LIBERTY-CD (ClinicalTrials.gov Identifier: NCT03945019) is a phase 3 study investigating the efficacy and safety of subcutaneous infliximab as maintenance therapy in moderately to severely active Crohn’s disease. In this touchIMMUNOLOGY interview we spoke with Dr. Jean-Frederic Colombel (Icahn School of Medicine, Mount Sinai, New York, NY, USA) to discuss the aims, methodology and findings from the study, we also discussed the impact subcutaneous administration could have on patient adherence and outcomes.
The abstract ‘Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn’s disease: A phase 3, randomised, placebo-controlled study (LIBERTY-CD).’ (Abstract number: DOP86) was presented at ECCO 2023, March 1-4, 2023.
Questions
- What do we already know about the efficacy and safety of subcutaneous infliximab compared with intravenous infliximab? (0:16)
- What were the aims and methodology of the LIBERTY-CD study? (1:22)
- What were the efficacy and safety findings from the study? (2:11)
- What impact could subcutaneous administration of infliximab maintenance therapy have on patient adherence and outcomes? (3:16)
Disclosures: Jean-Frederic Colombel discloses consulting for: AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Celgene Corporation, Eli Lilly, Ferring Pharmaceuticals, Galmed Research, Genentech, Glaxo Smith Kline, Janssen Pharmaceuticals, Kaleido Biosciences, Imedex, Immunic, Iterative Scopes, Merck, Microbia, Novartis, PBM Capital, Pfizer, Protagonist Therapeutics, Sanofi, Takeda, TiGenix, and Vifor; receiving grant/research support from: AbbVie, Janssen Pharmaceuticals and Takeda; serving on advisory boards for: AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Celgene Corporation, Eli Lilly, Ferring Pharmaceuticals, Galmed Research, Genentech, Glaxo Smith Kline, Janssen Pharmaceuticals, Kaleido Biosciences, Imedex, Immunic, Iterative Scopes, Merck, Microbia, Novartis, PBM Capital, Pfizer, Protagonist Therapeutics, Sanofi, Takeda, TiGenix, and Vifor; receiving honoraria from: AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Celgene Corporation, Eli Lilly, Ferring Pharmaceuticals, Galmed Research, Genentech, Glaxo Smith Kline, Janssen Pharmaceuticals, Kaleido Biosciences, Imedex, Immunic, Iterative Scopes, Merck, Microbia, Novartis, PBM Capital, Pfizer, Protagonist Therapeutics, Sanofi, Takeda, TiGenix, and Vifor and is a major stock shareholder in: Intestinal Biotech Development.
Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones.
Filmed in coverage of the European Crohn´s and Colitis Organisation Annual Meeting 2023.
Click here for more content from Jean-Frederic Colombel.
Transcript
What do we already know about the efficacy and safety of subcutaneous infliximab compared with intravenous infliximab? (0:16)
We actually have already a lot of data across all immune mediated diseases, including ankylosing spondylitis, rheumatoid arthritis and Crohn’s disease showing similar efficacy of original infliximab as compared to the biosimilar CT-P13. So, when comparing IV infliximab with IV CT-P13 showing similar efficacy and safety. There was also another study showing that actually IV was also comparable to subcutaneous. So basically, CT-P13 subcu showed comparable efficacy and safety compared to IV. So, there was already a strong background to support the efficacy and safety of this medication administered as a subcu instead of IV.
What were the aims and methodology of the LIBERTY-CD study? (1:22)
This was a randomized controlled study. All patients received induction with IV CT-P13 and then they were randomised to CT-P13 subcu 120 milligrams every two weeks and compared to placebo. Meaning the IV responders to IV CT-P13 at week 10 were then randomized and the primary endpoint was a co- primary endpoint, which was clinical remission and endoscopic response at week 54.
What were the efficacy and safety findings from the study? (2:11)
Basically, this study is showing clear evidence that CT-P13 subcu was superior to placebo for both co-primary endpoint and for a number of key secondary endpoints. When we looked at safety, basically, there was no new safety signals. There was something about immunogenicity. Approximately 70% of patients develop antibodies. But it’s very important to mention that this was using a very sensitive assay and actually the impact, there was no impact of the development of these antibodies on either efficacy or safety of the drug. So we can conclude from the studies that a CT-P13 subcu is a very nice alternative for maintenance with infliximab.
What impact could subcutaneous administration of infliximab maintenance therapy have on patient adherence and outcomes? (3:16)
Why should we aim for a subcu? Because it’s more practical. Many of our patients prefer subcutaneous administration over an IV because they don’t have to come to the hospital and so on and so forth. We have seen that a lot during the COVID pandemic, you know, because unfortunately, many patients stopped IV infusion because they didn’t want to come to the infusion centre.
Subtitles and transcript are autogenerated.
