Ustekinumab
Treatment for Inflammatory Bowel Disease
Typical Dosage: IV induction followed by 90 mg SC every 8 weeks
Effectiveness
77%
Safety Score
60%
Clinical Trials
100
Participants
10K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
60
DangerousModerateSafe
Treatment Details
Dosage Range
IV induction followed by 90 mg SC every 8 weeks
Time to Effect
6-8 weeks
Treatment Duration
lifetime
Evidence Quality
HIGHNumber Needed to Treat (NNT)
5(Treat 5 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
60(Treat 60 patients to see 1 additional serious adverse event)
Confidence Score
85%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$40,000
Monitoring:$3,000
Side Effect Mgmt:$1,000
Total Annual:$44,000
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POORICER
$190,000/QALY
QALYs Gained
0.3
Outcome-Based Costs
Cost per Responder
$80,000
Cost per Remission
$146,667
Comparison vs Azathioprine
Cost Difference
+$42,500/year
More expensive
QALY Difference
+0.15 QALYs
Better outcomes
Dominance
No dominance
Ustekinumab Outcomes
for Inflammatory Bowel Disease
Efficacy Outcomes
Overall Effectiveness
+77%
Response Rate
+55%
Remission Rate
+30%
Common Side Effects
Nasopharyngitis
+11%
Headache
+10%
Injection site reactions
+5%
Infections
+22%
Serious infections
+1.5%
Sources:
Active Clinical Trials
8 active trials recruiting for Ustekinumab in Inflammatory Bowel Disease
Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
NCT06453317RECRUITINGPHASE2
172 participants
INTERVENTIONAL
Lodz, Poland
Started: Feb 17, 2025
Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease
NCT06274554RECRUITINGPHASE3
120 participants
INTERVENTIONAL
New York, United States
Started: Oct 4, 2024
Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
NCT05387031RECRUITING
239 participants
OBSERVATIONAL
Beijing, China +7 more
Started: Aug 1, 2024
Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis.
NCT05725876RECRUITINGPHASE1
56 participants
INTERVENTIONAL
Groningen, Netherlands
Started: Jan 6, 2025
Study on the Correlation and Consistency of Measuring Biologic Drug Plasma Concentrations Based on Different Detection Methods
NCT06849739NOT YET RECRUITING
60 participants
OBSERVATIONAL
Guangzhou, China
Started: Mar 2, 2025
Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease
NCT06520397RECRUITINGPHASE4
214 participants
INTERVENTIONAL
Guangzhou, China
Started: Jul 15, 2024
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
NCT06045754RECRUITINGPHASE4
100 participants
INTERVENTIONAL
Dothan, United States +54 more
Started: Apr 18, 2024
An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients with Crohn's Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study
NCT05299931ACTIVE NOT RECRUITINGPHASE3
108 participants
INTERVENTIONAL
Zaventem, Belgium
Started: Sep 10, 2021
Completed Clinical Trials
9 completed trials for Ustekinumab in Inflammatory Bowel Disease
Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions
NCT03629379COMPLETEDPHASE4
20 participants
INTERVENTIONAL
Leuven, Belgium
Started: Jan 22, 2019
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
NCT02407236COMPLETEDPHASE3
961 participants
INTERVENTIONAL
Birmingham, United States +246 more
Started: Jul 10, 2015
A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease
NCT05029921COMPLETEDPHASE4
182 participants
INTERVENTIONAL
Beijing, China +28 more
Started: Dec 10, 2021
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
NCT03606499COMPLETED
111 participants
OBSERVATIONAL
Vandœuvre-lès-Nancy, France
Started: Sep 26, 2018
Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)
NCT03942120COMPLETED
685 participants
OBSERVATIONAL
Busan, South Korea +42 more
Started: Apr 8, 2019
Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells
NCT03043677COMPLETED
45 participants
OBSERVATIONAL
Started: Apr 1, 2016
Loss of RESponse to Ustekinumab Treated by Dose Escalation
NCT04245215COMPLETEDPHASE3
108 participants
INTERVENTIONAL
Zaventem, Belgium
Started: Mar 11, 2020
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
NCT01369355COMPLETEDPHASE3
1.28K participants
INTERVENTIONAL
Tucson, United States +219 more
Started: Sep 13, 2011
A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China
NCT06082986COMPLETED
200 participants
OBSERVATIONAL
Hangzhou, China +2 more
Started: Oct 9, 2023
Showing 20 of 106 total trials