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
Authors' conclusion
Data from this proof-of-concept trial support the continued development of a TNF-GRM ADC for the treatment of RA, with the potential to achieve superior outcomes compared to currently available therapies.
Study context
- Population
- Adults with moderate-to-severe rheumatoid arthritis (RA) receiving background MTXrandomised
- Participants
- 48 adults
- Comparison
- Intravenously (IV) ABBV-3373 100 mg every other week for 12 weeks then placebo for 12 weeks vs SC adalimumab 80 mg every other week for 24 weeks, on background MTX
- ABBV-3373n = 31
- Adalimumabn = 17reference
- Primary endpoint
- Change from baseline in DAS28-CRP; 2 prespecified primary comparisons: ABBV-3373 vs historical adalimumab and vs combined in-trial/historical adalimumab
- Follow-up
- Week 12
Methodological detailsdouble-blind, active-controlled, proof-of-concept, phase IIa
- Double-blind
- Active-controlled
- Proof-of-concept
- Phase IIa
Primary result
As reported in the abstract
Change from baseline in DAS28-CRP
ABBV-3373
−2.65
Adalimumab
−2.51
ABBV-3373 vs Historical adalimumab (−2.13): P = 0.022 · ABBV-3373 vs Combined in-trial/historical adalimumab (−2.29): probability 89.9%
Secondary outcomes
- Maintenance of DAS28-CRP ≤3.2 at week 24 after switch to placebo, among ABBV-3373 week-12 responders
- 70.6%
Secondary end points (CDAI, SDAI, DAS28-ESR changes; DAS28-CRP ≤3.2; ACR50)
- Probability ABBV-3373 more effective than adalimumab (combined in-trial/historical data)
- 79.3-99.5%
- Greater efficacy with ABBV-3373 vs historical adalimumab
Safety
Events
| Outcome | ABBV-3373 | Adalimumab |
|---|---|---|
| Serious adverse eventsAdalimumab: breast abscess, bronchitis | 4 | 2 |
- Serious adverse events: ABBV-3373: noncardiac chest pain, pneumonia, upper respiratory tract infection, anaphylactic shock
- Serious adverse events: No similar anaphylactic shock after IV administration lengthened from 3 minutes to 15-30 minutes
Original publication
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. Published 2 April 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →