Do high rheumatoid factor levels impact response to certolizumab pegol in patients with inadequately controlled rheumatoid arthritis? A post hoc analysis of the phase IIIb REALISTIC trial
Authors' conclusion
Patients with high and low RF levels experienced similar clinical responses to CZP treatment, irrespective of previous inadequate responses or intolerance to TNFis.
Study context
- Population
- Patients with rheumatoid arthritis (RA) (REALISTIC trial)
- Participants
- 930 patients
- Comparison
- Certolizumab pegol (CZP) vs placebo (PBO), stratified by rheumatoid factor (RF) level and prior TNFi use
- CZPn = 751
- PBOn = 179reference
- Primary endpoint
- Disease activity (DAS28-CRP, Clinical Disease Activity Index (CDAI), DAS28-CRP <2.6, CDAI remission ≤2.8) by RF level and prior TNFi use
- Follow-up
- Week 12
Methodological detailsplacebo-controlled, 12 weeks, followed by open-label CZP, stratified by baseline RF level and prior TNFi use
- Placebo-controlled
- 12 weeks, followed by open-label CZP
- Stratified by baseline RF level and prior TNFi use
Primary result
As reported in the abstract
Disease activity by RF level and prior TNFi use
- CZP-randomised patients: marked and similar improvements in disease activity, irrespective of RF level and prior TNFi use; PBO-randomised patients did not improve
- Post hoc
Further findings
Responses through week 36 in CZP-treated patients (incl. PBO switchers)
- Responses generally improved, with similar efficacy across subgroups
Original publication
Do high rheumatoid factor levels impact response to certolizumab pegol in patients with inadequately controlled rheumatoid arthritis? A post hoc analysis of the phase IIIb REALISTIC trial. RMD Open. Published 30 January 2026. doi:10.
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