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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

PubMedInflammatory bowel diseases2026-11-10

Impact of in vitro fertilization on disease activity and pregnancy outcomes in women with inflammatory bowel disease.

Khanna Rohit R, Garcia Nicole M NM, Fenton Cynthia C, Long Millie M et al.

Women with inflammatory bowel disease (IBD) increasingly utilize assisted reproductive technologies (ARTs) like in vitro fertilization and oocyte cryopreservation. Data regarding ART associated IBD flare risk are limited. We evaluated the risk of disease exacerbation among women with IBD undergoing ART. This retrospective single-center study evaluated women with IBD undergoing ART. Electronic medical records were abstracted for demographics, IBD history, and fertility history. Disease activity was assessed via medication exposure, biomarkers, and healthcare utilization 6 months pre- and post-ART. The primary outcome was disease flare (therapy modification, steroid initiation, or IBD-related hospitalization) within 6 months of ART. Secondary outcomes included successful egg retrieval, biochemical pregnancy, and live birth. Demographics were analyzed at the patient level and outcome data at the ART encounter level. We included 49 women (mean age 37.1 ± 4.01 years, body mass index 25.7 ± 4.72 kg/m2) who underwent 149 ART encounters. Most had Crohn's disease (63.3%) or ulcerative colitis (34.7%), with a mean disease duration of 13.4 ± 7.16 years. Pre-ART, therapies included ustekinumab (20.8%), anti-tumor necrosis factors (12.1%), and corticosteroids (6.7%), or no therapy (29.5%). In 149 ART encounters (86 oocyte retrievals and 63 embryo transfers), the overall disease flare rate was 3.4% (n = 5 of 149, representing 5 unique patients). Flares occurred after embryo transfer during established pregnancy (gestational week ≥8), with no flares occurring during or immediately following oocyte retrieval. Secondary endpoints showed low rates of new corticosteroid use (2.7%), IBD-related hospitalizations (0.7%), and medication dose escalation (0.7%). Among the 63 embryo transfers, biochemical pregnancy occurred in 63.5% (n = 40 of 63) and live births in 42.9% (n = 27 of 63). Across all 149 ART encounters, patients with IBD demonstrated low flare risk and live birth rates comparable to the general population. Under multidisciplinary guidance, ART is a safe and viable option in IBD.

PMID 43007293
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PubMedJournal of Crohn's & colitis2026-11-08

Risk of perianal penetrating complications among adult patients with non-penetrating Crohn's disease initiating advanced therapies: a retrospective cohort study.

Hupé Marianne M, Ahuja Dhruv D, Yeh Kuan-Hung KH, Patel Sagar B SB et al.

We conducted a retrospective cohort study comparing the risk of perianal penetrating complications with advanced therapies (AT) in patients with non-penetrating Crohn's disease (CD). Using an administrative claims database (OptumLabs Data Warehouse), we identified adult patients with CD who initiated treatment with tumor necrosis factor (TNF) antagonists, vedolizumab, ustekinumab, IL-23p19 antagonists or Janus kinase (JAK) inhibitors between 2016 and 2022. Patients with any CD-related penetrating complication, abdominal or perianal, during the baseline 1 year and up to 3 months post AT initiation were excluded. We compared on-therapy incidence and risk of developing perianal penetrating complications across different ATs, through multinomial propensity score-based inverse probability weighting. We identified 10 482 patients with non-penetrating CD who initiated TNF antagonists (n = 4463), vedolizumab (n = 2372), ustekinumab (n = 3027), IL-23p19 antagonists (n = 480) and JAK inhibitors (n = 140), of whom 360 (3.4%) developed perianal penetrating complications over a mean follow-up of 18.511.2 months. After adjusting for confounding variables, TNF antagonists (hazard ratio [HR], 0.56 [95% CI, 0.42-0.74]) and ustekinumab (HR, 0.62 [0.46-0.83]) were associated with lower risks of developing perianal penetrating complications compared with vedolizumab. Among advanced therapy-naive patients (n = 8240), TNF antagonists (HR, 0.66 [0.49-0.89]) and ustekinumab (HR, 0.69 [0.48-0.99]) were associated with lower risk of perianal penetrating complications compared with vedolizumab. Among patients with prior AT exposure (n = 2242), TNF antagonists (HR, 0.26 [0.08-0.85]) and ustekinumab (HR, 0.46 [0.30-0.72]) were associated with lower risk of perianal penetrating complications compared with vedolizumab. Among patients with non-penetrating CD starting an AT, TNF antagonists and ustekinumab were associated with a lower risk of developing perianal penetrating complications compared to vedolizumab.

