S967 Real-World Prevalence of Potential Drug-Drug Interactions Associated With Oral Advanced Therapies Indicated for Ulcerative Colitis
Bibliographic record
Abstract
Introduction: Presence of comorbidities and polypharmacy among patients with ulcerative colitis (UC) poses a risk of drug-drug interactions (DDIs). This study aimed to describe the prevalence of potential DDIs associated with oral advanced therapies among patients with UC. Methods: Adults with UC were selected from the Merative™ MarketScan® Commercial Database (01/01/2018-01/31/2023); the index date was the most recent UC diagnosis. Patients had no other immune conditions in the 12-month baseline period before the index date. A subgroup with moderate-to-severe UC (≥1 UC-related surgery or hospitalization, biologic, advanced therapy, immunomodulator, or continuous corticosteroid use for ≥90 days during baseline period) was analyzed separately. Potential DDIs were identified as claims for medications that may cause a moderate or severe DDI with ozanimod or Janus kinase (JAK) inhibitors (tofacitinib/upadacitinib) according to the Merative™ Micromedex® Complete Drug Interactions Tool. Potential DDIs were described during the 12 months before the index date. Results: Of 58,870 patients with UC, 24,654 (41.9%) had moderate-to-severe UC (Table 1). All potential DDIs with ozanimod were severe, while JAK inhibitors had both moderate and severe potential DDIs (Figure 1). Among patients with UC, mean [standard deviation] number of severe DDIs was 2.0 [2.4] for ozanimod and 0.2 [0.5] for JAK inhibitors; in moderate-to-severe UC, it was 2.3 [2.6] for ozanimod and 0.4 [0.6] for JAK inhibitors. The most common agents potentially causing DDIs for ozanimod in UC and moderate-to-severe UC were ondansetron (18.6% and 22.7%), azithromycin (11.9% and 12.8%), as well as hydrocodone, fentanyl, albuterol, ciprofloxacin, and metronidazole (9.0%-11.0% each). For JAK inhibitors, these were COVID-19 vaccines (30.7% and 31.4%), infliximab (8.5% and 20.2%), fluconazole (6.1% and 6.8%), and azathioprine (5.5% and 13.0%). Conclusion: In this descriptive analysis of patients with UC and moderate-to-severe UC, the prevalence of potential DDIs was higher for ozanimod than for JAK inhibitors. Commonly used medications with a potential to interact with oral advanced therapies were for nausea, pain, and infection management, which are common UC-related comorbidities or symptoms. Planned analyses will focus on class-level DDIs to better understand this relationship. These findings support the need for thorough evaluation of comorbidities and medication use when prescribing new UC therapies. Funded by Janssen Scientific Affairs, LLC.Figure 1.: DDIs: drug-drug interactions; JAK: Janus kinase inhibitor; UC: ulcerative colitis. Potential for DDIs* with ozanimod and JAK inhibitors among (A) patients with UC and (B) patients with moderate-to-severe UC . *The Merative™ Micromedex® Complete Drug Interactions Tool classifies DDI severity as contraindicated for concurrent use, major (potential to be life-threatening and/or require medical intervention), and moderate (potential to exacerbate condition and/or require an alteration in therapy). “Severe” DDIs refer to contraindicated or major DDIs. Table 1. - Selected baseline demographic and clinical characteristics among patients with UC Mean ± SD [median] or n (%) Patients with UC Patients with moderate-to-severe UC N = 58,870 N = 24,654 Age at the index date 45.6 ± 13.2 [47.0] 43.8 ± 13.5 [44.0] Female 30,485 (51.8) 12,084 (49.0) Selected general comorbidities Cardiovascular disease 19,995 (34.0) 8,737 (35.4) Pain 17,218 (29.2) 8,090 (32.8) Infections 13,134 (22.3) 6,864 (27.8) Nausea and vomiting 6,402 (10.9) 3,569 (14.5) Liver disease 4,702 (8.0) 2,556 (10.4) Selected UC-related medications Any biologics/advanced therapies 15,925 (27.1) 15,925 (64.6) Anti-TNF agents 9,467 (16.1) 9,467 (38.4) Vedolizumab 5,482 (9.3) 5,482 (22.2) Ustekinumab 1,505 (2.6) 1,505 (6.1) JAK Inhibitors 1,021 (1.7) 1,021 (4.1) Ozanimod 88 (0.1) 88 (0.4) Any conventional systemic therapies 43,965 (74.7) 18,306 (74.3) Immunomodulators 5,718 (9.7) 5,718 (23.2) 5-ASA 30,986 (52.6) 10,113 (41.0) Corticosteroids 20,529 (34.9) 10,880 (44.1) 5-ASA: 5-aminosalicylic acid; JAK: Janus kinase inhibitor; SD: standard deviation; TNF: tumor necrosis factor; UC: ulcerative colitis.
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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 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.004 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| 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".