Efficacy of subcutaneous vs intravenous infliximab in rheumatoid arthritis: a post-hoc analysis of a randomized phase III trial
Authors' conclusion
IFX s.c. showed improved efficacy at W30 compared with IFX i.v., and the reduced between-group difference in efficacy outcomes at W54 after switching supports the results suggesting benefits of IFX s.c. compared with IFX i.v. at W30.
Study context
- Population
- Patients with active RA and inadequate response to MTX
- Comparison
- Infliximab (IFX) s.c. 120 mg every 2 weeks vs IFX i.v. 3 mg/kg every 8 weeks (maintenance), after i.v. induction
- Primary endpoint
- DAS28-CRP improvement (pivotal trial's primary endpoint; non-inferiority of s.c. to i.v. IFX)
- Follow-up
- Week 22
Methodological detailsrandomized (1:1), switch from i.v. to s.c. at W30, last observation carried forward (LOCF) and non-responder imputation (NRI) imputation
- Randomized (1:1)
- Switch from i.v. to s.c. at W30
- LOCF and NRI imputation
Primary result
As reported in the abstract
Efficacy outcomes, s.c. vs i.v. IFX · W30
- Significantly improved DAS-CRP (DAS28-CRP)/DAS28-ESR/CDAI/Simplified Disease Activity Index (SDAI) scores with s.c. vs i.v. IFX (LOCF)
- Significantly improved ACR/good EULAR responses, DAS28-CRP/Boolean remission, and DAS28-CRP/DAS28-ESR/CDAI/SDAI low disease activity and remission with s.c. vs i.v. IFX (LOCF and/or NRI)
- Significantly improved MCID in HAQ score with s.c. vs i.v. IFX (LOCF and NRI)
- Post-hoc analysis
Further findings
Efficacy outcomes after switch of i.v. to s.c. · W54
- Fewer significant between-group differences identified
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Efficacy of subcutaneous vs intravenous infliximab in rheumatoid arthritis: a post-hoc analysis of a randomized phase III trial. Rheumatology (Oxford). Published 19 December 2022. doi:10.
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