By Fineline Cube 
AbbVie (NYSE: ABBV) announced positive topline data from its Phase IIIb/IV head‑to‑head trial, SELECT‑SWITCH, comparing upadacitinib extended‑release (ER) 15 mg once daily to adalimumab 40 mg every other week in adults with moderately to severely active rheumatoid arthritis (RA) on stable methotrexate (MTX) who had an inadequate response or intolerance to a tumor necrosis factor inhibitor (TNFi) other than adalimumab.
Key Findings
| Metric | Upadacitinib ER | Adalimumab | Statistical Significance |
|---|---|---|---|
| Low Disease Activity (LDA) / Remission | 43.3 % (≥ DAS28‑CRP ≤ 3.2) | 22.4 % | p < 0.001 |
| Remission (DAS28‑CRP < 2.6) | 28.4 % | 14.5 % | p < 0.001 |
| Primary Endpoint (Week 12) | Met | – | – |
| Safety | No new risks | No new risks | – |
The study demonstrated that at Week 12, the proportion of patients achieving low disease activity and remission with upadacitinib ER was nearly double that with adalimumab, meeting the primary endpoint and securing positive results on most ranked secondary endpoints.
Study Design
- Population: 1,200 adults with moderately/severely active RA on stable MTX, previously exposed to a TNFi (excluding adalimumab).
- Randomization: 1:1 to upadacitinib ER 15 mg q.d. or adalimumab 40 mg q.o.w.
- Duration: 12 weeks for primary assessment; ongoing extension for long‑term safety.
- Endpoints: Primary – proportion achieving LDA/remission at Week 12 (DAS28‑CRP ≤ 3.2). Secondary – DAS28‑CRP < 2.6, functional scores, patient‑reported outcomes.
Safety Profile
- Treatment‑emergent adverse events (TEAEs): Comparable between arms; most were mild‑moderate.
- Serious AEs: Low incidence; no new safety signals identified.
- Infections: Incidence rates of serious infections were similar across both treatment groups.
Implications for Rheumatology
SELECT‑SWITCH is the first head‑to‑head comparison of a TNF‑inhibitor cycling strategy with a JAK inhibitor. The data support upadacitinib ER as a superior alternative for patients who cannot tolerate or fail a TNFi other than adalimumab. The findings may influence treatment algorithms and reimbursement decisions for RA.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech