Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (\<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: Week 52

Population: Full analysis set (FAS) which was defined as all randomized participants.

PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools (total number of soft/liquid stools in the last 7 days) and abdominal pain (on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO-2 symptom remission was defined as an abdominal pain (AP) mean daily score at or below 1 and also stool frequency (SF) mean daily score at or below 3, that is, AP \<=1 and SF \<=3. PRO2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease.

Time frame: Week 52

Population: FAS which was defined as all randomized participants.

Percentage of participants with AP improvement through Week 52 were reported. AP improvement was defined as at least 1 point or greater improvement in mean daily CDAI AP score (ranges from 0 to 3 where higher score indicates severity of pain) from baseline, or a mean score of zero among participants with mean AP\>0 at baseline, compared at each visit through Week 52.

Time frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

Population: FAS among participants with mean daily AP Score \>0 at Baseline.

Percentage of participants with AE were reported. An AE is 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.

Time frame: Up to Week 52 and up to Week 76

Population: Safety analysis set included all the participants who were randomized and received at least one administration of study agent in the study.

Percentage of participants with anti-drug antibodies were reported. Serum samples were assessed for anti-drug antibodies. Anti-drug assays were performed for ustekinumab and adalimumab.

Time frame: Up to Week 52

Population: Immunogenicity analysis set included all participants who had received at least 1 administration of study agent and have at least one valid blood sample drawn for detection of antibodies to study agent.

Percentage of participants with clinical and biomarker remission was defined as the percentage of participants with CDAI \<150, CRP \<= 3 mg/L, and also fecal calprotectin \<=250 micrograms per gram (mcg/g). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: At Weeks 8, 16 and 52

Population: FAS which was defined as all randomized participants.

Percentage of participants with clinical remission (defined as CDAI \<150 points) at Week 16 were assessed. Clinical remission was defined as a CDAI score of \< 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: Week 16

Population: FAS which was defined as all randomized participants.

Percentage of participants with clinical remission at each postbaseline visit through Week 52 were reported. Clinical remission was defined as a CDAI score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

Population: FAS which was defined as all randomized participants.

Percentage of participants with clinical response at Week 52 were assessed. Clinical response at Week 52 was defined as a reduction from baseline in the CDAI score of greater than or equal (\>=) 100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: Week 52

Population: FAS which was defined as all randomized participants.

Percentage of participants with clinical response at each postbaseline visit through Week 52 were reported. Clinical response through Week 52 was defined as a reduction from baseline in the CDAI score of \>=100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

Population: FAS which was defined as all randomized participants.

Percentage of participants with Corticosteroid-free remission at Week 52 were assessed. Corticosteroid-free remission was defined as CDAI score \<150 points at Week 52 and not taking any corticosteroids for at least 30 days prior to Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: Week 52

Population: FAS which was defined as all randomized participants.

Percentage of participants with durable clinical remission at Week 52 were reported. Clinical remission was defined as CDAI score \<150 at Week 52 and was \>= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: Week 52

Population: FAS which was defined as all randomized participants.

Percentage of participants with durable clinical response at Week 52 were reported. Durable clinical response was defined as CDAI score decreased at least 100 from baseline or CDAI \<150 at Week 52 and was \>= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

Time frame: Week 52

Population: FAS which was defined as all randomized participants.

Percentage of participants with endoscopic remission at Week 52 were assessed. Endoscopic remission was defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score less than or equal to (\<=) 3, or SES-CD =0 for participants who entered the study with a SES-CD =3 at Week 52. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis) each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

Time frame: Week 52

Population: FAS among participants with SES-CD Score \>=3 at Baseline.

Percentage of participants with infections were reported.

Time frame: Up to Week 52 and up to Week 76

Population: Safety analysis set included all the participants who were randomized and received at least one administration of study agent in the study.

Number of participants with reduction in frequency of diarrhea were reported. Reduction in frequency of diarrhea was defined as a reduction of at least 3 (or a mean number \<1) in SF (that is, mean daily number of liquid or very soft stools from CDAI score \[ranges from 0 to 3 where higher score indicates severity of pain\] in the week prior to the visit) from baseline, among subjects with mean SF \>1 at baseline, compared at each visit through Week 52.

Time frame: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

Population: FAS among participants with mean daily stool frequency \>1 at Baseline.

Percentage of participants with SAEs were reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Coronavirus disease 2019 (COVID-19) related adverse events are adverse events with any of the following preferred terms COVID-19, Asymptomatic COVID-19, Suspected COVID-19, COVID-19 pneumonia, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive or with a reported term containing the string COVI.

Time frame: Up to Week 52 and up to Week 76

Population: Safety analysis set included all the participants who were randomized and received at least one administration of study agent in the study.

Percentage of participants with serious infections were reported.

Time frame: Up to Week 52 and up to Week 76

Population: Safety analysis set included all the participants who were randomized and received at least one administration of study agent in the study.