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adalimumab (Mabura)

✓ Approved

Hetero Labs · TNF · 单克隆抗体

什么是 adalimumab？

adalimumab 是一种单克隆抗体，由Hetero Labs研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)、Subcutaneous Injection。

药物档案

商品名Mabura
公司Hetero Labs
药物类别单克隆抗体, 抗体
分子靶点TNF
给药途径Injectable (Others), Intravenous (IV), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Hetero Labs

作用机制

分子靶点

adalimumab 作用于 1 个分子靶点：

TNFtumor necrosis factor (TNFA, TNF-alpha)
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

adalimumab 针对 10 个适应症，涉及 4 个治疗领域。

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

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相关研究文献

PubMedClinical journal of gastroenterology2026-07-26

Successful transition to mirikizumab following hepatic abscess during adalimumab therapy in a patient with ulcerative colitis.

Miyaguchi Kazuya K, Matsumoto Hisashi H, Shiomi Rie R, Tsuzuki Yoshikazu Y et al.

Ulcerative colitis (UC) is associated with an increased risk of infectious complications, particularly during anti-tumor necrosis factor (anti-TNF) therapy. Pyogenic hepatic abscess is a rare but potentially life-threatening extraintestinal complication of UC. Optimal biologic management following deep infection during anti-TNF therapy remains unclear. Mirikizumab, a selective interleukin-23 p19 inhibitor, may have a more favorable infectious safety profile than anti-TNF agents. We report the case of a 19-year-old woman with pancolitis-type UC who developed persistent fever, worsening diarrhea, hematochezia, and subsequent right upper quadrant abdominal pain during maintenance therapy with adalimumab. Contrast-enhanced computed tomography revealed active colitis complicated by hepatic abscess. Adalimumab was discontinued, and intravenous ceftriaxone plus metronidazole therapy was initiated. After confirmation of infection control and abscess regression, induction therapy with mirikizumab was initiated for active UC. Clinical symptoms rapidly improved, and the patient achieved sustained clinical and endoscopic remission without recurrence of the hepatic abscess during long-term follow-up. This case suggests that mirikizumab can be successfully administered after adequate infection control in a patient with UC complicated by hepatic abscess during anti-TNF therapy. However, larger studies are needed to determine the optimal biologic option as a second-line treatment for patients requiring treatment reintroduction after deep infection.

PMID 42503158
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PubMedClinical pharmacokinetics2026-07-26

Pharmacometric Targets During Anti-TNF Induction and Their Association with Deep Remission in Pediatric Crohn's Disease.

Nasr Alexander A, Mizuno Tomoyuki T, Irie Kei K, Dillman Jonathan R JR et al.

Personalizing anti-tumor necrosis factor (TNF) therapy in pediatric Crohn's disease (CD) remains challenging due to variable drug clearance and response. Identifying pharmacokinetic (PK) and pharmacodynamic (PD) predictors of deep remission could enable precision dosing strategies. The primary aim was to define PK metrics and PD biomarkers associated with deep remission. Patients initiating infliximab or adalimumab were prospectively enrolled from four pediatric centers with longitudinal blood and stool biospecimens collected for one year. Deep remission was defined as a combination of weighted pediatric CD activity index (wPCDAI) < 12.5 and Simple Endoscopic Score-CD < 3. Trough concentrations (cTrough) were measured throughout the study. Drug exposure (area under the curve, AUC) and clearance were estimated using drug-specific population PK models and Bayesian estimation using nonlinear mixed-effects modeling (NONMEM). Deep remission was achieved in 34/70 (48.6%) with no difference in outcomes between biologics. Infliximab cTrough thresholds associated with deep remission were 33 µg/mL (Week 2), 15 µg/mL (Week 6), and 4.7 µg/mL (Month 3) with Week 6 cTrough targets ranging 15-26 µg/mL depending on the outcome of interest. Higher AUC during induction for both infliximab and adalimumab was associated with deep remission, whereas rapid infliximab clearance at various timepoints was inversely associated with deep remission. Baseline predictors of rapid infliximab clearance included older age, low albumin, and elevations in body mass index, C-reactive protein, soluble CD64, and wPCDAI. We identified PK/PD cut-points associated with deep remission and rapid infliximab clearance, providing actionable metrics to individualize induction dosing and optimize maintenance therapy for children starting anti-TNF therapy.

