Drug Database
US

ustekinumab (Absimky / DMB 3115 / DA3115)

✓ Approved

Meiji Seika Pharma Co., Ltd. · IL12B · Monoclonal Antibodies

What is ustekinumab?

ustekinumab is a monoclonal antibodies developed by Meiji Seika Pharma Co., Ltd.. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesAbsimky, DMB 3115, DA3115
CompanyMeiji Seika Pharma Co., Ltd.
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetIL12B, IL23A
RouteInjectable (Others), Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Meiji Seika Pharma Co., Ltd.

Mechanism of Action

Molecular Targets

ustekinumab acts on 2 molecular targets:

IL12Binterleukin 12B (CLMF2, CLMF)
IL23Ainterleukin 23 subunit alpha (P19, SGRF)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

ustekinumab is developed for 4 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Skin and subcutaneous tissue disordersPsoriasis✓ Approved
Gastrointestinal disordersColitis ulcerative✓ Approved
Gastrointestinal disordersCrohn's disease✓ Approved
Musculoskeletal and connective tissue disordersPsoriatic arthropathy✓ Approved

Related Research Articles

PubMedJPGN reports2026-07-25

The safe and effective use of tofacitinib and ustekinumab combination therapy in infantile onset inflammatory bowel disease.

Mahajan Smridhi S, Wysocki Christian C, Gurram Bhaskar B

Infantile-onset inflammatory bowel disease (IOIBD) is a rare and severe subset of very-early-onset IBD, often associated with immune dysregulation and poor response to conventional therapies. Data regarding the use of Janus kinase inhibitors (JAKI) in this population is limited. We conducted a retrospective chart review of four patients treated with tofacitinib in combination with ustekinumab after failing multiple agents at a tertiary referral center. All four patients demonstrated clinical, laboratory, and endoscopic remission. No adverse events were observed. Genetic evaluation did not reveal monogenic causes in any of these patients. These findings suggest that JAKI may represent a safe and effective therapeutic option for carefully selected patients with difficult-to-treat IOIBD, either as a bridge to or in combination with ustekinumab. Larger prospective studies are warranted to better define the role of JAKI in this challenging patient population.

PMID 42499735
Read full article →
PubMedFrontiers in medicine2026-07-25

Efficacy of Ustekinumab for the treatment of perianal fistulizing Crohn's disease: a multicentre retrospective study.

Li Youran Y, Sun Xiaomei X, Wen Ke K, Lu Lu L et al.

Perianal fistulizing Crohn's disease (pfCD) is a refractory complication of Crohn's disease (CD) with limited therapeutic options, particularly for patients failing anti-tumor necrosis factor agents. Ustekinumab (UST) shows promise in pfCD, but long-term outcomes and predictive factors remain unclear. This multicenter retrospective study enrolled 163 pfCD patients treated with UST (2020-2023) with a median 15-month follow-up. Primary endpoints were fistula response and clinical remission rates. Univariate/multivariate logistic regression identified healing predictors, and a nomogram was developed for outcome prediction. At final follow-up, the fistula response rate was 88.3% and clinical remission rate 70.1%. Significant improvements were observed in inflammatory biomarkers (CRP: 21.2 ± 28.3 → 5.2 ± 8.9 mg/L; ESR: 36.6 ± 24.5 → 14.5 ± 18.3 mm/h) and hemoglobin (126.8 ± 18.5 → 148.2 ± 25.6 g/L; all p < 0.001). Definitive surgery (adjusted OR = 9.613, p < 0.001) and fewer prior biologics (adjusted OR = 0.541, p = 0.006) were independent healing predictors. The nomogram exhibited good discriminative ability (AUC = 0.852 for 24-week remission). UST was well-tolerated (adverse event rate = 7.4%) with no severe safety issues. UST demonstrated clinically meaningful efficacy within a combined multidisciplinary strategy for pfCD, with fistula response and clinical remission rates of 88.3 and 70.1%, respectively, though MRI-confirmed healing was modest (14.2%). Definitive surgery and fewer prior biologic exposures predicted better fistula healing. The developed nomogram facilitates individualized treatment decision-making.

