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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

PubMedAnnals of dermatology2026-08-04

Factors Associated With PASI90 Maintenance Without Flare-Up and Predictors of Biologics Discontinuation in Psoriasis: Two-Center Retrospective Cohort Study in Korea.

Choi Mi Soo MS, Yeom Kyujin K, Jung Seung-Won SW, Hong Seung Phil SP et al.

Biologics targeting key cytokines have enabled near-complete clearance in psoriasis treatment. As 90% reduction in the Psoriasis Area and Severity Index (PASI90) emerges as a meaningful goal of treatment, maintaining PASI90 without flare-up has become important. To identify factors associated with PASI90 maintenance for ≥1 year without flare-up and predictors of drug discontinuation. This multicenter retrospective cohort study included moderate-to-severe plaque psoriasis patients treated with adalimumab, ustekinumab, secukinumab, ixekizumab, guselkumab, or risankizumab (2010-2022). Treatment courses were defined as "Episodes." Patients with ≥2 years of therapy were analyzed. Relative risks (RR) for PASI90 maintenance were estimated using generalized linear mixed models, and Cox proportional hazards models assessed drug discontinuation. Among 136 patients (189 episodes), 40.1% of 162 eligible episodes achieved PASI90 maintenance without flare-up for ≥1 year. Secukinumab significantly increased the likelihood of PASI90 maintenance (RR, 2.1; 95% confidence interval [CI], 1.27-3.49). Body mass index (BMI) <30 and first biologic episode showed favorable with only trend toward significance. Psoriasis Area and Severity Index response at week 16 and first assessment strongly predicted maintenance (area under the curve, 0.80-0.82). Regarding drug discontinuation, drug were discontinued in 28.6% of episodes; BMI ≥30, family history of psoriasis, and adalimumab (hazard ratio, 4.50; 95% CI, 1.57-12.90 vs. ustekinumab) were associated with higher risk of drug discontinuation. Secukinumab, lower BMI, and biologic-naïve status favored durable PASI90 without flare-up. Obesity, family history, and adalimumab predicted drug discontinuation. Early treatment response strongly predicted long-term efficacy.

PMID 42547477
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PubMedSkin health and disease2026-08-02

Markedly improved disease control in Darier disease (ATP2A2-nonsyndromic epidermal differentiation disorder) with ustekinumab versus other biologics: a case series.

Skarnvad Andersen Anna A, Baez Elena E, Emmanuel Thomas T, Rønholt Kirsten K et al.

In this case series, we report six patients with severe, treatment-refractory Darier disease, or dyskeratosis follicularis, also known as ATP2A2-nEDD (nonsyndromic epidermal differentiation disorder), treated with off-label biologic therapy, including dupilumab (n = 3), secukinumab followed by guselkumab (n = 1), and ustekinumab (n = 2). All patients had longstanding disease with recurrent flares, frequent infections and substantial impairment of quality of life, despite multiple conventional treatments. All biologic treatments were well tolerated, with no serious adverse events. Dupilumab consistently improved pruritus but had limited effects on skin lesions. Secukinumab and guselkumab provided only transient or partial disease control. In contrast, both patients treated with ustekinumab achieved pronounced and sustained clinical improvement, with markedly reduced disease severity and pruritus, and considerable improved quality of life. The pronounced and sustained responses observed with ustekinumab support its prioritization for future studies in Darier disease.

PMID 42539885
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PubMedCureus2026-08-02

Real-World Drug Retention and Safety of Ustekinumab in Patients With Inflammatory Bowel Disease in Qatar: A Retrospective Cohort Study.

Hamid Abdulwahab A, Badi Ahmed A, Ayash Ahmad A, Bensuleiman Yahaya Y et al.

