Real-world effectiveness, safety and patient-reported outcomes of sarilumab in patients with rheumatoid arthritis: a 52-week, prospective, open-label, non-interventional, observational, nationwide, large-cohort study in Japan (PROFILE-J)
Authors' conclusion
This study described real-world treatment patterns of sarilumab, highlighting frequent initiation in biologic DMARD-naïve patients, particularly among older adults. Sarilumab demonstrated sustained effectiveness and a consistent safety profile with no new safety signals
Study context
- Population
- Adult patients with rheumatoid arthritis (RA) initiating sarilumab in routine clinical practice across Japan1,715 in effectiveness analysis
- Participants
- 1,998 patients
- Exposure
- Sarilumab monotherapy vs sarilumab in combination with csDMARDs
- Outcome
- Mean change from baseline in CDAI
- Follow-up
- Week 52
Methodological detailsopen-label, non-interventional, nationwide, 52-week
- Open-label
- Non-interventional
- Nationwide
- 52-week
Main finding
As reported in the abstract
Monotherapy
−14.2
mean
Combination
−14.9
mean
Observational data: associations, not effects.
Further findings
Mean
| Outcome | Monotherapy | Combination |
|---|---|---|
| Mean change from baseline in CDAI · week 24 | −13.6 | −13.1 |
Mean Clinical Disease Activity Index (CDAI), overall · week 12
- Baseline mean CDAI
- 21.2
- Mean CDAI at week 12 (low disease activity range)
- 9.7
Sarilumab retention, overall · week 52
- Retention
- 67.5%
Other measures, including patient-reported outcomes (PROs)
- Similar improvements in both groups
Safety
TEAEs · safety population
- Treatment-emergent adverse events (TEAEs) — TEAEs overall
- 44.6%
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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