Overview of treatment-emergent AEs and rates of AEs per 100 PYs between OLE entry and year 3 (years 2 and 5 of the study)
| MTX non-use (n=84) | MTX use (n=56) | |||
| n (%) | E (E/100 PY) | n (%) | E (E/100 PY) | |
| Any AE | 75 (89.3) | 550 (255.9) | 52 (92.9) | 398 (267.1) |
| Any serious AE | 25 (29.8) | 40 (18.6) | 16 (28.6) | 35 (23.5) |
| Any AE leading to discontinuation | 7 (8.3)* | 11 (5.1) | 5 (8.9) | 14 (9.4) |
| Any severe AE | 22 (26.2) | 33 (15.4) | 12 (21.4) | 20 (13.4) |
| Infectious AE | 56 (66.7) | 145 (67.5) | 41 (73.2) | 118 (79.2) |
| Serious infections | 7 (8.3) | 7 (3.3) | 4 (7.1) | 7 (4.7) |
| Opportunistic infection (excluding oral candidiasis and TB) | 0 | 0 | 0 | 0 |
| TB (active or conversion) | 0 | 0 | 0 | 0 |
| Lymphoma | 0 | 0 | 0 | 0 |
| NMSC | 1 (1.2) | 3 (1.4) | 2 (3.6) | 3 (2.0) |
| Malignancy other than lymphoma, leukaemia, NMSC or melanoma | 3 (3.6) | 3 (1.4) | 0 | 0 |
| Demyelinating disorder | 0 | 0 | 0 | 0 |
| Injection-site reaction | 2 (2.4) | 2 (0.9) | 1 (1.8) | 1 (0.7) |
| Deaths | 1 (1.2) | 1 (0.5) | 2 (3.6) | 2 (1.3) |
*Excludes one patient who experienced an AE before year 2 but who discontinued because of the AE between OLE years 0 and 3 (years 2 and 5 of the study).
AE, adverse event; E, event; MTX, methotrexate; NMSC, non-melanoma skin cancer; PY, patient-year; TB, tuberculosis.