PMID 42998364
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PubMedJournal of Crohn's & colitis2026-11-08

Treatment patterns and determinants of persistence with advanced therapies in adults with newly diagnosed Crohn's disease: an interim analysis of an inception cohort registry study (iCREST-CD).

Shinzaki Shinichiro S, Matsuoka Katsuyoshi K, Fujii Toshimitsu T, Okamoto Ryuichi R et al.

Multiple advanced therapies are available for the treatment of Crohn's disease (CD). Treatment patterns in newly diagnosed patients and the factors associated with persistence remain unclear. We present interim results of the iCREST-CD registry describing treatment patterns and persistence with advanced therapies. Patients aged ≥16 years with newly diagnosed CD and who had no prior exposure to advanced therapies were enrolled. Persistence of advanced therapies was estimated using Kaplan-Meier analyses, and associated factors were identified using multivariable Cox proportional hazards models. Persistence was also compared between patients who initiated therapy early or later after diagnosis. Of 672 patients (68.2% male; mean age 29.4 ± 13.1 years), 498 (74.1%) initiated advanced therapy: infliximab (IFX; 121), adalimumab (ADA; 244), ustekinumab (UST; 107), or vedolizumab (VDZ; 26). Advanced therapy was initiated within 1 year of diagnosis in 404 (60.1%). The 36-month treatment persistence rates for IFX, ADA, UST, and VDZ were 77.5%, 75.7%, 79.8%, and 49.0%, respectively. After propensity score adjustment using inverse probability of treatment weighting, the early initiation was associated with greater persistence than delayed initiation, although the difference did not reach statistical significance (hazard ratio, 0.61; 95% confidence interval, 0.35-1.09; P = .067). A high prevalence of early advanced therapy use and a high level of persistence with first-line advanced therapy were identified in this national cohort. Early initiation was associated with greater treatment persistence than delayed initiation, suggesting the potential clinical relevance of earlier advanced therapy use in routine practice. These findings require confirmation in other prospective studies aiming to evaluate early intervention strategies. The study was registered with the University Hospital Medical Information Network Clinical Trials Registry (umin.ac.jp/ctr Identifier: UMIN000032237) prior to initiation.

PMID 42998010
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PubMedFrontiers in pharmacology2026-11-08

Baseline mucosal transcriptomic endotypes stratify healing capacity and biologic therapy outcomes in ulcerative colitis: an integrative multi-cohort study.

Chen Wenbiao W, Zeng Shiyong S

Numerous baseline mucosal transcriptomic signatures have been proposed to stratify therapeutic outcomes in ulcerative colitis (UC), but cross-cohort transferability is frequently undermined by platform heterogeneity, endpoint/timepoint differences, and drug-specific biases. The resulting lack of a biologic-agnostic molecular baseline has limited clinical translation and prospective trial design. We integratively re-analyzed endpoint-linked baseline mucosal transcriptomes from seven public UC GEO series (778 unique baseline samples), with three additional public accessions used for disease-activity and contextual analyses. The primary response/healing synthesis used five study slices spanning anti-TNF, anti-integrin, and etrolizumab-treated cohorts. Unsupervised decomposition identified baseline endotypes, and endotype-outcome associations were estimated within each cohort (OR per 1-SD increase) and summarized by random-effects cross-cohort pooling with heterogeneity reporting, rank/seed sensitivity analyses, endpoint-restricted summaries, and negative controls. Across five primary response/healing study slices, an epithelial barrier endotype (EPITHELIAL_BARRIER/NMF_C3) was associated with higher odds of response/healing (random-effects cross-cohort pooling OR = 3.171, 95% CI 1.491-6.744), whereas macrophage-inflammation and lymphoid/complement-stromal axes (MACROPHAGE_INFLAMMATION/NMF_C1 and LYMPHOID_COMPLEMENT_STROMAL/NMF_C2) were associated with lower odds of response/healing (OR = 0.359, 0.175-0.735; OR = 0.378, 0.220-0.651). The epithelial estimate was largest in GSE73661 but remained significant in the five-study leave-one-out summary after excluding that cohort (OR = 2.547, 95% CI 1.271-5.105). Cross-mechanism evaluation included UNIFI ustekinumab week-8 mucosal healing (UST arm n = 358; EPITHELIAL_BARRIER OR = 4.483, 2.263-8.881) and directionally consistent effects in etrolizumab. Endotype axes were supported by independent single-cell localization (FDR = 0.0026). Treatment-interaction tests were imprecise and did not establish drug-class-specific prediction. In cohort-heldout prediction, AUC ranged from 0.717 to 0.758, but calibration was variable. A network-based therapeutic prioritization was enriched for UC-approved agents (AUC = 0.741; permutation p = 6.0 × 10- 4) and is presented as hypothesis-generating. Baseline mucosal endotypes stratify healing capacity and therapeutic outcomes across public cohorts, with orthogonal support from single-cell localization. These findings support prospective evaluation as biologic-agnostic outcome stratifiers rather than established drug-specific predictive biomarkers.