PMID 42503050
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PubMedZhonghua yi xue za zhi2026-07-26

[Efficacy and safety analysis of adalimumab in the treatment of pediatric patients with inflammatory bowel disease].

He X X, Luo X T XT, Wang M J MJ, Gong Y Z YZ et al.

To evaluate the efficacy and safety of adalimumab (ADA) in pediatric patients with inflammatory bowel disease (IBD). Clinical data of IBD children who initially received ADA treatment at the Capital Center for Children' s Health, Capital Medical University from January 2020 to August 2025 were retrospectively collected. At week 12 of ADA therapy, according to whether the children achieved clinical remission or endoscopic remission, they were divided into clinical remission group [pediatric Crohn's disease activity index (PCDAI)<10.0 points or pediatric ulcerative colitis activity index (PUCAI)<10 points] and clinical non-remission group, endoscopic remission group [Crohn's disease endoscopic index of severity (CDEIS)<3 points or ulcerative colitis endoscopic index of severity (UCEIS)=0 points] and endoscopic non-remission group. At weeks 12, 24 and 48, the clinical remission rate and endoscopic remission rate of the children were assessed, respectively. The baseline data of the remission group and the non-remission group at week 12 were compared, and the safety and antibody production status of ADA treatment were also evaluated. A total of 39 pediatric IBD patients were included, with 20 males and 19 females. The age at onset [M(Q1, Q3)] was 11 (6, 14) years, and the median follow-up time was 70 (19, 130) weeks. For ADA treatment at weeks 12, 24, and 48, the clinical remission rates of the children were 69.2% (27/39), 75.0% (18/24), and 73.7% (14/19), respectively; the endoscopic remission rates were 31.8% (7/22), 33.3% (1/3), and 42.9% (6/14), respectively. At week 12, the clinical remission group had a shorter baseline disease duration[12 (5, 24) vs 41 (34, 52) months, P<0.001] and lower baseline fecal calprotectin levels [560 (389, 1 800) vs 1 380 (813, 1 800) μg/g, P=0.015] compared to the clinical non-remission group; At week 4, ADA trough concentration was higher [22 (18, 32) vs 13 (9, 19) mg/L, P=0.017] than that in the non-remission group. Compared to the endoscopic non-remission group, at week 12 the endoscopic remission group had lower baseline fecal calprotectin levels [504 (369, 567) vs 1 200 (659, 1 800) μg/g, P=0.019] and fewer prior infliximab (IFX) users [28.6% (2/7) vs 80.0% (12/15), P=0.020]; while at week 4, ADA trough concentration was higher [35 (23, 35) vs 13 (10, 20) mg/L, P<0.001] than that in the endoscopic non-remission group. The incidence of adverse reactions was 13% (5/39), including alopecia, allergic reactions, and cytomegalovirus infection; only 3 cases produced relatively high antibodies (>30 ng/ml). ADA demonstrates good efficacy and safety in pediatric IBD patients.

PMID 42502070
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PubMedJPGN reports2026-07-25

Outcomes of adalimumab biosimilar nonmedical switches in children and young adults with inflammatory bowel disease.

Himelstein Daniel D, McNicol Megan M, Abdel-Rasoul Mahmoud M, Boyle Brendan M BM et al.

Adalimumab biosimilars are as safe and effective compared to the originator. Adult patients with inflammatory bowel disease (IBD) who switched to a biosimilar have comparable outcomes, but pediatric data are limited. This study evaluates clinical outcomes of children and young adults with IBD following a nonmedical, insurance-driven switch from the adalimumab originator to a biosimilar. A single-center retrospective chart review was conducted among pediatric and young adult patients with IBD who switched from the adalimumab originator to a biosimilar between May 2023 and July 2024. Demographics, Physician Global Assessment (PGA), laboratory values, adalimumab levels, and antibodies were collected preswitch and up to 6 months postswitch. Adalimumab biosimilar continuation was assessed 6 months postswitch. McNemar's exact test, linear mixed effect models, and paired t-tests compared variables preswitch and postswitch. Fifty patients switched to a biosimilar. Forty-two patients had PGAs pre and postswitch, and among them, 86% (36/42) of patients demonstrated stable or improved PGAs postwitch. Seventy-six percent (38/50) of patients continued on the biosimilar for at least 6 months postswitch. Of the 12 patients who discontinued adalimumab biosimilar, 42% (5/12) discontinuation was not related to the switch, while 58% (7/12) were due to the switch. Laboratory values remained stable pre and postswitch, although adalimumab levels decreased postswitch (18-15 µg/mL; p = 0.007). Switching from the adalimumab originator to a biosimilar resulted in comparable outcomes in children and young adults with IBD based on PGA, laboratory markers, and continuation of the medication.

