Shanghai Henlius Biotech · TNF · Monoclonal Antibodies
adalimumab is a monoclonal antibodies developed by Shanghai Henlius Biotech. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.
| Brand Names | Handayuan, Handafar, adalimumab, Henlius |
| Company | Shanghai Henlius Biotech |
| Drug Class | Monoclonal Antibodies, Antibody |
| Molecular Target | TNF |
| Route | Injectable (Others), Subcutaneous Injection |
| Status | Approved |
adalimumab acts on 1 molecular target:
| TNF | tumor necrosis factor (TNFA, TNF-alpha) |
adalimumab is developed for 11 unique indications across 4 therapeutic areas.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| Musculoskeletal and connective tissue disorders | Ankylosing spondylitis | ✓ Approved |
| Gastrointestinal disorders | Crohn's disease | ✓ Approved |
| Skin and subcutaneous tissue disorders | Psoriasis | ✓ Approved |
| Musculoskeletal and connective tissue disorders | Rheumatoid arthritis | ✓ Approved |
| Eye disorders | Uveitis | ✓ Approved |
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Sign up free to view all indications →Hazinedar Emel E, Ertop Doğan Pelin P, Acıman Demirel Esra E, Koca Rafet R
Brouwers Jonas J, Claessens Frederic F, Mergaerts Lise L, Vandezande Lisa L et al.
Dupuytren disease is a fibroproliferative disorder in which tumor necrosis factor (TNF)-driven myofibroblast activity contributes to progressive digital flexion contractures by causing collagen deposition. Needle fasciotomy mechanically releases established collagen cords but does not target the underlying fibroproliferative process. Adalimumab, an anti-TNF agent, has been shown to reduce nodule hardness in early-stage Dupuytren disease, but it remains unknown whether it has additional impact combined with needle fasciotomy in more established contractures. (1) Does a single perioperative intralesional injection of adalimumab immediately after needle fasciotomy increase the proportion of patients achieving at least 10° improvement in total passive extension deficit (TPED)? (2) Does adalimumab improve the change in TPED at 3 and 12 months? (3) Does adalimumab improve VAS pain and QuickDASH scores at 3 and 12 months? (4) What complications occurred in the adalimumab and placebo groups? We conducted a double-blind, randomized, placebo-controlled pilot trial at a hand surgery department in a single academic center in adults with Dupuytren disease and an indication for needle fasciotomy. Eligible patients had a Dupuytren diathesis score greater than 4 and a nonfixed compound metacarpophalangeal and/or proximal interphalangeal contracture. Thirty patients were randomized 1:1 to receive a single 40-mg intralesional injection of adalimumab or matching saline placebo immediately after needle fasciotomy. One patient was excluded after randomization, leaving 29 patients for analysis (14 in the adalimumab group and 15 in the placebo). Fisher exact and Mann-Whitney U tests were used for categorical and continuous outcomes, respectively. Adalimumab did not improve the proportion of patients achieving at least a 10° improvement in TPED. At 3 months, 86% (12 of 14) of patients in the adalimumab group and 87% (13 of 15) in the placebo group achieved this improvement level, with a between-group difference in proportions of -1% (95% confidence interval [CI] -31% to 29%; p > 0.99). At 12 months, 71% (10 of 14) and 80% (12 of 15) of patients, respectively, achieved the endpoint, with a between-group difference of -9% (95% CI -41% to 24%; p = 0.68). Both groups showed no difference in change in TPED at 3 months; the median (IQR) change was -30° (-60° to -10°) versus -26° (-86° to -14°) at 3 months (Hodges-Lehmann estimate of between-group difference -4°; p = 0.76) and -32° (-60° to -5°) versus -24° (-80° to 5°) at 12 months (Hodges-Lehmann estimate of between-group difference 7°; p = 0.75). Pain and QuickDASH scores improved over time in both groups, with no between-group difference at 3 or 12 months (p > 0.05 for all). One procedure-related complication occurred; no adverse events related to either study injection were reported or observed. A single 40-mg intralesional injection of adalimumab added to needle fasciotomy did not improve extension, TPED, pain, or QuickDASH outcomes compared with placebo at 3 or 12 months. Given the absence of detected benefit in this pilot trial, adalimumab should not be used routinely as an adjunct to needle fasciotomy outside a clinical trial. Further studies investigating repeated or higher-dose regimens, treatment at earlier disease stages, and potential combination approaches are needed to better define the therapeutic role of anti-TNF treatment and determine whether it may have a clinical application before its use in routine practice can be considered. Level II, therapeutic study.
Altay Derya D, Dursun Büşra Daşlı BD, Özçay Figen F, Kartal Demet D et al.
