Real‐World Effectiveness of Obeticholic Acid in Patients with Primary Biliary Cholangitis Article Swipe
Surain B. Roberts
,
Marwa Ismail
,
Gowthami Kanagalingam
,
Andrew L. Mason
,
Mark G. Swain
,
Catherine Vincent
,
Eric M. Yoshida
,
Cynthia Tsien
,
Jennifer A. Flemming
,
Harry L.A. Janssen
,
Gideon M. Hirschfield
,
Bettina E. Hansen
,
Aliya Gulamhusein
·
YOU?
·
· 2020
· Open Access
·
· DOI: https://doi.org/10.1002/hep4.1518
YOU?
·
· 2020
· Open Access
·
· DOI: https://doi.org/10.1002/hep4.1518
Patients with primary biliary cholangitis (PBC) with incomplete response to ursodeoxycholic acid are at risk of disease progression and need additional therapy. Obeticholic acid (OCA) was approved in Canada in May 2017, but its effectiveness in a real‐world setting has not been described. We sought to describe our experience with OCA in a Canadian cohort. OCA‐naive patients treated at two Canadian centers were included. Clinical and biochemical data were collected at OCA initiation and during follow‐up. Primary outcomes were changes in serum alkaline phosphatase (ALP), gamma‐glutamyl transferase (GGT), and total bilirubin (TB) over the duration of therapy. Secondary outcomes were changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST), immunoglobulin M (IgM), platelets, and albumin; and achievement of the primary endpoint of the original phase 3 study that led to OCA approval (A Placebo‐Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis [POISE]), dose reductions, discontinuations, and tolerability. Repeated‐measures models were used to assess changes in biochemistry over time. Sixty‐four patients were included; 4 carried a diagnosis of overlap with autoimmune hepatitis. Mean age was 54.6 years, median ALP was 250 U/L, TB was 13 µmol/L, platelet count was 225 × 10 9 /L, and 24% had liver stiffness measurements ≥16.9 kPa. There was a significant reduction in mean ALP of 55 U/L ( P < 0.001), GGT of 138 U/L ( P < 0.001), ALT of 11.9 U/L ( P < 0.001), AST of 5.7 U/L ( P < 0.05), and IgM of 0.70 g/L ( P < 0.001) over 12 months; TB remained stable ( P = 0.98). Forty‐four patients met POISE‐inclusion criteria, 39% (n = 17) of whom had 12‐month biochemical measurements. In this subset, 18% (n = 3/17) met the 12‐month POISE primary endpoint, but considering follow‐up to 19 months, 43% achieved this target (n = 9/21). Pruritus was the most commonly reported complaint. Conclusion : Use of OCA was associated with improvement in biochemical surrogates of outcome in PBC in a real‐world setting.
Related Topics
Concepts
Obeticholic acid
Medicine
Ursodeoxycholic acid
Internal medicine
Gastroenterology
Tolerability
Bilirubin
Clinical endpoint
Alkaline phosphatase
Cohort
Placebo
Primary biliary cirrhosis
Albumin
Clinical trial
Adverse effect
Pathology
Chemistry
Alternative medicine
Biochemistry
Enzyme
Receptor
Agonist
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1002/hep4.1518
- OA Status
- gold
- Cited By
- 55
- References
- 16
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3040342452
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W3040342452Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1002/hep4.1518Digital Object Identifier
- Title
-
Real‐World Effectiveness of Obeticholic Acid in Patients with Primary Biliary CholangitisWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2020Year of publication
- Publication date
-
2020-07-06Full publication date if available
- Authors
-
Surain B. Roberts, Marwa Ismail, Gowthami Kanagalingam, Andrew L. Mason, Mark G. Swain, Catherine Vincent, Eric M. Yoshida, Cynthia Tsien, Jennifer A. Flemming, Harry L.A. Janssen, Gideon M. Hirschfield, Bettina E. Hansen, Aliya GulamhuseinList of authors in order
- Landing page
-
https://doi.org/10.1002/hep4.1518Publisher landing page
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
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https://doi.org/10.1002/hep4.1518Direct OA link when available
- Concepts
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Obeticholic acid, Medicine, Ursodeoxycholic acid, Internal medicine, Gastroenterology, Tolerability, Bilirubin, Clinical endpoint, Alkaline phosphatase, Cohort, Placebo, Primary biliary cirrhosis, Albumin, Clinical trial, Adverse effect, Pathology, Chemistry, Alternative medicine, Biochemistry, Enzyme, Receptor, AgonistTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
55Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 17, 2024: 9, 2023: 5, 2022: 14, 2021: 8Per-year citation counts (last 5 years)
- References (count)
-
16Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.to | 9, 45, 128, 151, 290 |
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| abstract_inverted_index./L, | 192 |
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| abstract_inverted_index.17) | 267 |
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| abstract_inverted_index.225 | 188 |
| abstract_inverted_index.24% | 194 |
| abstract_inverted_index.250 | 179 |
