Table 2.
CD [n = 88] | UC [n = 79] | Total [n = 167] | |
---|---|---|---|
Completed XAP-PK sub-study to Week 56, n [%] | 80 [90.9] | 73 [92.4] | 153 [91.6] |
Remained on Q8W dosing to Week 56, n [%] | 76 [86.4] | 71 [89.9] | 147 [88.0] |
Changed dosing from Q8W to Q4W, n [%] | 4 [4.5]a | 2 [2.5] | 6 [3.6] |
Completed main study before Week 56b | 1 [1.1] | 2 [2.5] | 3 [1.8] |
Premature discontinuation, n [%] | 7 [8.0] | 4 [5.1] | 11 [6.6] |
Voluntary withdrawal | 4 [4.5] | 3 [3.8] | 7 [4.2] |
No longer adequate benefit | 2 [2.3] | 0 | 2 [1.2] |
Lost to follow-up | 0 | 1 [1.3] | 1 [0.6] |
Pregnancy | 1 [1.1] | 0 | 1 [0.6] |
CD, Crohn’s disease; PK, pharmacokinetic; Q4W, every 4 weeks; Q8W, every 8 weeks; UC, ulcerative colitis; XAP, Extended Access Program.
aOne additional patient re-escalated to Q4W dosing but prematurely discontinued the study due to loss of treatment benefit.
bPatients discontinued the XAP study and continued treatment with commercially available vedolizumab.