Trial reportUnited European gastroenterology journal2026
Impact of Immunogenicity on Clinical Outcomes in Patients With Moderate-to-Severe Inflammatory Bowel Disease Receiving Subcutaneous Infliximab: A Post Hoc Analysis of the LIBERTY Trials.
Trial report in United European gastroenterology journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease
A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis
Who cites it
1 citing paper in PubMed.
- Distinguishing Detectable From Clinically Relevant Immunogenicity With Subcutaneous Infliximab.United European gastroenterology journal · 2026Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
BACKGROUND AND
aimsLIBERTY-CD and LIBERTY-UC demonstrated superior efficacy of subcutaneous infliximab (IFX SC) to placebo in patients with Crohn's disease (CD) or ulcerative colitis (UC). Here, we investigated the impact of anti-drug antibodies (ADAs) on clinical outcomes.
methodsPatients randomized to IFX SC maintenance treatment in the LIBERTY trials were included (CD, n = 231; UC, n = 294). ADAs were tested using a highly sensitive, drug-tolerant assay. Patients were grouped by ADA occurrence and titer and evaluated for outcomes up to Week (W) 54.
resultsAmong patients with CD and UC, 150 (64.9%) and 187 (63.6%) were ADA-positive, respectively. No statistically significant differences were observed between the ADA-positive and ADA-negative groups in W54 efficacy (CD: clinical remission, 69.5% [95% confidence interval: 61.6-77.5] vs. 79.7% [70.2-89.2], p = 0.134; endoscopic response, 57.5% [48.9-66.1] vs. 65.2% [54.0-76.5], p = 0.359; UC: clinical remission, 49.1% [41.3-56.8] vs. 57.0% [46.5-67.4], p = 0.284), drug persistence (CD: 84.7% [79.1-90.6] vs. 85.2% [77.8-93.3]; UC: 84.5% [79.5-89.8] vs. 77.6% [70.1-85.9]), and safety (patients with ≥ 1 treatment-emergent adverse event; CD: 71.2% [64.0-78.3] vs. 74.4% [64.9-83.8]; UC: 69.5% [62.9-76.0] vs. 64.2% [55.0-73.3]), despite lower drug concentrations in ADA-positive patients at W54 (CD: 10.6 μg/mL [9.1-12.2] vs. 17.9 μg/mL [15.8-20.1]; UC: 12.2 μg/mL [10.8-13.5] vs. 21.0 μg/mL [18.4-23.6]). No significant relationship between ADA titer and efficacy or persistence was noted.
conclusionsAlthough ADAs affected drug levels, no significant differences by ADA occurrence were observed in W54 efficacy or safety among patients receiving IFX SC maintenance treatment. While high ADA titers were associated with lower drug levels, effectiveness was not diminished within 1 year.
trial registrationClinicalTrials.gov identifiers NCT03945019 (LIBERTY-CD) and NCT04205643 (LIBERTY-UC).
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