Vasculitis & polymyalgia rheumatica
Time‐Dependent Effect of Prophylactic Trimethoprim‐Sulfamethoxazole on the Incidence of Serious Infections in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis: A Target Trial Emulation Study
Main finding · Serious infectionResult — go to the resultHazard ratio 0.48 95% CI 0.32–0.72Authors' conclusion
Prophylactic TMP-SMX significantly reduced the risk of serious infections in patients with AAV, particularly during the first six months of induction therapy with RTX or CYC.
Study context
- Population
- Patients with antibody-associated vasculitis (AAV) treated with rituximab (RTX) or CYC as induction therapy
- Participants
- 296 patients
- Exposure
- Prophylactic trimethoprim-sulfamethoxazole (TMP-SMX) within 14 days after induction therapy vs no prophylaxis
- Prophylaxisn = 240
- Controln = 56reference
- Outcome
- Incidence of serious infection
- Follow-up
- One year
Methodological detailsmulticentre, inverse probability weighting, intention-to-treat, time-varying exposure analysis
- Multicentre
- Inverse probability weighting
- Intention-to-treat
- Time-varying exposure analysis
Main finding
Serious infection
Hazard ratio
0.48
95% CI 0.32–0.72
Prophylaxisvs Control
HR 0.48 (95% CI 0.32–0.72)
As reported in the abstract
Observational data: associations, not effects.
Further findings
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Serious infection, first 180 days | 0.41 (0.22–0.76) | interaction P = 0.044 | |
| Serious infection, after 180 days | 3.67 (0.46–29.43) | interaction P = 0.044 | |
| 0.050.21520Hazard ratio (log scale) |
Serious infections overall (whole cohort)
- Serious infections in 252.1 person-years
- 77
- Patients with serious infection
- 65
- Fatality rate
- 18.5%
- Serious infections within first 180 days
- 66, 85.7%
- NNT to prevent one serious infection
- 8.0
- Time-varying analysis
- consistent with ITT result
Safety
- Severe adverse drug reaction related to TMP-SMX (cases)
- 1
- NNH
- 127.4
- NNT to prevent one serious infection
- 8.0
Original publication
Time‐Dependent Effect of Prophylactic Trimethoprim‐Sulfamethoxazole on the Incidence of Serious Infections in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis: A Target Trial Emulation Study. Arthritis Rheumatol. Published 22 May 2025. doi:10.
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