Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study
Authors' conclusion
Tofacitinib was associated with early and sustained improvement in RA signs and symptoms in real-world patients.
Study context
- Population
- Patients with moderate to severe rheumatoid arthritis (RA) initiating tofacitinib, 45 Canadian sites, October 2017 to July 2020
- Participants
- 504 patients45 Canadian sites
- Outcome
- Co-primary: CDAI-defined low disease activity and remission
- Follow-up
- Month 6
Methodological detailsmulticentre, interim analysis
- Multicentre
- Interim analysis
Main finding
As reported in the abstract
Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA)
52.9%
CDAI-defined remission
15.4%
Observational data: associations, not effects.
Secondary outcomes
DAS28-ESR/DAS28-CRP LDA and remission · month 3
- DAS28-ESR-defined LDA
- 27.2%
- DAS28-CRP <3.2
- 41.7%
- DAS28-ESR remission
- 14.7%
- DAS28-CRP <2.6
- 25.8%
Pain (VAS) · month 3
- Mild pain (VAS <20 mm)
- 29.6%
- Moderate (≥30%) pain improvement
- 55.6%
- Substantial (≥50%) pain improvement
- 42.9%
HAQ DI · month 3
- HAQ DI ≥ normative values (≤0.25)
- 19.9%
- HAQ DI ≥ minimum clinically important difference (MCID) (≥0.22)
- 53.7%
Maintenance of outcomes · month 18
- Outcomes generally maintained to month 18
Safety
Incidence rates (events per 100 patient-years) · to month 36
- Treatment-emergent adverse events (AEs)
- 126.8
- Serious AEs
- 11.9
- Discontinuations due to AEs
- 14.5
- AEs of special interest were infrequent
Original publication
Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study. Arthritis Care Res (Hoboken). Published 10 October 2022. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →