Table 3.
Safety outcomes (Safety Set)
| MedDRA® v20.1 System Organ Class Preferred Term, n (%) [#] | Overall axSpA (n = 672) | r-axSpA (n = 469) | nr-axSpA (n = 201) |
|---|---|---|---|
| Patient exposure years | 663.9 | 462.5 | 200.1 |
| Any AE | 255 (37.9) [475] | 173 (36.9) [317] | 80 (39.8) [155] |
| EAIR, per 100 PY (95% CI) | 50.7 (44.7, 57.4) | 48.6 (41.7, 56.5) | 54.8 (43.4, 68.2) |
| Drug-related AEs | 139 (20.7) [192] | 87 (18.6) [123] | 50 (24.9) [66] |
| Drug withdrawal due to AE | 138 (20.5) [245] | 96 (20.5) [173] | 41 (20.4) [70] |
| Serious AEs | 42 (6.3) [53] | 29 (6.2) [35] | 13 (6.5) [18] |
| EAIR, per 100 PY (95% CI) | 6.6 (4.7, 8.9) | 6.5 (4.4, 9.3) | 6.8 (3.6, 11.6) |
| Serious infections and infestations | 12 (1.8) [15] | 7 (1.5) [8] | 5 (2.5) [7] |
| Opportunistic infections | 3 (0.4) [3] | 2 (0.4) [2] | 1 (0.5) [1] |
| EAIR, per 100 PY (95% CI) | 0.5 (0.1, 1.3) | 0.4 (0.1, 1.6) | 0.5 (0.0, 2.8) |
| Oral herpes | 2 (0.3) [2] | 2 (0.4) [2] | 0 |
| Ophthalmic herpes zoster | 1 (0.1) [1] | 0 | 1 (0.5) [1] |
| Serious cardiovascular events | 3 (0.4) [3] | 2 (0.4) [2] | 1 (0.5) [1] |
| Cardiac disorders | 2 (0.3) [2] | 1 (0.2) [1] | 1 (0.5) [1] |
| Angina pectoris | 1 (0.1) [1] | 0 | 1 (0.5) [1] |
| Myocardial infarction | 1 (0.1) [1] | 1 (0.2) [1] | 0 |
| Nervous system disorders | 1 (0.1) [1] | 1 (0.2) [1] | 0 |
| Paraplegia | 1 (0.1) [1] | 1 (0.2) [1] | 0 |
| Malignant or unspecified tumours | 1 (0.1) [1] | 1 (0.2) [1] | 0 |
| Neoplasms benign, malignant and unspecified | 1 (0.1) [1] | 1 (0.2) [1] | 0 |
| Basal cell carcinoma | 1 (0.1) [1] | 1 (0.2) [1] | 0 |
| Haematopoietic cytopenias | 1 (0.1) [1] | 0 | 1 (0.5) [1] |
| Blood and lymphatic system disorders | 1 (0.1) [1] | 0 | 1 (0.5) [1] |
| Leukopenia | 1 (0.1) [1] | 0 | 1 (0.5) [1] |
| Serious bleeding events | 1 (0.1) [1] | 1 (0.2) [1] | 0 |
| Gastrointestinal disorders | 1 (0.1) [1] | 1 (0.2) [1] | 0 |
| Gastrointestinal haemorrhage | 1 (0.1) [1] | 1 (0.2) [1] | 0 |
| Deaths | 0 | 0 | 0 |
Safety Set. AEs were recorded according to the MedDRA® version 20.1. The overall axSpA population includes two patients with an unconfirmed diagnosis of either r-axSpA or nr-axSpA. #: number of events; AE: adverse event; axSpA: axial spondyloarthritis; EAIR: exposure-adjusted incidence rate; MedDRA®: Medical Dictionary for Regulatory Activities; nr-axSpA: non-radiographic axSpA; PY: patient-years; r-axSpA: radiographic axSpA.