Table 3.
Outcome after first non-severe relapse
| 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