Inflammatory bowel disease (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), is an increasingly recognized condition in the Middle East and North Africa (MENA) region, yet real-world data on advanced therapies from this population remain scarce. Ustekinumab, a fully human monoclonal antibody targeting the shared p40 subunit of interleukin-12 and interleukin-23, has demonstrated efficacy and safety in pivotal randomized controlled trials for both CD and UC. However, its real-world performance in MENA populations has not been well characterized. This study aimed to evaluate the real-world drug retention, safety profile, and predictors of treatment discontinuation of ustekinumab in patients with IBD at two major referral centers in Qatar. This was a retrospective, observational cohort study conducted at two IBD referral centers in Qatar (the Ambulatory Care Center and Al Khor Hospital, Hamad Medical Corporation). Adult patients (≥18 years) with a confirmed diagnosis of CD or UC who received at least one induction dose of ustekinumab were included. The primary outcome was drug retention at 6, 12, and 24 months. Secondary outcomes included the safety profile. The study was approved by the Medical Research Committee of Hamad Medical Corporation (MRC-01-25-1395). A total of 345 episodes were included (216 CD, 129 UC). Overall retention at 6, 12, and 24 months was 92.2%, 83.9%, and 77.8%, respectively. CD exceeded UC at all time points; the difference reached statistical significance at six months (95.4% vs. 86.8%; p = 0.011) but attenuated at 12 months (86.5% vs. 79.5%; p = 0.163) and 24 months (81.0% vs. 72.4%; p = 0.087). Discontinuation occurred in 79 episodes (22.9%); primary non-response (10.7%) and secondary loss of response (10.1%) were the main causes. Adverse events were documented in 14 episodes (4.1%); serious adverse events in 5 (1.4%). No malignancies or deaths were recorded. Shorter pre-treatment disease duration was a consistent predictor of discontinuation across all time points (6 months: p = 0.046; 12 months: p = 0.028; 24 months: p = 0.045). Disease type also met the significance threshold at six months (p = 0.011), with patients with UC demonstrating higher early discontinuation rates than those with CD. In this retrospective cohort study, ustekinumab demonstrated high drug retention and an acceptable safety profile in a predominantly Arab IBD population in Qatar. Shorter disease duration prior to ustekinumab initiation was associated with treatment discontinuation across multiple time points, while patients with CD showed higher retention than those with UC at six months (p = 0.011). These findings suggest that disease type and timing of biologic initiation may be associated with ustekinumab persistence in this population. Further prospective studies are needed to confirm these observations in MENA populations with IBD.

PMID 42539933
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PubMedSkin health and disease2026-08-02

Drug survival of biologic treatments for psoriasis and psoriatic arthritis in Denmark, 2018-23: a nationwide register-based cohort study.

Kim Sejun S, Jensen Andreas A, Egeberg Alexander A, Stensballe Lone Graff LG

Psoriasis is a chronic inflammatory skin condition. It is being increasingly treated with biologic agents targeting specific immune pathways. These treatments target specific immune system pathways involved in the disease. Drug survival (how long patients remain on a given treatment) is a key measure of long-term effectiveness and safety. To analyse the drug survival rates of approved biologics for psoriasis using Danish nationwide register-based data from 2018 to 2023. This study used a nationwide register-based cohort of patients diagnosed with psoriasis in Denmark who were treated with biologics between 2018 and 2023. Patients were stratified by the presence or absence of psoriatic arthritis (PsA). Drug survival was assessed using Kaplan-Meier curves, and the rate of discontinuation was analysed using Cox proportional hazards regression models. Of the biologics studied, infliximab had the highest 1-year drug survival (49%), followed by ustekinumab (42%). Bimekizumab, the most recently introduced biologic in Denmark, had a 19% drug survival rate after 349 days. Ustekinumab had longer persistence in patients who only had psoriasis, but the drug survival rate was reduced in patients with PsA. In contrast, infliximab maintained robust performance across both patient groups, with a significantly lower risk of discontinuation compared with ustekinumab (hazard ratio 0.59, 95% confidence intervals 0.53-0.67), particularly in patients with PsA. Drug survival differed across biologic treatments and according to PsA status. Infliximab had higher overall drug survival, particularly in patients with PsA. Ustekinumab had greater treatment persistence in patients without PsA but lower drug survival in those with PsA.

