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Sunday Poster Session

Category: IBD

P0790 - Real-World Prevalence of Potential Drug-Drug Interactions Associated With Oral Advanced Therapies Indicated for Ulcerative Colitis

Sunday, October 22, 2023
3:30 PM – 7:00 PM PT
Location: Exhibit Hall
Maryia Zhdanava, MA1, Sabree Burbage, PharmD, MPH2, Todor I. Totev, MBA3, Sumesh Kachroo, PhD2, Lilian Diaz, MSc1, Bridget Godwin, MD2, Patrick Lefebvre, MA1, James Izanec, MD2, Dominic Pilon, MA1
1Analysis Group, Inc., Montreal, PQ, Canada; 2Janssen Scientific Affairs, LLC, Horsham, PA; 3Analysis Group, Inc., Boston, MA

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%).

Discussion: 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: DDIs: drug-drug interactions; JAK: Janus kinase inhibitor; UC: ulcerative colitis.

Figure 1. 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.



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)


Table: 5-ASA: 5-aminosalicylic acid; JAK: Janus kinase inhibitor; SD: standard deviation; TNF: tumor necrosis factor; UC: ulcerative colitis. Table 1. Selected baseline demographic and clinical characteristics among patients with UC


Disclosures:
Maryia Zhdanava: Analysis Group – Employee. Janssen Scientific Affairs, LLC – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC..
Sabree Burbage: Janssen Scientific Affairs, LLC – Employee.
Todor Totev: Analysis Group, Inc. – Employee. Janssen Scientific Affairs, LLC – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC..
Sumesh Kachroo: Johnson and Johnson Group of companies – Employee, Stock Options.
Lilian Diaz: Analysis Group, Inc. – Employee. Janssen Scientific Affairs, LLC – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC..
Bridget Godwin: Janssen Research & Development, LLC – Employee. Johnson & Johnson – Stock-publicly held company(excluding mutual/index funds).
Patrick Lefebvre: Acadia Pharmaceuticals – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Acadia Pharmaceuticals. Janssen Scientific Affairs, LLC – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC.. Myovant Sciences – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Myovant Sciences.. Novartis – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Novartis.. Otsuka – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Otsuka.. Pharmacyclics – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Pharmacyclics..
James Izanec: Janssen Scientific Affairs – Employee.
Dominic Pilon: Analysis Group, Inc – Employee. Janssen Scientific Affairs, LLC – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC..


Maryia Zhdanava, MA1, Sabree Burbage, PharmD, MPH2, Todor I. Totev, MBA3, Sumesh Kachroo, PhD2, Lilian Diaz, MSc1, Bridget Godwin, MD2, Patrick Lefebvre, MA1, James Izanec, MD2, Dominic Pilon, MA1. P0790 - Real-World Prevalence of Potential Drug-Drug Interactions Associated With Oral Advanced Therapies Indicated for Ulcerative Colitis, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.