Description of databases used in the validation of the DAS28-based flare criteria
| Database | No of pts | Study design | Study population | Intervention | Follow-up | Inclusion inanalysis | Which assessments: | Flare definition |
|---|---|---|---|---|---|---|---|---|
| 1 | 51 | Longitudinal cohort | - RA patients - >6 Months stable low DAS28 and treatment | Down-titration of infliximab dose | 1 year | - All patients (n=51) | - The first six observations per patient- No intra individual interval variation between assessments | - DAS28 increase ≥1.2 on two subsequent visits, if DAS28>3.2, increase in DAS28≥0.6- Physician's judgement |
| 2 | 147 | Observational and dynamic cohort | - RA patients - Treated withIFX for >6 months | None | Data collection during 1.5 year | - Patients with a DAS28≤3.2 at visit 3 (n=72) | - Visits at 4–6 months - Intraindividual interval change was allowed | - Not predefined- Based on physician's judgement -Treatment goal DAS28<3.2 |
| 3 | 744 (of 3612) | Observational and dynamic cohort | - Patients with rheumatic diseases- Starting with synthetic/biologic DMARDs | At t=0 DMARD or biologic initiation | At 0, 3, 6, 12 months, then yearly | - RA patients- DAS28>3.2 at entry database- At month 3 transition scale ‘improved’/‘much improved’ (n=744) | - Visit at months 3 and 6 | - Not predefined- Based on physician's judgement - Treatment goal DAS28<3.2 |
DAS28, Disease Activity Score 28; RA, rheumatoid arthritis; IFX, infliximab.