Table 2.
Safety profile of s.c.-TCZ in patients with sJIA and patients with pJIA
| Safety outcomes | sJIA |
pJIA |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <30 kg Q10D/Q2W n = 25 |
≥30 kg QW n = 26 |
All TCZ n = 51 |
<30 kg Q3W n = 27 |
≥30 kg Q2W n = 25 |
All TCZ n = 52 |
|||||||
| TCZ- naive n = 15 | TCZ- prior n = 10 | TCZ- naive n = 11 | TCZ- prior n = 15 | TCZ- naive n = 26 | TCZ- prior n = 25 | TCZ- naive n = 23 | TCZ- prior n = 4 | TCZ- naive n = 14 | TCZ- prior n = 11 | TCZ naive n = 37 | TCZ- prior n = 15 | |
| PY of follow-up | 13.9 | 9.1 | 11.2 | 12.6 | 25.1 | 21.7 | 22.6 | 4.0 | 13.3 | 10.5 | 35.8 | 14.6 |
| Patients with ≥1 AE, n (%) | 15 (100) | 10 (100) | 11 (100) | 14 (93.3) | 26 (100) | 24 (96) | 21 (91.3) | 4 (100) | 13 (92.9) | 10 (90.9) | 34 (91.9) | 14 (93.3) |
| Total AEs, n | 131 | 102 | 169 | 159 | 300 | 261 | 167 | 14 | 147 | 78 | 314 | 92 |
| Patients with ≥1 SAE, n (%) | 3 (20) | 2 (20) | 1 (9.1) | 1 (6.7) | 4 (15.4) | 3 (12) | 1 (4.3) | 0 | 1 (7.1) | 1 (9.1) | 2 (5.4) | 1 (6.7) |
| AEs by system organ class, n (%)a | ||||||||||||
| Infections and infestationsb | 12 (80)e | 10 (100) | 9 (81.8) | 9 (60) | 21 (80.8) | 19 (76) | 18 (78.3) | 2 (50) | 9 (64.3) | 7 (63.6) | 27 (73) | 9 (60) |
| Musculoskeletal and CTDs | 3 (20) | 4 (40) | 3 (27.3) | 4 (26.7) | 6 (23.1) | 8 (32) | 11 (47.8) | 0 | 7 (50.0) | 5 (45.5) | 18 (48.6) | 5 (33.3) |
| Gastrointestinal disordersc | 5 (33.3) | 6 (60) | 3 (27.3) | 9 (60) | 8 (30.8) | 15 (60) | 8 (34.8) | 2 (50.0) | 7 (50.0) | 4 (36.4) | 15 (40.5) | 6 (40.0) |
| General disorders and administrative site conditions | 5 (33.3) | 4 (40) | 6 (54.5) | 12 (80) | 11 (42.3) | 16 (64) | 4 (17.4) | 2 (50.0) | 9 (64.3) | 5 (45.5) | 13 (35.1) | 7 (46.7) |
| Respiratory, thoracic and mediastinal disorders | 9 (60) | 4 (40) | 6 (54.5) | 6 (40) | 15 (57.7) | 10 (40) | 10 (43.5) | 1 (25.0) | 1 (7.1) | 6 (54.5) | 11 (29.7) | 7 (46.7) |
| Skin and s.c. tissue disorders | 5 (33.3) | 3 (30) | 6 (54.5) | 1 (6.7) | 11 (42.3) | 4 (16) | 5 (21.7) | 0 | 5 (35.7) | 2 (18.2) | 10 (27.0) | 2 (13.3) |
| Nervous system disorders | 0 | 0 | 2 (18.2) | 5 (33.3) | 2 (7.7) | 5 (20.0) | 2 (8.7) | 0 | 5 (35.7) | 3 (27.3) | 7 (18.9) | 3 (20.0) |
| Psychiatric disordersd | 0 | 0 | 1 (9.1) | 0 | 1 (3.8) | 0 | 3 (13.0) | 1 (25.0) | 3 (21.4) | 1 (9.1) | 6 (16.2) | 2 (13.3) |
| Blood and lymphatic system disorders | 5 (33.3) | 3 (30) | 4 (36.4) | 6 (40) | 9 (34.6) | 9 (36) | 3 (13.0) | 0 | 1 (7.1) | 0 | 4 (10.8) | 0 |
| Injury, poisoning and procedural complications | 3 (20) | 4 (40) | 5 (45.5) | 3 (20) | 8 (30.8) | 7 (28) | 3 (13.0) | 1 (25.0) | 2 (14.3) | 1 (9.1) | 5 (13.5) | 2 (13.3) |
| Investigations | 2 (13.3) | 3 (30) | 2 (18.2) | 1 (6.7) | 4 (15.4) | 4 (16) | 4 (17.4) | 0 | 2 (14.3) | 0 | 6 (16.2) | 0 |
Multiple occurrences of the same event in a patient were counted once.
AE: adverse event; BW: body weight; pJIA: polyarticular JIA; PY: patient years; Q10D: every 10 days; QW: every week; Q2W: every 2 weeks; Q3W: every 3 weeks; SAE: serious adverse event; sJIA: systemic JIA; SOC: system organ class; TCZ: tocilizumab.
SOC included if all-grade AEs within that SOC occurred in ≥15% of sJIA patients or pJIA patients overall.
The most common infections (≥10% of all patients) were nasopharyngitis (34.6%), gastroenteritis (11.5%) and upper respiratory tract infections (9.6%) in pJIA patients and viral upper respiratory tract infection (25.5%), upper respiratory tract infection (21.6%) and rhinitis (11.8%) in sJIA patients.
No patients experienced gastrointestinal perforations.
The most common psychiatric disorder in pJIA patients was insomnia (four TCZ-naive patients). Others included depression (one TCZ-naive patient) and fear of injections (one patient who previously received TCZ).
One patient was receiving QW dosing at the time of infection (serious sepsis infection that was fatal) after a body weight increase to ≥30 kg.