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adalimumab (Handayuan / Handafar / adalimumab, Henlius)

✓ Approved

Shanghai Henlius Biotech · TNF · Monoclonal Antibodies

What is adalimumab?

adalimumab is a monoclonal antibodies developed by Shanghai Henlius Biotech. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesHandayuan, Handafar, adalimumab, Henlius
CompanyShanghai Henlius Biotech
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetTNF
RouteInjectable (Others), Subcutaneous Injection
StatusApproved

Mechanism of Action

Molecular Targets

adalimumab acts on 1 molecular target:

TNFtumor necrosis factor (TNFA, TNF-alpha)
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Therapeutic Indications

adalimumab is developed for 11 unique indications across 4 therapeutic areas.

Therapeutic AreaConditionPhase
Musculoskeletal and connective tissue disordersAnkylosing spondylitis✓ Approved
Gastrointestinal disordersCrohn's disease✓ Approved
Skin and subcutaneous tissue disordersPsoriasis✓ Approved
Musculoskeletal and connective tissue disordersRheumatoid arthritis✓ Approved
Eye disordersUveitis✓ Approved

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Related Research Articles

PubMedCurrent opinion in ophthalmology2026-08-30

Long-term safety of steroid-sparing immunosuppression in uveitis.

Placide John J, Uner Ogul E OE, Suhler Eric B EB

Corticosteroid-sparing immunosuppression is standard for chronic noninfectious uveitis, yet its long-term safety remains a dominant clinical concern. We synthesize the contemporary evidence on long-term safety, common adverse effects that drive treatment discontinuation, and how those effects are managed across various medication classes. The largest cohort data show no statistically significant excess in overall or cancer mortality for antimetabolites, calcineurin inhibitors, or antitumor necrosis factor agents, whereas alkylating agents remain the principal malignancy concern. Discontinuation for toxicity is modest across classes and is usually driven by reversible, organ-specific effects: most often gastrointestinal intolerance for antimetabolites, nephrotoxicity for calcineurin inhibitors, and cytopenia for alkylating agents. Long-term data led by a 7-year adalimumab extension showed no new safety signals, with infection and tuberculosis reactivation as the main risks of tumor necrosis factor blockade. Steroid-sparing agents appear to have excellent long-term safety when the agent is matched to disease severity and patients are screened and monitored proactively. The safest agent is the one whose specific toxicity is anticipated and managed.

PubMedFrontiers in immunology2026-08-29

Successful treatment of refractory classic juvenile pityriasis rubra pilaris with adalimumab in a 4-year-old girl: a case report.

Zhang Jianlan J, Zuo Yuyue Y, Jiang Ruili R, Xia Yun Y et al.

Classic juvenile pityriasis rubra pilaris (PRP) (Griffiths type III) is a rare inflammatory papulosquamous dermatosis that is often refractory to conventional topical and systemic treatments. Despite the growing use of tumor necrosis factor-α (TNF-α) inhibitors in adult PRP, clinical evidence for their efficacy and safety in children under 5 years remains extremely limited. We herein report a 4-year-and-7-month-old Chinese girl presenting with a 20-day history of rapidly progressive generalized erythema, follicular keratotic papules, diffuse scaling, severe palmoplantar keratoderma and intractable pruritus. Initial differential diagnoses included psoriasis and pityriasis rubra pilaris (PRP), and skin histopathology confirmed classic juvenile PRP. Prior interventions with topical corticosteroids, emollients, oral antihistamines and traditional Chinese medicine yielded minimal clinical improvement. From the caregiver's perspective, persistent extensive cutaneous lesions with unremitting pruritus disrupted the child's daily activities, and multiple unsuccessful conventional therapies triggered considerable anxiety regarding long-term disease management. Given disease refractoriness, off-label adalimumab therapy was initiated. The patient received subcutaneous adalimumab at an initial dose of 20 mg at week 0, followed by 20 mg at week 1, and subsequent maintenance doses of 20 mg every two weeks, with a total of 8 injections. Approximately 3 months after treatment initiation, all cutaneous lesions achieved complete resolution, with only residual hypopigmented macules observed. No severe adverse events occurred during the treatment course. At the latest follow-up, 8 months after the final adalimumab injection, the patient maintained sustained complete remission without relapse. This clinical case demonstrates that adalimumab achieves rapid therapeutic efficacy and favorable short-term safety in young children with refractory classic juvenile PRP. Our findings support the potential role of TNF-α inhibitors as an effective alternative for severe pediatric PRP unresponsive to conventional therapies. Further prospective controlled trials are warranted to validate the long-term safety profile and optimize the dosage regimen for young pediatric populations.

PubMedIDCases2026-08-29

Disseminated herpes zoster with pulmonary lesions mimicking miliary tuberculosis in an HIV-infected patient previously treated with adalimumab: A case report.

Tada Shuhei S, Fukushima Kazuaki K, Aizawa Yota Y, Kodaira Shota S et al.