PMID 42500534
Read full article →
PubMedGut2026-07-25

Ustekinumab for fistulising perianal Crohn's disease: a randomised placebo-controlled trial from the GETAID.

Wils Pauline P, Nancey Stéphane S, Messmer Elodie E, Bourreille Arnaud A et al.

Fistulising perianal Crohn's disease (CD) remains a debilitating condition, with few randomised controlled trials conducted so far. To evaluate the efficacy and safety of ustekinumab (UST) in patients with CD with active draining perianal fistulas (NCT04496063) in a randomised placebo-controlled trial. In this double-blind, multicentre Groupe d'Etudes Therapeutiques des Affections Inflammatoires Digestives trial, patients enrolled with active fistulising perianal CD were randomised 1:1 to receive UST (6 mg/kg intravenously at baseline followed by 90 mg subcutaneously at week 8, then every 8 weeks) or placebo, after standardised surgical management. The primary endpoint was combined clinical remission (absence of drainage from all external fistula openings) and radiological remission (absence of abscesses >2 cm on blinded central MRI) at week 12. At week 12, placebo non-responders could switch to UST, and UST non-responders could be intensified during the open-label phase. 32 patients were randomised (UST: 16; placebo: 16) across 10 French centres and 69% had prior anti-tumour necrosis factor failure. At week 12, combined remission was achieved in 62% with UST versus 25% with placebo (OR=5.1 (95% CI 1.07-24.4)). Clinical remission occurred in 62.5% vs 31% (OR=3.75 (95% CI 0.84 to 16.8)) and radiological remission in 87.5% vs 75% (OR=2.7 (95% CI 0.34 to 21.1)). Nine placebo-patients switched to UST during the open-label phase. Combined remission rates at week 48 were 50% in the placebo arm and 31% in the UST arm, respectively. These findings suggest greater short-term clinical benefit with UST compared with placebo and support its use in patients with active fistulising perianal CD. NCT04496063.

PMID 42498622
Read full article →
PubMedJournal of Crohn's & colitis2026-07-21

Corticosteroid-sparing effects of risankizumab versus ustekinumab in patients with moderately to severely active Crohn's disease: post hoc results from the phase 3b SEQUENCE trial.

Raine Tim T, Danese Silvio S, Schreiber Stefan S, Gao Xiang X et al.

This post hoc analysis evaluated the corticosteroid-sparing effects of risankizumab (RZB) versus ustekinumab (UST) in patients with moderate to severe Crohn's disease (CD) with prior inadequate response or intolerance to ≥ 1 anti-tumor necrosis factor (TNF) therapy. SEQUENCE (NCT04524611) was an open-label, multicenter, randomized, efficacy assessment-blinded study. Patients were randomized 1:1 to receive RZB (intravenous [IV] 600 mg induction dose at weeks 0, 4, and 8, then a subcutaneous [SC] 360 mg maintenance dose every 8 weeks [Q8w] starting at week 12) or UST (single weight-based IV induction dose, then a SC 90 mg maintenance dose Q8w starting at week 8) up to week 48. Patients tapered corticosteroids beginning at week 2. Achievement of clinical, endoscopic, and quality of life outcomes without concomitant use of steroids ("corticosteroid-free") and safety were assessed. In patients taking corticosteroids at baseline, response rate differences by the week 24 and 48 timepoints with RZB versus UST were 10.5% and 25.4% (P ≤ .01) for corticosteroid-free clinical remission per CD activity index and 20.4% (P ≤ .001) and 29.2% (P ≤ .01) per stool frequency/abdominal pain score, and 23.0% and 20.2% (both P ≤ .01) for corticosteroid-free endoscopic remission. Similar results were also observed for additional corticosteroid-free endpoints, including endoscopic, composite (clinical + endoscopic), and quality of life outcomes. Numerically higher exposure-adjusted event rates of serious infections and hypersensitivity with RZB and UST were observed with corticosteroid use. In patients with CD refractory to anti-TNF therapy, higher rates of corticosteroid-free clinical, endoscopic, and quality of life outcomes were achieved with RZB versus UST. Both treatments were well-tolerated. NCT04524611.

PMID 42479626
Read full article →
PubMedBMC gastroenterology2026-07-21

Meta-analysis: safety and efficacy of ustekinumab in pediatric inflammatory bowel disease patients with anti-TNF failure.

