Combotherapies in immune-mediated inflammatory diseases: A study using the Clinical Data Warehouse from Paris Hospitals’ Public Assistance
Authors' conclusion
The overall risk of SAE under combotherapy does not seem greatly increased compared to monotherapy, but certain combinations warrant caution.
Study context
- Population
- Immune-mediated inflammatory diseases (IMID) patients under combotherapy, Paris Hospitals' Public Assistance, 2017–2022 (median age 36 years, 58 % females)131 combotherapy lines
- Participants
- 125 vs 251
- Exposure
- Combotherapy vs matched monotherapy controls
- Combotherapyn = 125
- Monotherapyn = 251reference
- Outcome
- Occurrence of serious adverse events (SAE): severe infections, major cardiovascular events, neoplasia and all-cause mortality
Methodological detailsmatched monotherapy control group, Clinical Data Warehouse
- Matched monotherapy control group
- Clinical Data Warehouse
Main finding
As reported in the abstract
1-year cumulative incidence of SAE (severe infections, major cardiovascular events, neoplasia, all-cause mortality) under combotherapy
1-year cumulative incidence of serious adverse events (SAE)
29 %
95 %CI 21–38
Observational data: associations, not effects.
Further findings
SAE risk by combotherapy composition (multivariate analyses)
| HR (95 % CI) | ||
|---|---|---|
| Abatacept + JAKiIndependently associated with increased risk of SAE | 6.81 (1.88–24.68) | |
| Anti-IL-1-basedIndependently associated with increased risk of SAE | 4.82 (1.17–19.89) | |
| Anti-CD20-basedIndependently associated with increased risk of SAE | 4.03 (1.22–13.31) | |
| 0.050.21520Hazard ratio (log scale) |
1-year cumulative incidence of severe infections under combotherapy
- 1-year cumulative incidence of severe infections
- 24 % (95 %CI 16-32)
- Survival and incidence of severe infections not statistically different from monotherapy controls after adjustment for confounders
Safety
Events under combotherapy (median follow-up 15 months [IQR 19])
- Severe infections
- 30 (24 %)
- Neoplasia
- 5 (4 %)
- VTE
- 4 (3.2 %)
- Acute coronary syndromes
- 3 (2.4 %)
- Deaths
- 7 (5.6 %)
Original publication
Combotherapies in immune-mediated inflammatory diseases: A study using the Clinical Data Warehouse from Paris Hospitals’ Public Assistance. Semin Arthritis Rheum. Published 14 February 2025. doi:10.
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