Table 3. Adverse event summary table by treatment arm.
| n (%) | 3 Months | 6 Months | ||||||
| ALMS | AURA-LV/ AURORA 1 | ALMS | AURA-LV/ AURORA 1 | |||||
| IVC (n=91) | MMF (n=88) | Total (N=179) | Voclosporin (N=179) | IVC (n=91) | MMF (n=88) | Total (N=179) | Voclosporin (N=179) | |
| Select AEs bysystemorganclass, n (%) | ||||||||
| Gastrointestinal disorders | 54 (59.3) | 46 (52.3) | 100 (55.9) | 62 (34.6) | 60 (65.9) | 54 (61.4) | 114 (63.7) | 69 (38.5) |
| Infections and infestations | 42 (46.2) | 53 (60.2) | 95 (53.1) | 75 (41.9) | 53 (58.2) | 64 (72.7) | 117 (65.4) | 97 (54.2) |
| Skin and subcutaneous tissue disorders | 43 (47.3) | 25 (28.4) | 68 (38.0) | 35 (19.6) | 51 (56.0) | 33 (37.5) | 84 (46.9) | 43 (24.0) |
| Musculoskeletal/ connective tissue disorders | 31 (34.1) | 27 (30.7) | 58 (32.4) | 35 (19.6) | 40 (44.0) | 33 (37.5) | 73 (40.8) | 44 (24.6) |
| Blood and lymphatic system disorders | 19 (20.9) | 13 (14.8) | 32 (17.9) | 21 (11.7) | 37 (40.7) | 21 (23.9) | 58 (32.4) | 33 (18.4) |
| Psychiatric disorders | 12 (13.2) | 15 (17.0) | 27 (15.1) | 4 (2.2) | 14 (15.4) | 15 (17.0) | 29 (16.2) | 6 (3.4) |
| Endocrine disorders | 10 (11.0) | 7 (8.0) | 17 (9.5) | 2 (1.1) | 10 (11.0) | 7 (8.0) | 17 (9.5) | 2 (1.1) |
| Reproductive system and breast disorders | 9 (9.9) | 6 (6.8) | 15 (8.4) | 4 (2.2) | 11 (12.1) | 7 (8.0) | 18 (10.1) | 4 (2.2) |
| Renal and urinary disorders | 6 (6.6) | 4 (4.5) | 10 (5.6) | 13 (7.3) | 8 (8.8) | 8 (9.1) | 16 (8.9) | 19 (10.6) |
| Select AEs bypreferredterm, n (%) | ||||||||
| Alopecia | 33 (36.3) | 9 (10.2) | 42 (23.5) | 6 (3.4) | 37 (40.7) | 10 (11.4) | 47 (26.3) | 11 (6.1) |
| Leucopenia | 12 (13.2) | 1 (1.1) | 13 (7.3) | 2 (1.1) | 23 (25.3) | 6 (6.8) | 29 (16.2) | 4 (2.2) |
| Hypertension | 8 (8.8) | 9 (10.2) | 17 (9.5) | 28 (15.6) | 11 (12.1) | 13 (14.8) | 24 (13.4) | 31 (17.3) |
| Cushingoid | 6 (6.6) | 4 (4.5) | 10 (5.6) | 2 (1.1) | 6 (6.6) | 4 (4.5) | 10 (5.6) | 2 (1.1) |
| Amenorrhea | 6 (6.6) | 1 (1.1) | 7 (3.9) | 0 | 6 (6.6) | 1 (1.1) | 7 (3.9) | 0 |
| Cushing’s syndrome | 3 (3.3) | 3 (3.4) | 6 (3.4) | 0 | 3 (3.3) | 3 (3.4) | 6 (3.4) | 0 |
| Neutropenia | 3 (3.3) | 1 (1.1) | 4 (2.2) | 2 (1.1) | 6 (6.6) | 1 (1.1) | 7 (3.9) | 3 (1.7) |
| Hyperglycaemia | 2 (2.2) | 1 (1.1) | 3 (1.7) | 1 (0.6) | 2 (2.2) | 3 (3.4) | 5 (2.8) | 1 (0.6) |
| Anaemia | 2 (2.2) | 7 (8.0) | 9 (5.0) | 14 (7.8) | 6 (6.6) | 10 (11.4) | 16 (8.9) | 22 (12.3) |
| Dysuria | 2 (2.2) | 0 | 2 (1.1) | 1 (0.6) | 3 (3.3) | 0 | 3 (1.7) | 2 (1.1) |
| Thrombocytopenia | 0 | 0 | 0 | 0 | 1 (1.1) | 0 | 1 (0.6) | 0 |
| GFR decreased | 0 | 0 | 0 | 33 (18.4) | 0 | 0 | 0 | 44 (24.6) |
| Osteoporosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cataract | 1 (1.1) | 1 (1.1) | 2 (1.1) | 2 (1.1) | 2 (2.2) | 1 (1.1) | 3 (1.7) | 4 (2.2) |
| Overallincidence of AEs | ||||||||
| Overall AEs | 83 (91.2) | 83 (94.3) | 166 (92.7) | 149 (83.2) | 87 (95.6) | 84 (95.5) | 171 (95.5) | 161 (89.9) |
| Serious AEs | 11 (12.1) | 20 (22.7) | 31 (17.3) | 26 (14.5) | 14 (15.4) | 22 (25.0) | 36 (20.1) | 35 (19.6) |
| Death | 0 | 4 (4.5) | 4 (2.2) | 6 (3.4) | 0 | 4 (4.5) | 4 (2.2) | 7 (3.9) |
Propensity score methodology was used to generate two groups of matched participants (N=179) from the ALMS (IVC and MMF) and AURA-LV/AURORA 1 (voclosporin) studies based on the following parameters: age, duration of lupus nephritis, duration of SLE, albumin, C3, C4, creatinine, anti-dsDNA, eGFR, UPCR, biopsy class, sex, and geographical region. (AEs) occurred on or after the first dose of study drug up to either 3 or 6 months months of treatment and were coded by System Organ Class and Preferred Term using MedDRA v9.1 (ALMS), v17.0 (AURA-LV) and v20.0 (AURORA 1). AEs were selected for inclusion in this table to evaluate the impact of IVC, MMF, voclosporin, and GCs on these organ systems. Assignation of AEs wereas at the discretion of the study investigator and wereas not based on set definitions or changes from baseline values.
AE, adverse event; ALMSAspreva Lupus Management StudydsDNA, double-stranded DNA; GC, glucocorticoid; GFR, glomerular filtration rate; IVC, intravenous cyclophosphamide; MMF, mycophenolate mofetil; SLE, systemic lupus erythematosus; UPCR, urine protein creatinine ratio