Table 1. Groups of patients.
Total population N = 35* | Rituximab responders N = 7 | Rituximab non-responders N = 7 | P value | |
---|---|---|---|---|
Female, n [%] | 34 [97] | 6 [86] | 7 [100] | 1 |
Age, median [IQR] | 53 [45–61] | 46 [3–55] | 52 [40–55] | 0.65 |
Years since diagnosis, median [IQR] | 2 [1–5] | 1 [0.3–4] | 3 [1–7] | 0.14 |
Abnormal Schirmer’s test, n [%] | 18 [51] | 4 [57] | 4 [57] | 1 |
Salivary flow <0.1 mL/min, n [%] | 26 [74] | 5 [71] | 6 [86] | 1 |
Salivary flow [mL/min], median [IQR] | 0.09 [0.04–0.14] | 0.1 [0.06–0.14] | 0.04 [0–0.09] | 0.14 |
Anti-SSA/SSB positivity, n [%] | 31 [89] | 6 [86] | 7 [100] | 1 |
Centralised MSGB, n | 31 | 7 | 7 | |
Focus score, median [IQR] | 1.3 [0.0–5.0] | 0.3 [0.0–1.3] | 4.0 [2.7–5.3] | 0.02 |
SGUS performed, n | 28 | 7 | 5 | |
Highest single-gland SGUS grade, median [IQR]** | 3 [3–4] | 3 [2–3] | 4 [3–4] | 0.01 |
Total SGUS grade, median [IQR]*** | 9 [7–12] | 9 [6–11] | 16 [11–16] | 0.04 |
*17 patients were allocated at random to rituximab and 18 to the placebo. 3 patients had missing data precluding the computation of the Sjögren’s Syndrome Responder Index (SSRI)-30 at W24.
**The single-gland grade can range from 0 to 4.
***The total grade can range from 0 to 16.
IQR, interquartile range; MSGB, minor salivary gland biopsy; SGUS, salivary-gland ultrasonography. Categorical data were compared between responders and non-responders using the chi-square or Fisher’s test as appropriate, and continuous data were compared using the Mann-Whitney test.