P0264 - Comparative Adverse Events of Mirikizumab-mrkz and Etrasimod Arginine in Ulcerative Colitis: A Pharmacovigilance Analysis Using the FAERS Database

Sunday, October 26, 2025

3:30 PM - 7:00 PM MT

Location: Exhibit Hall

Presenting Author(s)

RT

Rukshar Thapa, MD (she/her/hers)

Lankenau Medical Center
Penn Wynne, PA

Munna William, MBBS¹, Rukshar Thapa, MD², Momena Rashid, MBBS¹, Nirmal Paudel, ¹, Anurag Jha, ³, Pragyat Singh, MBBS⁴, Venkateswarlu Chintagumpala, MD⁵
1Nishtar Medical University, Multan, Punjab, Pakistan; 2Lankenau Medical Center, Penn Wynne, PA; 3King Edward Medical University, Lahore, Punjab, Pakistan; 4Nepalese Army Institute of Health Sciences, Kathmandu, Bagmati, Nepal; 5Drexel University, Philadelphia, PA

Introduction: Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that inhibits the IL-23 pathway, and etrasimod arginine is a sphingosine 1-phosphate receptor modulator that partially and reversibly blocks the capacity of lymphocytes to egress from lymphoid organs. Both drugs have been promising treatments for ulcerative colitis (UC) and were approved by the FDA in October 2023. This study aimed to review the adverse events (AEs) of these drugs using real-world data.

Methods: The data were collected from the FDA Adverse Event Reporting System (FAERS), reviewing reports from October 2023 to March 2025. Only adverse events related to UC treatment were included, while reports for other indications, ambiguous or unspecified reasons were excluded. Outcomes of AEs were compared between mirikizumab-mrkz and etrasimod arginine using the Chi-square test. A p value of 0.05 was considered statistically significant

Results: In patients with ulcerative colitis, 282 AEs were reported for mirikizumab-mrkz and 276 for etrasimod arginine. Among these, 152 cases (53.90%) were classified as serious for mirikizumab-mrkz, compared to 96 cases (34.78%) for etrasimod arginine. Excluding UC, the most common AEs with mirikizumab-mrkz were injection site pain [40 (14.18%)], respiratory infection [26 (9.22%)], and arthralgia [11 (3.90%)]. For etrasimod arginine, the most frequent AEs were headache [26 (9.42%)], dizziness [24 (8.70%)], and fatigue [19 (6.88%)]. Hospitalization was significantly higher with mirikizumab-mrkz than etrasimod (25.89% vs. 7.97%, p < 0.001) (Figure 1). Additionally, 10 deaths were reported with mirikizumab-mrkz, linked to cardiac failure, acute kidney injury, intestinal ischemia, asphyxia, and ulcerative colitis, while no deaths were reported with etrasimod arginine.

Discussion:

Mirikizumab-mrkz has a higher incidence of serious adverse events and hospitalizations compared to etrasimod arginine in ulcerative colitis patients. While Mirikizumab-mrkz is more commonly associated with local and respiratory complications, etrasimod arginine is linked to neurological complications. The significantly higher hospitalization rate and reported deaths with mirikizumab-mrkz underscore the need for further research to better understand the comparative safety of these treatments.

Figure: Comparison of adverse events outcomes between mirikizumab-mrkz and etrasimod arginine

Disclosures:
Munna William indicated no relevant financial relationships.
Rukshar Thapa indicated no relevant financial relationships.
Momena Rashid indicated no relevant financial relationships.
Nirmal Paudel indicated no relevant financial relationships.
Anurag Jha indicated no relevant financial relationships.
Pragyat Singh indicated no relevant financial relationships.
Venkateswarlu Chintagumpala indicated no relevant financial relationships.

Munna William, MBBS¹, Rukshar Thapa, MD², Momena Rashid, MBBS¹, Nirmal Paudel, ¹, Anurag Jha, ³, Pragyat Singh, MBBS⁴, Venkateswarlu Chintagumpala, MD⁵. P0264 - Comparative Adverse Events of Mirikizumab-mrkz and Etrasimod Arginine in Ulcerative Colitis: A Pharmacovigilance Analysis Using the FAERS Database, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.