Candidate STAR
| Domain | Point | Definition of response |
| Systemic activity | 3 | Decrease of ≥3 in clinESSDAI. |
| Patient-reported outcome | 3 | Decrease of ≥1 point or ≥15% in ESSPRI. |
| Lachrymal gland function (assessed by Schirmer’s test or ocular staining score) | 1 | Schirmer’s test: If abnormal score at baseline: increase ≥5 mm from baseline. If normal score at baseline: no change to abnormal. Or Ocular staining score: If abnormal score at baseline: decrease of ≥2 points from baseline. If normal score at baseline: no change to abnormal. |
| Salivary gland function (assessed by unstimulated whole salivary flow or ultrasound) | 1 | Unstimulated whole salivary flow: If score is >0 at baseline: increase of ≥25% from baseline. If score is 0 at baseline: any increase from baseline. Or Ultrasound: Decrease of ≥25% in total Hocevar score from baseline. |
| Biological (assessed by serum IgG or RF level) | 1 | Serum IgG level: decrease of ≥10%. Or RF level: decrease of ≥25%. |
| Candidate STAR responder | ≥5 points | |
For ocular tests, Schirmer’s test should be performed without anaesthesia and is considered abnormal if <5 mm. Ocular staining score is considered abnormal if score is ≥3. The mean of both eyes was used for calculation.
Total RF or RF-IgM was measured in IU/mL.
For unstimulated whole salivary flow, we recommend establishing an SOP for each future trial using STAR. The SOP should specify if the collection should be done over 5 or 15 min (both are possible but one option should be selected for each trial and applied to all patients), and should specify that patients should no eat, drink or smoke for 60 min before the collection, should not take secretagogue morning dose, and should perform the collection in the morning and at a fixed time.
ESSDAI, EULAR Sjögren's Syndrome Disease Activity Index ; ESSPRI, EULAR Sjögren's Syndrome Patient Reported Index; RF, rheumatoid factor; SOP, standard operating procedures; STAR, Sjögren’s Tool for Assessing Response.