505. Bezlotoxumab Reduces Recurrence of Clostridium difficile Infection in Immunocompromised Patients: Early Experience at a Tertiary Care Center
Session: Poster Abstract Session: Healthcare Epidemiology: Updates in C. difficile
Thursday, October 4, 2018
Room: S Poster Hall
Posters
  • IDWeek - Bezlotoxumab Poster_Askar 04 - FINAL.pdf (2.3 MB)
  • Background:

    Bezlotoxumab (BEZ) was approved in 2017 for prevention of recurrent C. difficile infection (CDI), with a number needed to treat (NNT) of 10 reported in the registration trials. Little information is available on its effectiveness in high-risk populations. BEZ was added to the institutional outpatient formulary in 2017 for use in patients (pts) with CDI at high-risk for recurrent CDI (rCDI), i.e. history of solid organ (SOT) or hematopoietic stem cell (HCT) transplantation, active malignancy, chronic steroid (prednisone equivalent 20 mg/day) and failed fecal microbiome transplant (FMT). Pts that met criteria were referred by the antimicrobial stewardship team to the infectious disease clinic for BEZ insurance approval and administration. The goal of this study was to evaluate the effectiveness and safety of BEZ in this high-risk population.

     

    Methods:

    The cohort of pts referred for BEZ were compared by those who received BEZ versus those who did not receive BEZ (standard of care, SOC). The primary endpoint was rCDI at ≤100 days of BEZ infusion or end-of-treatment (EOT). Secondary endpoints were time to rCDI, and insurance status. Safety of BEZ was evaluated as infusion reaction ≤24 hours, and death ≤100 days.

    Results:

    29 pts were referred for BEZ; 14 (48%) received BEZ. Pt characteristics are in Table 1. rCDI at 100 days occurred in 14.3% BEZ vs. 28.6% SOC (p=0.3654) with a NNT of 7. Average time to rCDI was longer in the BEZ group vs. SOC (49 vs. 27 days). No infusion reactions or death were noted in the BEZ group. Insurance approval for BEZ was denied in 26.7%. Medicaid coverage was common in SOC (46.7% vs. 7.1%; p=0.0191) and Medicare coverage was more common in BEZ group (71.4% vs. 33.3%; p=0.0438).

    Conclusion:

    Early experience with BEZ appears promising in a high-risk, predominantly immunocompromised population. The NNT to prevent rCDI was 7. Larger cost-benefit studies in immunocompromised and transplant populations are warranted.

     

    Table 1. Characteristics of BEZ and SOC patients

    Variable

    BEZ (N=14)

    SOC (N=15)

    p-value

    Age ≥60

    57.1%

    26.7%

    0.1027

    ≥1 prior CDI episodes

    50%

    26.7%

    0.2042

    Average no. prior CDI episodes

    2

    2

     

    Immunocompromised

    78.6%

    86.7%

    0.5704

    SOT recipient

    42.8%

    33.3%

     

    HCT recipient

    21.4%

    13.3%

     

    Active cancer

    28.6%

    26.7%

     

    Failed FMT

    7.1%

    6.7%

    0.9667

     

    Sally Askar, MPH1, Rachel M Kenney, PharmD2, Ruth Conner, RN3, Mayur Ramesh, MD4 and George Alangaden, MD, FIDSA4, (1)Central Michigan University College of Medicine, Mount Pleasant, MI, (2)Henry Ford Health-System, Detroit, MI, (3)Henry Ford Health System, Detroit, MI, (4)Infectious Diseases, Henry Ford Health System, Detroit, MI

    Disclosures:

    S. Askar, None

    R. M. Kenney, None

    R. Conner, None

    M. Ramesh, None

    G. Alangaden, None

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 3rd with the exception of research findings presented at the IDWeek press conferences.