Table III.
Main outcomes for patients in observational cohorts and RCTs.
| Characteristics | Observational cohorts n= 437 |
Clinical RCTs n=657 |
p-value |
|---|---|---|---|
| Follow-up since diagnosis, months, mean±SD | 71.9 ± 63.4 | 56.9 ± 38.6 | <0.001 |
| Relapses* | 259 (59.3) | 276 (42.1) | <0.001 |
| GPA patients | 244 (61.6) | 211 (49.2) | <0.001 |
| MPA patients | 15 (36.6) | 65 (28.5) | 0.30 |
| Relapses at 56 months after diagnosis† | 78 (17.9) | 136 (20.7) | 0.24 |
| GPA patients | 72 (18.2) | 101 (23.5) | 0.06 |
| MPA patients | 6 (14.6) | 35 (15.4) | 0.91 |
| Relapse rates at 56 months after diagnosis, adjusted for age and MDRD-GFR | (14.3) | (20.2) | 0.03‡ |
| GPA patients | (15.6) | (22.5) | 0.03 |
| MPA patients | (10.1) | (16.6) | 0.39 |
| Deaths | 16 (3.7) | 99 (15.1) | <0.001 |
| GPA patients | 12 (3.0) | 63 (14.7) | <0.001 |
| MPA patients | 4 (9.8) | 36 (15.8) | 0.32 |
| Deaths at 56 months after diagnosis † | 11 (2.5) | 80 (12.2) | <0.001 |
| Survival for GPA patients | 7 (1.8) | 49 (11.4) | <0.001 |
| Survival for MPA patients | 4 (9.8) | 31 (13.6) | 0.50 |
| Death rates at 56 months after diagnosis, adjusted for age and MDRD-GFR | (3.4) | (9.7) | 0.004‡ |
| GPA patients | (2.5) | (10.7) | 0.001 |
| MPA patients | (6.6) | (6.2) | 0.92 |
*
Data are no. of patients with the characteristic/total no. of patients with the data available (%) unless indicated.
†
Follow-up was censored at 56 months (i.e. the mean follow-up for RCTs), shorter than that for cohorts.
‡
Odds ratio to relapse in RCTs compared to cohorts, at month 56 and adjusted for age and MDRD-GFR, was 1.52 (95% confidence interval, 1.04–2.23). Odds ratio for dying in RCTs compared to cohorts, at month 56 and adjusted for age and MDRD-GFR, was 3.04 (95% confidence interval, 1.42–6.54).
GPA: granulomatosis with polyangiitis; MDRD-GFR: modification of diet in renal disease - glomerular filtration rate; MPA: microscopic polyangiitis; RCT: randomised controlled trial.