P1767 - Sociodemographic Determinants of Response to Ursodiol: Is Age a Predictor of Ursodiol Non-Response?

Monday, October 25, 2021

10:30 AM – 4:15 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Presenting Author(s)

Mrinalini Buddha, MD, MPH

Liver Associates of Texas, PA
Dallas, TX, United States

Quynh-An Phan, BS¹, Mrinalini Buddha, MD, MPH¹, Jesus E. Romero, MD¹, Stephanie Panduano, ², Ana Romero, MD¹, Chukwuma Egwim, MD², Victor Ankoma-Sey, MD¹
¹Liver Associates of Texas, PA, Houston, TX; ²Liver Assosciates of Texas, PA, Houston, TX

Introduction: Primary biliary cholangitis (PBC) is a chronic autoimmune disorder characterized by portal inflammation and intrahepatic biliary duct destruction. Ursodiol is the first-line treatment for many patients with PBC. The primary aim of this study is to assess the role of socio-demographic variables on response to ursodiol elicited by Toronto criteria, which has been validated in previous studies.

Methods: A retrospective cohort study was conducted at Liver Associates of Texas Hepatology outpatient clinics in Houston, Texas. All patients diagnosed with PBC from January 2018-May 2021 were included. Lab and Fibroscan results before and 1 year after starting ursodiol in these patients were collected from their records. Response to Ursodiol was measured using the Toronto criteria [alkaline phosphatase (ALP)≤1.67 times upper limit of normal (ULN) are responders and ALP >1.67 times ULN are non-responders]. Continuous variables were compared with either the Student’s T-test or Wilcoxon Rank-sum test. Chi-square test, Fisher’s exact test and logistic regression were used for categorical variables. Significance level was set at 5%.

Results: Data for ursodiol response was available for 111/136 patients with PBC and included in the study. 65/111 (58.6%) were ursodiol responders and 46/111 (41.4%) were ursodiol non-responders. Majority of the patients were female with no significant difference in gender [p=0.191] distribution. Overall, 36.8% are Caucasian, 14.7% are Hispanic, 12.5% are African American, 3.7% are Asian, 2.2% are Native American, and 30.2% are of unspecified race, with no significant difference among responders vs non-responders [p=0.290] with respect to ethnicity. The median age for responders is 67 years and 61.5 years for non-responders, which was significantly different between the two groups [p=0.004]. On logistic regression, PBC patients ≤ 55 years of age have 2.62 times higher risk of non-response to ursodiol compared to patients > 55 years of age [OR=2.62, p=0.034]. On univariate analysis, BMI [p=0.434], gender [p=0.191], and PBC-AIH overlap syndrome [p=0.717] were not significantly different among ursodiol responders vs non-responders.

Discussion: PBC patients younger than or equal to 55 years of age are at a higher risk of non-response to ursodiol than PBC patients >55 years, thus need effective monitoring for their response to ursodiol. Further studies are needed to validate age as a predictor of ursodiol response in PBC patients.

	Responders	Non-Responders	p-value
Alkaline Phosphatase (U/L)	94 (90-124)	173 (130-225)	< 0.001*
Age (years)	67 (62-74)	61.5 (53-68)	0.004*
Gender Females Males	57/65 (87.7%) 8/65 (12.3%)	44/46 (95.7%) 2/46 (4.4%)	0.191
Race/ethnicity Caucasian Hispanic African American Asian Native American Unspecified	22/65 (33.9%) 8/65 (12.3%) 8/65 (12.3%) 5/65 (7.7%) 1/65 (1.5%) 21/65 (32.3%)	16/46 (34.8%) 10/46 (21.7%) 6/46 (13.0%) - 2/46 (4.4%) 12/46 (26.1%)	0.290

Table: Table 1: Sociodemographic variables in Ursodiol responders vs non-responders among PBC patients

Disclosures:

Quynh-An Phan indicated no relevant financial relationships.

Mrinalini Buddha indicated no relevant financial relationships.

Jesus Romero indicated no relevant financial relationships.

Stephanie Panduano indicated no relevant financial relationships.

Ana Romero indicated no relevant financial relationships.

Chukwuma Egwim: Allergan plc – Grant/Research Support. Genfit – Grant/Research Support. Gilead Sciences – Other Financial or Material Support, Speaking/Teaching. Intercept Pharmaceuticals – Grant/Research Support. Madrigal Pharmaceuticals – Grant/Research Support. NorthSea Therapeutics – Grant/Research Support.

Victor Ankoma-Sey: Abbvie – Other Financial or Material Support, Speaking/Teaching. Allergan plc – Grant/Research Support. Genfit – Grant/Research Support. Gilead Sciences – Other Financial or Material Support, Speaking/Teaching. Intercept Pharmaceuticals – Grant/Research Support, Other Financial or Material Support, Speaking/Teaching. Madrigal Pharmaceuticals – Grant/Research Support. NorthSea Therapeutics – Grant/Research Support.

Quynh-An Phan, BS¹, Mrinalini Buddha, MD, MPH¹, Jesus E. Romero, MD¹, Stephanie Panduano, ², Ana Romero, MD¹, Chukwuma Egwim, MD², Victor Ankoma-Sey, MD¹. P1767 - Sociodemographic Determinants of Response to Ursodiol: Is Age a Predictor of Ursodiol Non-Response?, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.