Vedolizumab (VDZ), a monoclonal anti-integrin antibody, was approved by the European Medicines Agency in 2014 and launched in Germany on 15 July 2014 for the treatment (Tx) of moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC). Subgroup analyses of the GEMINI trials revealed more pronounced treatment effects of VDZ in patients who were anti-TNFα naive compared to patients who were anti-TNFα experienced; real-world effectiveness in these populations is less well characterized.Methods:
A chart review study commenced in June 2016 in Germany for CD and UC patients who were biologic naïve or received one prior anti-TNFα and initiated Tx with VDZ or an anti-TNFα (adalimumab, infliximab, golimumab) between July 15, 2014 and October 20, 2015. Data collected from 10 centres (1 university hospital, 9 private practices) were analyzed using descriptive statistics on patient demographics, clinical characteristics and VDZ/anti-TNFα Tx patterns. The follow-up period was set to be from Tx initiation to the earliest of: date of death, loss to follow-up or date of chart abstraction initiation.Results:
Results represent an interim analysis of 109 patients; 53 patients (48.6%) received VDZ and 56 (51.4%) received anti-TNFα. Mean age was 41.6 years (SD = 13.8) for VDZ patients and 38.8 years (SD = 10.8) for anti-TNFα patients; 27 VDZ patients (50.9%) and 27 anti-TNFα patients (48.2%) were male. Mean follow-up period was 1.4 years (standard deviation [SD] = 0.4). Twenty-one VDZ patients (39.6%) had CD and 32 (60.4%) had UC; 31 anti-TNFα patients (55.4%) had CD and 25 (44.6%) had UC. Mean time since diagnosis to Tx initiation was 10.3 years (SD = 9.5) for VDZ patients and 9.6 years (SD = 8.9) for anti-TNFα patients; 17 VDZ patients (32.1%) and 39 anti-TNFα patients (69.6%) were biologic-naïve at Tx initiation. For biologic-naive patients, median Tx duration was 1.5 years (range = 0.7–1.8) for VDZ patients and 1.1 years (range = 0.4–1.9) for anti-TNFα patients; 0 VDZ patients (0%) and 9 anti-TNFα patients (23.1%) escalated dose. Discontinuation occurred in 1 VDZ patient (5.9%) and in 3 anti-TNFα patients (7.7%). For patients with one prior anti-TNFα at Tx initiation, lack of/incomplete response to prior therapy was the most common reason for initiating Tx for patients on VDZ and anti-TNFαs. Median Tx duration was 1.4 years (range = 0.1–1.9) for VDZ patients and 1.1 years (range = 0.2–1.9) for anti-TNFα patients; 5 VDZ patients (13.9%) and 3 anti-TNFα patients (17.7%) escalated dose. Discontinuation occurred in 8 VDZ patients (22.2%) and in 3 anti-TNFα patients (17.7%).Conclusions:
Findings from this interim analysis suggest that dose escalation of VDZ is infrequent compared to anti-TNFα therapy, especially amongst patients who have not previously received biologic therapy. Tx discontinuation was less frequent in biologic naïve patients versus patients with one-prior anti-TNFα. Analyses on the full set of patients will be conducted to confirm these findings in order to provide further information on potential positioning of VDZ therapy.