Table 2.
Safety of bimekizumab treatment in psoriatic arthritis patients across the BE ACTIVE randomized controlled trial and the OLE study (safety set)*
| Weeks 0–48† | Weeks 48–152 | Weeks 0–152‡ | ||
|---|---|---|---|---|
| 160 mg BKZ every 4 weeks | 320 mg BKZ every 4 weeks | Total BKZ | Total BKZ | |
| (n = 126; 113.2 patient‐years) | (n = 80; 72.9 patient‐years) | (N = 183; 392.7 patient‐years) | (N = 206; 570.1 patient‐years) | |
| Any TEAE | 94 (74.6) (177.6) | 57 (71.3) (165.9) | 148 (80.9) (94.3) | 184 (89.3) (126.4) |
| Serious TEAEs | 8 (6.3) (7.9) | 0 | 14 (7.7) (3.8) | 22 (10.7) (4.1) |
| Severe TEAEs | 5 (4.0) (4.6) | 2 (2.5) (2.9) | 8 (4.4) (2.1) | 14 (6.8) (2.5) |
| Withdrawal due to TEAEs | 6 (4.8) (5.9) | 2 (2.5) (3.1) | 9 (4.9) (2.3) | 17 (8.3) (3.0) |
| Drug‐related TEAEs | 43 (34.1) (52.7) | 29 (36.3) (57.0) | 60 (32.8) (20.0) | 97 (47.1) (26.4) |
| Deaths | 0 | 0 | 0 | 0 |
| Most frequently reported TEAEs (≥5%) by MedDRA preferred term | ||||
| Nasopharyngitis | 12 (9.5) (12.0) | 11 (13.8) (18.4) | 19 (10.4) (5.2) | 37 (18.0) (7.6) |
| Upper respiratory tract infection | 12 (9.5) (12.0) | 8 (10.0) (13.2) | 20 (10.9) (5.5) | 34 (16.5) (6.8) |
| Bronchitis | 7 (5.6) (6.9) | 3 (3.8) (4.8) | 11 (6.0) (2.9) | 19 (9.2) (3.5) |
| Oral candidiasis | 6 (4.8) (6.0) | 4 (5.0) (6.4) | 13 (7.1) (3.5) | 19 (9.2) (3.5) |
| Pharyngitis | 4 (3.2) (3.9) | 7 (8.8) (11.6) | 10 (5.5) (2.7) | 17 (8.3) (3.2) |
| Sinusitis | 6 (4.8) (5.9) | 4 (5.0) (6.5) | 10 (5.5) (2.6) | 17 (8.3) (3.2) |
| Psoriasis | 2 (1.6) (1.9) | 2 (2.5) (3.1) | 14 (7.7) (3.7) | 16 (7.8) (2.9) |
| Psoriatic arthropathy | 2 (1.6) (1.9) | 1 (1.3) (1.6) | 12 (6.6) (3.1) | 16 (7.8) (2.9) |
| Respiratory tract infection | 8 (6.3) (8.0) | 2 (2.5) (3.2) | 4 (2.2) (1.0) | 15 (7.3) (2.8) |
| Oral fungal infection | 3 (2.4) (2.9) | 3 (3.8) (4.7) | 9 (4.9) (2.4) | 14 (6.8) (2.6) |
| Tonsillitis | 6 (4.8) (5.9) | 2 (2.5) (3.2) | 6 (3.3) (1.6) | 14 (6.8) (2.6) |
| ALT increased | 6 (4.8) (6.0) | 3 (3.8) (4.7) | 6 (3.3) (1.6) | 13 (6.3) (2.4) |
| Safety topics of interest | ||||
| Serious infections | 3 (2.4) (2.9) | 0 | 1 (0.5) (0.3) | 4 (1.9) (0.7) |
| Fungal infections | 17 (13.5) (17.8) | 10 (12.5) (16.7) | 32 (17.5) (9.2) | 47 (22.8) (9.7) |
| Candida infections | 9 (7.1) (9.1) | 5 (6.3) (8.1) | 16 (8.7) (4.3) | 24 (11.7) (4.6) |
| Oral candidiasis | 6 (4.8) (6.0) | 4 (5.0) (6.4) | 13 (7.1) (3.5) | 19 (9.2) (3.5) |
| Skin candidiasis | 1 (0.8) (1.0) | 0 | 1 (0.5) (0.3) | 2 (1.0) (0.4) |
| Vulvovaginal candidiasis | 0 | 0 | 1 (0.5) (0.3) | 1 (0.5) (0.2) |
| Genital candidiasis | 1 (0.8) (1.0) | 0 | 1 (0.5) (0.3) | 1 (0.5) (0.2) |
| Oropharyngeal candidiasis | 1 (0.8) (1.0) | 0 | 0 | 1 (0.5) (0.2) |
| Fungal infections NEC | 9 (7.1) (9.0) | 4 (5.0) (6.3) | 17 (9.3) (4.6) | 25 (12.1) (4.7) |
| Oral fungal infection | 3 (2.4) (2.9) | 3 (3.8) (4.7) | 9 (4.9) (2.4) | 14 (6.8) (2.6) |
| Tongue fungal infection | 3 (2.4) (2.9) | 0 | 4 (2.2) (1.0) | 5 (2.4) (0.9) |
| Fungal skin infection | 0 | 1 (1.3) (1.6) | 3 (1.6) (0.8) | 4 (1.9) (0.7) |
