Table 3.
RTX | CYC/AZA | Total | |
---|---|---|---|
N=23 | N=21 | N=44 | |
Follow-up until next event*† (range, mos) | 7.8 (0.7–28.3) | 17.6 (1.4–39.2) | 12.5 (0.7–39.2) |
Median prednisone dose for treatment of relapse (range, mg) | 11 (2.5–80) | 20 (4–60) | 17.5 (2.5–80) |
Reached remission | 17 (74%) | 18 (86%) | 35 (80%) |
Time to remission (mos) | 2.2 (0.5–4.4) | 2.8 (0.9–4.2) | 2.5 (0.5–4.4) |
Reached complete remission¥ | 7 (30%) | 11 (52%) | 18 (41%) |
Time to complete remission (mos) | 3.9 (1.9–6.8) | 6.1 (2.1–12.5) | 5.3 (1.9–12.5) |
Outcome at end of follow-up | |||
Non-severe relapse | 10 (44%) | 7 (33%) | 17 (39%) |
Severe relapse | 5 (22%) | 9 (43%) | 14 (32%) |
Maintained remission until censoring | 4 (17%) | 0 (0%) | 4 (9%) |
Maintained remission until end of follow-up | 4 (17%) | 4 (19%) | 8 (18%) |
Data not available at time of censoring | 0 (0%) | 1 (5%) | 1 (2%) |
Time to second relapse (mos)‡ | 4.7 (0.7–17.6) | 13.7 (1.4–37.2) | 9.4 (0.7–37.2) |
Off prednisone at relapse | 5 (22%) | 10 (48%) | 15 (41%) |
Median prednisone dose at relapse if dose > 0mg (range in mg) | 7.5 (2.5–20) | 7.5 (5–10) | 7.5 (2.5–20) |
Next event was defined as 1) severe relapse 2) non-severe relapse 3) change in non-glucocorticoid immunosuppression (which could occur at the 18 month timepoint at the investigator’s best medical judgment) 4) withdrawal from the trial 5) common closeout date.
Of the four patients who had a non-severe flare before reaching remission all four reached remission and one had a subsequent severe flare.
p < 0.01
p < 0.01