Do newly approved drugs have a worse observed safety profile than once established? A study on time trends in risks of key safety outcomes with immunomodulatory drugs against rheumatoid arthritis
Authors' conclusion
Modest channelling makes the safety profile of b/tsDMARDs appear worse when new on the market.
Study context
- Population
- Patients with rheumatoid arthritis (RA) initiating b/tsDMARDs (Swedish Rheumatology Quality Register and national registers, 2006–2022), with an early bionaive RA cohort and a matched general population cohort as references33,550 b/tsDMARD initiations
- Exposure
- b/tsDMARDs initiated >5 vs <2 years since market entry of that class; and initiated 2016-2021 vs 2006-2010
- Outcome
- First of MACE, VTE, cancer or serious infection
Methodological detailsCox regression, adjusted for patient characteristics
- Cox regression
- Adjusted for patient characteristics
Main finding
As reported in the abstract
First of MACE, VTE, cancer or serious infection, by time since market entry
>5 years since market entry vs <2 years since market entryEstimate (95% CI)
First of MACE, VTE, cancer or serious infection, by time since market entry
unadjusted HR 0.74(0.67–0.81)
Adjusted for patient characteristics
aHR 0.93(0.84–1.03)
- Events observed in the b/tsDMARD initiator cohort
- 5862
Observational data: associations, not effects.
Further findings
| Outcome | aHR (95% CI) | |
|---|---|---|
| First of MACE, VTE, cancer or serious infection, by calendar period of treatment start2016-2021vs 2006-2010 | 0.74 (0.69–0.80) | |
| 0.512Adjusted hazard ratio (log scale) |
First of MACE, VTE, cancer or serious infection, by calendar period of treatment start
- Constant rate in the background population
Original publication
Do newly approved drugs have a worse observed safety profile than once established? A study on time trends in risks of key safety outcomes with immunomodulatory drugs against rheumatoid arthritis. Ann Rheum Dis. Published 17 February 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →