Patient Perspectives on Rectal Administration for Recurrent C difficile Infection
A study of patients with recurrent Clostridioides difficile infection (rCDI) found that Rebyota, a rectally administered live biotherapeutic, was considered easy, quick, and appealing due to the lack of bowel preparation.
Recent innovations and approvals have led to breakthrough therapeutic options to treat recurrent Clostridioides difficile infection (rCDI). Some of these include the orally administered Vowst (SER-109) and rectally administered Rebyota (RBX2660), as well as fecal microbiota transplantation (FMT).
A recent study evaluated rCDI patient perceptions of rectal administration acceptability. The study was accepted as an abstract and presented by author Glenn Tillotson at the recent 2023 MAD-ID Annual Antimicrobial Stewardship Meeting.
The study included patients with experience using Rebyota (fecal microbiota, live jsm), a rectally administered live biotherapeutic approved by the US Food and Drug Administration (FDA) for rCDI prevention. Other included participants were patients with rCD with no prior treatment history of FMT or live biotherapeutic products (LBPs). The study aimed to assess the ease, speed, and desirability of rectal administration as an rCDI treatment option.
The study patients were 18 years and older and had experienced at least 1 CDI episode within the previous 36 months. Arm 1 consisted of patients who received rectally administered Rebyota during a phase 3 clinical trial; these patients answered 4 questions. Arm 2 included FMT- or LBP-naive patients who answered 5 questions.
Responses were collected anonymously between June 2022 and January 2023 via a dedicated link. Arm 1 patients provided informed consent, while arm 2 patients were compensated for their time without knowledge of the sponsor.
The questionnaire collected responses from 46 arm 1 and 100 arm 2 patients. Among arm 1 patients, 96% described the Rebyota rectal administration process as "easy" or "very easy," and 94% considered it "quick" or "somewhat quick." Additionally, 98% of patients found the lack of need for bowel preparation appealing.
Most arm 1 patients (96%) expressed a desire for earlier access to Rebyota, citing reasons such as the ineffectiveness of prior therapies (35%), belief in faster disease improvement with earlier treatment (13%), and improvement in quality of life (9%). In arm 2, 42% "strongly preferred" and 38% "preferred" a treatment option without bowel preparation. Overall, 87% of arm 2 patients would consider rectally administered treatment, with only 2% being somewhat unlikely to consider it and none being very unlikely. Those likely to consider rectal administration expressed concerns about CDI recurrence (54% "very worried," 32% "worried") and the disruption of daily life.
Rebyota is a rectally delivered single-dose treatment that does not require bowel preparation, anesthesia, or an endoscopy suite. Both Rebyota-treated patients and LBP-naive patients found these factors appealing when considering treatment options for rCDI.
This study, “Patient Perception of Route of Administration of Live Biotherapeutic Products for Recurrent Clostridioides difficile Infection,” was presented as an abstract at the 2023 MAD-ID Annual Antimicrobial Stewardship Meeting.
