Meiji Seika Pharma Co., Ltd. · IL12B · 单克隆抗体
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。
| 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 |
ustekinumab 作用于 2 个分子靶点：
| IL12B | interleukin 12B (CLMF2, CLMF) |
| IL23A | interleukin 23 subunit alpha (P19, SGRF) |
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 disorders | Psoriasis | ✓ Approved |
| Gastrointestinal disorders | Colitis ulcerative | ✓ Approved |
| Gastrointestinal disorders | Crohn's disease | ✓ Approved |
| Musculoskeletal and connective tissue disorders | Psoriatic arthropathy | ✓ Approved |
Shobatake Chinatsu C, Miyagawa Fumi F, Mitsui Yasuhiro Y, Nakanishi Yukiko Y et al.
Yan Lihua L, Luo Xiaodong X, Chen Shuochun S, Zhang Jifan J et al.
To evaluate the longitudinal evolution of transabdominal bowel ultrasound parameters during ustekinumab therapy in patients with postoperative recurrence of Crohn's disease (CD), and to investigate the association between ultrasound changes and clinical and biochemical outcomes. This retrospective longitudinal study included 65 patients with endoscopically confirmed postoperative recurrence of CD who received ustekinumab therapy between April 2020 and December 2024. Patients were classified into improvement and non-improvement groups according to endoscopic outcomes at week 24. Serial transabdominal bowel ultrasound examinations were performed at baseline and at weeks 8, 16, and 24, including assessment of bowel wall thickness, Limberg vascularity grade, bowel wall stratification, perienteric fat edema, and luminal stenosis. Longitudinal changes in ultrasound parameters were analyzed using mixed-effects models and generalized estimating equations, as appropriate for each outcome type. Associations between bowel wall thickness changes and clinical/biochemical outcomes were evaluated using Spearman correlation analysis. Distinct temporal response patterns were observed among bowel ultrasound parameters during ustekinumab therapy. In the improvement group, bowel wall thickness and Limberg grade improved as early as week 8, bowel wall stratification improved at week 16, and perienteric fat edema improved at week 24, whereas no significant longitudinal changes were observed in the non-improvement group.Linear mixed-effects model analysis demonstrated a significant time × group interaction for bowel wall thickness (P < 0.001). Generalized estimating equation analyses demonstrated significant time × group interactions for Limberg grade, bowel wall stratification, and perienteric fat edema (all P < 0.001), while luminal stenosis remained relatively stable throughout follow-up (all P > 0.05).At week 24, patients in the improvement group showed significantly lower CRP levels (P < 0.001) and HBI scores (P = 0.006) than those in the non-improvement group. Furthermore, reductions in bowel wall thickness were significantly correlated with reductions in CRP levels (rs = 0.678, 95 % CI: 0.503-0.806, P < 0.001) and HBI scores (rs = 0.566, 95 % CI: 0.359-0.722, P < 0.001). Transabdominal bowel ultrasound may dynamically reflect transmural inflammatory changes during ustekinumab therapy in patients with postoperative recurrence of CD. Different ultrasound parameters demonstrated distinct temporal recovery patterns, with bowel wall thickness and vascularity showing the earliest improvement. The association between bowel wall thickness changes and CRP/HBI further supports the potential clinical utility of bowel ultrasound as a noninvasive longitudinal monitoring tool in this high-risk postoperative population.
Núñez Figueroa Paulina P, Sánchez Orozco Abel A, Alfaro Pérez Ignacio I, Andara Ramírez María Teresa MT et al.
To update the recommendations of the Pan American Crohn's and Colitis Organisation (PANCCO) for the treatment of moderate-to-severe ulcerative colitis (UC) in adults, incorporating recent evidence on new biologics, small molecules, subcutaneous formulations and appendectomy. The PAHO rapid GRADE methods were applied. PANCCO adapted the Colombian guideline 2025 for upadacitinib, tofacitinib, ozanimod and the switch to subcutaneous formulations, and developed de novo recommendations for etrasimod, guselkumab, risankizumab, ustekinumab, mirikizumab, filgotinib and appendectomy. The search was carried out in MEDLINE, Embase, Cochrane and Epistemonikos through February 2026, with quality appraised with ROBIS, AMSTAR-2, RoB 2.0 and ICEMAN; strength of recommendations was established using GRADE. Recommendations were issued for nine clinical questions. In moderate-to-severe UC, upadacitinib, tofacitinib, filgotinib, ustekinumab, mirikizumab, risankizumab and guselkumab are recommended; ozanimod and etrasimod are conditionally suggested, considering the cardiovascular profile. In patients with response to intravenous induction, switching to subcutaneous vedolizumab or subcutaneous infliximab is suggested. In UC refractory to advanced therapies, laparoscopic appendectomy is conditionally suggested as an adjuvant strategy. This third update expands the therapeutic armamentarium for moderate-to-severe UC in Latin America. Treatment choice should be individualized according to prior therapy, comorbidities, cardiovascular and thrombotic risk, availability and patient preferences.
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.
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.
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.
注册免费账户还可查看另外 3970 篇文献
免费注册查看全部文献 →