Gastroenterology. 2024 Oct;167(5):919-933.doi: 10.1053/j.gastro.2024.05.006. Epub 2024 May 23.

Stephen B Hanauer ¹, Bruce E Sands ², Stefan Schreiber ³, Silvio Danese ⁴, Maria Klopocka ⁵, Jaroslaw Kierkus ⁶, Roman Kulynych ⁷, Maciej Gonciarz ⁸, Artur Soltysiak ⁹, Patryk Smolinski ¹⁰, Slobodan Sreckovic ¹¹, Ekaterina Valuyskikh ¹², Adi Lahat ¹³, Marek Horynski ¹⁴, Antonio Gasbarrini ¹⁵, Marina Osipenko ¹⁶, Vladimir Borzan ¹⁷, Maciej Kowalski ¹⁸, Daria Saenko ¹⁹, Ruslan Sardinov ²⁰, Sang Joon Lee ²¹, Sunghyun Kim ²², Yunju Bae ²², Sunhee Lee ²², Seulgi Lee ²¹, Joon Ho Lee ²², Siyoung Yang ²², Jimin Lee ²², Juhyun Lee ²², Jong Min Kim ²¹, Gahee Park ²¹, William J Sandborn ²³, Jean-Frederic Colombel ²⁴

Author information

¹Division of Gastroenterology and Hepatology, Department of Medicine, Northwestern University, Feinberg School of Medicine, Chicago, Illinois.

²Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.

³Department of Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany.

⁴Department of Gastroenterology, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Hospital and Vita-Salute University, Milan, Italy.

⁵Department of Gastroenterology and Nutrition Disorders, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, Bydgoszcz, Poland.

⁶Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, Children's Memorial Health Institute, Warsaw, Poland.

⁷Department of Gastroenterology and Endoscopy, Zaporizhzhia Regional Clinical Hospital, Zaporizhzhia, Ukraine.

⁸Department of Gastroenterology and Internal Medicine, Military Institute of Medicine-National Research Institute, Warsaw, Poland.

⁹Department of Gastroenterology and General Surgery, Centrum Medyczne Lukamed Joanna Luka, Chojnice, Poland.

¹⁰Department of Gastroenterology Clinical Trials, EuroMediCare Szpital Specjalistyczny, Wroclaw, Poland.

¹¹Department of Gastroenterology and Hepatology, Clinical University Hospital Zvezdara, Belgrade, Serbia.

¹²Department of Clinical Research, LLC Novosibirskiy Gastrocenter, Novosibirsk, Russia.

¹³Department of Gastroenterology, Chaim Sheba Medical Center, Tel Hashomer, Israel, affiliated with Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

¹⁴Department of Gastroenterology, Endoskopia Sp. Z o.o, Sopot, Poland.

¹⁵Medicina Interna e Gastroenterologia, Università Cattolica del Sacro Cuore; Fondazione Policlinico Universitario Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

¹⁶LLC Medical Center Sibnovomed, Novosibirsk, Russia.

¹⁷Department of Gastroenterology, Faculty of Medicine, Clinical Hospital Center Osijek, Osijek, Croatia.

¹⁸Department of Gastroenterology, Centrum Diagnostyczno - Lecznicze Barska, Wloclawek, Poland.

¹⁹LLC "Clinica UZI 4D," Stavropol Region, Pyatigorsk, Russia.

²⁰Department of Therapy, BioTechService LLC, St Petersburg Medical and Social Institute, Saint Petersburg, Russia.

²¹Data Science Institute, Celltrion, Inc, Incheon, Republic of Korea.

²²Medical Science Division, Celltrion, Inc, Incheon, Republic of Korea.

²³Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California. Electronic address: wsandborn@health.ucsd.edu.

²⁴Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: Jean-frederic.colombel@mssm.edu.

Abstract

Background & aims: CT-P13 subcutaneous (SC), an SC formulation of the intravenous (IV) infliximab biosimilar CT-P13 IV, creates a unique exposure profile. The LIBERTY studies aimed to demonstrate superiority of CT-P13 SC vs placebo as maintenance therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC).

Methods: Two randomized, placebo-controlled, double-blind studies were conducted in patients with moderately to severely active CD or UC and inadequate response or intolerance to corticosteroids and immunomodulators. All patients received open-label CT-P13 IV 5 mg/kg at weeks 0, 2, and 6. At week 10, clinical responders were randomized (2:1) to CT-P13 SC 120 mg or placebo every 2 weeks until week 54 (maintenance phase) using prefilled syringes. (Co-) primary end points were clinical remission and endoscopic response (CD) and clinical remission (UC) at week 54 (all-randomized population).

Results: Overall, 396 patients with CD and 548 patients with UC received induction treatment. At week 54 in the CD study, statistically significant higher proportions of CT-P13 SC-treated patients vs placebo-treated patients achieved clinical remission (62.3% vs 32.1%; P < .0001) and endoscopic response (51.1% vs 17.9%; P < .0001). In the UC study, clinical remission rates at week 54 were statistically significantly higher with CT-P13 SC vs placebo (43.2% vs 20.8%; P < .0001). Achievement of key secondary end points was significantly higher with CT-P13 SC vs placebo across both studies. CT-P13 SC was well tolerated, with no new safety signals identified.

Conclusions: CT-P13 SC was more effective than placebo as maintenance therapy and was well tolerated in patients with moderately to severely active CD or UC who responded to CT-P13 IV induction.

Clinicaltrials: gov, Numbers: NCT03945019 (CD) and NCT04205643 (UC).