Safety overview for the double-blind treatment and overall periods
| n (%) (EAIR/100 PY) | Double-blind treatment period weeks 0–16 | Overall weeks 0–24 | |
| PBO | BKZ 160 mg Q4W | BKZ 160 mg Q4W Total* | |
| nr-axSpA (BE MOBILE 1) | n=126 (38.1 PY) | n=128 (40.4 PY) | n=244 (77.1 PY) |
| r-axSpA (BE MOBILE 2) | n=111 (34.6 PY) | n=221 (68.3 PY) | n=330 (119.1 PY) |
| Overview | |||
| Any TEAE | |||
| nr-axSpA | 71 (56.3) (277.5) | 80 (62.5) (338.7) | 124 (50.8) (276.2) |
| r-axSpA | 48 (43.2) (195.8) | 120 (54.3) (284.5) | 183 (55.5) (262.6) |
| Severe TEAEs | |||
| nr-axSpA | 1 (0.8) (2.6) | 0 | 1 (0.4) (1.3) |
| r-axSpA | 0 | 3 (1.4) (4.4) | 9 (2.7) (7.7) |
| TEAEs leading to discontinuation from the trial | |||
| nr-axSpA | 5 (4.0) (13.2) | 2 (1.6) (5.0) | 2 (0.8) (2.6) |
| r-axSpA | 0 | 6 (2.7) (8.8) | 11 (3.3) (9.4) |
| TEAEs leading to discontinuation of trial drug | |||
| nr-axSpA | 5 (4.0) (13.2) | 2 (1.6) (5.0) | 3 (1.2) (3.9) |
| r-axSpA | 0 | 7 (3.2) (10.3) | 12 (3.6) (10.3) |
| Drug-related TEAEs | |||
| nr-axSpA | 18 (14.3) (51.2) | 32 (25.0) (94.2) | 53 (21.7) (82.6) |
| r-axSpA | 19 (17.1) (63.0) | 65 (29.4) (118.5) | 96 (29.1) (102.8) |
| SAEs | |||
| nr-axSpA | 1 (0.8) (2.6) | 0 | 1 (0.4) (1.3) |
| r-axSpA | 1 (0.9) (2.9) | 4 (1.8) (5.9) | 12 (3.6) (10.3) |
| Death | |||
| nr-axSpA | 0 | 0 | 0 |
| r-axSpA | 0 | 0 | 0 |
| Most frequently reported TEAEs† | |||
| Nasopharyngitis | |||
| nr-axSpA | 6 (4.8) (16.3) | 12 (9.4) (31.3) | 16 (6.6) (22.0) |
| r-axSpA | 4 (3.6) (11.7) | 17 (7.7) (26.2) | 21 (6.4) (18.6) |
| Upper respiratory tract infection | |||
| nr-axSpA | 9 (7.1) (24.5) | 9 (7.0) (23.1) | 17 (7.0) (23.0) |
| r-axSpA | 7 (6.3) (21.2) | 6 (2.7) (9.0) | 8 (2.4) (6.9) |
| Pharyngitis | |||
| nr-axSpA | 1 (0.8) (2.6) | 4 (3.1) (10.1) | 7 (2.9) (9.2) |
| r-axSpA | 0 | 5 (2.3) (7.4) | 9 (2.7) (7.7) |
| Diarrhoea | |||
| nr-axSpA | 2 (1.6) (5.3) | 3 (2.3) (7.6) | 3 (1.2) (3.9) |
| r-axSpA | 1 (0.9) (2.9) | 7 (3.2) (10.5) | 13 (3.9) (11.2) |
| Headache | |||
| nr-axSpA | 2 (1.6) (5.3) | 3 (2.3) (7.6) | 5 (2.0) (6.6) |
| r-axSpA | 5 (4.5) (15.0) | 9 (4.1) (13.6) | 12 (3.6) (10.4) |
| Oral candidiasis‡ | |||
| nr-axSpA | 0 | 4 (3.1) (10.1) | 7 (2.9) (9.3) |
| r-axSpA | 0 | 9 (4.1) (13.4) | 10 (3.0) (8.6) |
| Pre-specified safety topics of interest and other important TEAEs | |||
| Serious infections | |||
| nr-axSpA | 0 | 0 | 0 |
| r-axSpA | 1 (0.9) (2.9) | 1 (0.5) (1.5) | 4 (1.2) (3.4) |
| Any fungal infections | |||
| nr-axSpA | 0 | 9 (7.0) (23.0) | 18 (7.4) (24.4) |
| r-axSpA | 0 | 13 (5.9) (19.5) | 21 (6.4) (18.3) |
| Systemic fungal infections | |||
| nr-axSpA | 0 | 0 | 0 |
| r-axSpA | 0 | 0 | 0 |
| Candida infections | |||
