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. 2020 Feb 15;14(8):1066–1073. doi: 10.1093/ecco-jcc/jjaa027

Table 2.

Patient disposition.

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.