Baseline ASCVD risk scores for patients in ORAL Surveillance with and without malignancies excluding NMSC, lung cancer and NMSC
| Combined to facitinib doses* | Tofacitinib 5 mg two times per day | Tofacitinib 10 mg two times per day | TNFi | |
| Malignancies excluding NMSC, n/N (%) | 96/2450 (3.92) | 49/1234 (3.97) | 47/1216 (3.87) | 31/1222 (2.54) |
| ASCVD score, mean (SD) for patients with event (based on n) | 18.53 (13.81) | 18.06 (14.29) | 19.02 (13.43) | 17.27 (12.82) |
| ASCVD score, mean (SD) for patients without event (based on N−n) | 14.03 (13.33) | 13.38 (12.59) | 14.68 (14.02) | 14.19 (13.37) |
| Lung cancer, n/N (%) | 21/2450 (0.86) | 10/1234 (0.81) | 11/1216 (0.90) | 5/1222 (0.41) |
| ASCVD score, mean (SD) for patients with event (based on n) | 27.68 (14.56) | 31.62 (13.54) | 24.10 (15.15) | 36.70 (11.94) |
| ASCVD score, mean (SD) for patients without event (based on N−n) | 14.09 (13.31) | 13.42 (12.58) | 14.77 (13.98) | 14.17 (13.29) |
| NMSC, n/N (%) | 46/2450 (1.88) | 24/1234 (1.94) | 22/1216 (1.81) | 12/1222 (0.98) |
| ASCVD score, mean (SD) for patients with event (based on n) | 20.06 (15.34) | 22.66 (17.91) | 17.22 (11.68) | 25.04 (18.20) |
| ASCVD score, mean (SD) for patients without event (based on N−n) | 14.09 (13.32) | 13.39 (12.51) | 14.81 (14.06) | 14.16 (13.27) |
Data are for patients without HxASCVD and with non-missing baseline CV risk score.
ASCVD score was calculated with the ASCVD-PCE calculator,18 and a 1.5 multiplier was applied to account for the influence of RA, as recommended by EULAR.19 20
For patients randomised to the tofacitinib 10 mg two times per day group who had their dose of tofacitinib reduced to 5 mg two times per day, the data collected after patients were switched to tofacitinib 5 mg two times per day were counted in the tofacitinib 10 mg two times per day group.
For malignancies excluding NMSC and lung cancer, the risk period was total time, defined as time from first dose of trial drug until last contact date.
For NMSC, the risk period was the 28-day on-treatment time, defined as time from the first until last dose of trial drug + 28 days, or to last contact date, whichever was earlier.
*Includes patients who received tofacitinib 5 or 10 mg two times per day in ORAL Surveillance.
ASCVD, atherosclerotic cardiovascular disease; ASCVD-PCE, ASCVD-Pooled Cohort Equations calculator; CV, cardiovascular; EULAR, European Alliance of Associations for Rheumatology; HxASCVD, history of atherosclerotic cardiovascular disease; N, number of patients without HxASCVD and non-missing baseline CV risk score; n, number of patients with events; NMSC, non-melanoma skin cancer; N–n, number of patients without events; TNFi, tumour necrosis factor inhibitors.