gms | German Medical Science

Background: Data on biologic treatment (Tx) persistence and switching in German IBD patients are rare. The main objective of this retrospective claims database analysis (8.5 Million insured, covering out- and inpatient care) were to describe rates of biologic Tx switching and discontinuation for anti-TNFα (adalimumab, golimumab, infliximab) and vedolizumab (VDZ) IBD patients and to report associated direct healthcare cost.

Materials and methods: Adult patients with a confirmed diagnosis of Crohn’s disease or ulcerative colitis, initiating Tx with anti-TNFα or VDZ between 01/07/2015-30/06/2016 and follow-up for 12 months (or death within 12 months) were included. First observed Tx discontinuation (prescription gap >90 days) and switching to another biologic were compared between anti-TNFα and VDZ patients, both unadjusted and adjusted (Cox regression). IBD-related costs of prescriptions and inpatient treatment documented in the claims database were reported per patient year for periods of continuous index Tx.

Results: We included 1,248 IBD patients who started a new biologic treatment (adalimumab (ADA) 502, golimumab (GOL) 77, infliximab (IFX) 441, vedolizumab (VDZ) 228). Amongst these, 837 patients were bio-naïve (773 anti-TNFα, 64 VDZ), and 411 were bio-experienced (247 anti-TNFα, 164 VDZ). Mean age of bio-naïve and bio-experienced anti-TNFα patients was 39.2 and 38.1 years, and 42.6 and 37.8 years for VDZ patients. 54.9% (bio-naïve) and 56.7% (bio-experienced) of anti-TNFα, and 56.3% (bio-naïve) and 54.9% (bio-experienced) of VDZ patients were female.

772 out of 1,248 patients (61.9%) were persistent with their index biologic therapy after 12 months (bio-naïve: 61.9%; bio-experienced: 61.8%). Overall percentage of patients persistent on index therapy after 12 months was 69.7% for VDZ (bio-naïve: 65.6%; bio-experienced: 71.3%) and 60.1% for anti-TNFα (bio-naïve: 61.4%; bio-experienced: 55.5%). Kaplan-Meier analysis showed that patients stayed significantly longer on VDZ than on anti-TNFα treatment (p=0.004). Among bio-naïve patients, the difference between VDZ and anti-TNFα was not significant (p=0.335), whereas it reached significance in bio-experienced patients (p=0.001). This result was confirmed in the multivariable Cox regression, with a HR=0.675 (p=0.003) for VDZ against anti-TNFα for early therapy discontinuation/switch.

Among those 476 patients who were not persistent with their index treatment after 12 months, 207 discontinued and 269 switched their index therapy. 55.3% of all VDZ discontinuations (21/38 patients) and 30.8% of all anti-TNFα discontinuations (56/169 patients) occurred during the induction phase. Treatment switch was rare during induction phase with only 3/31 events in VDZ patients and 34/238 in anti-TNFα patients. In contrast, 86.2% of all treatment switches occurred after formal completion of the induction phase, affecting 28/31 VDZ patients and 204/238 anti-TNFα patients.

Mean IBD-related direct healthcare cost per patient year in Germany was 30,246 € (anti-TNFα) and 28,227 € (VDZ) for bio-naïve patients (p=0.288 for comparison of anti-TNFα versus VDZ), and 34,136 € (anti-TNFα) and 32,112 € (VDZ) for bio-experienced patients (p=0.011).

Conclusion: Less than two thirds of IBD patients continued Tx with a biologic agent after 12 months in a cohort of 1,248 patients. There is a tendency towards a longer drug survival and significantly longer time on therapy in VDZ patients compared to anti-TNFα, with comparable healthcare cost in bio-naïve and significantly lower healthcare cost in bio-experienced patients.