Table 1

Patient demographics and baseline disease characteristics in ORAL Surveillance (safety analysis set)

Combined tofacitinib doses*
(N=2911)
Tofacitinib 5 mg two times per day
(N=1455)
Tofacitinib 10 mg two times per day
(N=1456)
TNFi
(N=1451)
OverallNorth America
(N=811)
ROW
(N=2100)
OverallNorth America
(N=402)
ROW
(N=1053)
OverallNorth America
(N=409)
ROW
(N=1047)
OverallNorth America
(N=432)
ROW
(N=1019)
Female sex, n (%)2293 (78.8)605 (74.6)1688 (80.4)1169 (80.3)305 (75.9)864 (82.1)1124 (77.2)300 (73.3)824 (78.7)1117 (77.0)303 (70.1)814 (79.9)
Age (years), mean (SD)61.1 (6.9)62.5 (7.3)60.5 (6.7)60.8 (6.8)62.1 (7.2)60.2 (60.6)61.4 (7.1)62.8 (7.4)60.9 (60.9)61.3 (7.5)63.3 (8.1)60.5 (7.0)
 ≥65 years, n (%)891 (30.6)316 (39.0)575 (27.4)413 (28.4)145 (36.1)268 (25.5)478 (32.8)171 (41.8)307 (29.3)462 (31.8)182 (42.1)280 (27.5)
Ethnicity, n (%)
 White2254 (77.4)690 (85.1)1564 (74.5)1128 (77.5)338 (84.1)790 (75.0)1126 (77.3)352 (86.1)774 (73.9)1099 (75.7)363 (84.0)736 (72.2)
 Black128 (4.4)88 (10.9)40 (1.9)63 (4.3)46 (11.4)17 (1.6)65 (4.5)42 (10.3)23 (2.2)83 (5.7)61 (14.1)22 (2.2)
 Asian121 (4.2)12 (1.5)109 (5.2)65 (4.5)4 (1.0)61 (5.8)56 (3.8)8 (2.0)48 (4.6)55 (3.8)3 (0.7)52 (5.1)
 Other408 (14.0)21 (2.6)387 (18.4)199 (13.7)14 (3.5)185 (17.6)209 (14.4)7 (1.7)202 (19.3)214 (14.7)5 (1.2)209 (20.5)
Duration of RA (years), n (%)
 <1241 (8.3)87 (10.7)154 (7.3)110 (7.6)34 (8.5)76 (7.2)131 (9.0)53 (13.0)78 (7.4)100 (6.9)39 (9.0)61 (6.0)
 ≥1–<5786 (27.0)207 (25.5)579 (27.6)378 (26.0)115 (28.6)263 (25.0)408 (28.0)92 (22.5)316 (30.2)394 (27.2)119 (27.5)275 (27.0)
 ≥5–<10659 (22.6)156 (19.2)503 (24.0)351 (24.1)78 (19.4)273 (25.9)308 (21.2)78 (19.1)230 (22.0)336 (23.2)104 (24.1)232 (22.8)
 ≥101225 (42.1)361 (44.5)864 (41.1)616 (42.3)175 (43.5)441 (41.9)609 (41.8)186 (45.5)423 (40.4)621 (42.8)170 (39.4)451 (44.3)
Smoking status, n (%)
 Current smoker813 (27.9)227 (28.0)586 (27.9)411 (28.2)106 (26.4)305 (29.0)402 (27.6)121 (29.6)281 (26.8)353 (24.3)95 (22.0)258 (25.3)
 Past smoker611 (21.0)234 (28.9)377 (18.0)720 (49.5)117 (29.1)192 (18.2)704 (48.4)117 (28.6)185 (17.7)679 (46.8)150 (34.7)176 (17.3)
 Never smoker1487 (51.1)350 (43.2)1137 (54.1)735 (50.5)179 (44.5)556 (52.8)752 (51.6)171 (41.8)581 (55.5)772 (53.2)187 (43.3)585 (57.4)
Baseline use of COX-1 inhibitors, n (%)1364 (46.9)295 (36.4)1069 (50.9)677 (46.5)148 (36.8)529 (50.2)687 (47.2)147 (35.9)540 (51.6)664 (45.8)147 (34.0)517 (50.7)
Baseline use of COX-2 inhibitors, n (%)232 (8.0)27 (3.3)205 (9.8)116 (8.0)12 (3.0)104 (9.9)116 (8.0)15 (3.7)101 (9.6)122 (8.4)19 (4.4)103 (10.1)
Prior bDMARD treatment, n (%)302 (10.4)89 (11.0)213 (10.1)164 (11.3)49 (12.2)115 (10.9)138 (9.5)40 (9.8)98 (9.4)150 (10.3)45 (10.4)105 (10.3)
Concomitant corticosteroid use†, n (%)1665 (57.2)381 (47.0)1284 (61.1)836 (57.5)188 (46.8)648 (61.5)829 (56.9)193 (47.2)636 (60.7)830 (57.2)207 (47.9)623 (61.1)
  • Patients assigned to receive tofacitinib at a dose of 10 mg two times per day who had their dose reduced to 5 mg two times per day or who discontinued the trial drug were counted in the group receiving 10 mg two times per day. Full baseline demographics and characteristics have been reported previously.12

  • *Includes patients who received tofacitinib 5 or 10 mg two times per day in ORAL Surveillance.

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

  • bDMARD, biologic disease-modifying antirheumatic drug; n, number of patients meeting baseline criteria; N, number of patients in each treatment group in the safety population; RA, rheumatoid arthritis; ROW, rest of the world; TNFi, tumour necrosis factor inhibitors.