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Disease Burden and Treatment Patterns Among Patients With Ulcerative Colitis With Isolated Proctitis in the USA: A Real-World Study
AIBD 2023
Background:
Approximately 30% of patients with ulcerative colitis (UC) initially present with isolated proctitis (IP); data on treatment experience, healthcare resource use (HCRU), and costs in these patients are lacking. This retrospective, observational study in the USA described the burden of disease in patients with IP.
Methods:
Patients with IP were selected by identifying the first instance (first inpatient visit or the first of two outpatient visits) involving the International Code of Diseases-9/10 diagnosis codes for IP from Optum® Market Clarity Data. Included patients had a first IP diagnosis index date between April 2016 and March 2020, were aged ≥18 years, and were insured for ≥24 months before and after index date. Patients with a diagnosis of Crohn’s disease during pre-index or at index were excluded. Patients with IP were classified and evaluated in two cohorts based on pre-index/at-index UC therapies: rectal therapy only (RTO-IP, patients without treatment for UC or treated with only rectal 5-aminosalicylic acid [5-ASA] and/or rectal steroids), and beyond rectal therapy (BRT-IP, patients who received UC treatment not restricted to rectal therapy). Two cohorts were included for comparison: UC (patients with incident UC and no documented IP diagnosis during the study) and non-inflammatory bowel disease (non-IBD; controls without UC/IP/Crohn’s disease diagnoses). Demographic/clinical characteristics, key treatment patterns, HCRU, and costs were examined in patients with IP vs the non-IBD cohort and contextualized vs the UC cohort.
Results:
In total, 2,417 patients in the RTO-IP, 1,765 in the BRT-IP, 12,872 in the UC, and 8,185,858 in the non-IBD cohorts were included. At index, the percentage of patients with depression and anxiety diagnoses, and symptoms of fatigue and abdominal pain, was higher in the IP and UC cohorts vs the non-IBD cohort; depression and anxiety were highest in the UC cohort. At index, in the RTO-IP, BRT-IP, and UC cohorts, respectively, the use of prescribed rectal 5-ASA was 28.6%, 44.0%, and 5.2%, oral 5-ASA was 0.0%, 84.7%, and 22.8%, thiopurines was 0.0%, 10.9%, and 1.3%, and biologics was 0.0%, 12.5% and 2.1%. Increases (from index to 24 months follow-up), suggestive of treatment intensification, were observed in the RTO-IP and UC cohorts, respectively, for oral 5-ASA (0.0–29.7%, 22.8–35.0%), thiopurines (0.0–2.6%, 1.3–4.9%), and biologics (0.0–7.0%, 2.1–11.1%). Increases were also observed in the BRT-IP cohort for thiopurines (10.9–13.1%) and biologics (12.5–25.0%), but not for oral 5-ASA (84.7–73.1%). Mean total costs (medical and pharmacy) per patient per year over 24 months were higher in the IP (RTO-IP: $28,203; BRT-IP: $45,061) and UC ($44,098) cohorts vs the non-IBD cohort ($12,997). At 24 months follow-up, the percentage of patients with >1 all-cause inpatient visit was higher in the UC (36.2%) vs IP (RTO-IP: 19.5%; BRT-IP: 18.2%) cohorts; all higher than the non-IBD cohort (9.8%).
Conclusions:
Patients with IP experienced a high disease burden and, similar to the UC cohort, an increased use of advanced UC treatments during 24 months follow-up, which suggests a need for investigation into new advanced treatment options in patients with IP.
