DOP022 Vedolizumab and anti-TNFα treatment effectiveness in patients with IBD treated in Germany: a retrospective chart review
Ehehalt R.*1, Schubert S.2, Stein D.3, Lambrelli D.4, Bassel M.5, Orzechowski H.-D.6, Minda K.7, Khalid J.M.8
1Gastroenterology Outpatient Clinic, Heidelberg, Germany 2Gastroenterologist in Private Practice, Berlin, Germany 3Evidera, Montreal, Canada 4Evidera, Hammersmith, United Kingdom 5UBC: An Express Scripts Company, Montreal, Canada 6Takeda Pharma GmbH, Berlin, Germany 7Takeda Pharmaceuticals International AG, Zurich, Switzerland 8Takeda Development Centre Europe Ltd, London, United Kingdom
Vedolizumab (VDZ) is a gut-selective monoclonal anti-integrin antibody indicated for the treatment (Tx) of moderate-to-severe Crohn's disease (CD) and ulcerative colitis (UC). Real-world outcomes in patients who received VDZ as 1st/2nd line biologic is limited. This study evaluated VDZ Tx patterns/effectiveness in Germany in comparison to anti-TNFα.
This was a descriptive retrospective chart review study of CD and UC patients who were biologic naïve or had only one anti-TNFα and initiated Tx with VDZ or an anti-TNFα (adalimumab, infliximab, golimumab) from 15 Jul 2014 to 20 Oct 2015. Data collection ended at death or at chart abstraction initiation. Patient characteristics and VDZ/anti-TNFα Tx effectiveness were analysed. Tx response at 12 months was defined as partial, complete response or stable disease, or in absence of documentation, as positive change from baseline for global physician assessment or endoscopic findings.
313 patients (47.0% VDZ, 53.0% anti-TNFα) from 13 sites were included in the study; 49.0% VDZ and 62.0% anti-TNFα patients had CD. 22.4% VDZ and 65.7% anti-TNFα patients were biologic naïve; mean (SD) follow-up was 1.4 (0.4) years. Mean (SD) age was 41.0 (13.7) for VDZ and 38.5 (12.6) for anti-TNFα patients. In biologic naïve patients, median (range) Tx duration (years) was 1.5 (0.1–1.9) for VDZ and 1.2 (0.3–2.1) for anti-TNFα. 18.2% VDZ and 18.3% anti-TNFα patients discontinued Tx mostly due to lack of response/inadequate symptom control; 9.1% VDZ and 10.1% anti-TNFα patients switched to a new biologic. 85.8% VDZ and 81.3% anti-TNFα patients with assessable data had documentation of 12 month Tx response. Among patients who had one prior biologic, median (range) Tx duration (years) was 1.2 (0–2.1) for VDZ and 1.2 (0–2.2) for anti-TNFα. 28.1% VDZ and 21.1% anti-TNFα patients discontinued Tx mostly due to lack of response/inadequate symptom control; 17.5% VDZ and 12.3% anti-TNFα patients switched to a new biologic. 80.4% VDZ and 66.7% anti-TNFα patients with assessable data had documentation of 12 month Tx response.
VDZ Biologic Naive VDZ Prior Biologics Anti-TNF Biologic Naive Anti-TNF Prior Biologics n (%) (N=33) (N=114) (N=109) (N=57) Patients with assessable data 14 (100) 51 (100) 48 (100) 21 (100) Positive (improvement) 12 (85.8) 41 (80.4) 39 (81.3) 14 (66.7) No change 1 (7.1) 7 (13.7) 4 (8.3) 3 (14.3) Negative (worsening) 0 (0) 0 (0) 0 (0) 1 (4.7) Unknown 1 (7.1) 3 (5.9) 5 (10.4) 3 (14.3)
In biologic naïve patients, VDZ patients appeared to continue Tx longer but had similar rates of discontinuation, Tx switching and Tx response compared to anti-TNFα patients within 1 year. More VDZ patients with one prior biologic experienced discontinuations and Tx switching compared to VDZ treatment in biologic naïve patients. In prior biologic exposed patients, VDZ resulted in a much higher proportion of Tx response compared to anti-TNFα.