Antibody Information

General Information of This Antibody
Antibody ID
ANI0JQASB
Antibody Name
Adalimumab
Brand Name
HUMIRA
Organization
AbbVie, Inc.; Eisai Co., Ltd.
Indication
Crohn's disease; Rheumatoid arthritis; Ankylosing spondylitis; Psoriatic arthritis; Juvenile Idiopathic Arthritis; Hidradenitis suppurativa; Ulcerative colitis; Uveitis
Approval Date
Dec. 2002
Synonyms
ABP-501; ABRILADA; ADALIMUMAB; ADALIMUMAB ADAZ; ADALIMUMAB-ADAZ; ADALIMUMAB ADBM; ADALIMUMAB-ADBM; ADALIMUMAB AFZB; ADALIMUMAB-AFZB; ADALIMUMAB AQVH; ADALIMUMAB-AQVH; ADALIMUMAB ATTO; ADALIMUMAB-ATTO; ADALIMUMAB BETA; DALIMUMAB BIOSIMILAR (ALVOTECH); ADALIMUMAB BIOSIMILAR (AVT02); ADALIMUMAB BIOSIMILAR (CELLTRION); ADALIMUMAB BIOSIMILAR (CT-P17); ADALIMUMAB BIOSIMILAR (FKB-327); ADALIMUMAB BIOSIMILAR (ZRC-3197); ADALIMUMAB BWWD; ADALIMUMAB-BWWD; ADALIMUMAB-FKJP; ADALIMUMAB (GENETICAL RECOMBINATION); ADALIMUMAB (HUMIRA); AMJEVITA; AVT02; AVT-02; BCD-057; BI695501; BI 695501; BI-695501; CHS-1420; CT-P17; CYLTEZO; D2E7; EXEMPTIA; FKB327; FKB-327; GP2017; GP-2017; HADLIMA; HLX03; HLX-03; HULIO; HYRIMOZ; LU200134; LU-200134; M923; M-923; MSB11022; MSB-11022; ONS-3010; TRUDEXA; YUSIMRY; ZRC3197; ZRC-3197
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Antibody Type
Monoclonal antibody (mAb)
Antibody Subtype
Humanized IgG1-kappa
Antigen Name
Tumor necrosis factor receptor superfamily member 1A (TNFRSF1A)
  Antigen Info 
ChEMBI ID
CHEMBL1201580
PDB ID
3wd5 , 4nyl , 6cr1
DrugBank ID
DB00051
Drug Central ID
4904
Click to Show/Hide the Sequence Information of This Antibody
Heavy Chain Sequence
EVQLVESGGGLVQPGRSLRLSCAASGFTFDDYAMHWVRQAPGKGLEWVSAITWNSGHIDY
ADSVEGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCAKVSYLSTASSLDYWGQGTLVTVS
SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS
SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLG
GPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQY
NSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRD
ELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSR
WQQGNVFSCSVMHEALHNHYTQKSLSLSPG
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Heavy Chain Varible Domain
EVQLVESGGGLVQPGRSLRLSCAASGFTFDDYAMHWVRQAPGKGLEWVSAITWNSGHIDY
ADSVEGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCAKVSYLSTASSLDYWGQGTLVTVS
S
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Heavy Chain CDR 1
GFTFDDYA
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Heavy Chain CDR 2
ITWNSGHI
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Heavy Chain CDR 3
AKVSYLSTASSLDY
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Light Chain Sequence
DIQMTQSPSSLSASVGDRVTITCRASQGIRNYLAWYQQKPGKAPKLLIYAASTLQSGVPS
RFSGSGSGTDFTLTISSLQPEDVATYYCQRYNRAPYTFGQGTKVEIKRTVAAPSVFIFPP
SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT
LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
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Light Chain Varible Domain
DIQMTQSPSSLSASVGDRVTITCRASQGIRNYLAWYQQKPGKAPKLLIYAASTLQSGVPS
RFSGSGSGTDFTLTISSLQPEDVATYYCQRYNRAPYTFGQGTKVEIK
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Light Chain CDR 1
QGIRNY
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Light Chain CDR 2
AAS
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Light Chain CDR 3
QRYNRAPYT
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
ABBV-154 [Phase 2 (discontinued)]
 ADC Info 
Identified from the Human Clinical Data
Click To Hide/Show 8 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Related Clinical Trial
NCT Number NCT04888585  Clinical Status Phase 2
Clinical Description
A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of ABBV-154 in subjects with moderately to severely active rheumatoid arthritis with inadequate response to biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsdmards).
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT04972968  Clinical Status Phase 2
Clinical Description
A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety and efficacy of ABBV-154 in subjects with polymyalgia rheumatica (PMR) dependent on glucocorticoid treatment.
Experiment 3 Reporting the Activity Date of This ADC [3]
Related Clinical Trial
NCT Number NCT05068284  Clinical Status Phase 2
Clinical Description
A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of ABBV-154 in subjects with moderately to severely active crohn's disease (CD): aim-cd.
Experiment 4 Reporting the Activity Date of This ADC [6]
Related Clinical Trial
NCT Number NCT05556226  Clinical Status Phase 1
Clinical Description
A phase 1 study in healthy subjects to evaluate the relative bioavailability of ABBV-154.
Experiment 5 Reporting the Activity Date of This ADC [8]
Patients Enrolled
Eligible participants must have a BMI between 18.0 and 29.9 kg/m2. Key exclusions include use of medications/supplements within 2 weeks (or 5 half-lives), prior exposure to similar biologic therapies, and history of significant medical conditions (e.g., epilepsy, cardiac/respiratory/neurologic disorders, or uncontrolled illnesses).
Related Clinical Trial
NCT Number NCT05556226  Clinical Status PHASE1
Clinical Description
A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of ABBV-154
Primary Endpoint
This study evaluates the pharmacokinetic profile of the investigational drug over approximately 58 days, measuring key parameters including Cmax, Tmax, terminal elimination rate constant (beta), half-life (t1/2), and AUC values (AUCt and AUC∞). Safety is assessed through adverse event monitoring for approximately 72 days, with investigators determining causality between reported AEs and study treatment.