Heng Zhaoyang Z, Zhan Li L, Zhang Yuhan Y, Xu Keyou K et al.

Evidence for ustekinumab (UST) in pediatric inflammatory bowel disease (IBD) is limited, particularly in patients who do not respond to anti-tumor necrosis factor (anti-TNF) therapy. We conducted a meta-analysis to evaluate the efficacy and safety of UST in pediatric IBD after anti-TNF failure. PubMed, Cochrane Library, Embase, and Web of Science were searched from inception through August 2025. We included studies reporting outcomes of UST in pediatric IBD patients with prior anti-TNF failure. Pooled estimates were calculated using fixed- or random-effects models according to heterogeneity (I2). Fifteen studies including 653 pediatric patients were analyzed. Pooled clinical remission rates were 57% (95% CI, 28%-86%) at 8-16 weeks and 68% (95% CI, 58%-79%) at week 52. Steroid-free clinical remission was 44% (95% CI, 38%-49%) at 8-16 weeks and 58% (95% CI, 45%-70%) at week 52. The pooled endoscopic remission rate was 42% (95% CI, 35%-49%) and a biochemical remission rate of 63% (95% CI, 40%-87%). Adverse events occurred in 20% of patients (95% CI, 9%-30%), and serious adverse events occurred in 1% (95% CI, 0%-2%). At week 52, clinical remission rates were 69% in Crohn's disease (CD) and 65% in ulcerative colitis (UC). In pediatric IBD patients with prior anti-TNF failure, UST was associated with favorable pooled remission rates and an acceptable safety profile, although substantial inter-study heterogeneity warrants cautious interpretation. These findings support UST as a feasible therapeutic option in this refractory pediatric setting; while highly generalizable to pediatric CD, the findings for the UC subgroup offer important preliminary evidence that warrants cautious interpretation due to limited precision.

PMID 42477587
Read full article →
PubMedThe American journal of gastroenterology2026-07-17

Absolute risk of malignancy by treatment in patients with Crohn's disease compared to the general population: a nationwide population-based cohort study.

Everhov Åsa H ÅH, Eriksson Julia J, Söderling Jonas J, Askling Johan J et al.

Real-world data quantifying absolute cancer risk in Crohn's disease (CD) by treatment status are lacking but are essential for patient counselling. We linked nationwide Swedish register data and assessed incident cancers overall and by type in patients with CD 2007-2023. We estimated age-stratified incidence rate (IR) differences compared to the general population in a "once-exposed-always-exposed" design. Treatment cohorts comprised new users of thiopurine, tumor necrosis factor inhibitors (TNFi), thiopurine+TNFi, vedolizumab, ustekinumab, and patients naïve to immunomodulatory drugs. We followed 38,733 patients and 360,616 comparator subjects for a median 7.3 years. The IR differences for any cancer (number of excess cancers in each treatment cohort per 1,000 person-years versus the matched population) were 2.43 (95%CI:1.92;2.94) for the naive cohort; 3.14 (95%CI:2.50;3.78) for thiopurine-treated, 2.42 (95%CI:1.63;3.22) for TNFi-treated, 2.59 (95%CI:1.53;3.64) for thiopurine +TNFi, 2.61 (95%CI:-0.08;5.30) for vedolizumab, and 1.54 (95%CI:-1.34;4.41) for ustekinumab. The excess cancer incidence was primarily due to non-melanoma skin cancer (squamous cell and basal cell carcinoma). After exclusion of non-melanoma skin cancers, the excess overall cancer incidence was 1.27 to 0.96 cases/1,000 person-years in the naïve, thiopurine, and TNFi-treated groups, but not significantly increased in the other. IR differences for overall cancer increased and HRs decreased with increasing patient age. Elevated overall cancer incidence was observed across all treatment cohorts, also in treatment-naïve patients. After exclusion of non-melanoma skin cancer, the excess cancer incidence in CD was around 1 extra case per 1,000 person-years due to lung-, small bowel -, hepatobiliary, and hematologic cancer.

PMID 42467952
Read full article →

+3967 more articles available with a free account

Sign up free to view all articles →

Ask about ustekinumab