Table 3.
Summary of sustained remission at week 52—data are presented with imputationa, unless otherwise stated (revised ITT population)
| Sustained remission disposition, n (%) | Sirukumab 100 mg q2w + 6-month prednisone (n = 17) | Sirukumab 100 mg q2w + 3-month prednisone (n = 13) | Sirukumab 50 mg q4w + 6-month prednisone (n = 9) | 6-month prednisone (n = 9) | 12-month prednisone (n = 7) |
|---|---|---|---|---|---|
| Sustained remission | 3 (17.6) | 2 (15.4) | 1 (11.1) | 0 | 0 |
| Early study withdrawalb | 8 (47.1) | 8 (61.5) | 4 (44.4) | 4 (44.4) | 3 (42.9) |
| Not in remission at week 12 | 4 (23.5) | 6 (46.2) | 1 (11.1) | 8 (88.9) | 4 (57.1) |
| Signs/symptoms | 4 (23.5) | 6 (46.2) | 1 (11.1) | 4 (44.4) | 2 (28.6) |
| CRP ≥ 1 mg/dl | 4 (23.5) | 6 (46.2) | 1 (11.1) | 7 (77.8) | 4 (57.1) |
| ESR ≥ 30 mm/h | 4 (23.5) | 6 (46.2) | 1 (11.1) | 7 (77.8) | 4 (57.1) |
| Presence of flare from week 12 to week 52 | |||||
| With imputation | 9 (52.9) | 9 (69.2) | 5 (55.6) | 8 (88.9) | 5 (71.4) |
| Without imputationc | 1 (5.9) | 1 (7.7) | 1 (11.1) | 5d (55.6) | 2 (28.6) |
| Use of glucocorticoid rescue therapy | 0 | 2 (15.4) | 1 (11.1) | 5 (55.6) | 2 (28.6) |
CRP C-reactive protein, ESR erythrocyte sedimentation rate, ITT intent-to-treat, q2w every 2 weeks, q4w every 4 weeks
aImputation rule: patients withdrawing from the study early counted as having had a flare
bReasons for study withdrawal are listed in Fig. 2
cAd hoc review of patient-level data after study completion without imputation rule
dIncluding one patient who withdrew early due to early study termination (sponsor request)