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Experiment 6 Reporting the Activity Date of This ADC [9]
Patients Enrolled
Comprehensive efficacy assessments focused on joint count improvements, composite disease activity scores, and patient-reported outcomes to evaluate treatment response, disease control, and functional status in this biologic-refractory RA population.
Related Clinical Trial
NCT Number NCT04888585  Clinical Status PHASE2
Clinical Description
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)
Primary Endpoint
The primary endpoint was achieving ACR50 response at Week 12, defined as ≥50% improvement in tender/swollen joint counts and ≥50% improvement in 3 of 5 additional measures including physician/patient global assessments, pain score, HAQ-DI, and hsCRP. Secondary endpoints included changes in DAS28 and CDAI scores, with lower scores indicating improvement, as well as ACR20/70 responses, low disease activity (DAS28 ≤3.2 or CDAI ≤10), clinical remission (DAS28 <2.6 or CDAI ≤2.8), and HAQ-DI improvement from baseline.

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Other Endpoint
Key inclusion criteria required confirmed RA diagnosis per 2010 ACR/EULAR criteria with ≥6 swollen/tender joints at baseline, inadequate response to prior biologics/tsDMARDs, and stable MTX dose. Exclusion criteria included prior discontinuation of adalimumab due to intolerance/toxicity.
Experiment 7 Reporting the Activity Date of This ADC [10]
Patients Enrolled
The study evaluated disease stability under glucocorticoid tapering by measuring flare events, steroid exposure reduction, and sustained remission in this recurrent PMR population.
Related Clinical Trial
NCT Number NCT04972968  Clinical Status PHASE2
Clinical Description
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment
Primary Endpoint
The primary endpoint was time to PMR flare (requiring glucocorticoid dose increase) from first dose through Week 52. Secondary endpoints included flare-free status rates, cumulative glucocorticoid dose, and dose changes from baseline by Week 24.
Other Endpoint
Eligible participants required confirmed PMR diagnosis per 2012 EULAR/ACR criteria with ≥2 prior flares, stable prednisone use, and willingness to follow protocol tapering. Key exclusions included prior TNF antagonist treatment or concurrent immunomodulators beyond prednisone/hydroxychloroquine.
Experiment 8 Reporting the Activity Date of This ADC [11]
Patients Enrolled
The study aimed to demonstrate mucosal healing and sustained clinical remission in moderate-to-severe CD patients refractory to multiple biologics, using comprehensive endoscopic and symptom-based assessments.
Related Clinical Trial
NCT Number NCT05068284  Clinical Status PHASE2
Clinical Description
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD
Primary Endpoint
The primary endpoint was endoscopic response (SES-CD reduction >50% or ≥2-point decrease in isolated ileal disease) at Week 12. Secondary endoscopic and clinical endpoints included SES-CD response at Week 40 and clinical remission (CDAI <150 or stool frequency/abdominal pain criteria) at Weeks 12 and 40.
Other Endpoint
Eligible participants required confirmed CD diagnosis ≥3 months, CDAI 220-450, and SES-CD ≥6 (≥4 for isolated ileal disease), with prior biologic failure/intolerance. Key exclusion was prior adalimumab intolerance.
ABBV-3373 [Phase 2 (discontinued)]
 ADC Info 
Identified from the Human Clinical Data
Click To Hide/Show 3 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [4]
Related Clinical Trial
NCT Number NCT03823391  Clinical Status Phase 2
Clinical Description
A randomized, double-blind, double-dummy, active controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ABBV-3373 in subjects with moderate to severe rheumatoid arthritis.
Experiment 2 Reporting the Activity Date of This ADC [5]
Patients Enrolled
RA (based on the 1987 American College of Rheumatology [ACR] classification criteria or 2010 ACR/EULAR criteria [16, 17]), with disease duration >3 months, and active disease defined as a Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) (18) of 3.2 and 4 of 28 swollen joints and 4 of 28 tender joints.
Administration Dosage
Intravenously (IV) ABBV-3373 100 mg every other week for 12 weeks, followed by placebo for 12 weeks, or subcutaneous adalimumab 80 mg every other week for 24 weeks.
Related Clinical Trial
NCT Number NCT03823391  Clinical Status Phase 2
Clinical Description
A randomized, double-blind, double-dummy, active controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ABBV-3373 in subjects with moderate to severe rheumatoid arthritis.
Primary Endpoint
48 patients were randomized to ABBV-3373 (n=31) or adalimumab (n=17). At week 12, ABBV-3373 reduced DAS28 (CRP) versus historical adalimumab (2.65 versus 2.13; P=0.022) and combined in-trial/historical adalimumab (2.65 versus 2.29; probability=89.9%), with numerically greater improvement than in-trial adalimumab (2.51).
Other Endpoint
For secondary endpoints, greater efficacy was observed with ABBV-3373 versus historical adalimumab; ABBV-3373 was predicted with 79.30-99.50% probability to be better than adalimumab based on combined in-trial/historical adalimumab data.
Experiment 3 Reporting the Activity Date of This ADC [12]
Patients Enrolled
Inclusion criteria require confirmed RA (1987 ACR/2010 EULAR criteria) lasting >3 months, with &ge;4 swollen/tender joints (28-count), DAS28-CRP &ge;3.2, and inadequate MTX response (stable dose 15-25mg/week [&ge;10mg/week if intolerant] for &ge;4 weeks). Exclusions include prior anti-TNF use (e.g., adalimumab) or non-anti-TNF biologics/tsDMARDs (unless used <3 months without efficacy/intolerability issues).

