Table 1.
Patient demographics and clinical characteristics at the time of initiation of tofacitinib or a bDMARD in the overall (unmatched) population for the analysis of MACE, SIEs, and HZ and in the PS‐trimmed population for the analysis of MACE
| Unmatched Population (MACE, SIEs, and HZ) | PS‐Trimmed Population (MACE) | |||||
|---|---|---|---|---|---|---|
| Tofacitinib Initiators (n = 1999) | bDMARD Initiators (n = 8358) | STD a | Tofacitinib Initiators (n = 1866) | bDMARD Initiators (n = 7767) | STD | |
| Age, mean (SD), yr | 59.6 (12.1) | 58.5 (13.0) | 0.088 | 59.6 (12.0) | 58.5 (12.9) | 0.082 |
| Sex, female, n (%) | 1610 (80.5) | 6716 (80.4) | 0.005 | 1505 (80.7) | 6223 (80.1) | 0.013 |
| Race, White, n (%) | 1700 (85.8) | 6896 (82.9) | 0.079 | 1588 (85.9) | 6441 (83.4) | 0.071 |
| Current smoker, n (%) | 307 (19.6) | 1268 (18.1) | 0.037 | 289 (19.7) | 1200 (18.4) | 0.035 |
| BMI, mean (SD), kg/m2 | 30.5 (7.6) | 30.4 (7.5) | 0.010 | 30.5 (7.6) | 30.4 (7.5) | 0.011 |
| Work status, n (%) | ||||||
| Full time | 606 (31.1) | 3001 (36.7) | –0.119 | 581 (31.1) | 2867 (36.9) | –0.122 |
| Disabled | 436 (22.4) | 1274 (15.6) | 0.173 | 419 (22.5) | 1188 (15.3) | 0.184 |
| Marital status, n (%) | ||||||
| Single | 179 (9.1) | 1008 (12.3) | –0.103 | 167 (9.0) | 937 (12.1) | –0.102 |
| Married | 1339 (68.0) | 5398 (65.7) | 0.051 | 1277 (68.4) | 5133 (66.1) | 0.050 |
| Divorced | 216 (11.0) | 948 (11.5) | –0.018 | 201 (10.8) | 897 (11.6) | –0.025 |
| Duration of disease, mean (SD), yr b | 13.8 (10.3) | 10.6 (10.0) | 0.316 | 14.0 (10.4) | 10.6 (10.0) | 0.332 |
| History of comorbidities, n (%) | ||||||
| Hypertension | 709 (35.5) | 2696 (32.3) | 0.068 | 658 (35.3) | 2514 (32.4) | 0.061 |
| Hyperlipidemia | 269 (13.5) | 1093 (13.1) | 0.011 | 254 (13.6) | 1020 (13.1) | 0.014 |
| Coronary heart disease | 154 (7.7) | 480 (5.7) | 0.078 | 145 (7.8) | 454 (5.9) | 0.076 |
| Stroke | 68 (3.4) | 246 (2.9) | 0.026 | 65 (3.5) | 233 (3.0) | 0.027 |
| VTE | 62 (3.1) | 199 (2.4) | 0.044 | 61 (3.3) | 192 (2.5) | 0.048 |
| Diabetes | 231 (11.6) | 864 (10.3) | 0.039 | 206 (11.0) | 806 (10.4) | 0.021 |
| Malignancy (excluding NMSC) | 157 (7.9) | 569 (6.8) | 0.040 | 148 (7.9) | 534 (6.9) | 0.040 |
| Serious infection | 277 (13.9) | 808 (9.7) | 0.130 | 262 (14.0) | 754 (9.7) | 0.134 |
| Prior DMARDs, n (%) | ||||||
| csDMARD‐naïve/bDMARD‐naïve | 11 (0.6) | 154 (1.9) | –0.121 | 10 (0.5) | 138 (1.8) | –0.116 |
| ≥1 prior csDMARD/bDMARD‐naïve | 212 (10.8) | 2289 (28.1) | –0.447 | 200 (10.7) | 2181 (28.1) | –0.450 |
| ≥1 prior csDMARD/1 prior bDMARD | 371 (18.9) | 2468 (30.1) | –0.266 | 351 (18.8) | 2349 (30.2) | –0.268 |
| ≥1 prior csDMARD/>1 prior bDMARD | 1365 (69.7) | 3232 (39.7) | 0.632 | 1305 (69.9) | 3099 (39.9) | 0.633 |
| Prior bDMARD use, n (%) | ||||||
| Naïve | 223 (11.2) | 2443 (29.2) | –0.462 | 210 (11.3) | 2319 (29.9) | –0.473 |
| 1 previous | 388 (19.4) | 2590 (31.0) | –0.269 | 351 (18.8) | 2349 (30.2) | –0.268 |
| 2 previous | 455 (22.8) | 1687 (20.2) | 0.063 | 414 (22.2) | 1553 (20.0) | 0.054 |
| 3 or more | 933 (46.7) | 1638 (19.6) | 0.600 | 891 (47.8) | 1546 (19.9) | 0.616 |
| Prior csDMARD use, n (%) | ||||||
| Naïve | 51 (2.6) | 369 (4.4) | –0.102 | 10 (0.5) | 138 (1.8) | –0.116 |
| 1 previous | 579 (29.0) | 3312 (39.6) | –0.226 | 545 (29.2) | 3116 (40.1) | –0.231 |
