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ustekinumab (Absimky / DMB 3115 / DA3115)

✓ Approved

Meiji Seika Pharma Co., Ltd. · IL12B · 单克隆抗体

什么是 ustekinumab？

ustekinumab 是一种单克隆抗体，由Meiji Seika Pharma Co., Ltd.研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Subcutaneous Injection。

药物档案

商品名Absimky, DMB 3115, DA3115
公司Meiji Seika Pharma Co., Ltd.
药物类别单克隆抗体, 抗体
分子靶点IL12B, IL23A
给药途径Injectable (Others), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Meiji Seika Pharma Co., Ltd.

作用机制

分子靶点

ustekinumab 作用于 2 个分子靶点：

IL12Binterleukin 12B (CLMF2, CLMF)
IL23Ainterleukin 23 subunit alpha (P19, SGRF)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

ustekinumab 针对 4 个适应症，涉及 3 个治疗领域。

治疗领域疾病/病症分期
Skin and subcutaneous tissue disordersPsoriasis✓ Approved
Gastrointestinal disordersColitis ulcerative✓ Approved
Gastrointestinal disordersCrohn's disease✓ Approved
Musculoskeletal and connective tissue disordersPsoriatic arthropathy✓ Approved

相关研究文献

PubMedCureus2026-09-09

Severe Dupilumab-Associated Psoriasis Flare After Switching From Ustekinumab for Biopsy-Proven Eczematous Dermatitis: A Case Report.

AlAwadhi Doaa D, AlQusaimi Reem R, AlRujaib Fawziah F, AlSharhan Fahad F et al.

Dupilumab is an effective treatment for moderate-to-severe atopic dermatitis but has been increasingly associated with paradoxical psoriasis and psoriasiform manifestations. Severe exacerbation of pre-existing psoriasis following dupilumab therapy remains uncommon and presents a therapeutic challenge. We report a patient with well-controlled chronic plaque psoriasis who developed eczematous dermatitis with histopathological findings consistent with the diagnosis. Although dupilumab effectively controlled the eczema, the patient subsequently developed a severe generalized psoriasis flare after switching from ustekinumab. Clinical improvement was achieved after restarting ustekinumab and methotrexate. This case highlights the potential for dupilumab to trigger severe paradoxical psoriasis in patients with pre-existing psoriatic disease. Clinicians should remain vigilant when prescribing dupilumab in this population, and early recognition with prompt modification of therapy may lead to favorable clinical outcomes.

PMID 42713476
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PubMedRevista espanola de enfermedades digestivas2026-09-09

Ustekinumab combined with upadacitinib promotes endoscopic healing in moderate-to-severe Crohn's disease with anti-TNF-α failure.

Liu Changqin C, Geng Qi Q, Lu Lu L, An Ping P et al.

Anti-tumor necrosis factor-α (TNF-α) therapy failure in moderate-to-severe Crohn's disease (CD) represents a major clinical challenge. However, the exploration of advanced combination therapy offers a promising direction. This study compared the efficacy of ustekinumab (UST) plus upadacitinib (UPA) with either agent as monotherapy in these patients. In this multicenter, retrospective study, 110 moderate-to-severe CD patients with anti-TNF-α failure were categorized into three groups according to the treatment they received: UST + UPA 30 mg (n = 41), UST monotherapy (n = 40), or UPA 45 mg monotherapy (n = 29). The primary outcome was endoscopic remission at 12-24 weeks, with secondary outcomes including clinical remission, clinical and endoscopic response, and safety. Following 12-24 weeks of treatment, UST + UPA 30 mg demonstrated superior efficacy. The combination group achieved significantly higher rates of endoscopic remission (51.2% vs. 17.5% UST, 24.1% UPA; p = 0.0029). The clinical remission rate in the combination group (85.4%) was significantly higher than that in the UST group (37.5%, p < 0.0001) but not significantly different from that in the UPA group (75.9%, p = 0.3138). All groups exhibited improvements in disease activity scores and inflammatory bowel disease questionnaire from baseline. Treatment-related adverse events occurred in 19.5%, 2.5%, and 13.8% of patients in the combination, UST, and UPA groups, respectively, with no serious events reported. For moderate-to-severe CD patients with anti-TNF-α therapy failure, the UST combined with UPA 30 mg regimen showed superior endoscopic healing to either monotherapy, with a tolerable safety profile. These findings suggest that this combination strategy may represent an effective treatment option for such CD patients.

