Rheumatoid arthritis

Efficacy and safety of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological treatments: results through 5 years from the SELECT-BEYOND study

RMD OpenPublished Long-term extension of the SELECT-BEYOND phase 3 randomised trial

Authors' conclusion

Upadacitinib 15/30 mg continued to be effective in treating clinical and functional outcomes in patients with RA. The safety profile observed over 5 years was consistent with earlier study-specific and integrated assessments of upadacitinib treatment.

Study context

Population
Patients with rheumatoid arthritis (RA) refractory to ≥1 bDMARD418 (84%) entered the long-term extension (LTE)
Participants
498 patients
Comparison
Upadacitinib 15 mg vs 30 mg once daily
  • Upadacitinib 15 mgn = 80
  • Upadacitinib 30 mgn = 81
Methodological detailsplacebo-controlled through week 12, as observed and non-responder imputation analyses
  • Placebo-controlled through week 12
  • As observed and non-responder imputation analyses

Primary result

As reported in the abstract

CDAI remission / low disease activity (as observed) · week 260
OutcomeUpadacitinib 15 mgUpadacitinib 30 mg
CDAI remission / low disease activity (as observed) · week 26036%36%
CDAI low disease activity81%77%

Further findings

Clinical Disease Activity Index (CDAI) improvement >12 among patients starting in high disease activity · week 260

≈47% with upadacitinib 15/30 mg

Functional and pain-related outcomes

Comparable improvements with both doses

Safety

Anaemia, herpes zoster and creatine phosphokinase elevation · up to 5 years

Numerically higher rates with upadacitinib 30 mg vs 15 mg
No new safety issues identified

Original publication

Efficacy and safety of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological treatments: results through 5 years from the SELECT-BEYOND study. RMD Open. Published 25 July 2024. doi:10.1136/rmdopen-2023-003918

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