Fig. 4: Treatment impact on the joints.

a,b, The mean change and s.e. in the number of tender and swollen joints and as compared to baseline are shown in a (tender-joint count) and in b (swollen-joint count). The vertical line at 3 months indicates the end of the double-blind period of the study and the beginning of open-label stimulation. For a and b, within double-blind period: stimulation, n = 116; sham, n = 114. At 6, 9 and 12 months, n = 96, 88 and 77 in arm 1, respectively, and n = 98, 87 and 80 in arm 2, respectively. c–f, The cumulative probability of a change in erosion score, as assessed via the OMERACT RAMRIS. The right part of the curve (positive values on the y axis) represents erosion progression (worsening), the left part of the curve represents erosion regression (improvement) and the flat line at y = 0 represents no change in erosion score. c,e, Plot change from baseline to 3 months during the controlled-blind period. d,f, Plot change from 3 months to 6 months during open-label stimulation. Patients who completed the 3-month and 6-month visits without augmented therapy are included in c and d. Patients at risk for erosion progression are included in e and f. g,h, The percentage of patients who had erosion progression, defined as >0.5 increase in RAMRIS erosion score by MRI. The vertical line at 3 months demarcates the double-blind period between baseline and 3 months and the open-label stimulation period between 3 months and 6 months. Data are presented as the mean (a,b) or the percentage of each group (g,h) with s.e. Statistical analyses were only performed at points through 3 months; a and b with mixed-effect model repeated measures and g and h with the CMH test. All tests use one-sided significance level of 0.025. In a, P = 0.0021, 0.0004 and 0.0014 at month 1, 2 and 3, respectively. In b, P = 0.0097, 0.0009 and 0.0131 at month 1, 2 and 3, respectively. *P < 0.025, **P < 0.01, ***P < 0.001.