Summary of studies with focus score evaluation on sequential samples
| Year | No. | PSS criteria | Duration of sicca symptoms | Average follow-up | Immunomodulatory treatment | Mean focus score baseline (SD) | Mean focus score follow-up (SD) | Time-related change (SD) |
|---|---|---|---|---|---|---|---|---|
| 199265 | 27 | Skopouli 198666 | Mean 5 years (range 1–16) | 3.5 years (range 1–16) | None | 4.2 (4.0) | 6.1 (4.1) | ND Variation 1.7 (2.6; range −3 to +10) |
| 199332 | 21 | NA | NA | 39 months (range 11–112) | NA | 3.4 | 4.4 | Mean↑0.4 per year |
| 200467 | 57 | AECG1 | NA | 10 weeks* | IFX or placebo† | IFX 1.5 (1.4) Placebo 1.9 (1.6) | NA | IFX −0.7 (1.7) Placebo −0.9 (1.7) |
| 201345 | 28 | NA | 3 years (IQR 1–7) | 55 months (IQR 42–81) | 50%‡ | 4.3 (IQR 2.3–5.8) | 4.4 (IQR 2.5–5.8) | – |
*Baseline biopsy could be up to 1 year prior to baseline.
†Stable doses of HCQ and prednisolone ≤15 mg allowed.
‡HCQ, steroids or MTX.
AECG, American-European Consensus Group Criteria; HCQ, hydroxychloroquine; IFX, infliximab; MTX, methotrexate; NA; not available; PSS; primary Sjögren's syndrome.