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Administration Dosage
Participants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22.
Related Clinical Trial
NCT Number NCT03823391  Clinical Status PHASE2
Clinical Description
A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis
Primary Endpoint
The primary endpoint is the change from baseline to Week 12 in Disease Activity Score 28 (DAS28-CRP), a composite index evaluating tender/swollen joint counts (28 joints), patient global assessment (VAS 0-100mm), and hsCRP (mg/L). Scores range from 0.96-10 (higher=worse activity); negative change indicates improvement.
Other Endpoint
Secondary endpoints include Week 12 changes in CDAI (sum of tender/swollen joints + patient/physician global assessments [VAS 0-10cm]; score 0-76), SDAI (CDAI+CRP; score 0-86), and DAS28-ESR (similar to DAS28-CRP but using ESR). Negative changes denote improvement. Additional measures: proportion achieving DAS28-CRP ≤3.2 (low disease activity) and American College of Rheumatology 50% (ACR50) response (≥50% improvement in joint counts + ≥3 of 5 key parameters).

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Obtained from the Model Organism Data
Click To Hide/Show 8 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [7]
Efficacy Data Paw swelling AUC
81%
Positive TNF expression (TNF+++/++)
Method Description
To evaluate the impact of the anti-mTNF GRM ADCs on inflammation in a chronic inflammatory setting,we progressed several ADCs into a mouse collagen-induced arthritis (mCIA) model. A single 3 mg/kg dose of the ADC was given at the first clinical signs of disease,a time point of intervention where anti-TNF treatment has a moderate impact.
In Vivo Model Collagen-induced arthritis (mCIA) model
Experiment 2 Reporting the Activity Date of This ADC [7]
Efficacy Data Paw swelling AUC
98%
Positive TNF expression (TNF+++/++)
Method Description
To evaluate the impact of the anti-mTNF GRM ADCs on inflammation in a chronic inflammatory setting,we progressed several ADCs into a mouse collagen-induced arthritis (mCIA) model. A single 10 mg/kg dose of the ADC was given at the first clinical signs of disease,a time point of intervention where anti-TNF treatment has a moderate impact.
In Vivo Model Collagen-induced arthritis (mCIA) model
Experiment 3 Reporting the Activity Date of This ADC [7]
Efficacy Data P1NP inhibition
0%
Positive TNF expression (TNF+++/++)
Method Description
In an acute in vivo model of contact hypersensitivity (CHS) mice were sensitized with fluorescein isothiocyanate (FITC) on the abdomen and challenged 6 days later with FITC on the ear,which resulted in an increase in ear swelling that was measured 24 h postchallenge. Anti-mTNF GRM ADCs were dosed at either 3 mg/kg once prior to FITC sensitization. Mice were challenged with adrenocorticotropic hormone (ACTH) 72 h following ADC dosing and plasma was collected 30 min later to assess P1NP level.

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In Vivo Model Acute contact hypersensitivity (CHS) model
Experiment 4 Reporting the Activity Date of This ADC [7]
Efficacy Data P1NP inhibition
19%
Positive TNF expression (TNF+++/++)
Method Description
In an acute in vivo model of contact hypersensitivity (CHS) mice were sensitized with fluorescein isothiocyanate (FITC) on the abdomen and challenged 6 days later with FITC on the ear,which resulted in an increase in ear swelling that was measured 24 h postchallenge. Anti-mTNF GRM ADCs were dosed at either 10 mg/kg once prior to FITC sensitization. Mice were challenged with adrenocorticotropic hormone (ACTH) 72 h following ADC dosing and plasma was collected 30 min later to assess P1NP level.

