Poster Session B - Monday Morning
Category: IBD
Wen Zhou, MD, PhD
AbbVie Inc.
North Chicago, IL
Primary and key secondary endpoints at Week 52 | PBO, n (%) [N]
N=223 | UPA 15 mg QD, n (%) [N] N=225 | Adjusted difference vs PBO, % (95% CI)a | UPA 30 mg QD, n (%) [N] N=233 | Adjusted difference vs PBO, % (95% CI)a |
Primary endpoint: Clinical remissionb | 24 (10.8) | 91 (40.4) | 30.1*** (22.7, 37.4) | 125 (53.6) | 42.9*** (35.4, 50.4) |
Maintenance of clinical responsec | 44 (21.5) [N=204] | 129 (65.6) [N=197] | 43.9*** (35.4, 52.5) | 168 (77.5) [N=217] | 55.6*** (47.8, 63.4) |
Endoscopic improvementd | 31 (14.1) | 109 (48.5) | 34.4*** (26.7, 42.1) | 147 (63.3) | 49.0*** (41.4, 56.7) |
Maintenance of clinical remissione | 16 (18.8) [N=85] | 41 (53.6) [N=76] | 34.9*** (21.2, 48.5) | 57 (65.8) [N=87] | 46.9*** (34.0, 59.8) |
Corticosteroid-free clinical remissionf | 16 (18.8) [N=85] | 40 (52.3) [N=76] | 33.7*** (20.0, 47.3) | 56 (64.6) [N=87] | 45.5*** (32.6, 58.5) |
Maintenance of endoscopic improvementg | 21 (18.4) [N=115] | 59 (61.2) [N=97] | 42.2*** (30.4, 53.9) | 84 (71.0) [N=118] | 51.5*** (40.9, 62.1) |
Endoscopic remissionh | 14 (6.1) | 56 (24.9) | 18.6*** (12.2, 25.0) | 66 (28.3) | 21.9*** (15.4, 28.5) |
Histologic-endoscopic mucosal improvementi
Mucosal healingj
| 27 (12.3)
11 (5.1)
| 91 (40.5)
42 (18.8)
| 28.5*** (21.1, 35.9)
13.5*** (7.8, 19.3) | 131 (56.0)
53 (22.6)
| 43.8*** (36.1, 51.5)
17.2*** (11.2, 23,3) |
***p< 0.001. The efficacy analysis was performed in patients who received up to 52 weeks’ maintenance treatment (ITT population). Non-responder imputation incorporating multiple imputations to handle missing data due to COVID-19 was used. aBased on adjusted Cochran–Mantel–Haenszel test adjusted for strata (corticosteroid use at Week 0 (yes or no), clinical remission status at Week 0 (yes or no), biologic-IR status at baseline (biologic-IR or non-biologic-IR)). bPer Adapted Mayo score ≤2: stool frequency subscore ≤1 and not greater than induction baseline, RBS=0, and ES ≤1. cMaintenance of clinical response, defined as a decrease in Adapted Mayo score ≥2 and ≥30% from induction baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1, at Week 52 among patients who achieved clinical response at the end of the induction therapy. dES ≤1. eMaintenance of CR at Week 52 among patients with CR at the end of the induction therapy. fCR at Week 52 and corticosteroid-free for ≥90 days prior to Week 52 among patients with CR at the end of the induction therapy. gEndoscopic improvement at Week 52 among patients with endoscopic improvement at the end of the induction therapy. hES=0. iES ≤1 and Geboes score ≤3.1. jES=0 and Geboes score < 2.0. CI, confidence interval; CR, clinical remission; ES, endoscopic subscore; IR, inadequate responders; ITT, intent-to-treat; PBO, placebo; QD, once daily; RBS, rectal bleeding subscore; UPA, upadacitinib |
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