Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-year data from the phase 3, randomised SELECT-COMPARE study
Authors' conclusion
The safety profile of upadacitinib through 5 years was consistent with the known safety profile of upadacitinib, with no new safety risks. Clinical responses were numerically higher with upadacitinib versus adalimumab at 5 years.
Study context
- Population
- Patients with RA and inadequate response to MTX
- Comparison
- Upadacitinib 15 mg once daily vs adalimumab 40 mg every other week, both with MTX
Methodological detailsSELECT-COMPARE, double-blind period to week 48, placebo- and active-controlled, rescue by week 26, non-responder imputation
- SELECT-COMPARE
- Double-blind period to week 48
- Placebo- and active-controlled
- Rescue by week 26
- Non-responder imputation
Primary result
As reported in the abstract
Clinical responses, randomised group (NRI) · 5 years (through week 264)
- Numerically greater proportions randomised to upadacitinib vs adalimumab achieved clinical responses (non-responder imputation (NRI))
- Non-responder imputation (NRI)
Further findings
| Outcome | Upadacitinib | Adalimumab | P value |
|---|---|---|---|
| CDAI remission (≤2.8) · 5 years (through week 264)Upadacitinib vs Adalimumab · NRI | 24.6% | 18.7% | nominal p=0.042 |
| DAS28-CRP <2.6 · 5 years (through week 264)Upadacitinib vs Adalimumab · NRI | 31.8% | 23.2% | nominal p=0.006 |
Radiographic progression · week 192
- Numerically lower with continuous upadacitinib vs adalimumab
Safety
Treatment-emergent adverse events (TEAEs) · through week 264
- Rates of TEAEs generally similar with upadacitinib vs adalimumab
- Numerically higher rates of herpes zoster, lymphopenia, creatine phosphokinase elevation, hepatic disorder and non-melanoma skin cancer with upadacitinib
Original publication
Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-year data from the phase 3, randomised SELECT-COMPARE study. RMD Open. Published 28 May 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →