Table 8.
Subgroup analyses of clinical response at week 6 and week 14.
| Clinical response stratified by | Week post-initiation of vedolizumab | |||||
|---|---|---|---|---|---|---|
| Week 6 | Week 14 | |||||
| No (n = 34) | Yes (n = 43) | p-value | No (n = 19) | Yes (n = 52) | p-value | |
| 1. Duration of UC | ||||||
| <1 year (%) | 0 (0.0) | 2 (7.7) | 0.201 | 0 (0.0) | 2 (5.4) | 0.539 |
| 1–<3 years (%) | 7 (26.9) | 8 (30.8) | 3 (23.1) | 12 (32.4) | ||
| 3–<7 years (%) | 11 (42.3) | 13 (50.0) | 6 (46.2) | 18 (48.6) | ||
| ⩾7 years (%) | 8 (30.8) | 3 (11.5) | 4 (30.8) | 5 (13.5) | ||
| 2. UC disease extent | ||||||
| Proctosigmoiditis (%) | 5 (14.7) | 14 (32.6) | 0.081 | 5 (26.3) | 13 (25.0) | 0.976 |
| Left-sided colitis (%) | 7 (20.6) | 9 (20.9) | 4 (21.1) | 14 (26.9) | ||
| Extensive colitis (%) | 1 (2.9) | 1 (2.3) | 0 (0.0) | 2 (3.8) | ||
| Pancolitis (%) | 17 (50.0) | 19 (44.2) | 10 (52.6) | 22 (42.3) | ||
| Unknown (%) | 4 (11.8) | 0 (0.0) | 0 (0.0) | 1 (1.9) | ||
| 3. Number of prior anti-TNF therapy | ||||||
| One (1) prior anti-TNF (%) | 19 (55.9) | 30 (69.8) | 0.478 | 7 (36.8) | 40 (76.9) | <0.001 |
| Two (2) prior anti-TNFs (%) | 12 (35.3) | 10 (23.3) | 7 (36.8) | 12 (23.1) | ||
| Three (3) prior anti-TNFs (%) | 3 (8.8) | 3 (7.0) | 5 (26.3) | 0 (0.0) | ||
| 4. Type of prior anti-TNF failure + | ||||||
| Inadequate response (%) | 20 (58.8) | 24 (55.8) | 0.766 | 8 (42.1) | 32 (61.5) | 0.452 |
| Loss of response (%) | 9 (26.5) | 10 (23.3) | 7 (36.8) | 13 (25.0) | ||
| Intolerance (%) | 1 (2.9) | 4 (9.3) | 2 (10.5) | 3 (5.8) | ||
| Unknown (%) | 4 (11.8) | 5 (11.6) | 2 (10.5) | 4 (7.7) | ||
| 5. Type of concomitant medication exposure | ||||||
| Corticosteroids only (%) | 3 (8.8) | 8 (18.6) | 0.640 | 2 (10.5) | 8 (15.4) | 0.691 |
| Immunosuppressants only (%) | 2 (5.9) | 3 (7.0) | 2 (10.5) | 2 (3.8) | ||
| Corticosteroids and immunosuppressants (%) | 1 (2.9) | 2 (4.7) | 0 (0.0) | 2 (3.8) | ||
| No corticosteroids or immunosuppressants (%) | 28 (82.4) | 30 (69.8) | 15 (78.9) | 40 (76.9) | ||
+
Data captured as free-text initially and subsequently coded manually into the four categories. Entries such as ‘dampened responsiveness’, ‘primary non-response’, ‘no response’, and ‘no effect’ were coded as inadequate responses. Entries such as ‘secondary loss of response’, ‘recurrence of symptoms’ and ‘loss of response’ were coded as a loss of response. Entries such as ‘cytomegalovirus infection’, ‘hypotension’, and ‘intolerance’ were coded as intolerance. Other free-text entries such as ‘principal investigator’s judgement’ and ‘drug change’ etc. were considered as unknowns.
TNF, tumor necrosis factor; UC, ulcerative colitis.