| nr-axSpA | 0 | 5 (3.9) (12.6) | 10 (4.1) (13.3) |
| r-axSpA | 0 | 10 (4.5) (14.9) | 12 (3.6) (10.3) |
| Fungal infections NEC | |||
| nr-axSpA | 0 | 4 (3.1) (10.1) | 7 (2.9) (9.3) |
| r-axSpA | 0 | 5 (2.3) (7.4) | 10 (3.0) (8.5) |
| Tinea infections | |||
| nr-axSpA | 0 | 0 | 1 (0.4) (1.3) |
| r-axSpA | 0 | 1 (0.5) (1.5) | 2 (0.6) (1.7) |
| Neutropenia | |||
| nr-axSpA | 0 | 1 (0.8) (2.5) | 2 (0.8) (2.6) |
| r-axSpA | 0 | 1 (0.5) (1.5) | 2 (0.6) (1.7) |
| Hepatic events§ | |||
| nr-axSpA | 3 (2.4) (7.9) | 7 (5.5) (17.9) | 11 (4.5) (14.8) |
| r-axSpA | 4 (3.6) (11.7) | 10 (4.5) (15.1) | 16 (4.8) (13.9) |
| Injection site reactions | |||
| nr-axSpA | 3 (2.4) (8.0) | 3 (2.3) (7.6) | 7 (2.9) (9.3) |
| r-axSpA | 1 (0.9) (2.9) | 9 (4.1) (13.6) | 12 (3.6) (10.4) |
| Adjudicated IBD¶ | |||
| Ulcerative colitis**†† | |||
| nr-axSpA | 1 (0.8) (2.6) | 0 | 0 |
| r-axSpA | 0 | 1 (0.5) (1.5) | 1 (0.3) (0.8) |
| Crohn’s disease**‡‡ | |||
| nr-axSpA | 0 | 0 | 0 |
| r-axSpA | 0 | 1 (0.5) (1.5) | 1 (0.3) (0.8) |
| Any uveitis event§§¶¶ | |||
| nr-axSpA | 6 (4.8) (15.9) | 2 (1.6) (5.0) | 2 (0.8) (2.6) |
| r-axSpA | 5 (4.5) (14.7) | 0 | 2 (0.6) (1.7) |
Safety set. MedDRA (V.19.0).
*Includes patients who switched from PBO to BKZ (events after switch only).
†TEAEs >3% in any BKZ group in either trial are reported by preferred term.
‡All oral candidiasis cases were mild to moderate.
§Most reported hepatic events were associated with non-serious abnormal liver function elevations. Those that were markedly abnormal were associated with factors other than trial treatment.
¶Adjudicated as probable or definite.
**Neither patient had a medical history of IBD.
††Moderate ulcerative colitis in a patient with nr-axSpA which led to discontinuation from the trial, and severe ulcerative colitis in a patient with r-axSpA which led to discontinuation of trial drug.
‡‡Moderate Crohn’s disease that led to discontinuation from the trial.
§§Of these patients in BE MOBILE 1, 1 BKZ-treated patient and 4 PBO-treated patients in weeks 0–16, and 1 BKZ-treated patient in weeks 0–24, had a medical history of uveitis at baseline. Of these patients in BE MOBILE 2, all had a medical history of uveitis at baseline.
¶¶Includes the preferred terms autoimmune uveitis, uveitis, iridocyclitis and iritis.
BKZ, bimekizumab; EAIR, exposure-adjusted incidence rate; IBD, inflammatory bowel disease; n, number of patients reporting ≥1 TEAE in that category; NEC, not elsewhere classified; nr-axSpA, non-radiographic axial spondyloarthritis; PBO, placebo; PY, patient-years; Q4W, every 4 weeks; r-axSpA, radiographic axial spondyloarthritis; SAE, treatment-emergent serious adverse event; TEAE, treatment-emergent adverse event.