PMID 42996168
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PubMedJournal of pediatric gastroenterology and nutrition2026-11-06

Efficacy and safety of ustekinumab and vedolizumab in very early-onset inflammatory bowel disease: A multicenter study from the pediatric inflammatory bowel disease Porto Group of ESPGHAN.

Scarallo Luca L, Lionetti Paolo P, Kierkus Jaroslaw J, Collen Lauren L et al.

We aimed to assess vedolizumab and ustekinumab efficacy and safety in patients with very-early onset inflammatory bowel disease (VEO-IBD). A retrospective study involving 29 European and North American sites affiliated with the IBD Porto Group of European Society for Paediatric Gastroenterology Hepatology and Nutrition. Clinical and laboratory data were collected from patients with VEO-IBD who commenced vedolizumab or ustekinumab before 6 years of age, between 2014 and 2024. Ninety-six patients (60.4% females) were included (58 ulcerative colitis, 29 Crohn's disease, and 9 IBD-Unclassified). Median (Q1-Q3) age at diagnosis was 2.3 (0.4-4.2) years, 37 (38.5%) patients were diagnosed at age <2 years old. Thirty-seven (38.5%) patients received ustekinumab, 67 (69.7%) vedolizumab, and 11 (11.5%) both drugs. Median (Q1-Q3) follow-up time was 11 (6-26) and 14 (7-39) months for ustekinumab and vedolizumab, respectively. Eighty (84.2%) patients were previously treated with infliximab, 23 (24.2%) with adalimumab, and 20 (20.8%) with both. The median (Q1-Q3) time from diagnosis to vedolizumab and ustekinumab initiation was 15 (9-26) and 20 (11-36) months, respectively. Ustekinumab-treated patients achieved clinical remission in 24.3%, 51.4%, and 40.5% at end of induction, week 26, and week 52, with steroid-free remission in 18.9%, 45.9%, and 35.3%, respectively. Vedolizumab-treated patients achieved clinical remission in 29%, 47.5%, and 40.3%, with steroid-free clinical remission (SFCR) rates of 10.4%, 43.3%, and 37.3% at the same time points. Infectious adverse events were reported in 3 (8.3%) of ustekinumab-treated and 5 (7.6%) vedolizumab-treated patients, none severe. Ustekinumab and vedolizumab demonstrated high therapeutic durability in patients with VEO-IBD; 1-year rates of SFCR were modest.

PMID 42989841
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PubMedFrontiers in pharmacology2026-11-06

Potential association between IL-12/23, IL-23, and IL-17 inhibitors and skin cancer: a pharmacovigilance study based on the FAERS database.

Jiang Xing X, Huang Yunbei Y, Xie Min M, Peng Li L et al.

Interleukin (IL)-12/23, IL-23, and IL-17 inhibitors are increasingly used for immune-mediated inflammatory diseases, yet their long-term risk of skin cancer remains unclear due to limited evidence from randomized controlled trials. We conducted a disproportionality analysis using individual case safety reports from the FDA Adverse Event Reporting System (FAERS) from 2004 to 2025 Q2. Reporting odds ratios (ROR) and information components (IC) were calculated to assess the association between IL-12/23, IL-23, and IL-17 inhibitors and skin cancer. Subgroup analyses by age and sex, time-to-onset analysis, Weibull modeling, and co-medication interaction analysis were further performed. A total of 3,661 skin cancer reports were identified. Significant disproportionality signals were observed for most interleukin inhibitors, with the strongest associations for risankizumab (ROR 8.01, 95% CI 7.62-8.42; IC025, 2.88), tildrakizumab (ROR 5.81, 95% CI 4.13-8.19; IC025, 1.84), and ustekinumab (ROR 5.53, 95% CI 5.23-5.85, IC025, 2.35). IL-17 inhibitors showed weaker signals and were no longer significant in psoriasis-restricted sensitivity analyses. The association was more pronounced in elderly patients, especially for those aged >75 years. Weibull analysis indicated a wear-out failure pattern for ustekinumab and risankizumab, suggesting an increasing reporting frequency over time. Co-medication analyses did not reveal significant synergistic reporting signals. This pharmacovigilance study identified disproportionate reporting of skin cancer in reports involving IL-12/23 and IL-23 inhibitors, particularly risankizumab and ustekinumab, with weaker signals for IL-17 inhibitors. These findings represent signal detection from a spontaneous reporting database and highlight the need for dermatological monitoring in high-risk patients, warranting further prospective investigation to clarify clinical significance.

PMID 42991782
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