PMID 42540015
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PubMedExpert review of clinical immunology2026-07-31

Ustekinumab for the treatment of psoriasis: a well-established therapy primed for resurgence.

Raheel Omar O, Uche Alexander A, Do Pauline P, McGuirt Victoria V et al.

Ustekinumab has been an approved biologic therapy for moderate-to-severe psoriasis for over 16 years. With the emergence of newer IL-17 and IL-23 inhibitors, its use was largely supplanted by these more effective treatments. With the introduction of biosimilars, ustekinumab's potential role in the current treatment landscape warrants reassessment, as insurers may encourage first line use again. This review summarizes the mechanism of action, clinical trial data, real-world evidence, and biosimilar development of ustekinumab in psoriasis. A literature search was conducted using PubMed and relevant clinical trial databases, focusing on studies published from 2008 to 2025. Key trials, including PHOENIX, ACCEPT, CLEAR, and UltIMMa, as well as registry data and recent observational studies, are discussed to evaluate efficacy, safety, and comparative effectiveness. While newer biologics are more effective, ustekinumab remains a good option due to its dosing convenience, established safety profile, efficacy for the common psoriatic arthritis comorbidity, and lower cost afforded by ustekinumab biosimilars. In health systems that prioritize exclusively efficacy and safety, ustekinumab may play little role in psoriasis management. However, in systems that prioritize lower cost treatment, biosimilar adalimumab and ustekinumab could be preferred first line treatments, and of these two, ustekinumab may be preferred over adalimumab because of greater efficacy, better safety, and fewer injections.

PMID 42536885
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PubMedGastroenterology report2026-07-31

Real-world data on clinical response to inflammatory bowel disease biological treatments in patients with concurrent primary sclerosing cholangitis: a case-control study.

Tosse Robert R, Maibier Martin M, Fischer Andreas A, Razpotnik Marcel M et al.

The intestinal therapy response in patients with primary sclerosing cholangitis-associated inflammatory bowel disease (PSC-IBD) is not well explored. This study compared the intestinal therapy response to biological therapies in patients with PSC and IBD (PSC-IBD group) vs patients with IBD alone (IBD group). We performed a case-control study and identified 46 patients in the PSC-IBD group and 180 in the IBD group who were treated with infliximab, vedolizumab, and/or ustekinumab at the IBD outpatient clinic of Charité-Universitätsmedizin Berlin, Campus-Virchow-Klinikum. To account for differences in demographics and disease characteristics, propensity score matching (ratio 1:1) was performed. The primary outcome was clinical therapy response within 20 weeks, defined as remission (partial Mayo Score ≤ 1 or Harvey-Bradshaw-Index < 5) or partial response (decrease of partial Mayo Score ≥ 2 or a decrease of Harvey-Bradshaw-Index > 3). Secondary outcomes included treatment persistence, endoscopic response, decrease in faecal calprotectin, concomitant medication and safety. After matching, 46 patients per group were analysed (median follow-up: PSC-IBD: 44 months; IBD: 60 months), with a total of 136 treatments administered. The cohort demographics and disease characteristics were balanced between both groups. While clinical response rates did not significantly differ between groups in patients receiving infliximab or vedolizumab, in patients receiving ustekinumab, clinical response rates within the first 20 weeks were significantly lower in the PSC-IBD group (9 of 21, 42.9%) compared with the IBD group (20 of 26, 76.9%; P = 0.017). Treatment persistence after 12 months of patients on biological therapy did not differ significantly between groups across all therapies, but a numerically lower persistence rate was observed for ustekinumab in the PSC-IBD group (6 of 21, 28.6%) compared with the IBD group (10 of 22, 45.5%; P = 0.252). Infliximab and vedolizumab appear equally effective for achieving clinical response in patients with PSC-IBD and IBD, while the early clinical response to ustekinumab was significantly lower in patients with PSC-IBD.

PMID 42535014
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