A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Clinical remission without disease recurrence at Week 48 was a composite endpoint defined by (1) Crohn's disease activity index (CDAI) <150 at Week 48 \& (2) no endoscopic recurrence as defined by modified Rutgeerts score < i2a by Week 48 \& (3) have not experienced disease recurrence. Disease recurrence was defined as (1) >=70 point increase from baseline in CDAI score at >8 weeks after randomization \& CDAI score >=200 and evidence of endoscopic recurrence (Rutgeerts score <i2a) or (2) initiation of physician-prescribed corticosteroids or increase in steroid dose of >5 milligrams per day (mg/day) for treatment of Crohn's disease (CD) and endoscopic recurrence or (3) new draining or reopening of an internal or external fistula or (4) new perianal abscess or (5) new intra-abdominal abscess more than 3 months post index surgery. If a patient tested positive for enteric pathogen, infection should be treated and then participant should be reassessed for whether they meet disease recurrence.

Disease recurrence was defined by (1) a >=70 point increase from baseline in CDAI score at >8 weeks after randomization \& CDAI score >=200 and evidence of endoscopic recurrence (Rutgeerts score <i2a) or (2) initiation of physician-prescribed corticosteroids or increase in steroid dose of >5 milligrams per day (mg/day) for treatment of Crohn's disease (CD) and endoscopic recurrence or (3) new draining or reopening of an internal or external fistula or (4) new perianal abscess or (5) new intra-abdominal abscess more than 3 months post index surgery. If a patient tested positive for enteric pathogen, infection should be treated and then participant should be reassessed for whether they meet disease recurrence.

Abdominal pain free at Week 48 is defined as abdominal pain (AP) score = 0 at Week 48. The scoring was done on a 4-point scale, ranged from 0 to 3, where 0 equals none, 1 equals mild, 2 equals moderate and 3 equals severe pain. Higher score indicated severe pain.

Time-to-recurrence of symptoms was defined as time to attaining an AP mean daily score >1 (and also >1 point higher than baseline) along with stool frequency (SF) mean daily score >3 (and also >3 higher per day than baseline) for 2 consecutive weeks through Week 48. AP score scaling was done on a 4-point score scale, ranged from 0 to 3, where 0 equals none, 1 equals mild, 2 equals moderate and 3 equals severe pain. Higher score indicated severe pain. Stool frequency score was calculated from the total number of liquid or very soft stools in the previous 7 days.

Number of participants with TEAEs and TESAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Any AE/SAE occurring at or after the initial administration of study intervention through early termination of trial (up to Week 28) was considered to be treatment emergent.

Serum guselkumab concentrations over time were reported. No summary analysis was done as study was terminated early and participant wise data were reported. This outcome measure was planned to be analyzed for "Guselkumab 200 mg + Guselkumab 100 mg" arm only.

Steroid free clinical remission at Week 48 is defined as CDAI <150 and no corticosteroids within 30 days. The CDAI was a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicated higher disease activities.