Safety overview for the double-blind treatment (Weeks 0–16) and overall periods (Weeks 0–52)
| n (%), overall period: (EAIR/100 PY) | Double-blind treatment period Weeks 0–16 | Maintenance period Weeks 16–52 | Overall Weeks 0–52 | ||
| PBO | BKZ 160 mg Q4W | BKZ 160 mg Q4W | BKZ 160 mg Q4W* | ||
| nr-axSpA (BE MOBILE 1) | n=126 (38.1 PYAR) | n=128 (40.4 PYAR) | n=242 (167.8 PYAR) | n=244 (208.2 PYAR) | |
| r-axSpA (BE MOBILE 2) | n=111 (34.6 PYAR) | n=221 (68.3 PYAR) | n=319 (220.0 PYAR) | n=330 (290.9 PYAR) | |
| Overview | |||||
| Any TEAE | nr-axSpA | 71 (56.3) | 80 (62.5) | 164 (67.8) | 183 (75.0) (202.1) |
| r-axSpA | 48 (43.2) | 120 (54.3) | 217 (68.0) | 249 (75.5) (200.8) | |
| Severe TEAEs | nr-axSpA | 1 (0.8) | 0 | 8 (3.3) | 8 (3.3) (3.9) |
| r-axSpA | 0 | 4 (1.8) | 10 (3.1) | 14 (4.2) (4.9) | |
| TEAEs leading to discontinuation from the study | nr-axSpA | 5 (4.0) | 2 (1.6) | 4 (1.7) | 6 (2.5) (2.9) |
| r-axSpA | 0 | 6 (2.7) | 9 (2.8) | 15 (4.5) (5.2) | |
| TEAEs leading to discontinuation of study drug | nr-axSpA | 5 (4.0) | 2 (1.6) | 6 (2.5) | 8 (3.3) (3.9) |
| r-axSpA | 0 | 7 (3.2) | 9 (2.8) | 16 (4.8) (5.6) | |
| Drug-related TEAEs | nr-axSpA | 17 (13.5) | 33 (25.8) | 67 (27.7) | 81 (33.2) (51.3) |
| r-axSpA | 19 (17.1) | 65 (29.4) | 133 (35.4) | 135 (40.9) (67.1) | |
| SAEs | nr-axSpA | 1 (0.8) | 0 | 9 (3.7) | 9 (3.7) (4.4) |
| r-axSpA | 1 (0.9) | 5 (2.3) | 15 (4.7) | 20 (6.1) (7.1) | |
| Death | nr-axSpA | 0 | 0 | 0 | 0 |
| r-axSpA | 0 | 0 | 0 | 0 | |
| Most frequently reported TEAEs† | |||||
| Nasopharyngitis | nr-axSpA | 6 (4.8) | 13 (10.2) | 18 (7.4) | 30 (12.3) (15.7) |
| r-axSpA | 4 (3.6) | 17 (7.7) | 17 (5.3) | 30 (9.1) (11.0) | |
| Upper respiratory tract infection | nr-axSpA | 10 (7.9) | 9 (7.0) | 15 (6.2) | 23 (9.4) (11.9) |
| r-axSpA | 8 (7.2) | 6 (2.7) | 16 (5.0) | 21 (6.4) (7.5) | |
| Oral candidiasis‡ | nr-axSpA | 0 | 4 (3.1) | 17 (7.0) | 18 (7.4) (9.0) |
| r-axSpA | 0 | 10 (4.5) | 12 (3.8) | 20 (6.1) (7.2) | |
| Corona virus infection | nr-axSpA | 1 (0.8) | 1 (0.8) | 17 (7.0) | 17 (7.0) (8.3) |
| r-axSpA | 3 (2.7) | 1 (0.5) | 6 (1.9) | 7 (2.1) (2.4) | |
| Headache | nr-axSpA | 2 (1.6) | 3 (2.3) | 10 (4.1) | 13 (5.3) (6.5) |
| r-axSpA | 5 (4.5) | 9 (4.1) | 11 (3.4) | 18 (5.5) (6.5) | |
| Pharyngitis | nr-axSpA | 1 (0.8) | 4 (3.1) | 7 (2.9) | 11 (4.5) (5.4) |
| r-axSpA | 0 | 5 (2.3) | 7 (2.2) | 11 (3.3) (3.9) | |
| Diarrhoea | nr-axSpA | 2 (1.6) | 3 (2.3) | 6 (2.5) | 9 (3.7) (4.4) |
| r-axSpA | 1 (0.9) | 7 (3.2) | 12 (3.8) | 18 (5.5) (6.5) | |
| Prespecified safety topics of interest and other important TEAEs | |||||
| Serious infections | nr-axSpA | 0 | 0 | 4 (1.7) | 4 (1.6) (1.9) |
