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adalimumab (9MW0113 / UBP 1211 / UBP1211)

✓ Approved

Jiangsu T-mab BioPharma · TNF · 单克隆抗体

什么是 adalimumab？

adalimumab 是一种单克隆抗体，由Jiangsu T-mab BioPharma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9MW0113, UBP 1211, UBP1211
公司Jiangsu T-mab BioPharma
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, Jiangsu T-mab BioPharma

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
Skin and subcutaneous tissue disordersPsoriasis✓ Approved
Musculoskeletal and connective tissue disordersRheumatoid arthritis✓ Approved
Gastrointestinal disordersColitis ulcerativePhase I
Gastrointestinal disordersCrohn's diseasePhase I

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相关研究文献

PubMedCase reports in infectious diseases2026-08-06

Disseminated Primary Mycobacterium bovis Infection in Patient Receiving Adalimumab Therapy: A Case Report.

Kirk Michele Bjerre MB, Rasmussen Kristina Høeg KH, Gotthelf Andreas A, Jensen Lisbeth Lund LL et al.

Anti-TNF-α therapies are associated with an increased risk of tuberculosis, mainly via the reactivation of latent Mycobacterium tuberculosis. Primary zoonotic Mycobacterium bovis infection is rare and diagnostically challenging, particularly in immunosuppressed patients. We report a case of disseminated Mycobacterium bovis infection in a man receiving long-term adalimumab for psoriasis, complicated by diagnostic delay, suspected hemophagocytic lymphohistiocytosis, and immune reconstitution inflammatory syndrome (IRIS), resulting in a challenging treatment course. Epidemiological history revealed recent travel to Turkey and ingestion of unpasteurized dairy products. This case highlights the need for ongoing exposure assessment, sustained clinical awareness, and individualized therapeutic strategies throughout immunomodulatory treatment.

PMID 42559117
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PubMedInflammatory intestinal diseases2026-08-06

A Case Study of PSTPIP1-Associated Myeloid-Related Proteinemia Inflammatory Syndrome Masquerading as Inflammatory Bowel Disease.

Rodsaward Pongsawat P, Kiattikunrat Keerati K, Tangnuntachai Nichthida N, Buranapraditkun Supranee S et al.

PSTPIP1-associated myeloid-related proteinemia inflammatory (PAMI) syndrome is a rare autoinflammatory disorder. Systemic inflammation, cytopenia, and skin lesions are classic features, accompanied by hypercalprotectinemia and hyperzincemia. Gastrointestinal manifestations such as colitis are infrequent. We present the first case in Thailand of PAMI syndrome presenting as refractory colitis. A 23-year-old male presenting with adult-onset refractory colitis and a history of a teenage perianal abscess. Despite the relatively late onset of intestinal symptoms, the patient exhibited a complex clinical picture across multiple domains of inborn errors of immunity, including autoimmune hemolytic anemia, chronic neutropenia, hepatosplenomegaly, and severe cystic acne. Genetic testing revealed a PSTPIP1 mutation (E250K variant), and laboratory results showed pathognomonic hyperzincemia, confirming PAMI syndrome. Treatment with adalimumab led to significant clinical and endoscopic remission. PAMI syndrome should be considered a differential diagnosis in patients with atypical or refractory colitis, particularly when accompanied by systemic clues such as cytopenia, severe acne, or organomegaly. Serum zinc levels serve as a simple, cost-effective screening tool to facilitate prompt diagnosis and can function as a practical biomarker for monitoring the response to therapy.

PMID 42559525
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PubMedExpert opinion on biological therapy2026-08-05

Originator versus biosimilar adalimumab in hidradenitis suppurativa: a real-world cohort study.

Demirbaş Abdullah A, Esen Mustafa M, Diremsizoğlu Esin E, Ulutaş Demirbaş Gözde G

Comparative real-world data on originator and biosimilar adalimumab in hidradenitis suppurativa (HS) are limited. We compared effectiveness, persistence, and safety of originator (ADL-O) versus three biosimilars (ADL-B1, ADL-B2, ADL-B3) in routine care. Retrospective cohort of 146 biologic-naive HS patients initiating adalimumab (January 2020-November 2025) at three tertiary centers in Turkiye. Primary outcomes were Week-12 HiSCR50 and IHS4-55 responses, compared using overlap weighting. Persistence was assessed by 24-week restricted mean survival time (RMST). Safety was summarized descriptively. Baseline characteristics were well balanced across groups. Overlap-weighted Week-12 analyses excluding the ADL-B3 evaluable subset (n = 118) showed no evidence of differential effectiveness: HiSCR50 RR 1.05 (95% CI 0.78-1.42); IHS4-55 RR 1.07 (95% CI 0.76-1.52). Inclusion of ADL-B3 as a sensitivity analysis did not alter the findings. Among Week-52 evaluable ADL-O and ADL-B1 patients, HiSCR50 was 68.8% in both groups. Product-level 24-week RMST was 23.4 versus 22.3 weeks (difference -1.1 weeks, 95% CI - 2.7 to 0.5). Safety comparisons were descriptive given limited sample size. No statistically significant difference in short-term effectiveness was detected between originator and biosimilar adalimumab in HS. The findings reflect absence of evidence for a difference rather than equivalence. Larger prospective studies with immunogenicity assessment are needed.

PMID 42552996
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PubMedJAMA dermatology2026-08-05

Approved Monoclonal Antibody Therapies for Hidradenitis Suppurativa.

Pham James J, Sholji Tara T, Aghajani Marra M, Kok Cindy C et al.

