Table 2.
Baseline Characteristics of IBD Biological Drugs Users, Stratified by Indication for Use, as Reported in the First Electronic Therapeutic Plan
| Crohn’s Disease N=83 | Ulcerative Colitis N=51 | Other Indications for Use N=489 | Crohn’s Disease vs Other Indications for Use (Effect Size#) |
Ulcerative Colitis vs other Indications for Use (Effect Size#) |
|
|---|---|---|---|---|---|
| Sex – N (%) | |||||
| Male | 47 (56.6) | 28 (54.9) | 231 (47.2) | (0.066) | (0.045) |
| Female | 36 (43.4) | 23 (45.1) | 258 (52.8) | ||
| Age (years) – mean± SD | 36.4 (15.4) | 43.6 (15.8) | 49.5 (14.7) | (0.887) | (0.394) |
| Age categories – N (%) | |||||
| <45 | 61 (73.5) | 25 (49.0) | 158 (32.3) | (0.301) | (0.107) |
| 45–64 | 19 (22.9) | 21 (41.2) | 253 (51.7) | ||
| 65–79 | 3 (3.6) | 5 (9.8) | 72 (14.7) | ||
| ≥80 | 0 (0) | 0 (0) | 6 (1.3) | ||
| Follow-up period (months) – median (Q1–Q3) | 24.6 (11.6–27.1) | 22.9 (9.7–26.5) | 25.3 (20.2–27.0) | (0.060) | (0.128) |
| Index drug – N (%) | |||||
| Adalimumab | 56 (67.5) | 14 (27.4) | 343 (70.1) | (0.021) | (0.264) |
| Golimumab | 0 (0) | 12 (23.5) | 85 (17.4) | (0.172) | (0.047) |
| Infliximab | 20 (24.1) | 16 (31.4) | 32 (6.5) | (0.215) | (0.255) |
| Vedolizumab | 6 (7.2) | 9 (17.6) | 0 (0) | (0.250) | (0.403) |
| Ustekinumab | 1 (1.2) | 0 (0) | 0 (0) | (0.102) | (0) |
| Other | 0 (0) | 0 (0) | 29 (5.9) | (0.095) | (0.077) |
| Comorbidities – N (%)a | |||||
| Hypertension | 9 (10.8) | 9 (17.6) | 89 (18.2) | (0.069) | (0.004) |
| Diabetes mellitus | 3 (3.6) | 4 (7.8) | 64 (13.1) | (0.104) | (0.046) |
| Respiratory disease | 52 (62.6) | 37 (72.5) | 327 (66.9) | (0.031) | (0.035) |
| Renal failure | 0 (0) | 0 (0) | 1 (0.2) | (0.017) | (0.014) |
| Neoplasms | 27 (32.5) | 16 (31.4) | 109 (22.3) | (0.085) | (0.063) |
| Cerebrovascular disease | 2 (2.4) | 0 (0) | 24 (4.9) | (0.042) | (0.070) |
| Other autoimmune diseases | |||||
| Spondyloarthritis | 3 (3.6) | 0 (0) | 82 (16.8) | (0.130) | (0.137) |
| Psoriasis | 5 (6.0) | 5 (9.8) | 217 (44.4) | (0.277) | (0.206) |
| Psoriatic arthritis | 2 (2.4) | 1 (1.9) | 152 (31.1) | (0.228) | (0.189) |
| Rheumatoid arthritis | 2 (2.4) | 2 (3.9) | 193 (39.5) | (0.275) | (0.216) |
| Previous use of conventional drugs – N (%)a | |||||
| Aminosalicylic acid and similar agents | 80 (96.4) | 51 (100.00) | 150 (30.7) | (0.472) | (0.419) |
| Immunosuppressants | 50 (60.2) | 30 (58.8) | 366 (74.8) | (0.116) | (0.106) |
| Glucocorticoids | 64 (77.1) | 50 (98.0) | 348 (71.2) | (0.047) | (0.179) |
| Corticosteroids acting locally | 56 (67.4) | 47 (92.1) | 36 (7.4) | (0.576) | (0.688) |
| Concomitant drugs – N (%)b | |||||
| Antithrombotic agents | 11 (13.2) | 3 (5.8) | 78 (15.9) | (0.026) | (0.083) |
| Platelet aggregation inhibitors excl. heparin | 3 (3.6) | 2 (3.9) | 57 (11.6) | (0.092) | (0.073) |
| Antiarrhythmics | 4 (4.8) | 5 (9.8) | 112 (22.9) | (0.158) | (0.093) |
| Antibacterials for systemic use | 65 (78.3) | 37 (72.5) | 335 (68.5) | (0.075) | (0.026) |
| Drugs for peptic ulcer and gastro-esophageal reflux disease (GORD) | 34 (40.9) | 35 (68.6) | 294 (60.1) | (0.136) | (0.051) |
| Antivirals for systemic use | 0 (0) | 2 (3.9) | 16 (3.3) | (0.070) | (0.011) |
| NSAIDs | 5 (6.0) | 11 (21.6) | 269 (55.0) | (0.345) | (0.196) |
| Statins | 3 (3.6) | 3 (5.9) | 71 (14.5) | (0.114) | (0.074) |
Notes: aEvaluated any time prior to index date (ID), defined as the first date of the biologic dispensing. bEvaluated within one year prior to ID. #Effect sizes are reported as Cramér’s V for categorical variables and standardized mean difference or “standardized Z-score” from the Mann–Whitney U-test for continuous variables as appropriate. SD, standard deviation; Q1–Q3: first–third quartiles; Antithrombotic agents: vitamin K antagonists, heparin group, direct thrombin inhibitors, direct factor Xa inhibitors, other antithrombotic agents; Aminosalicylic acid and similar agents: sulfasalazine, mesalazine, olsalazine, balsalazide; Corticosteroids acting locally: budesonide; Glucocorticoids: prednisone, hydrocortisone, methylprednisolone; Immunosuppressants: azathioprine, mercaptopurine, methotrexate, cyclosporine.