PMID 42714117
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PubMedWorld journal of gastrointestinal pharmacology and therapeutics2026-09-08

Beyond class switching in multi-refractory inflammatory bowel disease: Nine case reports and review of literature.

Soldera Jonathan J, Pertile Maria Antonia Selbach MAS, Carobin Leticia Nodari LN, Brambilla Daniel Jun Funatsu DJF et al.

A clinically relevant subset of patients with inflammatory bowel disease (IBD) remain partial responders despite multiple advanced therapies. In this setting, reflexive class switching risks forfeiting incremental mechanistic gains, whereas a deliberate "build-on-partial-response" strategy - through dose optimization, extended induction, and, in selected cases, advanced combination therapy (ACT) [an oral Janus kinase inhibitor (iJAK) plus a biologic] - may consolidate disease control. However, real-world data supporting ACT remain limited, particularly regarding phenotype-driven selection, objective reassessment, and safety considerations. We report nine multi-refractory IBD patients [ulcerative colitis (UC), n = 5; Crohn's disease, n = 4] managed with ACT after incomplete response to an initial advanced therapy. UC strategies included infliximab plus tofacitinib, ustekinumab plus tofacitinib, and vedolizumab combined with iJAK. Crohn's disease cases illustrate three patterns: Add-on anti-tumor necrosis factor therapy after partial iJAK response (e.g., upadacitinib plus adalimumab in two patients with stenosing or perianal phenotypes), interleukin-23 pathway intensification combined with iJAK (guselkumab plus tofacitinib), and phenotype discordance between extraintestinal and luminal disease control. Overall, 8/9 patients (89%) achieved clinical response with improvement in biochemical markers and/or endoscopic findings; among these, 6/9 (67%) achieved documented deep remission (clinical and biochemical, with endoscopic confirmation in 5/6). One patient with severe refractory UC failed ustekinumab plus tofacitinib and infliximab rescue and proceeded to colectomy with ileal pouch construction (11%). Patients did not present any adverse event associated with therapy, only secondary to uncontrolled disease. In multi-refractory IBD, add-on ACT may convert partial response into deep remission, averting surgery in selected patients.

PMID 42707483
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PubMedAdvances in therapy2026-09-08

Comparative Cost-Effectiveness of Advanced Treatment Sequences for Moderately to Severely Active Ulcerative Colitis in Japan.

Kamei Kazumasa K, Enami Miwa M, Matsuda Hiroyuki H, Yamagami Katsuya K et al.

Ulcerative colitis (UC) is a chronic immune-mediated inflammatory disease characterized by a relapsing course, substantial symptom burden, and long-term healthcare utilization. Although multiple advanced therapies (ATs) are available for patients with moderately to severely active UC, evidence to guide optimal treatment sequencing remains limited, particularly in Japan. This study evaluated the cost-effectiveness of clinically relevant AT sequences for moderately to severely active UC in Japan. A hybrid decision-tree and Markov model was developed to compare AT sequences over a lifetime horizon from the payer perspective. The model captured both induction and maintenance phases for each therapy. Efficacy and safety inputs were derived from a previously published Bayesian network meta-analysis and supplemented with Japan-specific clinical and economic data. Costs and quality-adjusted life years (QALYs) were discounted at an annual rate of 2.0%. Incremental cost-effectiveness ratios (ICERs) were calculated, and cost-effectiveness was assessed against a Japanese cost-effectiveness threshold of JPY 7,500,000 per QALY (USD 49,547 per QALY). A total of 79 treatment sequences were evaluated. First-line etrasimod followed by second-line upadacitinib yielded the greatest health benefit (17.801 QALYs). Four treatment sequences-infliximab followed by ustekinumab, infliximab followed by etrasimod, infliximab followed by upadacitinib, and etrasimod followed by upadacitinib-were located on the efficiency frontier. Compared with infliximab-ustekinumab, infliximab-etrasimod resulted in an ICER of JPY 1,095,181 (USD 7235) per QALY. In turn, infliximab-upadacitinib had an ICER of JPY 1,218,896 (USD 8052) per QALY compared with infliximab-etrasimod. Etrasimod-upadacitinib had an ICER of JPY 6,684,442 (USD 44,160) per QALY compared with infliximab-upadacitinib. All ICERs were below the Japanese cost-effectiveness threshold. Under the assumptions of this model, a treatment sequence with first-line etrasimod followed by second-line upadacitinib was identified as the most cost-effective strategy for advanced therapy-naïve patients with moderately to severely active UC in Japan.

