Comprehensive Review of Ustekinumab Utilization in Inflammatory Bowel Diseases: Insights from the ClinicalTrials.gov Registry

Figures & data

Table 1 Clinical Trial Characteristics

Status	Number	Percentage (%)
Recruiting	28	40.6
Not yet recruiting	6	8.7
Unknown	1	1.4
Completed	22	31.9
Terminated	1	1.4
Withdrawn	2	2.9
Active, not recruiting	5	7.2
Enrolling by invitation	2	2.9
Number Enrolled	Number	Percentage (%)
≤ 100	20	29.0
101–199	16	23.2
≥ 200	33	47.8
N/A	1	1.4
Study type, design and allocation	Number	Percentage (%)
Interventional (clinical trial)	37	53.6
- Randomized	28	40.6
Non-randomized	6	8.7
N/A	3	4.3
Observational	31	44.9
Case-Control	2	2.9
Case-Only	4	5.8
Cohort	23	33.3
Other	2	2.9
Expanded access	1	1.4
Study Phase	Number	Percentage (%)
Phase 1 Clinical Trial	3	4.3
Phase 2 Clinical Trial	9	13.0
Phase 3 Clinical Trial	16	23.2
Phase 4 Clinical Trial	7	10.1
N/A Clinical Trial	4	5.7
Region	Number	Percentage (%)
World	69	100.0
Africa	6	8.7
North America	34	49.3
Canada	14	20.3
- United States	32	46.4
Central America and the Caribbean	2	2.9
South America	8	11.6
East Asia	32	46.4
- Japan	11	15.9
- Korea	12	17.4
Middle East	10	14.5
South Asia	2	2.9
Southeast Asia	1	1.4
Europe	49	71.0
- Belgium	23	33.3
- Others	26	37.7
Oceania	10	14.5
Funding body	Number	Percentage (%)
Government, excluding US Federal	3	4.3
Industry	15	21.7
National Institutes of Health	2	2.9
University/Organization	33	47.8
Others	16	23.3

Table 2 Drug Intervention and Number of Studies in Which That Intervention Had Been Used

Drug Intervention	Number of Studies	Percentage (%)
Vedolizumab	22	31.9
Adalimumab	15	21.7
Infliximab	15	21.7
Golimumab	7	10.1
Benzocaine	4	5.8
Mesalamine	4	5.8
Tannic Acid	4	5.8
Tofacitinib	4	5.8
Azathioprine	3	4.3
Certolizumab Pegol	3	4.3
Methotrexate	3	4.3
Gastrointestinal Agents	4	9.8
Micronutrients	1	2.4
Pharmaceutical Solutions	1	2.4
Psychotropic Drugs	1	2.4
Reproductive Control Agents	1	2.4
Respiratory System Agents	3	7.3
Vasoconstrictor Agents	1	2.4

Table 3 Drug Intervention and Number of Drugs in the Class Used to Manage the Disease

Drug Intervention	Number of Drugs	Percentage (%)
Adjuvants, Anaesthesia	1	2.4
Analgesic	2	4.9
Anti-Inflammatory Agents	4	9.8
Anti-Obesity Agents	1	2.4
Anticoagulants	1	2.4
Antineoplastic Agents	5	12.2
Anti-rheumatic Agents	7	17.1
Antitussive Agents	1	2.4
Central Nervous System Depressants	2	4.9
Central Nervous System Stimulants	1	2.4
Coagulants	1	2.4
Dermatologic Agents	3	7.3

Table 4 Digestive System Diseases

Condition	Number of Studies
Colitis	8
Colitis, Ulcerative	5
Colonic Diseases	7
Crohn’s Disease	16
Digestive System Diseases	21
Gastroenteritis	21
Gastrointestinal Diseases	21
Hepatitis	1
Hepatitis A	1
Hepatitis B	1
Hepatitis, Viral, Human	1
Inflammatory Bowel Diseases	22
Intestinal Diseases	22
Liver Diseases	1

Table 5 Completed Intervention Studies

Phase	Objective	Subjects	Comparison	Key Outcome
1	Pharmacokinetics (PK) of Ustekinumab	Paediatric patients diagnosed with moderate to severe Crohn’s disease, who had previously been treated with conventional medication for Crohn’s disease but had not yet received any biologic treatment.	- Dosage regimen of Ustekinumab	- Serum drug concentration - Clinical response - Clinical remission
2	Safety and efficacy of Ustekinumab	Crohn’s disease that is currently in a moderate to severe active state despite standard treatment, or has not responded adequately to Infliximab.	- Ustekinumab - Placebo	- Clinical response - Clinical remission
2	Safety and effectiveness of Ustekinumab	Individuals diagnosed with moderate to severe active Crohn’s disease who have previously received treatment with anti-tumour necrosis factor (TNF) therapy but have either experienced treatment failure or intolerance.	- Ustekinumab - Placebo	- Clinical response - Clinical remission
2	Safety and efficacy study of JNJ-64304500	Participants with moderately to severely active Crohn’s disease who required concomitant conventional but never received a biologic agent.	- Ustekinumab - Placebo - JNJ-64304500	- Clinical response - Clinical remission - Crohn’s Disease Activity Index (CDAI) score
3	Efficacy of Ustekinumab between treat to target versus routine care maintenance strategies	Crohn’s disease that is classified as moderate to severe, and has shown inadequate response, failure, or intolerance to conventional therapy, or has had prior treatment with one biologic therapy approved for the management of Crohn’s disease.	- Dosage regime Ustekinumab	- Endoscopic response - Clinical response - Clinical remission - Endoscopic remission - Mucosal healing - Corticosteroid-free clinical remission
3	Safety and efficacy of Ustekinumab maintenance therapy	Patients with moderately to severely active Crohn’s disease.	- Ustekinumab - Placebo	- Clinical response - Clinical remission - Corticosteroid-free remission
3	Efficacy and safety of IV and subcutaneous Ustekinumab	Moderately to severely active UC in patients who fail to respond to biologic therapy or are naïve to biologic therapy but have had a clinical response to induction treatment with IV Ustekinumab.	- Ustekinumab - Placebo	- Clinical response - Clinical remission - Endoscopic response
3	Safety and efficacy of Ustekinumab	Patients with moderately to severely active Crohn’s disease who have failed to respond to or are intolerant to TNF-antagonist therapy (UNITI-1).	- Ustekinumab - Placebo	- Clinical response - Clinical remission
3	Safety and efficacy of Ustekinumab induction therapy	Individuals diagnosed with moderate to severe Crohn’s disease who have not responded to conventional therapy but have not previously experienced treatment failure or intolerance to one or more TNF-antagonist therapies.	- Ustekinumab - Placebo	- Clinical response - Clinical remission
3	Safety and efficacy of Adalimumab versus Ustekinumab for one year	Patients with moderately to severely active Crohn’s disease who failed to respond to conventional therapy, but had not previously received biologic therapies.	- Ustekinumab - Placebo - Adalimumab	- Clinical remission - Clinical response - Endoscopic remission - Corticosteroid-free clinical remission - Adverse side effects