Vedolizumab's (Crohn's) data:
Vedolizumab's Crohn's study said...https://www.nejm.org/doi/full/10.1056/nejmoa1215739
At week 6, a total of 14.5% of the patients in cohort 1 who received vedolizumab and 6.8% who received placebo were in clinical remission (i.e., had a score on the Crohn's Disease Activity Index [CDAI] of ≤150, with scores ranging from 0 to approximately 600 and higher scores indicating greater disease activity) (P=0.02); a total of 31.4% and 25.7% of the patients, respectively, had a CDAI-100 response (≥100-point decrease in the CDAI score) (P=0.23). Among patients in cohorts 1 and 2 who had a response to induction therapy, 39.0% and 36.4% of those assigned to vedolizumab every 8 weeks and every 4 weeks, respectively, were in clinical remission at week 52, as compared with 21.6% assigned to placebo (P<0.001 and P=0.004 for the two vedolizumab groups, respectively, vs. placebo). Antibodies against vedolizumab developed in 4.0% of the patients. Nasopharyngitis occurred more frequently, and headache and abdominal pain less frequently, in patients receiving vedolizumab than in patients receiving placebo. Vedolizumab, as compared with placebo, was associated with a higher rate of serious adverse events (24.4% vs. 15.3%), infections (44.1% vs. 40.2%), and serious infections (5.5% vs. 3.0%).
Review article said...https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6010939/
Two coprimary endpoints in the induction trial, clinical remission and CDA-100 response, were evaluated at week 6. A significantly greater proportion of patients receiving vedolizumab achieved clinical remission at 6 wk with respect to the placebo group (14.5% vs 6.8%; P = 0.02) (Table (Table1).1). However, the CDAI-100 response rate was comparable to the placebo (31.4% vs 25.7%; P = 0.23).
During the maintenance phase, 461 patients who were vedolizumab responders were randomized to receive vedolizumab 300 mg iv administered at either 4- or 8-weekly intervals up to week 52. Clinical remission at week 52, the primary endpoint of this phase, was significantly greater in patients assigned to vedolizumab therapy every 4 wk or 8 wk (36.4% and 39.0%) than in the placebo group (21.6%; P = 0.004 and P < 0.001, respectively, vs placebo). The rates of steroid-sparing remission were also significantly higher among patients treated with vedolizumab (P = 0.04 and P < 0.02, respectively, vs placebo), while the rates of durable clinical remission showed no significant differences (Table (Table11).
Similar results were observed in the GEMINI 3 trial, which evaluated the efficacy of vedolizumab in 315 patients with moderately to severely active CD and inadequate response, loss of response, or intolerance to previous TNFα antagonists. Patients were assigned randomly to receive vedolizumab 300 mg iv or placebo at weeks 0, 2, and 6. Clinical remission at week 6 was observed in 15.2% of vedolizumab patients compared to 12.1% in the placebo group (P = 0.4) (Table (Table1).1). Therefore, the primary endpoint of the study was not met. However, the rates of clinical remission at week 10 were significantly higher in patients treated with vedolizumab (26.6% vs 12.1% in the placebo group; p = 0.001). The benefit in this population was therefore observed at week 10, suggesting a delayed response in obtaining clinical remission. In clinical practice, there is an opportunity for a fourth induction dose at week 10 in patients with CD, with insufficient response to the first three administrations of vedolizumab.
A meta-analysis pooling data from the phase II and phase III randomized controlled studies involving patients with active CD showed that vedolizumab increased the rates of clinical remission and CDAI-100 response during the induction phase, although it failed to meet some of the primary endpoints of the GEMINI 2 and GEMINI 3 trials.
Post Edited (xy123) : 3/18/2019 12:49:27 AM (GMT-6)