| r-axSpA | 1 (0.9) | 1 (0.5) | 5 (1.6) | 6 (1.8) (2.1) | |
| Opportunistic infections | nr-axSpA | 0 | 1 (0.8) | 4 (1.7) | 5 (2.0) (2.4) |
| r-axSpA | 0 | 0 | 3 (0.9) | 3 (0.9) (1.0) | |
| Any fungal infections | nr-axSpA | 0 | 9 (7.0) | 32 (13.2) | 37 (15.2) (19.6) |
| r-axSpA | 0 | 14 (6.3) | 31 (9.7) | 40 (12.1) (14.9) | |
| Candida infections | nr-axSpA | 0 | 5 (3.9) | 23 (9.5) | 25 (10.2) (12.8) |
| r-axSpA | 0 | 11 (5.0) | 15 (4.7) | 23 (7.0) (8.3) | |
| Fungal infections NEC | nr-axSpA | 0 | 4 (3.1) | 9 (3.7) | 13 (5.3) (6.4) |
| r-axSpA | 0 | 5 (2.3) | 11 (3.4) | 14 (4.2) (5.0) | |
| Tinea infections | nr-axSpA | 0 | 0 | 2 (0.8) | 2 (0.8) (1.0) |
| r-axSpA | 0 | 1 (0.5) | 5 (1.6) | 6 (1.8) (2.1) | |
| Neutropenia | nr-axSpA | 0 | 1 (0.8) | 2 (0.8) | 2 (0.8) (1.0) |
| r-axSpA | 0 | 1 (0.5) | 2 (0.6) | 2 (0.6) (0.7) | |
| Hepatic events§ | nr-axSpA | 3 (2.4) | 7 (5.5) | 14 (5.8) | 20 (8.2) (10.2) |
| r-axSpA | 4 (3.6) | 10 (4.5) | 24 (7.5) | 33 (10.0) (12.1) | |
| Potential Hy’s law | nr-axSpA | 0 | 0 | 0 | 0 |
| r-axSpA | 0 | 1 (0.5)¶ | 0 | 1 (0.3) (0.3) | |
| Liver enzyme elevations | |||||
| >3 xULN ALT or AST | nr-axSpA | 1 (0.8) | 2 (1.6) | 4 (1.7) | 6 (2.5) (2.9) |
| r-axSpA | 2 (1.8) | 3 (1.4) | 9 (2.8) | 12 (3.6) (4.3) | |
| >5 xULN ALT or AST | nr-axSpA | 0 | 0 | 1 (0.4) | 1 (0.4) (0.5) |
| r-axSpA | 1 (0.9) | 3 (1.4) | 3 (0.9) | 6 (1.8) (2.1) | |
| Hypersensitivity** | nr-axSpA | 3 (2.4) | 3 (2.3) | 17 (7.0) | 18 (7.4) (9.1) |
| r-axSpA | 2 (1.8) | 17 (7.7) | 28 (8.8) | 41 (12.4) (15.3) | |
| Anaphylactic reactions | nr-axSpA | 0 | 0 | 0 | 0 |
| r-axSpA | 0 | 0 | 0 | 0 | |
| Injection site reactions | nr-axSpA | 1 (0.8) | 0 | 1 (0.4) | 1 (0.4) (0.5) |
| r-axSpA | 0 | 1 (0.5) | 0 | 1 (0.3) (0.3) | |
| Dermatitis and eczema | nr-axSpA | 0 | 1 (0.8) | 7 (2.9) | 8 (3.3) (3.9) |
| r-axSpA | 1 (0.9) | 6 (2.7) | 17 (5.3) | 19 (5.8) (6.8) | |
| Adjudicated MACE | nr-axSpA | 0 | 0 | 0 | 0 |
| r-axSpA | 0 | 0 | 0 | 0 | |
| Malignancies†† | nr-axSpA | 0 | 0 | 1 (0.4) | 1 (0.4) (0.5) |
| r-axSpA | 0 | 0 | 1 (0.3) | 1 (0.3) (0.3) | |
| Adjudicated SIB‡‡ | nr-axSpA | 0 | 0 | 1 (0.4) | 1 (0.4) (0.5) |
| r-axSpA | 0 | 0 | 1 (0.3) | 1 (0.3) (0.3) | |
| Adjudicated IBD§§ | nr-axSpA | 1 (0.8) | 0 | 2 (0.8) | 2 (0.8) (1.0) |
| r-axSpA | 0 | 2 (0.9) | 1 (0.3) | 3 (0.9) (1.0) | |
| Ulcerative colitis¶¶*** | nr-axSpA | 1 (0.8) | 0 | 1 (0.4) | 1 (0.4) (0.5) |
| r-axSpA | 0 | 1 (0.5) | 0 | 1 (0.3) (0.3) | |
| Crohn’s disease¶¶††† | nr-axSpA | 0 | 0 | 1 (0.4) | 1 (0.4) (0.5) |
| r-axSpA | 0 | 1 (0.5) | 1 (0.3) | 2 (0.6) (0.7) | |
| Uveitis‡‡‡§§§ | nr-axSpA | 6 (4.8) | 2 (1.6) | 3 (1.2) | 3 (1.2) (1.5) |
