AEs through week 38
| Part A | Part B | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo wk 0–12; (%) | Placebo → Sirukumab 100 mg every 2 weeks 12–38; (%) | Sirukumab 100 mg every 2 weeks 0–12; (%) | Sirukumab 100 mg every 2 weeks → placebo 12–38; (%) | Placebo* (%) | Placebo → Sirukumab 100 mg every 2 weeks (%) | Sirukumab | ||||
| 100 mg every 2 weeks (%) | 100 mg every 4 weeks (%) | 50 mg every 4 weeks (%) | 25 mg every 4 weeks (%) | |||||||
| Patients treated, n | 19 | 18 | 17 | 16 | 30 | 26 | 30 | 30 | 30 | 31 |
| Mean duration of follow-up, weeks | 11.6 | 25.3 | 11.6 | 26.0 | 12.3 | 24.5 | 36.2 | 35.6 | 35.5 | 38.2 |
| Patients with ≥1 AE | 12 (63.2) | 13 (72.2) | 12 (70.6) | 10 (62.5) | 20 (66.7) | 15 (57.7) | 26 (86.7) | 24 (80.0) | 28 (93.3) | 26 (83.9) |
| Patients with ≥1 infection | 5 (26.3) | 4 (22.2) | 5 (29.4) | 4 (25.0) | 4 (13.3) | 8 (30.8) | 11 (36.7) | 11 (36.7) | 11 (36.7) | 8 (25.8) |
| Upper respiratory tract infection | 2 (10.5) | 1 (5.6) | 0 | 0 | 0 | 1 (3.8) | 0 | 3 (10.0) | 3 (10.0) | 1 (3.2) |
| Nasopharyngitis | 1 (5.3) | 2 (11.1) | 2 (11.8) | 1 (6.3) | 0 | 0 | 3 (10.0) | 0 | 1 (3.3) | 2 (6.5) |
| Pharyngitis | 0 | 0 | 0 | 0 | 0 | 0 | 2 (6.7) | 0 | 2 (6.7) | 2 (6.5) |
| Investigations | 2 (10.5) | 4 (22.2) | 4 (23.5) | 2 (12.5) | 5 (16.7) | 6 (23.1) | 5 (16.7) | 9 (30.0) | 13 (43.3) | 10 (32.3) |
| ALT increased† | 0 | 4 (22.2) | 2 (11.8) | 0 | 1 (3.3) | 1 (3.8) | 4 (13.3) | 7 (23.3) | 10 (33.3) | 6 (19.4) |
| AST increased‡ | 0 | 0 | 2 (11.8) | 0 | 0 | 1 (3.8) | 3 (10.0) | 4 (13.3) | 6 (20.0) | 3 (9.7) |
| Gastrointestinal disorders | 1 (5.3) | 0 | 4 (23.5) | 1 (6.3) | 3 (10.0) | 3 (11.5) | 5 (16.7) | 7 (23.3) | 5 (16.7) | 8 (25.5) |
| Blood and lymphatic system disorders | 0 | 2 (11.1) | 1 (5.9) | 0 | 0 | 3 (11.5) | 5 (16.7) | 8 (26.7) | 6 (20.0) | 5 (16.1) |
| Leukopenia§ | 0 | 1 (5.6) | 1 (5.9) | 0 | 0 | 3 (11.5) | 4 (13.3) | 4 (13.3) | 5 (16.7) | 3 (9.7) |
| Neutropenia¶ | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 2 (6.7) | 2 (6.7) | 0 |
| Patients with ≥1 SAE | 0 | 0 | 1 (5.9) | 0 | 4 (13.3) | 2 (7.7) | 2 (6.7) | 5 (16.7) | 1 (3.3) | 3 (9.7) |
| Patients with ≥1 serious infection | 0 | 0 | 1 (5.9) | 0 | 1 (3.3) | 1 (3.8) | 1 (3.3) | 3 (10.0) | 0 | 2 (6.5) |
| Patients with injection-site reactions | 2 (10.5) | 4 (22.2) | 6 (35.3) | 0 | 1 (3.3) | 3 (11.5) | 5 (16.7) | 2 (6.7) | 8 (26.7) | 5 (16.1) |
Data presented as n (%) unless noted otherwise.
*Patients in the placebo group began receiving sirukumab 100 mg every 2 weeks at week 12. AEs reported prior to receiving sirukumab were summarised in the placebo group, and AEs reported from start of receiving sirukumab for placebo patients who crossed over were summarised in the placebo → sirukumab group. Twenty-six of the 30 placebo patients received sirukumab crossover treatment.
†ALT increase reported as AE, regardless of degree of increase.
‡AST increase reported as AE, regardless of degree of increase.
§Leukopoenia reported as an AE.
¶Neutropenia reported as an AE.
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; SAE, serious AE.