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001-es BibID:	BIBFORM120677
035-os BibID:	(WOS)001032215200024 (Scopus)85165221969
Első szerző:	Hirschfield, Gideon M.
Cím:	Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis : ENHANCE, a phase 3, randomized, placebo-controlled study / Gideon M. Hirschfield, Mitchell L. Shiffman, Aliya Gulamhusein, Kris V. Kowdley, John M. Vierling, Cynthia Levy, Andreas E. Kremer, Ehud Zigmond, Pietro Andreone, Stuart C. Gordon, Christopher L. Bowlus, Eric J. Lawitz, Richard J. Aspinall, Daniel S. Pratt, Karina Raikhelson, Maria S. Gonzalez-Huezo, Michael A. Heneghan, Sook-Hyang Jeong, Alma L. Ladrón de Guevara, Marlyn J. Mayo, George N. Dalekos, Joost P. H. Drenth, Ewa Janczewska, Barbara A. Leggett, Frederik Nevens, Victor Vargas, Eli Zuckerman, Christophe Corpechot, Eduardo Fassio, Holger Hinrichsen, Pietro Invernizzi, Palak J. Trivedi, Lisa Forman, David E. J. Jones, Stephen D. Ryder, Mark G. Swain, Alexandra Steinberg, Pol F. Boudes, Yun-Jung Choi, Charles A. McWherter, ENHANCE Study Group
Dátum:	2023
ISSN:	0270-9139
Megjegyzések:	Background and Aims: ENHANCEwas a phase 3 study that evaluated efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-? (PPAR) agonist, versus placebo in patients with primary biliary cholangitis with inadequate response or intolerance to ursodeoxycholic acid (UDCA). Approach and Results: Patients were randomized 1:1:1 to oral seladelpar 5 mg (n=89), 10 mg (n=89), placebo (n=87) daily (with UDCA, as appropriate). Primary end point was a composite biochemical response [alkaline phosphatase (ALP) < 1.67?upper limit of normal (ULN), ?15% ALP decrease from baseline, and total bilirubin ? ULN] at month 12. Key secondary end points were ALP normalization at month 12 and change in pruritus numerical rating scale (NRS) at month 6 in patients with baseline score ?4. Aminotransferases were assessed. ENHANCE was terminated early following an erroneous safety signal in a concurrent, NASH trial.While blinded, primary and secondary efficacy end points were amended to month 3. Significantly more patients receiving seladelpar met the primary end point (seladelpar 5 mg: 57.1%, 10mg: 78.2%) versus placebo (12.5%) (p < 0.0001). ALP normalization occurred in 5.4% (p=0.08) and 27.3% (p < 0.0001) of patients receiving 5 and 10 mg seladelpar, respectively, versus 0% receiving placebo. Seladelpar 10 mg significantly reduced mean pruritus NRS versus placebo [10 mg: ?3.14 (p=0.02); placebo: ?1.55]. Alanine aminotransferase decreased significantly with seladelpar versus placebo [5 mg: 23.4% (p=0.0008); 10 mg: 16.7% (p=0.03); placebo: 4%]. There were no serious treatment-related adverse events. Conclusions: Patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to UDCA who were treated with seladelpar 10 mg had significant improvements in liver biochemistry and pruritus. Seladelpar appeared safe and well tolerated.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Hepatology. - 78 : 2 (2023), p. 397-415. -
További szerzők:	Shiffman, Mitchell L. Gulamhusein, Aliya Kowdley, Kris V. Vierling, John M. Levy, Cynthia Kremer, Andreas E. Zigmond, Ehud Andreone, Pietro Gordon, Stuart C. Bowlus, Christopher L. Lawitz, Eric J. Aspinall, Richard J. Pratt, Daniel S. Raikhelson, Karina Gonzalez-Huezo, Maria S. Heneghan, Michael A. Jeong, Sook-Hyang Guevara, Alma L. Ladrón de Mayo, Marlyn J. Dalekos, George N. Drenth, Joost P. H. Janczewska, Ewa Leggett, Barbara A. Nevens, Frederik Vargas, Victor Zuckerman, Eli Corpechot, Christophe Fassio, Eduardo Hinrichsen, Holger Invernizzi, Pietro Trivedi, Palak J. Forman, Lisa Jones, David E. J. Ryder, Stephen Swain, Mark G. Steinberg, Alexandra Boudes, Pol F. Choi, Yun-Jung McWherter, Charles A. Papp Mária (1975-) (belgyógyász, gasztroenterológus) ENHANCE Study Group
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