TABLE 1.
Demographics and disease characteristics for patients enrolled in the INSPECT study
| Patient Demographic/Disease Characteristic | DVS Group (n = 43) | Control Group (n = 46) |
|---|---|---|
| Age, y | 42.1 ± 13.7 | 37.7 ± 13.5 |
| Male | 24 (55.8) | 25 (54.3) |
| Race | ||
| White | 40 (93.0) | 42 (91.3) |
| Black or African American | 3 (7.0) | 1(2.2) |
| Missing | 0 | 3 (6.5) |
| Weight at INSPECT baseline, kga | 73.5 ± 15.0 | 75.4 ± 17.7 |
| Smoking status | ||
| Smoker | 8 (18.6) | 4 (8.7) |
| Nonsmoker | 7 (16.3) | 6 (13.0) |
| Unknown | 28 (65.1) | 36 (78.3) |
| Concomitant medications at INSPECT baselinea | ||
| Immunosuppressants only | 3 (7.0) | 7 (15.2) |
| Anti-TNF only | 18 (41.9) | 14 (30.4) |
| Anti-TNF and immunosuppressants | 15 (34.9) | 17 (37.0) |
| Neither | 7 (16.3) | 8 (17.4) |
| Duration of CD at INSPECT baseline, ya | 12.7 ± 11.1 | 11.0 ± 8.4 |
| Duration of perianal fistulizing disease at INSPECT baseline, ya,b | 4.7 ± 5.9 | 3.0 ± 3.6 |
| Fistula typec | ||
| High intersphincteric | 3 (7.0) | 3 (6.5) |
| High transsphincteric | 13 (30.2) | 19 (41.3) |
| Extrasphincteric | 2 (4.7) | 3 (6.5) |
| Suprasphincteric | 1 (2.3) | 1 (2.2) |
| Low intersphincteric | 5 (11.6) | 4 (8.7) |
| Low transsphincteric | 5 (11.6) | 4 (8.7) |
| Unknown | 20 (46.5) | 16 (34.8) |
| Number of internal openings | ||
| 0 | 0 | 1 (2.2) |
| 1 | 35 (81.4) | 39 (84.8) |
| 2 | 8 (18.6) | 6 (13.0) |
| Number of external openings | ||
| 1 | 22 (51.2) | 30 (65.2) |
| 2 | 15 (34.9) | 13 (28.3) |
| 3 | 6 (14.0) | 3 (6.5) |
| Anatomic complexity of fistula | ||
| Single-tract fistula | 20 (46.5) | 29 (63.0) |
| Multiple-tract fistula | 23 (53.5) | 17 (37.0) |
Values are mean ± SD or n (%).
Abbreviations: ADMIRE-CD, Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn\'s Disease; CD, Crohn’s disease; DVS, darvadstrocel; INSPECT, A retrospectIve chart review study evaluatINg the longer-term effectiveneSs of darvadstrocel in PatiEnts who CompleTed ADMIRE-CD; TNF, tumor necrosis factor.
The INSPECT baseline was 1 day after completing the ADMIRE-CD trial.
Duration of perianal fistulizing disease was collected from medical charts as part of INSPECT. All other variables were taken from the ADMIRE-CD trial.
The sum may exceed the number of patients because patients may have had multiple fistulas in different locations.