Efficacy and Safety of ABBV ‐154 for the Treatment of Active Rheumatoid Arthritis: A Phase 2b, Randomized, Placebo‐Controlled Trial
- terminated early
- Clinical development of ABBV-154 was discontinued; study terminated early
Authors' conclusion
ABBV-154 demonstrated superior efficacy over placebo in patients with RA and inadequate response to prior b/tsDMARDs. TEAE rates in all ABBV-154 arms were comparable with placebo.
Study context
- Population
- Patients with moderately to severely active rheumatoid arthritis (RA) on background MTX with inadequate response to at least one prior b/tsDMARDtreated
- Participants
- 472 patients
- Comparison
- Subcutaneous ABBV-154 vs placebo
- Primary endpoint
- ACR50 response
- Follow-up
- Week 12
Methodological detailsphase 2b, placebo-controlled
- Phase 2b
- Placebo-controlled
Primary result
As reported in the abstract
Placebo
6.3%
- ACR50 with ABBV-154 across dose groups, higher vs placebo (all P < 0.001)
- 25.5%-44.4%
Secondary outcomes
ACR20 response
- ACR20 response rates higher in all ABBV-154 groups vs placebo (P < 0.001)
Other secondary endpoints (incl. ACR70)
- Most ABBV-154 groups achieved the other secondary endpoints
Safety
Treatment-emergent adverse events (TEAEs) · through week 12
- TEAE rates similar to placebo for all ABBV-154 doses
Serious infection TEAEs
- Serious infection TEAEs in the ABBV-154 groups
- 10
Original publication
Efficacy and Safety of ABBV ‐154 for the Treatment of Active Rheumatoid Arthritis: A Phase 2b, Randomized, Placebo‐Controlled Trial. Arthritis Rheumatol. Published 1 September 2025. doi:10.
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