P1768 - Improvement in Survival Scores After Ursodiol Use Among Ursodiol Responders vs. Non-Responders in a Community Setting – Newcastle Model and ALBI Score

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

Mrinalini Buddha, MD, MPH, Sadde Mohamed, BS, Jesus E. Romero, MD, Quynh-An Phan, BS, Ana Romero, MD, Chukwuma Egwim, MD, Victor Ankoma-Sey, MD
Liver Associates 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. Response to ursodiol has been effectively measured by Toronto criteria in previous studies. The primary aim of this study was to assess for the improvement of recently used prognostic scores after ursodiol use among ursodiol responders vs non-responders. The secondary aim was to identify non-responders early to potentially prevent undesired liver decompensation events.

Methods: A retrospective cohort study was conducted at Liver Associates of Texas Hepatology outpatient clinic 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*ULN are responders and ALP >1.67*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: Ursodiol response data was available for 111/136 patients with PBC. 65/111 (58.6%) were ursodiol responders and 46/111 (41.4%) were ursodiol non-responders. Majority of the patients were female and there was no significant difference in gender and race/ethnicity distribution. Age, ALP, and APRI score were significantly different among two groups. AST/ALT ratio [p=0.037] and Newcastle Model score [p=0.023] were significantly different after ursodiol use. Newcastle model score was significantly different among ursodiol responders after ursodiol use [p=0.012 vs 0.780]. Non-response to ursodiol is significantly negatively correlated with the Newcastle model score [OR=0.58, p=0.036] and significantly positively correlated with the ALBI score [OR=3.70, p=0.009] in a multiple logistic regression model.

Discussion: Non-responders had a 42% lower Newcastle model score compared to responders after ursodiol use. The ALBI score increased 3.7 times among non-responders compared to responders after ursodiol use. Hence, there is an improvement in Newcastle model score and ALBI score after ursodiol use among responders and can be used to identify non-responders early.

	Responders [Before vs After use]	Non-Responders [Before vs After use]
Alkaline Phosphatase (ALP) (U/L)	< 0.001*	0.040*
Aspartate aminotransferase (AST)	0.022*	0.023*
Alanine aminotransferase (ALT)	0.030*	0.017*
Newcastle Model score	0.012*	0.780
ALBI score	0.068	0.633

Table: Table 1: P-values for Lab parameters Before vs After 1 year of Ursodiol use among Ursodiol responders and non-responders in PBC patients

Disclosures:

Mrinalini Buddha indicated no relevant financial relationships.

Sadde Mohamed indicated no relevant financial relationships.

Jesus Romero indicated no relevant financial relationships.

Quynh-An Phan 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 and 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 and Teaching. Allergan Plc – Grant/Research Support. Genfit – Grant/Research Support. Gilead Sciences – Other Financial or Material Support, Speaking and Teaching. Intercept Pharmaceuticals – Grant/Research Support, Other Financial or Material Support, Speaking and Teaching. Madrigal Pharmaceuticals – Grant/Research Support. NorthSea Therapeutics – Grant/Research Support.

Mrinalini Buddha, MD, MPH, Sadde Mohamed, BS, Jesus E. Romero, MD, Quynh-An Phan, BS, Ana Romero, MD, Chukwuma Egwim, MD, Victor Ankoma-Sey, MD. P1768 - Improvement in Survival Scores After Ursodiol Use Among Ursodiol Responders vs. Non-Responders in a Community Setting – Newcastle Model and ALBI Score, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.