Table 2

Demographic and baseline disease characteristics in the ORAL Surveillance overall population and in patients with and without a history of ASCVD

OverallHistory of ASCVDNo history of ASCVD
Tofacitinib
5 mg
two times
per day
(N=1455)
Tofacitinib
10 mg
two times
per day
(N=1456)
TNFi
(N=1451)
Tofacitinib
5 mg
two times
per day
(N=204)
Tofacitinib
10 mg
two times
per day
(N=222)
TNFi
(N=214)
Tofacitinib
5 mg
two times
per day
(N=1251)
Tofacitinib
10 mg
two times
per day
(N=1234)
TNFi
(N=1237)
Age (years), mean (SD)60.8 (6.8)61.4 (7.1)61.3 (7.5)63.2 (7.1)64.7 (7.5)65.6 (7.8)60.4 (6.7)60.8 (6.8)60.6 (7.2)
 Median (range)60 (50–86)61 (50–85)60 (50–88)62 (50–83)64 (50–82)66 (50–88)60 (50–86)60 (50–85)60 (50–87)
 ≥65 years, n (%)413 (28.4)478 (32.8)462 (31.8)84 (41.2)109 (49.1)113 (52.8)329 (26.3)369 (29.9)349 (28.2)
Female sex, n (%)1169 (80.3)1124 (77.2)1117 (77.0)141 (69.1)143 (64.4)139 (65.0)1028 (82.2)981 (79.5)978 (79.1)
History of ASCVD, n (%)204 (14.0)222 (15.2)214 (14.7)204 (100)222 (100)214 (100)
 History of CAD161 (11.1)172 (11.8)164 (11.3)161 (78.9)172 (77.5)164 (76.6)
 History of CeVD41 (2.8)49 (3.4)31 (2.1)41 (20.1)49 (22.1)31 (14.5)
 History of PAD15 (1.0)20 (1.4)35 (2.4)15 (7.4)20 (9.0)35 (16.4)
10-year risk of MACE, n (%)*
 High (≥20%)258 (17.7)289 (19.8)278 (19.2)258 (20.6)289 (23.4)278 (22.5)
 Intermediate (≥7.5–<20%)472 (32.4)490 (33.7)483 (33.3)472 (37.7)490 (39.7)483 (39.0)
 Borderline (≥5–<7.5%)198 (13.6)169 (11.6)153 (10.5)198 (15.8)169 (13.7)153 (12.4)
 Low (<5%)306 (21.0)268 (18.4)308 (21.2)306 (24.5)268 (21.7)308 (24.9)
Smoking status, n (%)
 Current smoker411 (28.2)402 (27.6)353 (24.3)54 (26.5)58 (26.1)56 (26.2)357 (28.5)344 (27.9)297 (24.0)
 Past smoker309 (21.2)302 (20.7)326 (22.5)71 (34.8)77 (34.7)78 (36.4)238 (19.0)225 (18.2)248 (20.0)
 Never smoked735 (50.5)752 (51.6)772 (53.2)79 (38.7)87 (39.2)80 (37.4)656 (52.4)665 (53.9)692 (55.9)
History of diabetes mellitus, n (%)243 (16.7)261 (17.9)255 (17.6)53 (26.0)51 (23.0)52 (24.3)190 (15.2)210 (17.0)203 (16.4)
History of hypertension, n (%)955 (65.6)954 (65.5)969 (66.8)156 (76.5)181 (81.5)168 (78.5)799 (63.9)773 (62.6)801 (64.8)
History of hyperlipidaemia, n (%)525 (36.1)518 (35.6)491 (33.8)120 (58.8)143 (64.4)117 (54.7)405 (32.4)375 (30.4)374 (30.2)
Family history of CHD, n (%)
 First-degree male relative <55 years154 (10.6)132 (9.1)151 (10.4)27 (13.2)29 (13.1)25 (11.7)127 (10.2)103 (8.3)126 (10.2)
 First-degree female relative <65 years115 (7.9)107 (7.3)100 (6.9)19 (9.3)23 (10.4)19 (8.9)96 (7.7)84 (6.8)81 (6.5)
Baseline corticosteroids, n (%)836 (57.5)829 (56.9)830 (57.2)106 (52.0)137 (61.7)116 (54.2)730 (58.4)692 (56.1)714 (57.7)
Baseline antiplatelets including aspirin, n (%)226 (15.5)244 (16.8)237 (16.3)110 (53.9)124 (55.9)107 (50.0)116 (9.3)120 (9.7)130 (10.5)
Baseline statins, n (%)349 (24.0)350 (24.0)321 (22.1)107 (52.5)127 (57.2)105 (49.1)242 (19.3)223 (18.1)216 (17.5)
Prior use of TNFi, n (%)115 (7.9)110 (7.6)105 (7.2)15 (7.4)15 (6.8)14 (6.5)100 (8.0)95 (7.7)91 (7.4)
  • 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.

  • *A 10-year risk of MACE was calculated with the ASCVD-PCE calculator and a 1.5 multiplier was applied for RA, as recommended by EULAR.2 15 In the tofacitinib 5 mg two-times-per-day, tofacitinib 10 mg two-times-per-day and TNFi groups, there were 17 patients (1.2%), 18 patients (1.2%) and 15 patients (1.0%) without a history of ASCVD who had missing ASCVD-PCE scores due to missing components.

  • †Based on day 1 of treatment with tofacitinib or TNFi in ORAL Surveillance.

  • ASCVD, atherosclerotic cardiovascular disease; ASCVD-PCE, atherosclerotic cardiovascular disease-Pooled Cohort Equations; CAD, coronary artery disease; CeVD, cerebrovascular disease; CHD, coronary heart disease; EULAR, European Alliance of Associations for Rheumatology; MACE, major adverse cardiovascular events; n, number of patients with characteristic; N, number of patients in the safety population; PAD, peripheral artery disease; RA, rheumatoid arthritis; SD, standard deviation; TNFi, tumour necrosis factor inhibitor.