Summary of treatment-emergent adverse events (all causalities)
| Induction study | Maintenance study | |||||
|---|---|---|---|---|---|---|
| Placebo | Tofacitinib 5 mg twice daily | Tofacitinib 10 mg twice daily | Placebo | Tofacitinib 5 mg twice daily | Tofacitinib 10 mg twice daily | |
| Patient-year exposure | 13.08 | 12.95 | 12.43 | 20.17 | 22.87 | 23.55 |
| Patients evaluable for AEs | 91 | 86 | 86 | 59 | 60 | 61 |
| Patients with AEs, n (%) | 55 (60.4) | 50 (58.1) | 52 (60.5) | 44 (74.6) | 50 (83.3) | 48 (78.7) |
| Patients with SAEs, n (%) | 3 (3.3) | 3 (3.5) | 10 (11.6) | 7 (11.9) | 6 (10.0) | 8 (13.1) |
| Patients with severe AEs, n (%) | 8 (8.8) | 5 (5.8) | 7 (8.1) | 6 (10.2) | 5 (8.3) | 6 (9.8) |
| Patients discontinued due to AEs, n (%) | 5 (5.5) | 3 (3.5) | 8 (9.3) | 3 (5.1) | 7 (11.7) | 6 (9.8) |
| Most frequently occurring AEs by preferred term,* n (%) | ||||||
| Headache | 7 (7.7) | 8 (9.3) | 5 (5.8) | 2 (3.4) | 4 (6.7) | 2 (3.3) |
| Nausea | 8 (8.8) | 5 (5.8) | 7 (8.1) | 1 (1.7) | 1 (1.7) | 2 (3.3) |
| Crohn's disease worsening | 6 (6.6) | 5 (5.8) | 6 (7.0) | 13 (22.0) | 11 (18.3) | 9 (14.8) |
| Abdominal pain | 5 (5.5) | 3 (3.5) | 7 (8.1) | 2 (3.4) | 5 (8.3) | 4 (6.6) |
| Nasopharyngitis | 3 (3.3) | 3 (3.5) | 6 (7.0) | 4 (6.8) | 11 (18.3) | 5 (8.2) |
| Urinary tract infection | 5 (5.5) | 1 (1.2) | 2 (2.3) | 4 (6.8) | 6 (10.0) | 8 (13.1) |
| Arthralgia | 2 (2.2) | 2 (2.3) | 2 (2.3) | 2 (3.4) | 6 (10.0) | 4 (6.6) |
| Laboratory parameters, n (%) | ||||||
| Blood creatine phosphokinase increased | 0 (0.0) | 1 (1.2) | 2 (2.3) | 0 (0.0) | 2 (3.3) | 0 (0.0) |
| Blood cholesterol increased | 0 (0.0) | 1 (1.2) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (1.6) |
| Serious infections, n (%) | ||||||
| Abdominal abscess | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Cytomegalovirus infection | 1 (1.1)† | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Clostridium difficile colitis/infection | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (3.3)† | 0 (0.0) |
| Perianal‡ abscess | 1 (1.1) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 2 (3.3) | 1 (1.6) |
| Gastroenteritis | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Influenza/pneumonia influenza | 0 (0.0) | 0 (0.0) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (1.6) |
| Septic shock | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.7)§ | 0 (0.0) |
| Special events of interest, n (%) | ||||||
| Malignancy confirmed by adjudication | 0 (0.0) | 0 (0.0) | 1 (1.2)¶ | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Intestinal perforation confirmed by adjudication | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.7)** | 0 (0.0) |
| Herpes zoster (non-serious) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (3.3) |
Safety analysis set.
*In >5.0% of patients in any treatment group.
†Opportunistic infection confirmed by adjudication.
‡Perirectal, anal and/or rectal.
§These serious infections occurred in the same subject and may have consisted of one episode of C. difficile that required re-hospitalisation.
¶Breast cancer.
**Large intestine perforation.
AE, adverse event; SAE, serious adverse event.