PMID 42709323
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PubMedDigestive diseases (Basel, Switzerland)2026-09-07

Pretreatment Histopathological Features are Associated with Ustekinumab Efficacy in Ulcerative Colitis: A Retrospective Pilot Study.

Horii Toshiki T, Ikehara Hisatomo H, Harada Yohei Y, Fukagawa Naomi N et al.

Biologic therapy options for ulcerative colitis (UC) have increased in recent years. Although predicting treatment response may support personalized treatment strategies, the predictive value of histopathological features in UC remains unclear. This exploratory study aimed to evaluate the association between ustekinumab effectiveness and pre-treatment histopathological findings. This single-center, retrospective, observational pilot study included patients with moderate-to-severe UC who were administered ustekinumab at the Kitasato University Hospital between April 2020 and March 2024. The endpoints were the relationship between pre-treatment histopathological findings, assessed using the Geboes score, and clinical efficacy at weeks 8 and 52, stratified by prior exposure to advanced therapies. The study enrolled 33 patients. Among advanced therapy-naïve (AT-naïve) patients, responders at week 8 were significantly more likely to have low neutrophilic infiltration in the lamina propria than non-responders (66.7% vs. 0%, p = 0.03). Among advanced therapy-exposed (AT-exposed) patients, the degree of neutrophilic or eosinophilic infiltration in colonic tissue at week 8 did not differ significantly between responders and non-responders. Among AT-naïve patients, those who achieved clinical remission at week 52 tended to have mild eosinophilic infiltration in the lamina propria compared with non-responders (80.0% vs. 33.3%, p = 0.07). Among AT-exposed patients, the degree of neutrophilic or eosinophilic infiltration in colonic tissue at week 52 did not differ significantly between responders and non-responders. In moderate-to-severe UC, pre-treatment mucosal histopathological assessment may serve as a treatment response marker. This information can guide development of personalized treatment strategies.

PMID 42704744
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PubMedTherapeutic advances in gastroenterology2026-09-06

Pregnancy safety of biologics in inflammatory bowel disease: A systematic review and network meta-analysis.

Huang Chih-Wen CW, Yen Hsu-Heng HH, Chen Yang-Yuan YY, Su Pei-Yuan PY et al.

Biologic safety during pregnancy in patients with inflammatory bowel disease (IBD) remains a clinical concern, particularly with the increasing use of novel agents such as ustekinumab (UST) and vedolizumab (VDZ). A network meta-analysis (NMA) was performed to compare pregnancy-related outcomes among various biological agents and nonbiologic-exposed patients. Systematic review and frequentist random-effects NMA of comparative observational studies. This study systematically searched from inception to 23 March 2025 for comparative studies reporting pregnancy outcomes in biologics or conventional therapies (CT)-exposed patients with IBD. Outcomes included preterm birth, congenital malformation (CM), low birth weight (LBW), and spontaneous abortion. An NMA model was applied. Subgroup analysis was conducted for studies with comparable baseline disease activity between the treatment groups. This NMA included 12 studies. Anti-tumor necrosis factor alpha (TNF-α) agents were not associated with an increased risk of any adverse pregnancy outcomes. UST and VDZ were associated with increased CM risks (UST: odds ratio [OR]: 2.32 [1.31-4.10]; VDZ: OR: 1.98 [1.11-3.52]), and VDZ was associated with LBW (OR: 2.17 [1.15-4.11]). These associations were not significant in the subgroup analyses limited to studies with similar disease activity. Sensitivity analysis revealed that a single important study influenced the CM risk of UST/VDZ, whereas the LBW risk with VDZ remained consistent. This is the first NMA to comprehensively assess the pregnancy-related safety of biologic therapies, including the novel biologics VDZ and UST, in patients with IBD. Anti-TNF agents have the most robust pregnancy safety evidence and were not associated with an increased risk of adverse pregnancy outcomes in this analysis. The findings for UST and VDZ should be framed as exploratory and potentially affected by residual confounding, as the observed risk signals were not consistently maintained in the additional analyses. INPLASY202540012.

PMID 42699013
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