Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis
Authors' conclusion
Findings from this analysis demonstrate that upadacitinib is generally well tolerated with observed differences in safety profiles likely reflective of varying patient characteristics across RA, PsA, AS and AD populations.
Study context
- Population
- Patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) or atopic dermatitis in clinical trials of upadacitinib, data as of 30 June 202115,425 PY of exposure
- Participants
- 6,991 patients
- Comparison
- Upadacitinib 15 mg (and 30 mg, atopic dermatitis (AD) only) across RA, PsA, AS and AD; adalimumab and MTX as active comparators in some RA and PsA studies
- RAn = 3,209
- PsAn = 907
- ASn = 182
- ADn = 2,693
- Outcome
- TEAEs as exposure-adjusted event rates per 100 patient-years (E/100 PY), by disease
Methodological detailspooled clinical trial data, exposure-adjusted event rates, active comparators (adalimumab, MTX) in some RA and PsA studies
- Pooled clinical trial data
- Exposure-adjusted event rates
- Active comparators (adalimumab, MTX) in some RA and PsA studies
Main finding
As reported in the abstract
Exposure-adjusted TEAE rates (E/100 PY), range across diseases
Any TEAE, similar across diseases
205.5-278.1
TEAE leading to discontinuation, similar across diseases
4.5-5.4
Further findings
Deaths, serious infections, MACE, VTE and malignancies (E/100 PY)
- Deaths
- 0-0.8
- Serious infections
- 0-3.9
- MACE
- 0-0.4
- VTE
- <0.1-0.4
- Malignancies
- 0.3-1.4
- Rates generally lowest in AS and AD
Safety
Herpes zoster, NMSC and creatine phosphokinase elevations (E/100 PY)
- Herpes zoster
- 1.6-3.6
- Non-melanoma skin cancer
- 0-0.8
- Creatine phosphokinase elevations
- 4.4-7.9
- Higher with upadacitinib than with active comparators in RA and PsA
Acne
- Increased rates in AD only
Original publication
Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. Published 8 February 2023. doi:10.
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