Abstract
Methods: This TN post hoc analysis used grouP-based trajectory modeling (GBTM) to identify patterns of OZA response trajectories during the TN maintenance period (MP) in W10 OZA clinical responders who were rerandomized to continue OZA (OZA/OZA arm; n=230) in MP. Change from baseline (BL; TN W0) in partial Mayo score (PMS) was used as a variable for identifying pt clusters with various OZA response patterns. Results: Of 230 pts in the MP OZA/OZA arm, 1 did not have post-BL PMS data available and was excluded from this analysis; 5 groups of pt-response patterns to OZA therapy were identified during MP. At W10, a PMS response was observed in all 5 trajectory groups (TGs). Pt characteristics at BL (TN W0) or W10 G1: Fast sustained improvement (n=38; 6.6% [38/229]) G2: Slow sustained improvement (n=85; 37.1% [85/229]) G3: Gradual improvement (n=60; 26.2% [60/229]) G4: Fast rebound (n=25; 10.9% [25/229]) G5: Slow rebound (n=21; 9.2% [21/229]) Sex, male, n (%) 15 (39.5) 43 (50.6) 33 (55.0) 13 (52.0) 12 (57.1) Age at UC diagnosis, y, mean (SD) 34.6 (12.4) 35.7 (14.1) 35.3 (13.0) 29.8 (11.5) 31.5 (11.0) Corticosteroid use at screening, n (%) 11 (28.9) 28 (32.9) 14 (23.3) 11 (44.0) 7 (33.3) Prior use of tumor necrosis factor antagonist, n (%) 9 (23.7) 28 (32.9) 22 (36.7) 9 (36.0) 7 (33.3) Complete Mayo score at W10, mean (SD) 2.8 (1.7) 3.5 (1.8) 3.8 (1.9) 4.8 (2.1) 3.7 (1.6) PMS at W10, mean (SD) 1.3 (1.0) 1.9 (1.2) 2.1 (1.4) 3.0 (1.8) 2.1 (1.2) Mucosal endoscopy subscore of 2 (moderate) at BL, n (%) 14 (36.8) 39 (45.9) 28 (46.7) 9 (36.0) 8 (37.1) Mucosal endoscopy subscore of 3 (severe) at BL, n (%) 24 (63.2) 46 (54.1) 32 (53.3) 16 (64.0) 13 (61.9) Geboes continuous index score at W10, mean (SD) 5.9 (4.3) 5.8 (4.9) 7.0 (5.2) 7.7 (5.1) 7.6 (4.8) Author Notes *Presenter