Evaluation of serious infections, including Mycobacterium tuberculosis, during treatment with biologic disease-modifying anti-rheumatic drugs: does line of therapy matter?
Authors' conclusion
The risk of serious infections does not appear to be influenced by the line of therapy in patients with RA. However, the risk of TB seems to be more frequent during the initial lines of treatment or prior to 2009.
Study context
- Population
- Patients with RA from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA) cohort initiating a bDMARD from first to fifth line of therapy; follow-up up to 3 years33,897 treatment courses
- Exposure
- Seven bDMARDs compared overall and by line of therapy
- Outcome
- SI
- Follow-up
- Up to 3 years
Methodological detailsregistry-based (BSRBR-RA), inverse probability of treatment weighting, Cox proportional hazards models, stratified by line of therapy
- Registry-based (BSRBR-RA)
- Inverse probability of treatment weighting
- Cox proportional hazards models
- Stratified by line of therapy
Main finding
As reported in the abstract
Serious infection
Overall incidence of serious infection (SI)
/100 patient-years 4.4
95% CI 4.2, 4.5
Observational data: associations, not effects.
Secondary outcomes
Active tuberculosis (TB)
- TB cases, all during the first three lines of treatment and rarely since 2009
- 49
SI, sensitivity analysis (treatment courses 2009–2018)
- Similar hazards ratios (HRs) among these treatments
Original publication
Evaluation of serious infections, including Mycobacterium tuberculosis, during treatment with biologic disease-modifying anti-rheumatic drugs: does line of therapy matter? Rheumatology (Oxford). Published 27 September 2023. doi:10.
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