Table 2.
Rapid taper | Standard of care | |
n=13 | n=14 | |
Corticosteroid treatment, count (%) or median (IQR) | ||
Received intravenous pulse methylprednisolone | 3 (23%) | 6 (43%) |
Grams of methylprednisolone | 0.75 (0.2–1.0) | 0.65 (0.13–1) |
Initial daily oral prednisone dose, mg | 60 (60–60) | 60 (6–60) |
Median days at initial oral prednisone dose* | 7 (3–7) | 7 (6–8) |
Median days until≤10 mg of prednisone | 20 (15–25) | 38 (30–58) |
Received second-line immunosuppression | 0 | 0 |
Renal recovery (defined by creatinine<1.5 fold baseline) | ||
Renal recovery within 30 days | 11 (85%) | 6 (46%) |
Best creatinine (mg/dL) within 30 days, median (IQR) | 1.31 (1.13–1.45) | 1.49 (1.29–1.62) |
Renal recovery within 60 days | 11 (85%) | 9 (64%) |
Best creatinine within 60 days | 1.18 (1.02–1.34) | 1.35 (1.29–1.49) |
Corticosteroid refractory nephritis† at 90 days | 1 (8%) | 4 (29%) |
Steroid re-initiated or re-escalated prior to ICI-rechallenge | 2 (15%) | 2 (14%) |
Median time to renal recovery, days (IQR) | 11 (7–18) | 36 (20–100) |
Rechallenge with ICI | ||
Rechallenged with ICI | 7 (54%) | 8 (57%) |
Median days until rechallenge (IQR) | 26 (15–182) | 135 (53–290) |
Relapse of ICI-induced nephritis after ICI rechallenge | 1 (14%) | 1 (13%) |
Relapse within another severe irAE after rechallenge‡ | 2 (29%) | 3 (38%) |
Receiving prednisone at rechallenge | 6 (86%) | 7 (88%) |
Median dose of oral prednisone at rechallenge | 10 (3.8–10) | 7.5 (3.8–10) |
Experienced clinical benefit from ICI rechallenge | 4 (57%) | 4 (50%) |
Clinical benefit from ICI rechallenge was defined as at least stable disease for >6 months.
*One patient received an oral methylprednisolone taper; the dose was converted to prednisone equivalent.
†The one patient that did not experience renal recovery at any point in the follow-up period was assigned the last follow-up date for calculating time to renal recovery. This patient had extremely low baseline creatinine (0.58 mg/dL) and her follow-up creatinine improved to 1.2 but never recovered to within 1.5-fold baseline.
‡Among the patients treated with rapid taper who were rechallenged with ICIs, a new severe irAE requiring corticosteroids occurred in two patients (one colitis, one pneumonitis). Among the patients treated with standard of care corticosteroid regimens who were rechallenged with ICIs, a new severe irAE requiring corticosteroids occurred in three patients (one pneumonitis, two hepatitis).
ICI, immune checkpoint inhibitor; irAE, immune related adverse event.