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Gamma Glutamyltransferase Reduction Is Associated With Favorable Outcomes in Pediatric Primary Sclerosing Cholangitis

MR. Deneau, C. Mack, R. Abdou, M. Amin, A. Amir, M. Auth, F. Bazerbachi, A. Marie Broderick, A. Chan, M. DiGuglielmo, W. El-Matary, M. El-Youssef, F. Ferrari, KN. Furuya, F. Gottrand, N. Gupta, M. Homan, MK. Jensen, BM. Kamath, K. Mo Kim, KL....

. 2018 ; 2 (11) : 1369-1378. [pub] 20180925

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc19001561

Adverse clinical events in primary sclerosing cholangitis (PSC) happen too slowly to capture during clinical trials. Surrogate endpoints are needed, but no such validated endpoints exist for children with PSC. We evaluated the association between gamma glutamyltransferase (GGT) reduction and long-term outcomes in pediatric PSC patients. We evaluated GGT normalization (< 50 IU/L) at 1 year among a multicenter cohort of children with PSC who did or did not receive treatment with ursodeoxycholic acid (UDCA). We compared rates of event-free survival (no portal hypertensive or biliary complications, cholangiocarcinoma, liver transplantation, or liver-related death) at 5 years. Of the 287 children, mean age of 11.4 years old, UDCA was used in 81% at a mean dose of 17 mg/kg/day. Treated and untreated groups had similar GGT at diagnosis (314 versus 300, P= not significant [NS]). The mean GGT was reduced at 1 year in both groups, with lower values seen in treated (versus untreated) patients (99 versus 175, P= 0.002), but 5-year event-free survival was similar (74% versus 77%, P= NS). In patients with GGT normalization (versus no normalization) by 1 year, regardless of UDCA treatment status, 5-year event-free survival was better (91% versus 67%, P< 0.001). Similarly, larger reduction in GGT over 1 year (> 75% versus < 25% reduction) was also associated with improved outcome (5-year event-free survival 88% versus 61%, P= 0.005). Conclusion:A GGT < 50 and/or GGT reduction of > 75% by 1 year after PSC diagnosis predicts favorable 5-year outcomes in children. GGT has promise as a potential surrogate endpoint in future clinical trials for pediatric PSC.

Academic Medical Centre Amsterdam the Netherlands

Alder Hey Children's Hospital Liverpool United Kingdom

Children's Health Memorial Institute Warsaw Poland

Children's National Medical Center Washington DC

Columbia University College of Physicians and Surgeons New York NY

Dana Dwek Children's Hospital Tel Aviv Medical Center Tel Aviv University Tel Aviv Israel

Emory University School of Medicine Atlanta GA

Lille University Hospital of Lille Lille France

Mayo Clinic Rochester MN

Medical College of Wisconsin Milwaukee WI

Memorial University St John's Newfoundland and Labrador Canada

Nassau University Medical Center East Meadow NY

Nemours Alfred 1 duPont Hospital For Children Wilmington DE

Northwest Pediatric Gastroenterology LLC Portland OR

Palacky University Olomouc Czech Republic

Phoenix Children's Hospital Phoenix AZ

Phoenix Children's Hospital Phoenix AZ Texas Children's Hospital Houston TX

Sapienza University of Rome Rome Italy

Shaare Zedek Medical Center Jerusalem Israel

Teikyo University School of Medicine Tokyo Japan

University College Dublin Dublin Ireland

University of Alberta Edmonton Canada

University of Athens Athens Greece

University of Colorado School of Medicine Aurora CO

University of Helsinki Helsinki Finland

University of Liverpool Liverpool United Kingdom University of Manchester Manchester United Kingdom

University of Ljubljana Ljubljana Slovenia

University of Manitoba Winnipeg Canada

University of Naples Federico 2 Naples Italy

University of Pittsburgh Medical Center Pittsburgh PA

University of Rochester Medical Center Rochester NY

University of Toronto Toronto Canada

University of Ulsan Seoul South Korea

University of Utah Salt Lake City UT

Yale University School of Medicine New Haven CT

Citace poskytuje Crossref.org

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$a Gamma Glutamyltransferase Reduction Is Associated With Favorable Outcomes in Pediatric Primary Sclerosing Cholangitis / $c MR. Deneau, C. Mack, R. Abdou, M. Amin, A. Amir, M. Auth, F. Bazerbachi, A. Marie Broderick, A. Chan, M. DiGuglielmo, W. El-Matary, M. El-Youssef, F. Ferrari, KN. Furuya, F. Gottrand, N. Gupta, M. Homan, MK. Jensen, BM. Kamath, K. Mo Kim, KL. Kolho, A. Konidari, B. Koot, R. Iorio, M. Martinez, P. Mohan, S. Palle, A. Papadopoulou, A. Ricciuto, L. Saubermann, P. Sathya, E. Shteyer, V. Smolka, A. Tanaka, PL. Valentino, R. Varier, V. Venkat, B. Vitola, MB. Vos, M. Woynarowski, J. Yap, T. Miloh,
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$a Adverse clinical events in primary sclerosing cholangitis (PSC) happen too slowly to capture during clinical trials. Surrogate endpoints are needed, but no such validated endpoints exist for children with PSC. We evaluated the association between gamma glutamyltransferase (GGT) reduction and long-term outcomes in pediatric PSC patients. We evaluated GGT normalization (< 50 IU/L) at 1 year among a multicenter cohort of children with PSC who did or did not receive treatment with ursodeoxycholic acid (UDCA). We compared rates of event-free survival (no portal hypertensive or biliary complications, cholangiocarcinoma, liver transplantation, or liver-related death) at 5 years. Of the 287 children, mean age of 11.4 years old, UDCA was used in 81% at a mean dose of 17 mg/kg/day. Treated and untreated groups had similar GGT at diagnosis (314 versus 300, P= not significant [NS]). The mean GGT was reduced at 1 year in both groups, with lower values seen in treated (versus untreated) patients (99 versus 175, P= 0.002), but 5-year event-free survival was similar (74% versus 77%, P= NS). In patients with GGT normalization (versus no normalization) by 1 year, regardless of UDCA treatment status, 5-year event-free survival was better (91% versus 67%, P< 0.001). Similarly, larger reduction in GGT over 1 year (> 75% versus < 25% reduction) was also associated with improved outcome (5-year event-free survival 88% versus 61%, P= 0.005). Conclusion:A GGT < 50 and/or GGT reduction of > 75% by 1 year after PSC diagnosis predicts favorable 5-year outcomes in children. GGT has promise as a potential surrogate endpoint in future clinical trials for pediatric PSC.
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