Criteria for VEDOLIZUMAB INJ,LYPHL and VEDOLIZUMAB INJ,SOLN in Inflammatory Bowel Disease
Exclusion Criteria
- Active infection (may initiate or restart once treatment for the infection is initiated)
- Untreated latent or active tuberculosis infection
- Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
- Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
- Congenital or acquired immunodeficiency
- Concomitant live or live-attenuated vaccines or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation
- Concomitant treatment with drugs that have a contraindicated drug interaction (e.g., Bacillus Calmette-Guerin [BCG] vaccine) unless risk-benefits favor use
- Primary nonresponse to natalizumab
General Inclusion Criteria
- Prescribed and monitored by a VA/VA Community Care gastroenterologist or locally designated expert
- Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
- Completed hepatitis B screening (HBsAg, total antibody to hepatitis B core antigen [anti-HBc] and antibody to hepatitis B surface antigen [anti-HBs])
- Current or past completion of hepatitis C screening (may initiate while waiting for test results)
- Current or prior overall physician assessment of “moderate to severe” Crohn’s disease (CD) or ulcerative colitis (UC) AND medical inadvisability, primary nonresponse, inadequate partial response, or loss of response to ustekinumab
Additional Inclusion Criteria (Disease/Indication Specific)
- Current or prior overall physician assessment of “moderate to severe” CD or UC confirmed by endoscopy or imaging, and tumor necrosis factor inhibitor (TNFI) is medically inadvisable
- Current or prior overall physician assessment of “moderate to severe” CD or UC, and primary nonresponse, inadequate partial response, or loss of response after 12 weeks of one TNFI in the presence of adequate TNFI levels (mechanistic failure)
- Current or prior overall physician assessment of “moderate to severe” CD and loss of response to infliximab and another TNFI despite therapeutic drug monitoring (TDM)-based optimized dosing to address pharmacokinetic failure
- Current or prior overall physician assessment of “moderate to severe” UC and loss of response to a TNFI (infliximab preferred) despite therapeutic drug monitoring (TDM)-based optimized dosing to address pharmacokinetic failure
- No prior TNFI was deemed required because of documented current or prior overall physician assessment of “moderate” CD or UC disease or documented absence of extraintestinal manifestations
- Underwent ileal-pouch anal anastomosis (IPAA) and has documented chronic antibiotic-refractory or -dependent CD or UC pouchitis with intolerance, loss of response, or medical inadvisability to long-term antibiotic therapy (no prior TNFI required)
- Maintenance of clinical response or remission achieved with cyclosporine rescue therapy when immunomodulator maintenance is medically inadvisable (for acute, severe UC)
- Prevention of recurrence after surgery for CD if TNFI therapy is medically inadvisable
Additional Inclusion Criteria (Patient-Specific Requirements)
- If HBsAg-negative but anti-HBc-positive: A GI/liver or infectious diseases expert has been consulted for advice on whether to start antiviral prophylaxis or to preemptively monitor for HBV reactivation
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception
Administration, Monitoring, and Sequencing Guidelines
- Switching from intravenous to subcutaneous administration may be started when a clinical response is achieved after Week 6 following IV induction doses at Weeks 0 and 2, or when receiving IV doses to maintain clinical remission
- Clinical response definitions: UC criteria include reduction in total Mayo score of ≥3 points and ≥30% from baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1; CD criteria include a ≥70-point decrease in Crohn's Disease Activity Index (CDAI) score from baseline
- Routine retesting for TB and hepatitis screening is not required for prescription renewals; retesting in high-risk patients should be considered
- Sequencing for CD: First-line includes infliximab, adalimumab, or ustekinumab; vedolizumab may be used first-line for “moderate” CD, absence of extraintestinal manifestations, or pouchitis. Second-line includes TNFI (if not previously used) or ustekinumab (if not previously used). Third-line includes vedolizumab, upadacitinib (after TNFi or alternative systemic therapy if TNFi is medically inadvisable), guselkumab, or risankizumab. Fourth-line includes mirikizumab
- Sequencing for UC: First-line includes infliximab (preferred), adalimumab, or ustekinumab; vedolizumab may be used first-line for “moderate” UC, absence of extraintestinal manifestations, or pouchitis. Second-line includes TNFI (if not previously used) or ustekinumab (if not previously used). Third-line includes vedolizumab, either tofacitinib or upadacitinib after TNFi (or alternative systemic therapy if TNFi is medically inadvisable), guselkumab, risankizumab, or either etrasimod or ozanimod. Mirikizumab is also listed under third-line
- Certain patients with severe CD or UC may require earlier escalation to third-line therapies after initial TNFI failure to reduce the risk of disease-related complications or colectomy; such decisions should be made collaboratively by the IBD prescriber and pharmacy
- Infliximab/biosimilar and adalimumab/biosimilar are the preferred TNFIs in CD. Another option for CD is certolizumab. Infliximab/biosimilar is preferred in UC. Other options for UC in TNFI-naïve patients are adalimumab and golimumab. Adalimumab is less preferred than vedolizumab and tofacitinib in TNFI-exposed UC patients
- Ustekinumab failure timing: In CD, after 8 weeks of ustekinumab. In UC, after 8 weeks (single IV induction dose) or 16 weeks (if using second IV induction dose) of ustekinumab.
- Note: All criteria above apply to both VEDOLIZUMAB INJ,LYPHL and VEDOLIZUMAB INJ,SOLN as presented in the source document.