Table 1.
Patient Characteristics at Baseline (Intention-to-Treat and Safety Population).*
| Characteristic | AK002 | Placebo (N = 22) | Overall (N = 65) | ||
|---|---|---|---|---|---|
| Low Dose (N = 22) | High Dose (N = 21) | Combined (N = 43) | |||
| Median age (range) — yr | 39 (18–74) | 41 (20–67) | 40 (18–74) | 36 (18–67) | 40 (18–74) |
| Female sex — no. (%) | 17 (77) | 13 (62) | 30 (70) | 10 (45) | 40 (62) |
| Race or ethnic group — no. (%)† | |||||
| White | 21 (95) | 17 (81) | 38 (88) | 22 (100) | 60 (92) |
| Asian | 0 | 1 (5) | 1 (2) | 0 | 1 (2) |
| Black | 1 (5) | 2 (10) | 3 (7) | 0 | 3 (5) |
| American Indian or Alaska Native | 0 | 1 (5) | 1 (2) | 0 | 1 (2) |
| Median weight (range) — kg | 78 (54–127) | 82 (42–121) | 80 (42–127) | 78 (46–141) | 80 (42–141) |
| Median body-mass index (range)‡ | 26 (19–50) | 27 (16–43) | 27 (16–50) | 24 (19–53) | 27 (16–53) |
| Primary diagnosis — no. (%) | |||||
| Eosinophilic gastritis | 4 (18) | 1 (5) | 5 (12) | 5 (23) | 10 (15) |
| Eosinophilic duodenitis | 6 (27) | 10 (48) | 16 (37) | 9 (41) | 25 (38) |
| Eosinophilic gastritis and duodenitis | 12 (55) | 10 (48) | 22 (51) | 8 (36) | 30 (46) |
| History of eosinophilic gastritis or duodenitis — no. (%)§ | 20 (91) | 15 (71) | 35 (81) | 17 (77) | 52 (80) |
| Median time since diagnosis of eosinophilic gastritis or duodenitis (range) — yr | 6 (0–18) | 4 (1–16) | 5 (0–18) | 4 (0–16) | 4 (0–18) |
| History of eosinophilic esophagitis — no. (%)§ | 15 (68) | 8 (38) | 23 (53) | 12 (55) | 35 (54) |
| Baseline use of low-dose systemic glucocorticoid — no. (%)¶ | 2 (9) | 3 (14) | 5 (12) | 2 (9) | 7 (11) |
| Baseline use of proton-pump inhibitor — no. (%) | 14 (64) | 10 (48) | 24 (56) | 8 (36) | 32 (49) |
| Baseline use of physician-prescribed diet regimen — no. (%)‖ | 3 (14) | 4 (19) | 7 (16) | 4 (18) | 11 (17) |
| Total serum IgE concentration — kU/liter | 716±1624 | 309±395 | 517±1198 | 635±1225 | 556±1198 |
| Blood absolute eosinophil count/mm3 | 991±1369 | 497±847 | 750±1158 | 562±537 | 686±991 |
| Gastrointestinal eosinophil count — eosinophils/high-power field** | 101±66 | 76±40 | 89±55 | 74±46 | 84±52 |
| Gastrointestinal mast-cell count — cells/high-power field** | 74±25 | 58±26 | 66±27 | 58±19 | 64±25 |
| Total symptom score†† | 34±13 | 33±14 | 33±13 | 29±14 | 32±14 |
Plus–minus values are means ±SD. Percentages may not total 100 because of rounding.
Race and ethnic group were reported by the patient.
Body-mass index is the weight in kilograms divided by the square of the height in meters.
A history of the condition was considered to be present if a documented clinical diagnosis had been made by the patient’s physician and was noted in the patient’s clinical chart history.
Prednisone at a dose no higher than 10 mg daily (or equivalent) was permitted if it was a preexisting regimen and was taken throughout the trial.
Patients were required to maintain their baseline diet regimen throughout the study.
The included count was for the site (gastric or duodenal) with the highest number of cells per high-power field at baseline.
The total symptom score was determined with a patient-reported outcome questionnaire (see Appendix 1 in the protocol). The questionnaire assessed eight symptoms on a daily basis: abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating, and diarrhea. Individual symptom scores ranged from 0 to 10, allowing for a maximum daily total symptom score of 80, with higher scores indicating greater severity.