Long-term safety and efficacy of sarilumab with or without background csDMARDs in rheumatoid arthritis
Authors' conclusion
Long-term sarilumab treatment with/without csDMARDs in patients with RA revealed no new safety findings. Efficacy and HRQOL were maintained or further increased over the open-label assessment period.
Study context
- Population
- Patients with RA from six randomized trialstwo open-label extensions (OLEs)
- Participants
- 111 / 1,910 / 165 / 155
- Comparison
- Sarilumab 200 mg q2w as monotherapy or with csDMARDs
- Sarilumab Monotherapyn = 111
- Sarilumab + csDMARDn = 1,910
- Continuationn = 165
- Switchn = 155
- Outcome
- Safety, immunogenicity and changes in laboratory parameters
- Follow-up
- ≥264 up to 516 weeks (EXTEND); 276 weeks (MONARCH OLE)
Methodological detailspooled analysis of EXTEND and MONARCH OLE, long-term extension, patients from six randomized trials
- Pooled analysis of EXTEND and MONARCH OLE
- Long-term extension
- Patients from six randomized trials
Pooled result
As reported in the abstract
≥1 treatment-emergent adverse event, events/100 patient-years
Further pooled results
Clinical signs and symptoms and health-related quality-of-life (HRQOL)
- Improvements seen in the initial blinded trials maintained throughout the OLE period
Safety
Neutropenia
- Most common AE; not associated with increased incidence of infections; most cases normalized on-treatment
AEs of special interest (malignancies, MACE, VTE, gastrointestinal perforations)
- Rare
Original publication
Long-term safety and efficacy of sarilumab with or without background csDMARDs in rheumatoid arthritis. Rheumatology (Oxford). Published 2 February 2023. doi:10.
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