Biologic therapies are increasingly used for moderate to severe hidradenitis suppurativa (HS), yet their high cost presents challenges for health systems and payers. Comparative economic evaluations of these therapies are limited. To evaluate the efficiency frontier of approved monoclonal antibody therapies for HS across multiple countries. This economic evaluation used publicly available clinical trial data and drug pricing data. Phase 3 trial efficacy data for adalimumab, secukinumab, and bimekizumab from 6 trials were combined with drug price data from the US, Canada, France, Germany, and Australia as of January 31, 2026. Data analysis was conducted between March 15 and May 22, 2026. Efficiency frontier analysis using Hidradenitis Suppurativa Clinical Response (HiSCR) 50 (indicating 50% reduction from baseline) and HiSCR-75 (indicating 75% reduction from baseline) metrics. Incremental cost-effectiveness ratios were calculated where multiple agents lay on the frontier. Across all examined countries, adalimumab, 40 mg, weekly, consistently was on the efficiency frontier for both HiSCR-50 and HiSCR-75 outcomes. Secukinumab, 300 mg, every 4 weeks, appeared on the frontier only when US wholesale acquisition costs were used. Annual therapy costs ranged from $11 345 for adalimumab, 40 mg, weekly in Australia to $411 990 for bimekizumab, 320 mg, every 2 weeks in the US. Analyses using cost-efficiency estimates adjusted for baseline disease severity showed an efficiency frontier composition similar to unadjusted analyses. In this study, among currently approved monoclonal antibody therapies for HS, adalimumab showed dominant cost-efficiency performance across multiple health systems. These findings highlight substantial international variation in biologic drug pricing and provide a framework for value-based pricing in HS therapeutics.

PMID 42555037
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PubMedThe Journal of dermatological treatment2026-08-04

Increasing formulary adoption of adalimumab biosimilars and differential cost-sharing in Medicare Part D plans.

Feng Alina S AS, Liao Wilson W

Adalimumab was among the first biologics to face widespread biosimilar competition following US market entry of multiple adalimumab biosimilars in 2023. However, Medicare Part D formulary adoption of these products and their associated specialty-tier cost-sharing requirements remain unknown. To evaluate adalimumab biosimilar adoption and associated cost-sharing patterns across Medicare Part D formularies, Centers for Medicare & Medicaid Services (CMS) Medicare Part D Formulary and Plan Benefit Package files were analyzed. Plans were categorized as covering originator adalimumab-only, both originator and biosimilar products (dual coverage), or biosimilars-only. In 2023, all Medicare Part D plans covering adalimumab listed only the originator product. By 2024, 52.5% of plans provided dual coverage, increasing to 79.9% in 2025. Biosimilar-exclusive coverage increased from 8.6% of plans in 2025 to 45.9% in 2026, while originator-only coverage declined to 0.8%. Median specialty-tier coinsurance differed according to coverage strategy. In 2026, median specialty-tier coinsurance was 33% among originator-only plans, 27% among dual-coverage plans, and 25% among biosimilar-only plans. Medicare Part D formularies rapidly included adalimumab biosimilars following market entry, with substantial growth in biosimilar-exclusive coverage by 2026. Specialty tier coinsurance varied by medication coverage type, suggesting that evolving formulary strategies may influence beneficiary cost-sharing requirements.

PMID 42550081
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PubMedCrohn's & colitis 3602026-08-04

Comparative effectiveness of adalimumab versus infliximab in children with Crohn's disease: real-world data from the prospective PIBD-SETQuality inception cohort study.

Vuijk Stephanie A SA, Klomberg Renz C W RCW, Katgert Eva E, Wessels Margreet M S MMS et al.

Infliximab and adalimumab are effective anti-tumor necrosis factor (anti-TNF) therapies for the treatment of pediatric Crohn's disease (CD). The aim of this study was to compare the effectiveness of infliximab and adalimumab in a real-world cohort of children with CD. Data from biological-naïve children with luminal CD (age 3-18 years) who commenced anti-TNF and completed at least 1 year of follow-up were collected from the prospective multicenter observational PIBD-SETQuality study. The primary outcome was steroid-free clinical remission (SFCR), defined as clinical remission (weighted pediatric Crohn's disease activity index [wPCDAI] <12.5) without systemic steroids or luminal surgery at 1 year. The relative risk (RR) of SFCR was calculated using standardization, correcting for the following baseline covariates: age, upfront anti-TNF, C-reactive protein, erythrocyte sedimentation rate, albumin, leukocytes, disease behavior, wPCDAI, perianal disease, and concomitant immunomodulator use. Secondary outcomes included the durability of anti-TNF treatment without luminal surgery. Between January 1, 2017, and June 14, 2024, 178 patients with anti-TNF were included (infliximab: n = 121 [68%], adalimumab: n = 57 [32%]). At 12 months, 34/56 (61%) patients treated with adalimumab and 66/120 (55%) patients treated with infliximab had reached SFCR. The RR of SFCR at 1 year with adalimumab compared to infliximab was 1.25 (95% confidence interval [CI] 0.94-1.66], P = .13. Adalimumab was associated with a significant lower adjusted hazard ratio (aHR) of treatment discontinuation than infliximab in patients with a concomitant immunomodulator (aHR 0.17 [95% CI 0.04-0.75], P = .020), adjusted for upfront anti-TNF. In this prospective cohort of children with CD, adalimumab and infliximab showed comparable clinical effectiveness 1 year after the start of anti-TNF treatment. The ClincalTrials.gov ID of this study is NCT03571373.

PMID 42549261
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