Table 4.
Tofacitinib safety profile in inflammatory bowel disease
| Sandborn et al (2012) | OCTAVE 1 Sandborn et al 2017 |
OCTAVE 2 Sandborn et al 2017 |
OCTAVE Sustain Sandborn et al 217 |
Sandborn et al (2014) | Panés et al induction (2017) | Panés et al maintenance (2017) | |
|---|---|---|---|---|---|---|---|
| Treatment | Placebo 0.5 mg BID 3 mg BID 10 mg BID 15 mg BID |
Placebo 10 mg BID |
Placebo 10 mg BID |
Placebo 5 mg BID 10 mg BID |
Placebo 1 mg BID 5 mg BID 15 mg BID |
Placebo 5 mg BID 10 mg BID |
Placebo 5 mg BID 10 mg BID |
| Disease | UC | UC | UC | UC | CD | CD | CD |
| No. AE, n (%) | 23 (48) 19 (61) 11 (33) 14 (42) 20 (41) |
73 (59.8) 269 (56.5) |
59 (52.7) 232 (54.1) |
149 (75.3) 143 (72.2) 156 (79.6) |
22 (64.7) 18 (50.0) 21 (61.8) 22 (62.9) |
55 (60.4) 50 (58.1) 52 (60.5) |
44 (74.6) 50 (83.3) 48 (78.7) |
| Serious AE, n (%) | 4 (8) 1 (3) 1 (3) 2 (6) 2 (4) |
5 (4.1) 16 (3.4) |
9 (8.0) 18 (4.2) |
13 (6.6) 10 (5.1) 11 (5.6) |
5 (14.7) 4(11.1) 4 (11.8) 1 (2.9) |
3 (3.3) 3 (3.5) 10 (11.6) |
7 (11.6) 6 (10.0) 8 (13.1) |
| Infectious AE, n (%) | 7 (15) 8 (26) 3 (9) 9 (27) 3 (6) |
19 (15.6) 111 (23.3) |
17 (15.2) 78 (18.2) |
48 (24.2) 71 (35.9) 78 (39.8) |
8 (23.5) 5 (13.9) 8 (23.5) 5 (14.3) |
Not reported | Not reported |
| Serious infection, n (%) | 0 (0) 0 (0) 0 (0) 2 (6) 0 (0) |
0 (0) 6 (1.3) |
0 (0) 1 (0.2) |
2 (1.0) 2 (1.0) 1 (0.5) |
4 (11.7) 0 (0) 1 (0.03) 0 (0) |
2 (2.2) 2 (2.3) 2 (2.3) |
0 (0) 3 (0.05) 2 (3.2) |
| Discontinuation due to AE, n (%) | 4 (8) 2 (6) 0 (0) 1 (3) 2 (4) |
2 (1.6) 18 (3.8) |
8 (7.1) 17 (4.0) |
37 (18.7) 19 (9.1) 19 (9.7) |
3 (8.8) 1 (2.8) 1 (2.9) 1 (2.9) |
5 (5.5) 3 (3.5) 8 (9.3) |
3 (5.1) 7 (11.7) 6 (9.8) |
Abbreviations: AE, Adverse events; BID, twice daily; UC, ulcerative colitis; CD, Crohn’s disease.