P206. Indicators of inadequate response to anti-tumour necrosis factor therapies in patients with ulcerative colitis from real-world practice settings
H.T. Hatoum1,2, H. Patel3, S.-J. Lin1,2, R. Mody3, 1Hind T. Hatoum and Company, Consulting, Chicago, United States, 2University of Illinois at Chicago, Department of Pharmacy Systems, Outcomes and Policy, Chicago, United States, 3Takeda Pharmaceuticals International, Inc., Global Outcomes and Epidemiology Research, Deerfield, United States
The study objective was to determine the incidence of inadequate response (IR) to induction (I-phase) and maintenance (M-phase) treatment with anti-tumour necrosis factor therapies (anti-TNFs) in ulcerative colitis (UC) patients in real-world practice settings.
A retrospective cohort study was performed using the US Clinformatics administrative health claims database (2005–2012). UC patients were identified as having ≥2 claims for UC (ICD-9-556.xx); ≥1 claim for an anti-TNF [adalimumab (ADA) or infliximab (INF)]; ≥6 months of plan enrolment prior to the first diagnosis of UC (index date); and ≥1 year follow-up from the first anti-TNF (index drug). Non anti-TNF UC treatments included 5-ASA, oral or injectable corticosteroids, enteral budesonide, or immunomodulators. The indicators used as a proxy for assessing IR during the I-phase were switching to another anti-TNF or augmentation with any new non anti-TNF treatment. Additional indicators of dose escalation, flares, UC-related surgery, and UC-related urgent care (hospitalization or emergency room visit) were included in the M-phase. Patients who received labelled doses of anti-TNFs without any encounters of UC-related surgery or urgent care (during the I-phase) and with ≥2 claims for anti-TNF were included in the M-phase. Bivariate statistical analyses were performed using chi-square and t-tests. Median time to and rates of IR were estimated using the Kaplan–Meier method.
A total of 587 UC patients met the study inclusion criteria, with 51.8% of whom were male, the mean±SD age of patients was 42.8±13.4 years. A total of 22.3% received ADA and 74.5% received INF, as index anti-TNF. Mean duration from initial UC diagnosis to first anti-TNF was 471±476 days. After diagnosis, 89.8% of patients received ≥1 a new non anti-TNF treatment within 6 months prior to index drug. During the I-phase, 5.3% (n = 31) of patients had ≥1 indicator of IR. Of 338 patients included in the M-phase, 77.8% had ≥1 indicator of IR (Table 1). There were no significant differences in IR rates between the two anti-TNFs. Estimated cumulative rates of IR in the M-phase were 66.2% and 77.7% in first and second year, respectively, with a median time to IR was 197 days and no significant difference between the two anti-TNFs.
|Total (N = 338)||Adalimumab (N = 58)||Infliximab (N = 280)||p-value*|
|Inadequate response, n (%)||263 (77.81)||41 (70.69)||222 (79.29)||0.1516|
|Dose escalation||171 (50.59)||27 (46.55)||144 (51.43)||0.499|
|Flares||142 (42.01)||19 (32.76)||123 (43.93)||0.1167|
|UC-related surgery||32 (9.47)||5 (8.62)||27 (9.64)||0.8088|
|UC-related urgent care||76 (22.49)||14 (24.14)||62 (22.14)||0.7405|
|Switched to another anti-TNF||47 (13.91)||4 (6.9)||43 (15.36)||0.0901|
|Augmentation with any new non anti-TNF treatment||97 (28.7)||16 (27.59)||81 (28.93)||0.837|
|*Comparisons between adalimumab and infliximab using chi-square tests.|
This large scale real-world assessment of index anti-TNF for treatment of UC demonstrated that over three quarters of patients on maintenance therapy had at least one indicator of IR within two years, with dose escalation being the most commonly observed indicator.