Laura Stong, PhD1, Winnie W. Nelson, PharmD, MS, MBA1, Paul Feuerstadt, MD, FACG2, Mena Boules, MD1, Naomi Sacks, PhD3, Alexandria Portelli, MPH3, Bridget Healey, MPH3, Kathleen Lang, PhD4, David N. Dahdal, PhD1
1Ferring Pharmaceuticals, Inc., Parsippany, NJ; 2Yale New Haven Hospital, Hamden, CT; 3Precision Xtract, Boston, MA; 4Precision Xtract, New York, NY
Introduction: Clostridioides difficile infection (CDI), especially recurrent CDI (rCDI), is associated with high morbidity and resource utilization, imposing significant burden on the US healthcare system. This study evaluated the association of rCDI with medical procedures, complications, and medication use after an index CDI episode.
Methods: We performed a retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus™ database for patients aged 18-64 years with CDI episodes requiring inpatient stay with CDI diagnosis code (ICD-9-CM 008.45; ICD-10-CM A04.7, A04.71, A04.72) or an outpatient medical claim for CDI plus a CDI treatment. We considered index CDI episodes from 1/1/2010 to 6/30/2017, including only those patients who were observable 6 months a priori and 12 months after the index episode. Each CDI episode was followed by a 14-day claim-free period after the end of treatment to distinguish rCDI from continuous CDI. rCDI was defined as another CDI episode within an 8-week window immediately after the claim-free period. Medication use, procedures, and complications were calculated over 12 months and stratified by number of rCDI episodes.
Results: 46,571 patients with an index CDI episode were included, of whom 3,129 (6.7%) experienced 1 rCDI, 472 (1.0%) experienced 2 rCDI, and 134 (0.3%) had 3 or more rCDI episodes. Mean (SD) age was 47.4 (12.7) years, and 62.4% were female (similar across rCDI groups; Table 1). Mean baseline Charlson Comorbidity Index (CCI) scores were 1.15, 1.54, 1.83, and 2.29 for those with no rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI episodes, respectively. Vancomycin was the most commonly prescribed antibiotic during follow-up (Table 2). Follow-up prescription rates of metronidazole decreased with increasing rCDI episodes. In the 12-month follow up, sepsis occurred in 16.5% of patients with no rCDI, 27.3% with 1 rCDI, 33.1% with 2 rCDI, and 43.3% with 3+ rCDI episodes; subtotal colectomy or diverting loop ileostomy was performed as a follow-up procedure for 4.6%, 7.3%, 8.9%, and 10.4% of patients, respectively, in the four study groups (Figure 1).
Discussion: There appears to be a stepwise increase in number of rCDI episodes associated with increasing baseline CCI score. During the 12 months after index CDI episode, the frequency of sepsis and colectomy increased in parallel to the number of CDI recurrences. Prevention of rCDI is an important step to reduce the burden of such complications.
Citation: Laura Stong, PhD; Winnie W. Nelson, PharmD, MS, MBA; Paul Feuerstadt, MD, FACG; Mena Boules, MD; Naomi Sacks, PhD; Alexandria Portelli, MPH; Bridget Healey, MPH; Kathleen Lang, PhD; David N. Dahdal, PhD. P0136 - CLINICAL BURDEN OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION: A REAL-WORLD DATA ANALYSIS. Program No. P0136. ACG 2019 Annual Scientific Meeting Abstracts. San Antonio, Texas: American College of Gastroenterology.