Table 1.
Demographic and Baseline Characteristics
| Oral Ferric Maltol | IV Ferric Carboxymaltose | |||
|---|---|---|---|---|
| ITT (n = 125) | PP (n = 78)* | ITT (n = 125) | PP (n = 88)* | |
| Age, y, mean (SD) | 40.0 (14.6) | 41.4 (15.3) | 40.4 (15.5) | 40.2 (15.9) |
| Range | 18-81 | 18-81 | 19-77 | 19-77 |
| Sex, n (%) | ||||
| Male | 57 (46) | 33 (42) | 48 (38) | 29 (33) |
| Female | 68 (54) | 45 (58) | 77 (62) | 59 (67) |
| Race, n (%) | ||||
| White | 110 (88) | 72 (92) | 111 (89) | 78 (89) |
| Black | 6 (5) | 2 (3) | 3 (2) | 3 (3) |
| Asian | 0 | 0 | 2 (2) | 2 (2) |
| Other | 9 (7) | 4 (5) | 9 (7) | 5 (6) |
| IBD subgroup, n (%) | ||||
| Crohn disease† | 79 (63) | 46 (63) | 79 (63) | 54 (61) |
| Ulcerative colitis | 46 (37) | 29 (37) | 46 (37) | 34 (39) |
| IBD activity scores | ||||
| CDAI, mean (SD) | 129.6 (60.1) | 130.9 (60.3) | 140.5 (75.8) | 130.7 (63.6) |
| (range) | (0-294) | (37-294) | (33-339) | (36-283) |
| SCCAI, mean (SD) | 2.2 (1.8) | 2.0 (1.7) | 2.3 (1.6) | 2.4 (1.7) |
| (range) | (0-5) | (0-5) | (0-5) | (0-5) |
| Hb, g/dL‡ | ||||
| Mean (SD) | 10.0 (1.1) | 10.0 (1.0) | 10.1 (1.0) | 10.1 (1.1) |
| Median (range) | 10.1 (7.6-12.6) | 10.2 (7.6-12.2) | 10.2 (8.0-12.3) | 10.1 (8.0-12.3) |
| Hb <10 g/dL (women) or <11 g/dL (men), n (%) | 67 (54) | 43 (55) | 67 (54) | 47 (53) |
| Ferritin, ng/mL | ||||
| Mean (SD) | 16.6 (71.6) | 9.6 (11.5) | 9.3 (12.2) | 10.3 (13.8) |
| Median (range) | 6.0 (2.0-797.2) | 5.4 (2.0-66.0) | 5.8 (2.0-76.0) | 6.0 (2.0-76.0) |
| Concomitant vitamin B12 and/or folic acid, n (%)§ | 31 (24) | 20 (17) | ||
| Concomitant IBD medications, n (%)§ | ||||
| Corticosteroids | ||||
| Systemic | 39 (31) | 31 (26) | ||
| Topical | 3 (2) | 6 (5) | ||
| Anti-inflammatory | ||||
| Mesalamine | 55 (43) | 48 (40) | ||
| Immunomodulator | ||||
| Azathioprine | 32 (25) | 37 (31) | ||
| Biologics | ||||
| Infliximab | 25 (20) | 27 (23) | ||
| Adalimumab | 28 (22) | 19 (16) | ||
| Vedolizumab | 18 (14) | 13 (11) | ||
*Patient numbers for the PP populations are the numbers completing 12 weeks of treatment.
†Four patients had CDAI scores > 300 (exclusion criterion) and were randomized in error; these patients were included in the ITT analysis but not the PP analysis.
‡Three patients had Hb < 8 g/dL at baseline; all 3 patients had Hb ≥ 8 g/dL at screening, thus meeting the eligibility criteria.
§Data for concomitant medications are assessed in the safety population: ferric maltol n = 127, ferric carboxymaltose n = 120.
CDAI indicates Crohn’s Disease Activity Index; SCCAI, Simple Clinical Colitis Activity Index.