Ball Darryn L DL, Duong Nancy N, Hackett Gary D GD, Scott Greyson H GH et al.
Interleukin-17 A and interleukin-17 A/F inhibitors (collectively, IL-17i) and adalimumab (ADA) effectively treat psoriatic arthritis (PsA), but comparative multidomain evidence remains limited. We compared their efficacy and safety in biologic-naïve PsA. PubMed, Embase and Cochrane CENTRAL were searched through April 2026 for randomised controlled trials comparing IL-17i with ADA. Outcomes encompassed musculoskeletal and skin disease activity, patient-reported outcomes, physical function, composite disease activity and safety. Random-effects meta-analyses were performed. Four trials (n = 2198) were included. No significant differences were observed in principal musculoskeletal, patient-reported, functional or minimal disease activity outcomes. IL-17i favoured near-complete skin clearance (PASI90, week 24: RR 1.38; 95% CI 1.19-1.61; p = 0.006; I2 = 0%; k = 4) and combined joint-skin responses (ACR50/PASI100, week 52: RR 1.49; 95% CI 1.18-1.89; p = 0.02; I2 = 0%; k = 3). Enthesitis resolution also favoured IL-17i at week 52 (RR 1.10; 95% CI 1.01-1.20; p = 0.04; I2 = 0%; k = 3). At week 24, Candida infections were numerically higher with IL-17i in the primary analysis (OR 4.44; 95% CI 0.89-22.25; p = 0.06; I2 = 0%; k = 3), with a significant Peto sensitivity estimate (OR 3.66; 95% CI 1.61-8.32; p = 0.002; I2 = 0%; k = 3). IL-17i were also associated with fewer adverse-event discontinuations than ADA (OR 0.57; 95% CI 0.34-0.96; p = 0.04; I2 = 0%; k = 3). IL-17i and ADA showed no significant differences in principal joint outcomes, while IL-17i favoured skin and combined joint-skin responses. Treatment selection should therefore be individualised according to the predominant disease domains and safety considerations, rather than assuming overall superiority of either treatment approach.
Schreiber Stefan S, Yajnik Vijay V, Wei Cenfu C, Paraskevopoulou Maria D MD et al.
A barrier to precision medicine for ulcerative colitis (UC) is the inability to predict and mechanistically explain treatment responses. Using patient-reported outcomes (PROs) from a phase 3b comparative trial of 768 participants, we identified four distinct patient response-trajectory groups for vedolizumab (anti-integrin) and adalimumab (antitumor necrosis factor). Validation in a second phase 3 trial of 576 participants linked PRO-defined vedolizumab trajectories to long-term disease complications. Bulk, single cell, and spatial transcriptomics and proteomics identified vascular inflammation as associated with vedolizumab nonresponse through interactions between SPP1+ macrophages and endothelial cells. In two separate real-world cohorts of 4,981 and 3,854 patients with UC, concomitant use of renin-angiotensin system inhibitors (modulators of vascular inflammation) was associated with reduced long-term complications for vedolizumab but not anticytokine therapies. These findings define a response-trajectory-based taxonomy that requires prospective validation for clinical utility and applications for selecting vedolizumab combination therapy in UC.
Sfikakis Petros P PP, Hatemi Gulen G
Herein we summarize data on the use of TNF inhibitors for Behcet's Syndrome (BS) published in past 25 years and discuss future perspectives. Anti-TNF monoclonal antibodies proved first efficacious for BS-associated sight-threatening panuveitis, resulting in a dramatic drop in current rates of blindness compared to the pre-anti-TNF era. In addition to ocular disease, their remarkable efficacy was subsequently documented in all clinical domains of BS, namely mucocutaneous, articular, vascular, gastrointestinal and central nervous system disease. To date TNF inhibitors have moved to the front line and most patients with vital organ involvement, including children, have been, or currently are under anti-TNF treatment. Moreover, large retrospective studies showed that both anti-TNF monoclonal antibodies Infliximab and Adalimumab reduced the emergence of new clinical manifestations of BS in most patients under treatment. Smaller studies have shown that, if successful, anti-TNF treatment can be discontinued after at least two years with half of patients remaining disease-free in the long term. These findings suggest that TNF inhibitors may modify BS natural history, however, a prospective international study of consecutive patients who start treatment for mucocutaneous or articular manifestations only, is needed. Thus, we debate on the earliest possible use of TNF inhibitors in severe BS, in order to achieve remission and perhaps preservation of vital organ function and quality of life. Although not demonstrated yet, this approach may also reduce mortality rates as has happened in other rheumatic diseases. We propose that every candidate drug for BS should be compared for efficacy and safety to TNF inhibitors.
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