PMID 42499715
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PubMedJoint bone spine2026-07-24

The influence of symptom duration on flare risk after biologic DMARD withdrawal in axial spondyloarthritis: a meta-analysis of randomized withdrawal trials.

Benavent Diego D, Navarro-Compán Victoria V, Capelusnik Dafne D, Ramiro Sofia S

To assess whether symptom duration modifies flare risk after biologic/targeted synthetic DMARD (b/ts DMARDs) withdrawal in axial spondyloarthritis (axSpA) following remission/inactive disease. We systematically identified randomized placebo-controlled trials evaluating withdrawal or tapering of b/tsDMARDs in axSpA through a previous systematic literature review. Eligible studies included adults with axSpA who achieved inactive disease or remission by ASDAS and were randomized to continuation or withdrawal/tapering, with available flare data. Patient-level data were obtained from Vivli and stratified by symptom duration thresholds of ≤2, 3, 4, or 5 years. Relative risks (RRs) of flare for continuation versus withdrawal were calculated within each subgroup, and relative risk ratios (RRRs) were estimated. Random-effects meta-analysis was performed. A subgroup analysis included only patients with nr-axSpA. Three RCTs involving 773 patients were included, evaluating adalimumab, certolizumab pegol, and ixekizumab versus placebo; no tsDMARD or tapering studies were eligible. Continuation of bDMARDs was consistently associated with fewer flares than withdrawal. Symptom duration did not significantly modify flare risk overall. In the overall axSpA population, pooled RRRs showed no statistically significant effect modification: 0.61 (95% CI 0.29-1.28) for ≤2 years, 0.77 (0.54-1.12) for ≤3 years, 0.83 (0.45-1.54) for ≤4 years and 0.82 (0.49-1.37) for ≤5 years. In nr-axSpA (n=508), pooled RRRs favoured shorter symptom duration at ≤4 years (0.25 (0.07-0.96)) but not at ≤2, ≤3 or ≤5 years. Symptom duration did not consistently modify flare risk after bDMARD withdrawal in axSpA overall, although exploratory findings suggest a potential effect in early nr-axSpA.

PMID 42492835
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PubMedPediatric gastroenterology, hepatology & nutrition2026-07-23

Reactive Therapeutic Drug Monitoring Guides Optimal Management of Adalimumab Failure in Pediatric Crohn's Disease: A Real-World Single-Center Experience.

Jeong In Sook IS, Kim Tae-Gyeong TG, Yi Dae Yong DY, Kim Kyung Mo KM

Although biologics, including anti-tumor necrosis factor (TNF) drugs, are increasingly used for treating pediatric Crohn's disease (CD), the potential loss of response (LOR) to these drugs requires attention. This retrospective study investigated reactive therapeutic drug monitoring (TDM) and the clinical course of pediatric-onset CD in patients treated with adalimumab. Patients aged <18 years diagnosed with CD and treated with adalimumab were enrolled in this study. Reactive TDM levels, presence of anti-drug antibodies (ADAs), and LOR were evaluated from 2017 to 2019, and clinical outcomes were followed up until June 2022. Thirty-two pediatric patients with CD were enrolled: 14 in the LOR group and 18 in the remission group. The median ages at CD diagnosis and first adalimumab injection were 13 and 14 years, respectively. The median duration of adalimumab injection was 12.5 months. Among 7 patients with therapeutic trough levels (TLs) and undetectable ADAs, 5 achieved clinical remission with continued adalimumab, whereas 2 remained refractory and subsequently switched to alternative biologics. Among 5 patients with subtherapeutic TLs (<5 µg/mL) and undetectable ADAs, 3 eventually underwent a switch to other biologic agents despite interval shortening, while the remaining 2 were ultimately diagnosed with monogenic inflammatory bowel disease (IBD) after further genetic evaluation. Reactive TDM and ADA categorizes the mechanisms of LOR to adalimumab in pediatric CD, guiding appropriate dose escalation or biologic switching. When these strategies fail, exploring underlying monogenic disorders is essential for optimal management.

PMID 42487992
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