Induction Combination Therapy With Guselkumab and Golimumab Followed by Guselkumab Monotherapy Maintenance: Results of the Phase 2a, Randomized, Double-Blind, Proof-of-Concept VEGA Study

ABSTRACT

GUS Clinical remission c,d 16 (22.2) 22 (31.0) 31 (43.7) 21.5 (11.9, 31.2) 0.006 12.7 (2.7, 22.7) 0.109 Clinical remission (based on mMayo) c,e 15 (20.8) 22 (31.0) 34 (47.9) 27.1 (17.7, 36.6) < 0.001 16.9 (7.0, 26.8) 0.033 Symptomatic remission c,f 43 (59.7) 49 (69.0) 49 (69.0) 9.4 (-0.6, 19.4) 0.238 0.0 (-9.7, 9.7) 1.000 Endoscopic improvementc.g 16 (22.2) 23 (32.4) 35 (49.3) 27.2 (17.6, 36.7) < 0.001 16.9 (7.0, 26.8) 0.033 Endoscopic normalization c,h 5 (6.9) 11 (15.5) 18 (25.4) 18.5 (11.1, 25.9) 0.002 9.9 (1.6, 18.2) 0.134 Histologic remission c,i 18 (25.0) 29 (40.8) 36 (50.7) 25.8 (16.1, 35.5) 0.001 9.9 (-0.4, 20.1) 0.224 Both histologic remission and endoscopic improvement c,g,i 10 (13.9) 15 (21.1) 30 (42.3) 28.5 (19.6, 37.4) < 0.001 21.1 (11.8, 30.5) 0.005 Both histologic remission and endoscopic normalization c,h,i 4 (5.6) 9 (12.7) 17 (23.9) 18.5 (11.3, 25.6) 0.002 11.3 (3.3, 19.2) 0.074 a The adjusted treatment difference between the combination therapy vs. the monotherapy groups and the confidence interval were based on the Wald statistic with the Cochran-Mantel-Haenszel (CMH) weight. b The p-value was based on the 2-sided CMH chi-square test, stratified by corticosteroid use at baseline (Yes, No). All P-values are nominal. c Pts who had an ostomy or colectomy, had a protocol-prohibited change in concomitant UC medications, or discontinued study intervention due to lack of a therapeutic effect or an adverse event of worsening UC, or discontinued study agent early due to COVID-19 related reasons (excluding COVID-19 infection) prior to the wk 38 visit were considered to not have achieved the binary endpoints. Pts with missing data at wk 38 were considered to not have achieved the binary endpoints. d Clinical remission is defined as Mayo score ≤2, with no individual subscore >1. e Clinical remission (based on the mMayo) is defined as a stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on endoscopy. f Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1, where the stool frequency subscore has not increased from baseline, and a rectal bleeding subscore of 0. g Endoscopic improvement is defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy. h Endoscopic normalization is defined as an endoscopy subscore of 0. i Histologic remission is defined as absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system.