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P205. Indicators of inadequate response to biologic therapies in patients with Crohn's disease 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) therapies with biologic agents in Crohn's disease (CD) patients in the real-world clinical settings.


A retrospective cohort study was performed using the US Clinformatics administrative health claims database (2005–2012). CD patients were identified as having the following: >2 claims for CD (ICD-9-555.xx); ≥1 claim for a biologic [adalimumab (ADA), certolizumab (CER), infliximab (INF), or natalizumab (NAT)]; ≥6 months of plan enrolment prior to the first diagnosis of CD (index date); and ≥1 year follow-up from the first biologic (index drug). Non-biologic CD treatments included 5-ASA, oral or injectable corticosteroids, enteral budesonide, or immunomodulators. Indicators used as a proxy to assess IR during the I-phase were switching to another biologic or augmentation with any new non-biologics. Additional indicators of dose escalation, flares, CD-related surgery, and urgent care (hospitalization or emergency room visit) were included in the M-phase. Patients who received labelled doses of biologics without any encounters of CD-related surgery or urgent care (during the I-phase), and with ≥2 claims for biologics were included in the M-phase. Bivariate statistical analyses were performed using chi-square tests. Median time to and rates of IR were estimated using the Kaplan–Meier Method.


Of 1417 CD patients who met inclusion criteria, 45.1% were males, and the mean±SD age of patients was 39.4±13.4 years. As the index biologic, 39.8% received ADA, 11.2% CER, 48.7% INF, and 0.2% NAT. Mean duration from the initial CD diagnosis to first biologic was 388±440 days. After diagnosis, 80.5% of patients received ≥1 non-biologic treatment within 6 months prior to index drug. During I-phase, 8.0% of patients had ≥1 indicator of IR. Of 906 patients in the M-phase, 75.9% had ≥1 indicator of IR (Table 1). There were no significant differences between the three biologics on the indicators of inadequate response, except for dose escalation. Estimated cumulative rates of IR were 58.7% and 75.3% in first and second year, respectively, with a median time of 271 days and no significant differences between biologics.

Table 1. Indicators of inadequate response to biologics during the maintenance phase among patients with CD
Total (N = 906)Adalimumab (N = 371)Certolizumab (N = 95)Infliximab (N = 440)p-value*
Inadequate response, n (%)688 (75.94)282 (76.01)64 (67.37)342 (77.73)0.1008
Dose escalation354 (39.07)148 (39.89)8 (8.42)198 (45.00)<0.0001
Flares326 (35.98)134 (36.12)36 (37.89)156 (35.45)0.9017
CD-related surgery134 (14.79)47 (12.67)20 (21.05)67 (15.23)0.1137
CD-related urgent care298 (32.89)107 (28.84)38 (40.00)153 (34.77)0.0597
Switched to another biologic163 (17.99)65 (17.52)17 (17.89)81 (18.41)0.9472
Augmentation with a non-biologic treatment316 (34.88)121 (32.61)31 (32.63)164 (37.27)0.3398
Note: Natalizumab was not included in the analyses due to low sample size.
*Comparisons between adalimumab, certolizumab and infliximab treated groups with chi-square test.


This real-world database study showed that within two years, over 75% of CD patients had at least one indicator of IR during maintenance therapy with biologics. Dose escalation, flares, CD-related urgent care, and augmentation with non-biologic treatment were the major indicators of IR.