| 2 or more | 1369 (68.5) | 4677 (56.0) | 0.260 | 1311 (70.3) | 4513 (58.1) | 0.255 |
| Prednisone use, n (%) | ||||||
| Naïve | 1367 (68.4) | 5794 (69.3) | –0.020 | 1281 (68.7) | 5395 (69.5) | –0.018 |
| <10 mg | 411 (20.6) | 1612 (19.3) | 0.032 | 384 (20.6) | 1505 (19.4) | 0.030 |
| ≥10 mg | 191 (9.6) | 856 (10.2) | –0.023 | 172 (9.2) | 778 (10.0) | –0.027 |
| Concomitant medication, n (%) | ||||||
| Methotrexate alone | 576 (28.8) | 3444 (41.2) | –0.262 | 553 (29.6) | 3253 (41.9) | –0.258 |
| Methotrexate and other csDMARD | 145 (7.3) | 919 (11.0) | –0.130 | 140 (7.5) | 877 (11.3) | –0.130 |
| csDMARD (excluding methotrexate) | 413 (20.7) | 1606 (19.2) | 0.036 | 388 (20.8) | 1525 (19.6) | 0.029 |
| Any NSAID use, n (%) | 848 (42.4) | 3764 (45.0) | –0.053 | 801 (42.9) | 3560 (45.8) | –0.059 |
| Statin use, n (%) | 445 (22.3) | 1827 (21.9) | 0.010 | 422 (22.6) | 1733 (22.3) | 0.007 |
| Swollen joint count (0‐28), mean (SD) | 4.7 (5.0) | 5.1 (5.4) | –0.092 | 4.6 (5.0) | 5.1 (5.4) | –0.098 |
| Tender joint count (0‐28), mean (SD) | 6.8 (7.1) | 7.2 (7.3) | –0.050 | 6.8 (7.1) | 7.2 (7.3) | –0.054 |
| Patient pain (0‐100), mean (SD) | 50.8 (28.7) | 49.7 (28.4) | 0.040 | 50.8 (28.6) | 49.5 (28.3) | 0.048 |
| PtGA (0‐100), mean (SD) | 47.9 (26.9) | 47.1 (26.8) | 0.030 | 47.9 (26.9) | 46.9 (26.7) | 0.036 |
| PGA (0‐100), mean (SD) | 32.6 (21.9) | 34.8 (23.1) | –0.095 | 32.6 (21.8) | 34.7 (23.0) | –0.092 |
| Patient fatigue (0‐100), mean (SD) | 52.1 (30.0) | 50.2 (29.4) | 0.065 | 52.1 (30.1) | 50.1 (29.4) | 0.069 |
| CDAI, mean (SD) | 19.5 (13.3) | 20.5 (14.1) | –0.072 | 19.5 (13.2) | 20.5 (14.1) | –0.074 |
| CDAI categorized, n (%) | ||||||
| Remission | 98 (6.2) | 487 (6.9) | –0.028 | 91 (6.2) | 461 (7.0) | –0.033 |
| LDA | 343 (21.8) | 1387 (19.7) | 0.052 | 325 (22.1) | 1289 (19.6) | 0.062 |
| Moderate | 561 (35.7) | 2384 (33.9) | 0.038 | 523 (35.6) | 2234 (34.0) | 0.033 |
| High | 569 (36.2) | 2775 (39.5) | –0.067 | 530 (36.1) | 2585 (39.4) | –0.068 |
| HAQ, mean (SD) | 1.1 (0.7) | 1.0 (0.7) | 0.096 | 1.1 (0.7) | 1.0 (0.7) | 0.102 |
| EQ‐5D (0‐1), mean (SD) | 0.7 (0.2) | 0.7 (0.2) | –0.070 | 0.7 (0.2) | 0.7 (0.2) | –0.08 |
bDMARD, biological disease‐modifying antirheumatic drug; BID, twice daily; BMI, body mass index; CDAI, Clinical Disease Activity Index; csDMARD, conventional synthetic disease‐modifying antirheumatic drug; DMARD, disease‐modifying antirheumatic drug; EQ‐5D, EuroQol Five‐Dimensions Health Questionnaire; HAQ, Health Assessment Questionnaire; HZ, herpes zoster; LDA, low disease activity; MACE, major adverse cardiovascular events; NMSC, nonmelanoma skin cancer; NSAID, nonsteroidal anti‐inflammatory drug; PGA, Physician’s Global Assessment; PS, propensity score; PtGA, Patient’s Global Assessment; RA, rheumatoid arthritis; SIE, serious infection event; STD, standardized difference; VTE, venous thromboembolic event.
Tofacitinib initiators primarily received tofacitinib 5 mg BID; N is the total number of patients; the number of patients evaluated for each category may be fewer than N.
Covariates in the unmatched population with STDs >|0.10| in absolute value (bold font) were included in the construction of a PS model in order to derive PS‐trimmed populations.
Duration of disease represents time after initial diagnosis of RA until initiation of the new treatment.