A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent AEs (TEAEs) were AEs with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. All TEAEs including serious and non-serious AEs were reported.

Number of participants with TESAEs were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. A serious adverse event (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.

Number of participants with TEAESI was reported. Active tuberculosis (TB) or malignancies were considered as TEAESIs. TEAESIs were AESIs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.

Number of participants with treatment-emergent abnormalities in hematology laboratory parameters were reported. Laboratory tests included in hematology were hemoglobin, lymphocytes, neutrophils, platelet count, Total WBC (white blood cell) Count. National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.

Number of participants with treatment-emergent abnormalities in chemistry laboratory parameters were reported. Laboratory parameters included in clinical chemistry were albumin, corrected calcium, creatinine, glucose, potassium, sodium. NCI-CTCAE) toxicity grades were Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life-Threatening). TE abnormalities are laboratory abnormalities with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.

Number of participants with TEAEs of infections were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.

Number of participants with TEAEs of injection-site reactions were reported. A significant injection-site reaction was defined as an adverse reaction that was manifested through 1 or more of the following symptoms: significant bruising, erythema, hemorrhage, irritation, pain, pruritus at the site of injection. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline.

Number of participants with TEAEs temporally associated with infusion were reported. TEAEs are AEs with onset during the intervention phase or that are a consequence of a preexisting condition that had worsened since baseline.

TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. The Columbia-suicide severity rating scale (C-SSRS) defined was 5 subtypes of suicidal ideation and 4 possible suicidal behaviors, as well as non-suicidal self-injurious behavior and completed suicide. The C-SSRS was an investigator-administered questionnaire: 1) No suicidal ideation or behaviors (including self-injurious behavior without suicidal intent): No further action was needed; 2) Suicidal ideation levels 1-3 or non-suicidal self-injurious behavior; participant risk is assessed by the investigator. 3) Suicidal ideation levels 4 or 5 or any suicidal behavior: participant risk assessed and referral to a mental health professional. If no events qualify for scores of 1 to 10, score of 0 was assigned (0= "no event that can be assessed on the basis of C-SSRS"). Higher scores indicated greater severity.

Number of participants with clinically significant treatment-emergent abnormalities in vital signs were reported. Vital signs included weight, pulse rate, temperature, respiratory rate, systolic blood pressure, and diastolic blood pressure. TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline.

Number of participants with concomitant medications for Crohn's disease were reported.

Number of participants with clinical response through Week 48 were reported. Clinical response was defined as a greater than or equal to (>=) 100-point reduction from baseline in CDAI score or CDAI score less than <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.

Number of participants with clinical remission through Week 48 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.

Number of participants with PRO-2 remission through Week 48 were reported. PRO-2 remission was defined as abdominal pain (AP) mean daily score at or below 1 and stool frequency (SF) mean daily score at or below 3, and no worsening of AP or SF from baseline. Mean daily AP score was defined as the sum of abdominal pain/cramps ratings in the previous 7 days in a diary card divided by the total number of days assessments were performed. Average daily SF score was defined as the sum of number of liquid or very soft stools in the previous 7 days in a diary card divided by the total number of days assessments were performed. Mean daily SF and AP scores score at a scheduled visit were not calculated if total number of days of assessment was less than 5. Higher PRO-2 scores indicated more severe disease.

Change from baseline in SES-CD score at Week 48 were reported. The SES-CD score was used to evaluate endoscopic improvement. The SES-CD was based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in a total score of up to 15 for each component, except for the narrowing component which only attain a maximum total score of 11 because, the presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was the sum of all the component scores across all the segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.

Serum concentration of guselkumab were reported.

Number of participants with anti-guselkumab antibodies through Week 48 were reported.

Number of participants with neutralizing-guselkumab antibodies through Week 48 were reported.

Change from baseline in inflammatory PD marker of CRP concentration were reported.

Change from baseline in inflammatory PD marker of FC levels were reported.

Change from baseline in CDAI score at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.

Number of participants in clinical response at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Clinical response was defined as a >=100-point reduction from baseline in CDAI score or CDAI score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.

Number of participants in clinical remission at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150. The multi-item CDAI score assessed severity of illness by collecting information on 8 different Crohn's disease-related variables (extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid or very soft stools, abdominal pain/cramps, and general well-being). The last 3 variables were scored over 7 days by the participant on a diary card. The total CDAI score ranged from 0 (improvement in disease activity) to 600 (more disease activity) in general: higher score indicated higher disease activities and a decrease in total CDAI score over time indicated improvement in disease activity.

Number of participants in endoscopic response at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Endoscopic response was defined as >=50 % improvement from baseline in SES-CD score or SES-CD score less than or equal to (<=) 2. The SES-CD was based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in a total score of up to 15 for each component, except for narrowing component which only attain a maximum total score of 11 because, presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was sum of all component scores across all segments and it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.

Number of participants in endoscopic remission at Week 48 by serum guselkumab concentration quartiles at Week 48 were reported. Endoscopic remission: an SES-CD score <= 4 with at least a 2-point reduction from baseline and no sub score >1 in any individual subcomponent. The SES-CD was based on evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component was scored from 0 (best) to 3 (worst) for each segment, resulting in total score of 15 for each component, except for narrowing component which only attain a maximum total score of 11 because, presence of a narrowing that cannot be passed can be only observed once. The total SES-CD score was sum of all component scores (all segments) & it ranged from 0 (best) to 56 (worst), where higher scores indicated more severe disease.

Change from baseline in the average daily P.Eq oral corticosteroid dose (excluding Budesonide) through Week 48 among participants receiving oral corticosteroids other than Budesonide at baseline were reported.

Number of participants not receiving concomitant corticosteroids at Week 48 among participants receiving concomitant corticosteroids at baseline were reported.

Number of participants not receiving concomitant corticosteroids for at least 30 days prior to Week 48 among participants receiving concomitant corticosteroids at baseline were reported.

Number of participants not receiving concomitant corticosteroids for at least 90 days prior to Week 48 among participants receiving concomitant corticosteroids at baseline were reported.