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In Vivo Model Acute contact hypersensitivity (CHS) model
Experiment 5 Reporting the Activity Date of This ADC [7]
Efficacy Data Ear swelling inhibition
55%
Positive TNF expression (TNF+++/++)
Method Description
In an acute in vivo model of contact hypersensitivity (CHS) mice were sensitized with fluorescein isothiocyanate (FITC) on the abdomen and challenged 6 days later with FITC on the ear,which resulted in an increase in ear swelling that was measured 24 h postchallenge. Anti-mTNF GRM ADCs were dosed at either 3 mg/kg once prior to FITC sensitization.
In Vivo Model Fluorescein isothiocyanate (FITC)-induced CHS model
Experiment 6 Reporting the Activity Date of This ADC [7]
Efficacy Data Ear swelling inhibition
88%
Positive TNF expression (TNF+++/++)
Method Description
In an acute in vivo model of contact hypersensitivity (CHS) mice were sensitized with fluorescein isothiocyanate (FITC) on the abdomen and challenged 6 days later with FITC on the ear,which resulted in an increase in ear swelling that was measured 24 h postchallenge. Anti-mTNF GRM ADCs were dosed at either 10 mg/kg once prior to FITC sensitization.
In Vivo Model Fluorescein isothiocyanate (FITC)-induced CHS model
Experiment 7 Reporting the Activity Date of This ADC [7]
Efficacy Data Corticosterone inhibition
6%
Positive TNF expression (TNF+++/++)
Method Description
In an acute in vivo model of contact hypersensitivity (CHS) mice were sensitized with fluorescein isothiocyanate (FITC) on the abdomen and challenged 6 days later with FITC on the ear,which resulted in an increase in ear swelling that was measured 24 h postchallenge. Anti-mTNF GRM ADCs were dosed at either 3 mg/kg once prior to FITC sensitization. Mice were challenged with adrenocorticotropic hormone (ACTH) 72 h following ADC dosing and plasma was collected 30 min later to assess corticosterone level.

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In Vivo Model Acute contact hypersensitivity (CHS) model
Experiment 8 Reporting the Activity Date of This ADC [7]
Efficacy Data Corticosterone inhibition
15%
Positive TNF expression (TNF+++/++)
Method Description
In an acute in vivo model of contact hypersensitivity (CHS) mice were sensitized with fluorescein isothiocyanate (FITC) on the abdomen and challenged 6 days later with FITC on the ear,which resulted in an increase in ear swelling that was measured 24 h postchallenge. Anti-mTNF GRM ADCs were dosed at either 10 mg/kg once prior to FITC sensitization. Mice were challenged with adrenocorticotropic hormone (ACTH) 72 h following ADC dosing and plasma was collected 30 min later to assess corticosterone level.

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In Vivo Model Acute contact hypersensitivity (CHS) model
Revealed Based on the Cell Line Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [7]
Efficacy Data Half Maximal Effective Concentration (EC50)
0.08 ug/mL
Positive TNF expression (TNF+++/++)
Method Description
All the DAR purified ADCs were screened in both the TNF-expressing and wild-type K562 GRE reporter cell assay to confirm that their activity was consistent with ADCs having heterogeneous average DAR.
In Vitro Model Chronic myelogenous leukemia K-562 cells (TNF expression) CVCL_0004
Experiment 2 Reporting the Activity Date of This ADC [7]
Efficacy Data Half Maximal Effective Concentration (EC50)
5.8 ug/mL
Negative TNF expression (TNF-)
Method Description
All the DAR purified ADCs were screened in both the TNF-expressing and wild-type K562 GRE reporter cell assay to confirm that their activity was consistent with ADCs having heterogeneous average DAR.
In Vitro Model Chronic myelogenous leukemia K-562 cells CVCL_0004
References
Ref 1 A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs), NCT04888585
Ref 2 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, NCT04972968
Ref 3 A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD, NCT05068284
Ref 4 A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis, NCT03823391
Ref 5 Efficacy and Safety of ABBV-3373, a Novel Anti-Tumor Necrosis Factor Glucocorticoid Receptor Modulator Antibody-Drug Conjugate, in Adults with Moderate-to-Severe Rheumatoid Arthritis Despite Methotrexate Therapy: A Randomized, Double-Blind, Active-Controlled Proof-of-Concept Phase IIa Trial. Arthritis Rheumatol. 2023 Jun;75(6):879-889.
Ref 6 A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of ABBV-154, NCT05556226
Ref 7 Discovery of ABBV-3373, an Anti-TNF Glucocorticoid Receptor Modulator Immunology Antibody Drug Conjugate. J Med Chem. 2022 Dec 8;65(23):15893-15934.
Ref 8 Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants
Ref 9 Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
Ref 10 A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154
Ref 11 A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease
Ref 12 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)