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항목
AntibodyCurated CoreFDAApproved
adalimumab (Humira, Hyrimoz, Amjevita)
AbbVie·TNF-α
574 trials·t½ ~14–19 days (SC)
Overview
Program
Humira (adalimumab)
Overview
Company
AbbVie
Overview
Modality
ANTIBODY
Overview
Target
TNF-α
Overview
Indication
Rheumatoid arthritis, psoriasis, Crohn's disease, ulcerative colitis, axial SpA
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
novel object recognition test
Positioning
Known limitation
Anti-drug antibodies, TNF-independent inflammation, and immunogenicity lowering trough levels.
MoA
Mechanism
Adalimumab binds specifically to TNF-α and blocks its interaction with p55 and p75 cell-surface TNF receptors, neutralizing TNF-mediated inflammatory cascades (IL-6, adhesion molecules, acute-phase proteins).
MoA
Biomarker
CRP, ESR, disease-specific scores (DAS28, PASI, Mayo for IBD).
PK/PD
Half-life
~14–19 days (SC)
PK/PD
Species
Rat, xenografts, which corroborat, CRP reduction, clinical remission scores
PK/PD
Animal (cat.)
Rat
PK/PD
Experiment
pd
Toxicology
Species
Cynomolgus monkey, Rat, xenografts, which corroborat
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
Serious infections (TB reactivation, invasive fungal), malignancy risk signal, injection-site reactions, and rare demyelinating events.
Toxicology
CRS
N/A
Clinical
Safety signal
Serious infections (TB reactivation, invasive fungal), malignancy risk signal, injection-site reactions, and rare demyelinating events.
Clinical
Result source
ClinicalTrials.gov NCT02405780
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT02405780