S801 Long-Term Persistence to Ustekinumab and Adalimumab Among Bio-Naïve Patients With Crohn's Disease
Bibliographic record
Abstract
Introduction: Persistence on biologics in Crohn’s disease (CD) is an important measure, reflecting real-world treatment effectiveness, safety, and other factors. In the real world among bio-naïve patients with CD, evidence of superior one-year persistence on newer biologics, such as ustekinumab, relative to adalimumab exists, however, an understanding of persistence beyond one year is lacking. Methods: Adults with CD initiated on ustekinumab or adalimumab between 09/23/2016 (approval of ustekinumab for CD in the US) and 08/01/2019 were selected from IBM® MarketScan® Commercial Database. Patients without other CD-indicated biologics (bio-naive) and diagnoses for other autoimmune diseases in the 12 months pre-index date (baseline) were included. No minimal follow-up was imposed post-index date. Persistence on index agent was defined as absence of gaps >120 days (ustekinumab) or >60 days (adalimumab) between days of therapy supply. Composite endpoints of being persistent and corticosteroid-free (no corticosteroids with ≥14 days of supply after day 90 post-index) and persistent while on monotherapy (no immunomodulators or non-index biologics) were also assessed. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. All endpoints were estimated at 24 months post-index using weighted Kaplan-Meier and Cox's proportional hazards models. Results: There were 671 and 2,975 patients in the ustekinumab and adalimumab cohorts, respectively, and the cohorts were well-balanced at baseline (Table). At 24 months post-index, a significantly higher proportion of patients in the ustekinumab versus adalimumab cohort was persistent on index agent, as well as persistent and corticosteroid-free and persistent while on-monotherapy (Figure). At 24 months in ustekinumab versus adalimumab cohort, the rate of being persistent on index agent was 66% higher (hazard ratio [HR]: 1.66; 95% confidence interval [CI]: 1.40-1.97), the rate of being persistent and corticosteroid-free 15% higher (HR: 1.15; 95% CI: 1.01-1.31), and the rate of being persistent while on-monotherapy 44% higher (HR: 1.44; 95% CI: 1.26-1.64). Conclusion: Bio-naïve patients with CD initiated on ustekinumab versus adalimumab were significantly more persistent, more persistent and corticosteroid-free, and also more persistent while on-monotherapy 24 months after treatment initiation. These results are consistent with those in our previous work at 12 months.Figure 1.: Kaplan-Meier curves of being: a) persistent on index biologic, b) persistent and corticosteroid-free following a 90 days grace period, c) persistent and on monotherapy in weighted ustekinumab and adalimumab cohorts1,2 Notes: 1. Cohorts were weighted on baseline characteristics using inverse probability of treatment weights 2. Rates and log-rank p-values provided at 24 months. Table 1. - Selected baseline characteristics in weighted1 ustekinumab and adalimumab cohorts Mean ± SD or n (%) UstekinumabN=671 AdalimumabN=2,975 Std diff, % Age 41.7 ± 13.3 41.6 ± 13.8 0.8 Female 371 (55.3%) 1,642 (55.2%) 0.2 All-cause costs (US$ 2020) 35,258 ± 57,472 30,104 ± 52,884 9.3 Prescription drug costs 5,095 ± 11,691 5,029 ± 18,564 0.4 Total medical costs 30,163 ± 55,485 25,075 ± 47,187 9.9 Charlson Comorbidity Index 0.60 ± 1.2 0.61 ± 1.1 0.8 CD-related surgery 57 (8.5%) 221 (7.4%) 4.0 Medication Corticosteroids 440 (65.6%) 2,068 (69.5%) 8.4 ≥1 episode with ≥60 days of continuous use 164 (24.4%) 736 (24.8%) 0.7 Immunomodulators 177 (26.4%) 797 (26.8%) 1.0 5-ASA 177 (26.4%) 795 (26.7%) 0.8 Antidiarrheals 51 (7.6%) 204 (6.9%) 2.8 Abbreviations: CD: Crohn’s disease; Std diff: standardized difference; SD: standard deviation; 5-ASA: 5-aminosalicylic acid Notes: (1) Cohorts were weighted on baseline characteristics using inverse probability of treatment weights; characteristics considered well balanced if standardized difference is <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 | 0.000 |
| 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) | 0.003 | 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".