Table 2.
Meaningful improvementa at month 6 in nonbleeding symptoms and menstrual bleeding across different patient subpopulations as evaluated using the Patient Global Impression of Change scale.
| Subpopulationb | Treatment | Patients with meaningful improvementa, n/N (%) |
|||||
|---|---|---|---|---|---|---|---|
| Abdominal or pelvic pain | Abdominal or pelvic pressure | Abdominal or pelvic cramping | Back pain | Abdominal bloating | Menstrual bleeding | ||
| Overall | |||||||
| ELA + AB | 222/304 (73.0)∗∗∗ | 212/304 (69.7)∗∗∗ | 221/304 (72.7)∗∗∗ | 174/304 (57.2)∗∗∗ | 174/304 (57.2)∗∗∗ | 266/305 (87.2)∗∗∗ | |
| Placebo | 33/153 (21.6) | 26/153 (17.0) | 38/153 (24.8) | 32/153 (20.9) | 23/153 (15.0) | 35/153 (22.9) | |
| BMI, kg/m2 | |||||||
| <30 | ELA + AB | 67/101 (66.3)∗∗∗ | 63/101 (62.4)∗∗∗ | 68/101 (67.3)∗∗∗ | 56/101 (55.4)∗∗∗ | 62/101 (61.4)∗∗∗ | 86/101 (85.1)∗∗∗ |
| Placebo | 10/54 (18.5) | 7/54 (13.0) | 11/54 (20.4) | 9/54 (16.7) | 6/54 (11.1) | 9/54 (16.7) | |
| 30–<35 | ELA + AB | 61/85 (71.8)∗∗∗ | 58/85 (68.2)∗∗∗ | 61/85 (71.8)∗∗∗ | 45/85 (52.9)∗∗∗ | 44/85 (51.8)∗∗∗ | 75/85 (88.2)∗∗∗ |
| Placebo | 8/35 (22.9) | 6/35 (17.1) | 9/35 (25.7) | 7/35 (20.0) | 6/35 (17.1) | 8/35 (22.9) | |
| ≥35 | ELA+AB | 93/117 (79.5)∗∗∗ | 90/117 (76.9)∗∗∗ | 92/117 (78.6)∗∗∗ | 73/117 (62.4)∗∗∗ | 68/117 (58.1)∗∗∗ | 104/118 (88.1)∗∗∗ |
| Placebo | 15/64 (23.4) | 13/64 (20.3) | 18/64 (28.1) | 16/64 (25.0) | 11/64 (17.2) | 18/64 (28.1) | |
| Primary FIGO fibroid classification | |||||||
| 0–3 | ELA + AB | 45/65 (69.2)∗∗∗ | 48/65 (73.8)∗∗∗ | 44/65 (67.7)∗∗∗ | 33/65 (50.8)∗∗∗ | 39/65 (60.0)∗∗∗ | 55/65 (84.6)∗∗∗ |
| Placebo | 1/28 (3.6) | 1/28 (3.6) | 2/28 (7.1) | 2/28 (7.1) | 2/28 (7.1) | 1/28 (3.6) | |
| 4 | ELA + AB | 101/140 (72.1)∗∗∗ | 92/140 (65.7)∗∗∗ | 97/140 (69.3)∗∗∗ | 81/140 (57.9)∗∗∗ | 79/140 (56.4)∗∗∗ | 122/141 (86.5)∗∗∗ |
| Placebo | 21/71 (29.6) | 16/71 (22.5) | 22/71 (31.0) | 16/71 (22.5) | 15/71 (21.1) | 18/71 (25.4) | |
| 5–8 | ELA + AB | 73/94 (77.7)∗∗∗ | 69/94 (73.4)∗∗∗ | 78/94 (83.0)∗∗∗ | 59/94 (62.8)∗∗∗ | 55/94 (58.5)∗∗∗ | 85/94 (90.4)∗∗∗ |
| Placebo | 9/50 (18.0) | 8/50 (16.0) | 12/50 (24.0) | 12/50 (24.0) | 5/50 (10.0) | 14/50 (28.0) | |
Note: BMI = body mass index; ELA + AB = elagolix plus add-back therapy (estradiol [1 mg] and norethindrone acetate [0.5 mg]); FIGO = International Federation of Gynecology and Obstetrics; PGIC = Patient Global Impression of Change.
∗P<.05; ∗∗P<.01; ∗∗∗P<.001. P values were descriptive only, and no adjustments were made for multiplicity.
a
Meaningful improvement is defined using PGIC responses of “very much improved” or “much improved.”
b
Subpopulations on the basis of baseline demographic or clinical characteristics.