4 weeks of starting therapy and during therapy
✓  Initial/baseline bloodwork such as complete blood count, renal function, liver function and consider fasting lipid profile
*The Inactive Herpes Zoster vaccine (Shingrix) should be considered, especially if patient is above the age of 50 but can be considered in patients 19 years or older.

While on Therapy
✓  Fasting lipid profile, recommended 4-12 weeks after starting therapy
✓  Annual TB risk assessment and screening if you meet criteria for high risk
✓  Routine bloodwork such as complete blood count, renal function, liver function every 3-6 months

NOTE: More frequent lab monitoring may be necessary during first few months of therapy

Patient Traveling Soon?
They may be considered high-risk for TB if traveling to certain countries. Check if destination is high-risk for TB here: https://wwwnc.cdc.gov/travel/destinations/list

Patient Considering Pregnancy?
You may need to adjust your patient’s IBD therapy plan, so
please remind your patient to include you in discussions when family- planning

small molecules – S1P Receptor Molecules (ozanimod) Zeposia®

Prior to Initiating Therapy
✓  Electrocardiogram (EKG) to screen for preexisting conduction abnormalities
✓  Monitor blood pressure
✓  Review all medications to ensure they don’t impact
heart rate
✓  Recommend an ophthalmologist visit if patient has diabetes, or is diagnosed with inflammation or swelling inside the eye
✓  Initial/baseline bloodwork such as complete blood count, renal function, liver function

While on Therapy

✓  Routine bloodwork such as complete blood count, renal function, liver function every 3-6 months

Initial Dosing Schedule

NOTE: More frequent lab monitoring may be necessary during first few months of therapy

Patient Considering Pregnancy?
It is recommended to stop this therapy 3-6 months prior to getting pregnant. Please remind your patient to include you in discussions when family-planning so you can support them in having a healthy pregnancy while keeping their IBD under control.

D.  IBD Vaccine Reference Guide

Vaccine Vaccine Type Live vs. Non-Live Information & Tips
COVID-19 Non-live Stay Up to Date with Covid-19 Vaccines at https://www.cdc.gov/ coronavirus/2019-ncov/vaccines/stay-up-to-date.html
“Chicken Pox” Varicella (VAR)

Live

This vaccine should not be administered when taking certain IBD medications, such as biologics or immunosuppress ants including corticosteroids

The varicella vaccine is the best way to protect patients from getting the chicken pox. People 13 years of age and older who have never had chickenpox or received the chickenpox vaccine should get two doses, at least 28 days apart. The chickenpox vaccine was added to the childhood immunization schedule in 1995, so most people born prior to 1995 had a higher likelihood of getting chickenpox and getting immunity that way.

Note that even if your patient had chickenpox in the past, their immunity may have weakened over time and the titers can be checked. If low titers patient may be recommended to receive 2 doses of the chickenpox vaccine.

Patients on low-dose immunosuppression may consider the chickenpox vaccine (e.g., ≤ 20 mg/day prednisone,≤0.4 mg/kg/week MTX, ≤ 1.5 mg/kg/day 6-MP, ≤
3 mg/kg/day azathioprine.)

“Flu”
Influenza inactivated (IIV)
Non-live when given as an injection
Live when given intranasally

The flu shot (non-live) and not the nasal mist (live vaccine) is recommended

If possible, members of the household should also opt for the flu shot and avoid the nasal mist.

Hepatitis A (HepA) Non-live The CDC recommends the HepA vaccine for special situations such as prior to traveling to specific countries.
Hepatitis B (HepB) Non-live Your patient can protect against Hepatitis B infections/reinfections by receiving the Hepatitis B vaccine series, especially if starting or already receiving any Anti-TNF (Remicade® and infliximab biosimilars, Humira®, Cimzia®, Simponi®).
Herpes Zoster recombinant (RZV) Non-live Getting the Shingrix (Herpes Zoster) vaccine is the best way to protect against getting shingles, especially when patients are on certain IBD therapies (Xeljanz®, Rinvoq®, Zeposia®, Azathioprine, 6-MP) or if above age 50 or above the age of 18 and are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.
Human papillomavirus (HPV) Non-live The HPV vaccine can protect against some HPV types that commonly cause cervical cancer and genital warts. The CDC recommends the HPV vaccine for males and females between the ages of 9 and 26 and some adults aged 27 to 45 years.
Measles, Mumps, and Rubella (MMR)

Live

This vaccine should not be administered when taking certain IBD medications, such as biologics or immunosuppress ants including corticosteroids

The MMR vaccine protects patients against Measles, Mumps, and
Rubella and is routinely completed by 6 years old. This vaccine, particularly its immunity to Rubella, is especially important for women of child-bearing age.

Patients on low-dose immunosuppression may consider the chickenpox vaccine (e.g., ≤ 20 mg/day prednisone,≤0.4 mg/kg/week MTX, ≤ 1.5 mg/kg/day 6-MP, ≤ 3 mg/kg/day azathioprine.)

Meningococcal A, C, W, Y
(MenACWY)
Non-live

Meningococcal A, C, W, Y (MenACWY) is typically given at 11-12 years, and 16 years of age.

This vaccine is recommended for first-year college students who live in residential housing and military recruits.

Meningococcal B (MenB) Non-live Meningococcal group B (MenB) recommended for those 16-23 years old
Pneumococcal conjugate (PCV13) (PCV15) (PCV20) Non-live

PCV13 (Prevnar 13®) PCV15 (Prevnar15®), PCV20 (Prevnar20® )is a routine vaccination for those with chronic medical conditions, like IBD, that can protect patients against pneumonia. Prevnar 7 ® was a routine vaccination for infants up until February 2010, when the other Prevnar vaccines replaced it.

Studies show that patients with IBD, regardless of age, would benefit from this one-time vaccination. PPSV23 can be given at least 8 weeks from PCV13 and PCV15. PPSV23 is not recommended if the patient received PCV20.

Pneumococcal polysaccharide (PPSV23) Non-live PPSV23 (Pneumovax® 23) is a routine vaccination for those with chronic medical conditions, like IBD, that can protect patients against pneumonia. This should be administered at least 8 weeks after PCV13 or PCV15. They do not need PPSV23 if they received PCV20