Table 3.
Characteristics of patients reporting fatigue as an ADR compared with patients with other ADRs and patients without ADRs
| Patients with fatigue | Patients with other ADRs | p-value | Patients without ADRs | p-value | |
|---|---|---|---|---|---|
| No. of patients | 108 (100) | 622 (100) | 652 (100) | ||
| Age, years (median [IQR]) | 52 [39–63] | 56 [45–64] | 0.02 | 58 [48–67] | < 0.001 |
| Female sex | 66 (61) | 407 (65) | 0.39 | 331 (51) | 0.05 |
| Smoking | 27 (25) | 99 (16) | 0.03 | 98 (15) | 0.02 |
| BMI, kg/m2 (median [IQR]) | 25.4 [22.7–27.5] | 25.1 [22.5–28.4] | 0.83 | 25.8 [23.2–29.0] | 0.11 |
| Biologic | |||||
| Adalimumab | 30 (28) | 225 (36) | 0.10 | 238 (37) | 0.08 |
| Infliximab | 24 (22) | 54 (9) | < 0.001 | 82 (13) | 0.01 |
| Etanercept | 13 (12) | 180 (29) | < 0.001 | 220 (34) | < 0.001 |
| Rituximab | 10 (9) | 19 (3) | 0.01 | 5 (1) | < 0.001 |
| Tocilizumab | 8 (7) | 30 (5) | 0.25 | 12 (2) | 0.004 |
| Ustekinumab | 6 (6) | 25 (4) | 0.44 | 33 (5) | 0.81 |
| Vedolizumab | 6 (6) | 12 (2) | 0.04 | 7 (1) | 0.01 |
| Other | 13 (12) | 116 (19) | 0.10 | 78 (12) | 1.00 |
| Indication | |||||
| Rheumatoid arthritis | 32 (30) | 277 (45) | 0.004 | 279 (43) | 0.01 |
| Psoriatic arthritis | 15 (14) | 95 (15) | 0.77 | 132 (20) | 0.15 |
| Axial spondyloarthritis | 11 (10) | 83 (13) | 0.44 | 78 (12) | 0.75 |
| Crohn’s disease | 30 (28) | 78 (13) | < 0.001 | 86 (13) | < 0.001 |
| Ulcerative colitis | 5 (5) | 30 (5) | 1.00 | 25 (4) | 0.60 |
| Psoriasis | 6 (6) | 27 (4) | 0.61 | 50 (8) | 0.55 |
| Other indication | 17 (16) | 64 (10) | 0.06 | 37 (6) | 0.001 |
| Combination therapya | |||||
| Methotrexate | 24 (22) | 173 (28) | 0.24 | 221 (34) | 0.02 |
| Corticosteroidsb | 21 (19) | 111 (18) | 0.69 | 93 (14) | 0.19 |
| Thiopurinesc | 12 (11) | 45 (7) | 0.17 | 58 (9) | 0.47 |
| Aminosalicylatesd | 9 (8) | 51 (8) | 1.00 | 39 (6) | 0.39 |
| Hydroxychloroquine | 5 (5) | 33 (5) | 1.00 | 36 (6) | 0.82 |
| Leflunomide | 2 (2) | 42 (7) | 0.05 | 23 (4) | 0.56 |
| No combination therapy | 45 (42) | 264 (42) | 0.92 | 240 (37) | 0.34 |
| Comorbidity | |||||
| Cardiovascular disorder | 23 (21) | 155 (25) | 0.47 | 162 (25) | 0.47 |
| Hypercholesterolaemia | 15 (14) | 93 (15) | 0.88 | 117 (18) | 0.34 |
| Respiratory disorder | 14 (13) | 77 (12) | 0.88 | 75 (12) | 0.63 |
| Psychiatric disorder | 11 (10) | 49 (8) | 0.45 | 31 (5) | 0.04 |
| Nervous system disorder | 3 (3) | 19 (3) | 1.00 | 19 (3) | 1.00 |
| Cancer | 2 (2) | 15 (2) | 1.00 | 14 (2) | 1.00 |
| Other comorbidity | 33 (31) | 126 (20) | 0.02 | 99 (15) | < 0.001 |
| No comorbidity | 30 (28) | 213 (34) | 0.22 | 230 (35) | 0.15 |
| Mean burden score ± SD | 2.8 ± 0.9 | 2.4 ± 1.0 | < 0.001 | ||
Data are expressed as n (%) unless otherwise specified
ADR adverse drug reaction, BMI body mass index, IQR interquartile range, SD standard deviation
aCombination therapy at the time of reporting the ADR for the first time. For the patients without ADRs, the reported combination therapy at any time during participation was included
bCorticosteroids include predniso(lo)ne, methylprednisolone, hydrocortisone
cThiopurines include azathioprine, thioguanine, mercaptopurine
dAminosalicylates include mesalamine, sulfasalazine