Safety endpoints across serotype subgroups for patients receiving tofacitinib or placebo
|
n (%)
IR ( 95% CI ) | Tofacitinib 5 mg two times a day N=1194 | Tofacitinib 10 mg two times a day N=1197 | Placebo N=670 | |||||||||
| Anti-CCP+/RF+ N=776 | Anti-CCP+/RF- N=136 | Anti-CCP-/RF+ N=74 | Anti-CCP-/RF- N=208 | Anti-CCP+/RF+ N=775 | Anti-CCP+/RF- N=113 | Anti-CCP-/RF+ N=68 | Anti-CCP-/RF- N=241 | Anti-CCP+/RF+ N=410 | Anti-CCP+/RF- N=88 | Anti-CCP-/RF+ N=40 | Anti-CCP-/RF- N=132 | |
| TEAEs | 393 (50.6) | 65 (47.8) | 39 (52.7) | 113 (54.3) | 417 (53.8) | 54 (47.8) | 39 (57.4) | 125 (51.9) | 206 (50.2) | 46 (52.3) | 23 (57.5) | 77 (58.3) |
| SAEs | 27 (3.5) | 3 (2.2) | 2 (2.7) | 7 (3.4) | 21 (2.7) | 5 (4.4) | 2 (2.9) | 4 (1.7) | 13 (3.2) | 5 (5.7) | 1 (2.5) | 4 (3.0) |
| Discontinuations due to AEs* | 77 (9.9) 10.4 [ 8.3 to 13.0 ) | 11 (8.1) 7.9 ( 4.4 to 14.2 ) | 8 (10.8) 11.2 ( 5.6 to 22.3 ) | 16 (7.7) 10.2 ( 6.3 to 16.7 ) | 77 (9.9) 10.1 ( 8.1 to 12.6 ) | 11 (9.7) 10.1 ( 5.6 to 18.3 ) | 8 (11.8) 13.3 ( 6.6 to 26.5 ) | 21 (8.7) 10.8 ( 7.0 to 16.5 ) | 13 (3.2) 10.3 ( 6.0 to 17.7 ) | 5 (5.7) 19.7 ( 8.2 to 47.4 ) | 2 (5.0) 16.8 ( 4.2 to 67.1 ) | 3 (2.3) 8.6 ( 2.8 to 26.7 ) |
| Serious infections* | 27 (3.5) 3.6 ( 2.5 to 5.3 ) | 4 (2.9) 2.8 ( 1.1 to 7.6 ) | 2 (2.7) 2.8 ( 0.7 to 11.1 ) | 3 (1.4) 1.9 ( 0.6 to 5.9 ) | 23 (3.0) 3.0 ( 2.0 to 4.5 ) | 4 (3.5) 3.7 ( 1.4 to 9.8 ) | 1 (1.5) 1.6 ( 0.2 to 11.6 ) | 9 (3.7) 4.6 ( 2.4 to 8.8 ) | 2 (0.5) 1.6 ( 0.4 to 6.3 ) | 1 (1.1) 4.0 ( 0.6 to 28.1 ) | 0 (0.0) 0 | 0 (0.0) 0 |
| Herpes zoster*† | 27 (3.5) 3.7 ( 2.5 to 5.4 ) | 8 (5.9) 5.9 ( 3.0 to 11.8 ) | 6 (8.1) 9.1 ( 4.1 to 20.3 ) | 3 (1.4) 1.9 ( 0.6 to 6.0 ) | 32 (4.1) 4.3 ( 3.0 to 6.0 ) | 9 (8.0) 8.7 ( 4.5 to 16.8 ) | 3 (4.4) 5.1 ( 1.6 to 15.7 ) | 8 (3.3) 4.2 ( 2.1 to 8.4 ) | 3 (0.7) 2.4 ( 0.8 to 7.4 ) | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 |
| Malignancies (excluding NMSC) | 6 (0.8) 0.8 ( 0.4,1.8 ) | 0 (0.0) 0 | 1 (1.4) 1.4 ( 0.2 to 9.8 ) | 1 (0.5) 0 .6 ( 0.1 to 4.5 ) | 9 (1.2) 1.2 ( 0.6 to 2.3 ) | 1 (0.9) 0.9 ( 0.1,6.5 ) | 1 (1.5) 1.6 ( 0.2,11.6 ) | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 |
| NMSC | 7 (0.9) 0.9 ( 0.5 to 2.0 ) | 1 (0.7) 0.7 ( 0.1 to 5.1 ) | 0 (0.0) 0 | 1 (0.5) 0.6 ( 0.1 to 4.5 ) | 6 (0.8) 0.8 ( 0.4 to 1.7 ) | 0 (0.0) 0 | 0 (0.0) 0 | 0 (0.0) 0 | 1 (0.2) 0.8 ( 0.1 to 5.6 ) | 1 (1.1) 3.9 ( 0.6 to 27.9 ) | 0 (0.0) 0 | 0 (0.0) 0 |
*IRs are representative up to month 24.
†All HZ events include both serious and non-serious events.
AE, adverse event; CCP, cyclic citrullinated peptide; HZ, herpes zoster; IR, incidence rate; NMSC, non-melanoma skin cancer; RF, rheumatoid factor; SAE, serious adverse event; TEAE, treatment-emergent adverse event.