Primary and secondary outcomes
| Outcome | Proportion of participants (%) |
|---|---|
| Primary outcome | 23/30 (77%) |
| Disease response (6 months) | 29/30 (97%) |
| Sustained disease response | 22/30 (73%) |
| Complete remission (6 months) | 14/30 (47%) |
| Complete remission (6 months), exclusive of serum IgG4 | 18/30 (60%) |
| Complete remission (any time point) | 18/30 (60%) |
| Complete remission (any time point), exclusive of serum IgG4 | 20/30 (67%) |
| Relapses occurring before month 6 | 3 |
| Relapses occurring between months 6 and 12 | 4 |
| Time to endpoint | Duration (days) |
| Time to disease response (mean±SD)* | 43±37 |
| Time to complete remission (mean±SD)* | 198±87 |
| Time to relapse (mean±SD) | 210±105 |
| Treatment | |
| Total prednisone dose equivalent (mg) administered in the 28 days prior to the 6 month study visit (mean, range) | 15 (0–280) |
| Retreatment with RTX for relapses during the 12 months after enrolment | 4/30 (13%) |
*The time to disease response and time to complete remission measures overestimate the speed required to achieve these measures because an in-person visit was required for these measures.
RTX, rituximab.