Abstract
Abstract Background Inflammatory Bowel Disease (IBD) frequency has been increasing in Latin American countries. Argentinapresents significant heterogeneity in healthcare systems, which may delay access to advanced therapeutic drugs (ATDs) for IBD. We aimed to evaluate the delay in access to ADT and its impact on patients with IBD. Methods An observational study was conducted using data from the registry (n=395) of a private center in Córdoba, Argentina. We included adult patients diagnosed with IBD [ulcerative colitis (UC) or Crohn’s disease (CD)] who had at least one prescribed ATD. Patients who accessed ATDs through clinical trials were excluded. We defined access time as the period (in days) between the ATD request and the start of treatment. During this period, complications were assessed based on a composite endpoint including IBD flare (defined as an increase in oral corticosteroid dosage or need of hospitalization), the need for IBD-related surgery, or severe infections (requiring hospitalization and intravenous treatment). Qualitative variables were described as percentages, while quantitative variables were reported as medians and interquartile ranges (IQR 25-75). Variables were compared using the chi-square and Mann-Whitney U tests. Results We included 108 patients (58.5% UC, 41.5% CD) who received 163 ATDs across different lines of therapy during follow-up from 2017-2024 (1L: 108, 2L: 38, 3-5L: 17). The median age was 44 years (IQR 25-75: 30-55), and 55.6% were female. The median access time for all ATD lines was 31 days (IQR 25-75: 28-62), with no significant differences between therapy lines [1L: 31 days (IQR 25-75: 28-76), 2L: 32 days (IQR 25-75: 30-61), 3L-5L: 29 days (IQR 25-75: 20-38), p=NS]. 101/163 (62%) of the requested ADTs were anti-TNF. Access time was similar according to the drug class [anti-TNFs 31 days (IQR 25-75: 27-62) vs. non-anti-TNF agents 31 days (IQR 25-75: 28-63) (p=0.6)]. A total of 36 (22%) ATD indications were associated with complications while patients awaited therapy (32 flare, 3 IBD-related surgeries and one severe infection). Patients who experienced complications had a longer access time compared to those who did not experience complications [61 days (IQR 25-75: 31-122) vs. 31 days (IQR 25-75: 25-61) respectively, p<0.01]. Conclusion A delay of more than 4 weeks was observed in more than half of the patients with an indication for ADT. The delay was similar according to the type of IBD, drug class and line of treatment. A higher frequency of complications was observed in patients with a longer delay in receiving the requested ADT. Policies are needed to improve the time to access ADT, avoiding the complications associated with delayed access. References Balderramo D, Quaresma AB, Olivera PA, Savio MC, Villamil MPG, Panaccione R, Ng SC, Kaplan GG, Kotze PG. Challenges in the diagnosis and treatment of inflammatory bowel disease in Latin America. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):263-272. doi: 10.1016/S2468-1253(23)00284-4. PMID: 38340754.
Published Version
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have