S965 Real-World Treatment Persistence Among Bio-Naïve Patients With Ulcerative Colitis Initiated on Ustekinumab or Adalimumab
Bibliographic record
Abstract
Introduction: Therapy persistence is a useful measure of real-world therapy performance, including effectiveness and safety. Biologics are used for management of moderate-to-severe ulcerative colitis (UC). This study aimed to compare treatment persistence among bio-naïve patients with UC initiated on ustekinumab or adalimumab. Methods: Adults with UC initiated on ustekinumab or adalimumab (index date) between 10/21/2019 and 03/02/2022 were selected from the IQVIA PharMetrics® Plus database. Patients were excluded if, during the 12-month baseline period before the index date, they used other UC-indicated biologics/advanced therapies or had other immune conditions. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Persistence was defined as absence of gaps >120 days (ustekinumab) or >60 days (adalimumab) between days of therapy supply. Additionally, composite endpoints of being persistent and corticosteroid-free (< 14 consecutive days of corticosteroid supply after day 90 post-index) and persistent and on monotherapy (no immunomodulators, non-index biologics, or advanced therapies) were assessed. All endpoints were estimated during maintenance phase until earlier of 12 months follow-up, end of insurance eligibility or end of data using weighted Kaplan-Meier and Cox proportional hazards models. Results: There were 371 and 1,726 patients in the ustekinumab and adalimumab cohorts, respectively. Baseline characteristics were balanced in weighted cohorts (Table 1). At 12 months of maintenance phase, a higher proportion of patients initiated on ustekinumab compared to adalimumab were persistent on index biologic, including persistent and corticosteroid-free, and persistent and on monotherapy (Figure 1; log-rank P-values< 0.001). Patients initiated on ustekinumab had a 77% higher rate of persistence (hazard ratio [HR] 1.77; 95% confidence interval [CI]: 1.44-2.18), 58% higher rate of persistence while being corticosteroid-free (HR: 1.58; 95% CI: 1.33-1.88), and 80% higher rate of persistence while on monotherapy (HR: 1.80; 95% CI: 1.48-2.18) than those initiated on adalimumab. Conclusion: Bio-naïve patients with UC treated with ustekinumab were more persistent, including persistent while corticosteroid-free and persistent while on monotherapy, than patients treated with adalimumab. These findings may aid healthcare providers in choosing a biologic for bio-naïve patients with UC. Funded by Janssen Scientific Affairs, LLC.Figure 1.: Kaplan-Meier curves of being: a) persistent on index biologic, b) persistent and corticosteroid-free, c) persistent and on monotherapy in weighted* ustekinumab and adalimumab cohorts. *Cohorts were weighted on baseline characteristics using inverse probability of treatment weights. Table 1. - Selected baseline characteristics in weighted ustekinumab and adalimumab cohorts* Mean ± SD [median] or n (%) UstekinumabN=371 AdalimumabN=1,726 Std diff (%) Age (years) 42.0 ± 13.5 [42.1] 42.2 ± 13.9 [41.5] 0.8 Female 178 (48.1) 823 (47.7) 0.8 Any intestinal complication 59 (15.9) 239 (13.8) 5.8 Selected general comorbid condition Diarrhea 182 (49.1) 883 (51.2) 4.1 Pain 166 (44.8) 765 (44.3) 1.0 Anemia 103 (27.7) 451 (26.1) 3.5 UC-related medication Corticosteroids 283 (76.4) 1,343 (77.8) 3.5 5-ASA 284 (76.5) 1,320 (76.5) 0.1 Immunomodulators 45 (12.2) 226 (13.1) 2.9 Antidiarrheals 17 (4.7) 73 (4.2) 2.2 Concomitant medication Opioids 115 (31.0) 559 (32.4) 2.9 Antibiotics 97 (26.0) 489 (28.3) 5.2 All-cause costs (US$ 2022) 18,702 ± 35,981 [10,942] 16,889 ± 27,018 [10,420] 5.7 Pharmacy costs 5,912 ± 16,753 [3,126] 5,216 ± 9,011 [3,366] 5.2 Medical costs 12,790 ± 30,399 [5,629] 11,672 ± 25,146 [5,009] 4.0 *Cohorts were weighted on baseline characteristics using inverse probability of treatment weights; characteristics considered well balanced if standardized difference is <10%. 5-ASA: 5-aminosalicylic acid; SD: standard deviation; Std diff: standardized difference; UC: ulcerative colitis; US: United States.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".