| Literature DB >> 31887799 |
Minkyung Han1, Yoon Suk Jung2, Jae Hee Cheon3, Sohee Park4.
Abstract
PURPOSE: Data on the comparative effectiveness of infliximab (IFX) or adalimumab (ADA) in patients with ulcerative colitis (UC) are extremely limited, especially in the Asian population. We compared clinically important outcomes [colectomy, UC-related emergency room (ER) visits, UC-related hospitalizations, and need for corticosteroids] for these two biologics in biologic-naïve Korean patients with UC.Entities:
Keywords: Ulcerative colitis; adalimumab; infliximab
Mesh:
Substances:
Year: 2020 PMID: 31887799 PMCID: PMC6938779 DOI: 10.3349/ymj.2020.61.1.48
Source DB: PubMed Journal: Yonsei Med J ISSN: 0513-5796 Impact factor: 2.759
Fig. 1Flowchart of the identification of biologic-naïve patients with UC. UC, ulcerative colitis; IFX, infliximab; ADA, adalimumab.
Baseline Characteristics of the Study Population
| Characteristics | IFX users (n=630) | ADA users (n=232) | |
|---|---|---|---|
| Male sex | 399 (63.3) | 146 (62.9) | 0.977 |
| Age at diagnosis of UC (yr) | 37.6±16.1 | 39.1±16.3 | 0.229 |
| Age at first biologics use (yr) | 39.4±16.2 | 41.5±16.4 | 0.093 |
| Period from UC diagnosis to first biologics use (yr) | 1.8±1.5 | 2.4±1.6 | <0.001 |
| Period of biologics use (yr) | 1.7±1.5 | 1.2±0.9 | <0.001 |
| <6 months | 160 (25.4) | 65 (28.0) | 0.491 |
| ≥6 months | 470 (74.6) | 167 (72.0) | |
| Region at first biologics use | 0.030 | ||
| Seoul | 293 (46.5) | 88 (37.9) | |
| Outside Seoul | 337 (53.5) | 144 (62.1) | |
| Hospital scale at first biologics use | 0.102 | ||
| Tertiary hospital | 456 (72.4) | 154 (66.4) | |
| General hospital/community hospital/clinic | 174 (27.6) | 78 (33.6) | |
| Medication use at first biologics use | |||
| 5-ASA 411 (65.2) | 155 (66.8) | 0.726 | |
| Steroids | 323 (51.3) | 64 (27.6) | <0.001 |
| Immunomodulators | 285 (45.2) | 99 (42.7) | 0.552 |
| Concomitant immunomodulators (±30 days) | 0.219 | ||
| No | 230 (36.5) | 96 (41.4) | |
| Yes | 400 (63.5) | 136 (58.6 |
IFX, infliximab; ADA, adalimumab; UC, ulcerative colitis; 5-ASA, 5-aminosalicylic acid.
Data are presented as a number (%) or mean±standard deviation.
Fig. 2Survival free of (A) colectomy, (B) emergency room visit, (C) hospitalization, and (D) new corticosteroid use. IFX, infliximab; ADA, adalimumab.
Comparative Effectiveness of ADA vs. IFX in Biologics-Naïve Patients with UC
| Outcomes | ADA | IFX | ADA vs. IFX | |||
|---|---|---|---|---|---|---|
| Number of events | Incidence rate, per 100 py (95% CI) | Number of events | Incidence rate, per 100 py (95% CI) | Adjusted HR (95% CI)* | ||
| Overall biologics users | ||||||
| Colectomy | 2 | 0.6 (0.1–1.9) | 5 | 0.3 (0.1–0.7) | 1.87 (0.30–11.63) | 0.505 |
| UC-related ER visit | 13 | 4.1 (2.3–6.8) | 35 | 2.3 (1.6–3.1) | 1.58 (0.79–3.16) | 0.192 |
| UC-related hospitalization | 44 | 16.4 (12.0–21.8) | 189 | 17.1 (14.8–19.6) | 0.83 (0.59–1.17) | 0.283 |
| New steroid use (after 2 months) | 31 | 10.9 (7.5–15.2) | 94 | 7.0 (5.7–8.5) | 1.16 (0.76–1.78) | 0.498 |
| Biologics users for ≥6 months | ||||||
| Colectomy | 2 | 0.7 (0.1–2.2) | 2 | 0.2 (0.03–0.5) | 7.61 (0.85–67.92) | 0.069 |
| UC-related ER visit | 9 | 3.3 (1.6–5.9) | 24 | 2.0 (1.3–2.8) | 1.49 (0.66–3.37) | 0.338 |
| UC-related hospitalization | 36 | 15.8 (11.2–21.5) | 140 | 15.3 (12.9–17.9) | 0.89 (0.61–1.31) | 0.558 |
| New steroid use (after 2 months) | 26 | 10.7 (7.1–15.4) | 75 | 7.0 (5.5–8.7) | 1.18 (0.74–1.90) | 0.480 |
IFX, infliximab; ADA, adalimumab; py, person-years; CI, confidence interval; HR, hazard ratio; UC, ulcerative colitis; ER, emergency room.
*Adjusted for sex, age, region, and hospital scale at first biologics use; cumulative biologics use period; medication (5-aminosalicylic acid, immunomodulators, and steroids) use; and the period from UC diagnosis to first biologics use.
Comparative Effectiveness of ADA vs. IFX in Biologics-Naïve Patients with UC Stratified according to Use of TNF-α Inhibitor Monotherapy and Concomitant Immunomodulatory Therapy
| Outcomes | TNF-α inhibitor monotherapy (n=326) | TNF-α inhibitor+immunomodulatory therapy (n=536) | ||
|---|---|---|---|---|
| Adjusted HR (95% CI)* (ADA vs. IFX) | Adjusted HR (95% CI)* (ADA vs. IFX) | |||
| Overall biologics users | ||||
| Colectomy | -† | - | 3.06 (0.43–22.09) | 0.267 |
| UC-related ER visit | 1.33 (0.42–4.19) | 0.624 | 1.73 (0.73–4.13) | 0.215 |
| UC-related hospitalization | 0.65 (0.36–1.19) | 0.160 | 0.94 (0.62–1.43) | 0.771 |
| New steroid use (after 2 months) | 1.07 (0.54–2.10) | 0.848 | 1.23 (0.71–2.15) | 0.459 |
| Biologics users for ≥6 months | ||||
| Colectomy | -† | - | 8.00 (0.86–74.68) | 0.068 |
| UC-related ER visit | 0.64 (0.13–3.23) | 0.586 | 2.10 (0.79–5.58) | 0.138 |
| UC-related hospitalization | 0.60 (0.29–1.23) | 0.164 | 1.06 (0.68–1.67) | 0.794 |
| New steroid use (after 2 months) | 0.94 (0.42–2.12) | 0.888 | 1.39 (0.77–2.50) | 0.270 |
IFX, infliximab; ADA, adalimumab; TNF-α, tumor necrosis factor-α; HR, hazard ratio; CI, confidence interval; UC, ulcerative colitis; ER, emergency room.
*Adjusted for sex, age, region, and hospital scale at first biologics use; cumulative biologics use period; medication (5-aminosalicylic acid, immunomodulators, and steroids) use; and the period from UC diagnosis to first biologics use; †Results were not estimated because of patients who underwent TNF-α inhibitor monotherapy, only one in the overall biologics user group and none in the biologics user for ≥6 months group later underwent colectomy.