| Fungal esophagitis | 1 (0.8) (1.0) | 1 (1.3) (1.6) | 1 (0.5) (0.3) | 3 (1.5) (0.5) |
| Vulvovaginal mycotic infection | 2 (1.6) (1.9) | 0 | 0 | 2 (1.0) (0.4) |
| Onochomycosis | 0 | 0 | 2 (1.1) (0.5) | 2 (1.0) (0.4) |
| Fungal pharyngitis | 0 | 0 | 1 (0.5) (0.3) | 1 (0.5) (0.2) |
| Tinea infections | 0 | 1 (1.3) (1.6) | 1 (0.5) (0.3) | 2 (1.0) (0.4) |
| Tinea pedis | 0 | 1 (1.3) (1.6) | 0 | 1 (0.5) (0.2) |
| Tineas cruris | 0 | 0 | 1 (0.5) (0.3) | 1 (0.5) (0.2) |
| Serious hypersensitivity reactions | 0 | 0 | 0 | 0 |
| Opportunistic infections | 1 (0.8) (1.0) | 1 (1.3) (1.6) | 1 (0.5) (0.3) | 3 (1.5) (0.5) |
| Active tuberculosis | 0 | 0 | 0 | 0 |
| Liver enzyme elevation | ||||
| ALT increased | 6 (4.8) (6.0) | 3 (3.8) (4.7) | 6 (3.3) (1.6) | 13 (6.3) (2.4) |
| AST increased | 4 (3.2) (4.0) | 2 (2.5) (3.1) | 6 (3.3) (1.6) | 10 (4.9) (1.8) |
| Hepatic enzymes increased | 2 (1.6) (1.9) | 1 (1.3) (1.6) | 1 (0.5) (0.3) | 4 (1.9) (0.7) |
| MACE | 0 | 0 | 0 | 0 |
| Malignancies | 1 (0.8) (1.0) | 0 | 0 | 1 (0.5) (0.2) |
| IBD | 0 | 0 | 1 (0.5) (0.3) | 1 (0.5) (0.2) |
| Microscopic colitis | 0 | 0 | 1 (0.5) (0.3) | 1 (0.5) (0.2) |
| Anterior uveitis | 0 | 0 | 0 | 0 |
| Neutropenia | 0 | 1 (1.3) (1.6) | 5 (2.7) (1.3) | 6 (2.9) (1.1) |
| Drug hypersensitivity | 2 (1.6) (1.9) | 0 | 1 (0.5) (0.3) | 3 (1.5) (0.5) |
| Injection site reactions | 0 | 3 (3.8) (4.9) | 0 | 3 (1.5) (0.5) |
| SIB | 1 (0.8) (1.0) | 0 | 0 | 1 (0.5) (0.2) |
| Depression | 1 (0.8) (1.0) | 1 (1.3) (1.6) | 2 (1.1) (0.5) | 4 (1.9) (0.7) |
Values are the number (%) of patients (exposure‐adjusted incidence rate per 100 patient‐years). The safety set consisted of all randomized study participants who received ≥1 dose of BKZ in weeks 48–152 of the OLE study. After week 48, all patients received 160 mg of BKZ every 4 weeks, regardless of prior dosing regimen. All oral candidiasis treatment‐emergent adverse events (TEAEs) were mild to moderate (no serious cases), and all fungal infections were mild to moderate and localized, not systemic. Two patients reported 3 opportunistic events (2 fungal esophagitis, 1 oropharyngeal candidiasis) in weeks 0–48, 1 patient reported 2 events (fungal pharyngitis, fungal esophagitis) in weeks 48–152. No Hy's law cases reported. Suicidal ideation and behavior (SIB) events were adjudicated by an independent committee. One malignant melanoma in situ case was reported. No drug hypersensitivity reactions were anaphylactic. OLE = open‐label extension; MedDRA = Medical Dictionary for Regulatory Activities; ALT = alanine aminotransferase; AST = aspartate aminotransferase; MACE = major adverse cardiac events; IBD = inflammatory bowel disease. See Table 1 for other definitions.
Patients re‐randomized 1:1 at week 12 from placebo or 16 mg of BKZ every 4 weeks to 160 mg BKZ every 4 weeks or 320 mg BKZ every 4 weeks; 2 patients completing the double‐blind period on placebo were re‐randomized but did not receive BKZ. Two patients were included in both groups due to a dosing error, allocation done per actual treatment.
Includes safety follow‐up to possible 168 weeks total for some patients.