Disseminated herpes zoster (DHZ) in immunocompromised patients is uncommon but potentially life-threatening. Pulmonary involvement is particularly rare and can mimic miliary tuberculosis, complicating the diagnosis. We report herein a 51-year-old, male, Japanese patient with a human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, and hidradenitis suppurativa in whom DHZ developed five months after he discontinued adalimumab therapy. He presented with a five-day history of fever, abdominal pain, and generalized vesicular eruptions. Chest computed tomography revealed small, diffusely distributed, bilateral nodules suggestive of miliary tuberculosis. However, acid-fast bacillus tests repeatedly returned negative. Endoscopic evaluation revealed multiple, gastric ulcerations, and immunohistochemical staining of gastric ulcer biopsy specimens confirmed a varicella-zoster virus infection. Intravenous acyclovir rapidly improved the cutaneous lesions, and the pulmonary nodules resolved almost entirely within 18 days. The gastrointestinal ulcers also healed with the antiviral therapy. The present case highlights the importance of considering DHZ in the differential diagnosis of diffuse, pulmonary nodules in immunocompromised patients, especially those with an HIV infection and a history of biologic therapy. Prompt diagnosis, appropriate, radiological follow-up, and early administration of antiviral therapy are crucial to ensuring a favorable clinical outcome.

PubMedThe Australasian journal of dermatology2026-08-29

Behçet's-Like Syndrome Associated With Psoriasis, Lichen Sclerosus and Variant in NF-κB1.

Lee Hyun Kyoung HK, Corkill Michael M, Kennedy Harriet H

Behçet's disease is a rare multisystem inflammatory disorder characterised by recurrent oral and genital ulceration with systemic involvement. Heterozygous mutations in NF-κB1 have been associated with Behçet's-like presentations. We present a woman with psoriasis, lichen sclerosus, non-small-cell lung cancer, anogenital ulcers and features of a Behçet's-like syndrome associated with a novel NF-κB1 mutation. She responded well to adalimumab after failed treatment with systemic and topical corticosteroids, antibiotics and colchicine.

PubMedBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2026-08-29

Comparison of the Risk of Acute Anterior Uveitis Flare Between Adalimumab and Subcutaneous Infliximab in Patients with Radiographic Axial Spondyloarthritis and Prior Acute Anterior Uveitis: A Randomized Controlled Trial.

Kwon Oh Chan OC, Ahn Soo Min SM, Hong Seokchan S, Seo Yeon Hong YH et al.

Acute anterior uveitis (AAU) is the most common extra-musculoskeletal manifestation of radiographic axial spondyloarthritis (r-axSpA) and is an important consideration when selecting biological therapy. Although adalimumab (ADA) and infliximab are commonly used in patients with r-axSpA and AAU, direct comparative evidence, particularly between ADA and subcutaneous infliximab (IFX-SC), remains limited. The objective of this study was to compare the risk of AAU flare between ADA and IFX-SC in patients with r-axSpA and a history of AAU. This multicenter, head-to-head, randomized, open-label trial enrolled patients with r-axSpA and a documented AAU event within the preceding 2 years. Participants were randomly assigned (1:1) to receive ADA (40 mg every 2 weeks) or IFX-SC (intravenous 5 mg/kg induction followed by subcutaneous 120 mg every 2 weeks) and were followed for 48 weeks. The primary endpoint was AAU flare occurrence. Hazard ratios (HRs) were estimated using Cox proportional hazards models. Secondary endpoints included changes in best-corrected visual acuity (BCVA), r-axSpA disease activity and functional indices, and safety outcomes. Fifty-six patients were randomized (ADA, n = 28; IFX-SC, n = 28). During follow-up, one AAU flare episode occurred in each group. The adjusted HR of IFX-SC (vs ADA) for an AAU flare was 0.496 (95% confidence interval 0.025-9.768, p = 0.645). No significant differences in secondary endpoints were observed between groups (right BCVA, p = 0.622; left BCVA, p = 0.306; Axial Spondyloarthritis Disease Activity Score, p = 0.293; Bath Ankylosing Spondylitis Disease Activity Index, p = 0.262; Bath Ankylosing Spondylitis Functional Index, p = 0.307). Adverse events were similar in frequency and severity, with no new safety signals identified. No statistically significant differences in AAU flare risk or secondary ocular and rheumatologic outcomes were observed between ADA and IFX-SC over 48 weeks in patients with r-axSpA and prior AAU. These findings suggest that IFX-SC may represent a potential alternative to ADA for AAU flare prevention as well as disease activity control in this population. Clinical Research Information Service (CRIS), Republic of Korea; KCT0007239.

PubMedJAAD international2026-08-28

Adalimumab biosimilar uptake among dermatologists in Medicare Part D through 2023: A retrospective analysis using the Prescribers - by Provider and Drug dataset.

Schedler Nathan C NC, Saqib Manaal M, Huang Chenan A CA, Feldman Steven R SR

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