| r-axSpA | 5 (4.5) | 0 | 7 (2.2) | 7 (2.1) (2.4) | |
Safety set. MedDRA (v.19.0). Overall period includes all data available up to the last Week 52 visit, including data for patients treated beyond Week 24.
*Includes patients who switched from PBO to BKZ (events after switch only).
†TEAEs >5% in any group are reported by preferred term.
‡Only one case of oral candidiasis (in BE MOBILE 1) was severe, the remainder were mild or 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 the study treatment.
¶Potential Hy’s law case was diagnosed with hepatitis A infection
**Hypersensitivity events were identified using the MedDRA standardised medical query ‘Hypersensitivity (SMQ)’.
††One clear cell renal carcinoma event in BE MOBILE 1 and one superficial spreading melanoma stage I event in BE MOBILE 2, both adjudicated as not related to study drug by investigator.
‡‡One intentional self-injury event in BE MOBILE 1 adjudicated as not related to study drug by investigator and one suicidal ideation event in BE MOBILE 2, adjudicated as related to study drug by investigator.
§§Definite or probable IBD reported per external adjudication committee.
¶¶No patients with nr-axSpA and one patient with r-axSpA who had IBD events had a medical history of IBD.
***Moderate ulcerative colitis in a patient with nr-axSpA and severe ulcerative colitis in patients with r-axSpA, both of which led to discontinuation of study drug.
†††One case of mild Crohn’s disease in a patient with nr-axSpA that did not lead to discontinuation of study drug and two cases of moderate Crohn’s disease that led to discontinuation of study drug.
‡‡‡Of these patients in BE MOBILE 1, one BKZ-treated patient and four PBO-treated patients in Weeks 0–16, and one BKZ-treated patient in Weeks 0–52, had a medical history of uveitis at baseline. Of these patients in BE MOBILE 2, five PBO-treated patients in Weeks 0–16, and five BKZ-treated patients in Weeks 0–52, had a medical history of uveitis at baseline.
§§§Includes the preferred terms autoimmune uveitis, uveitis, iridocyclitis and iritis.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BKZ, bimekizumab; DILI, drug-induced liver events; EAIR, exposure-adjusted incidence rate; IBD, inflammatory bowel disease; MACE, major adverse cardiac event; n, number of patients reporting at least one TEAE in that category; NEC, not elsewhere classified; PBO, placebo; PY, patient years; PYAR, patient years at risk; Q4W, every 4 weeks; SAE, serious adverse event; SIB, suicidal ideation and behaviour; TEAE, treatment-emergent adverse event; ULN, upper limit of normal.