| abstract_inverted_index.39% | 264 |
| abstract_inverted_index.43% | 293 |
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| abstract_inverted_index.ALT | 224 |
| abstract_inverted_index.AST | 232 |
| abstract_inverted_index.GGT | 216 |
| abstract_inverted_index.IgM | 241 |
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| abstract_inverted_index.OCA | 50, 71, 129, 311 |
| abstract_inverted_index.PBC | 322 |
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| abstract_inverted_index.Use | 309 |
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| abstract_inverted_index.but | 32, 287 |
| abstract_inverted_index.g/L | 244 |
| abstract_inverted_index.had | 195, 270 |
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| abstract_inverted_index.its | 33 |
| abstract_inverted_index.led | 127 |
| abstract_inverted_index.met | 261, 281 |
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| abstract_inverted_index.our | 47 |
| abstract_inverted_index.the | 93, 117, 121, 282, 302 |
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| abstract_inverted_index.< | 214, 222, 230, 238, 247 |
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| abstract_inverted_index.0.70 | 243 |
| abstract_inverted_index.11.9 | 226 |
| abstract_inverted_index.54.6 | 174 |
| abstract_inverted_index.Acid | 136 |
| abstract_inverted_index.Mean | 171 |
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| abstract_inverted_index.(PBC) | 5 |
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| abstract_inverted_index.3/17) | 280 |
| abstract_inverted_index.POISE | 284 |
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| abstract_inverted_index.Trial | 133 |
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| abstract_inverted_index.liver | 196 |
| abstract_inverted_index.phase | 123 |
| abstract_inverted_index.serum | 81 |
| abstract_inverted_index.study | 125 |
| abstract_inverted_index.time. | 157 |
| abstract_inverted_index.total | 89 |
| abstract_inverted_index.(ALP), | 84 |
| abstract_inverted_index.(ALT), | 104 |
| abstract_inverted_index.(AST), | 107 |
| abstract_inverted_index.(GGT), | 87 |
| abstract_inverted_index.(IgM), | 110 |
| abstract_inverted_index.0.001) | 248 |
| abstract_inverted_index.0.05), | 239 |
| abstract_inverted_index.0.98). | 258 |
| abstract_inverted_index.9/21). | 299 |
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| abstract_inverted_index.assess | 152 |
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| abstract_inverted_index.median | 176 |
| abstract_inverted_index.models | 148 |
| abstract_inverted_index.sought | 44 |
| abstract_inverted_index.stable | 254 |
| abstract_inverted_index.target | 296 |
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| abstract_inverted_index.0.001), | 215, 223, 231 |
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| abstract_inverted_index.Primary | 76, 138 |
| abstract_inverted_index.alanine | 102 |
| abstract_inverted_index.biliary | 3 |
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| abstract_inverted_index.centers | 61 |
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| abstract_inverted_index.disease | 16 |
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| abstract_inverted_index.months; | 251 |
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| abstract_inverted_index.overlap | 167 |
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| abstract_inverted_index.setting | 38 |
| abstract_inverted_index.subset, | 276 |
| abstract_inverted_index.treated | 57 |
| abstract_inverted_index.≥16.9 | 199 |
| abstract_inverted_index.Canadian | 53, 60 |
| abstract_inverted_index.Clinical | 64 |
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| abstract_inverted_index.aspartate | 105 |
| abstract_inverted_index.bilirubin | 90 |
| abstract_inverted_index.collected | 69 |
| abstract_inverted_index.criteria, | 263 |
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| abstract_inverted_index.endpoint, | 286 |
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| abstract_inverted_index.included; | 161 |
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| abstract_inverted_index.stiffness | 197 |
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| abstract_inverted_index.OCA‐naive | 55 |
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| abstract_inverted_index.achievement | 115 |
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| abstract_inverted_index.Sixty‐four | 158 |
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| abstract_inverted_index.measurements | 198 |
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| corresponding_author_ids | https://openalex.org/A5025186476 |
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| institutions_distinct_count | 13 |
| corresponding_institution_ids | https://openalex.org/I1325899441, https://openalex.org/I185261750, https://openalex.org/I2801845744 |
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