S966 Persistence Among Patients with Ulcerative Colitis Previously Treated with an Anti-Tumor Necrosis Factor Inhibitor and Switching or Cycling to Another Biologic Agent
Bibliographic record
Abstract
Introduction: In ulcerative colitis (UC), anti-TNF agents often are first-line biologic therapy. Switching to a different class of biologics (ustekinumab, vedolizumab) or cycling to another anti-TNF agent (adalimumab, infliximab, golimumab) is necessary if an initial anti-TNF fails. Real-world persistence in patients with UC who switch or cycle from an anti-TNF agent was compared. Methods: Adults with UC treated with an anti-TNF, who switched or cycled (index date) between 10/21/2019 and 03/02/2022, were selected from the IQVIA PharMetrics® Plus database. Patients had ≥12 months of continuous insurance eligibility before the first anti-TNF without UC-indicated biologics or advanced therapies. During the 12-months before the index date (baseline period), patients had no other immune disorders and discontinued the first anti-TNF. Baseline characteristics were balanced using inverse probability of treatment weights. Persistence on index biologic was defined as no therapy exposure gaps >120 days (ustekinumab, vedolizumab, infliximab) or >60 days (adalimumab, golimumab) between days of supply. Composite endpoints were persistence and being corticosteroid-free (< 14 consecutive days of corticosteroids supply after day 90 post-index), and persistence while on monotherapy (no immunomodulators/non-index biologics/advanced therapies). Endpoints were assessed with weighted Kaplan-Meier and Cox proportional hazards models at 12 months after maintenance phase start. Results: The switch and cycle cohorts included 488 and 129 patients, respectively; baseline characteristics were well balanced (Table 1). At 12 months after maintenance phase start, proportions of persistent patients and patients persistent on monotherapy were significantly higher in the switch vs the cycle cohort (Figure 1). In the switch cohort, the rate of persistence was 53% higher (hazard ratio [HR]: 1.53; 95% confidence interval [CI]: 1.10-2.12), the rate of persistence and being corticosteroid-free 23% higher (HR: 1.23; 95% CI: 0.93-1.63), and the rate of persistence while on-monotherapy was 2 times higher (HR: 2.18; 95% CI: 1.64-2.92) than in the cycle cohort. Conclusion: Patients with UC who switched from an anti-TNF agent to a different class of biologic were more persistent than patients who cycled to another anti-TNF agent. Findings may aid physicians whose patients experience treatment failure on the first anti-TNF agent. Funded by Janssen Scientific Affairs, LLC.Figure 1.: Kaplan-Meier curves in weighted* switch and cycle cohorts of being: a) persistent to index biologic, b) persistent and corticosteroid-free, c) persistent while on monotherapy. *Cohorts were weighted on baseline characteristics using inverse probability of treatment weights. Table 1. - Selected baseline characteristics in weighted switch and cycle cohorts** Mean ± SD [median] or n (%) SwitchN=488 CycleN=129 Std diff (%) Age (years) 41.4 ± 13.9 [40.8] 40.7 ± 12.6 [40.2] 5.4 Female 219 (44.9) 57 (43.8) 2.1 Any intestinal complication 71 (14.5) 22 (17.3) 7.8 Selected general comorbid condition Diarrhea 269 (55.2) 73 (56.8) 3.2 Pain 219 (44.8) 60 (46.2) 2.8 Anemia 164 (33.6) 40 (31.2) 5.2 UC-related medication Baseline anti-TNF Adalimumab 295 (60.5) 73 (56.9) 7.5 Infliximab and biosimilars 188 (38.6) 56 (43.1) 9.2 Golimumab 4 (0.8) 0 (0.0) 12.9* Corticosteroids 387 (79.4) 98 (75.8) 8.7 5-ASA 324 (66.3) 80 (62.2) 8.5 Immunomodulators 84 (17.2) 21 (16.4) 2.1 Antidiarrheals 28 (5.8) 6 (4.4) 6.4 Concomitant medication Opioids 166 (34.1) 43 (33.2) 1.9 Antibiotics 139 (28.6) 38 (29.2) 1.5 All-cause costs (US$ 2022) 62,103 ± 46,224 [54,686] 60,596 ± 35,758 [57,779] 3.7 Prescription drug costs 37,478 ± 35,277 [35,119] 37,298 ± 34,639 [29,749] 0.5 Medical costs 24,626 ± 40,172 [13,650] 23,298 ± 27,065 [13,113] 3.9 **Cohorts were weighted on baseline characteristics using inverse probability of treatment weights; characteristics considered well balanced if standardized difference is <10%. SD: standard deviation; Std diff: standardized difference; TNF: tumor necrosis factor; UC: ulcerative colitis; 5-ASA: 5-aminosalicylic acid *denotes standardized difference ≥10%.
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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 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 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".