Pharma Focus Asia

ZYMFENTRA™ (infliximab-dyyb) demonstrates enduring efficacy and safety in maintenance treatment for adults with moderately to severely active Crohn's disease and ulcerative colitis

Tuesday, May 21, 2024

Celltrion USA unveiled today positive findings from the extended LIBERTY studies (LIBERTY-CD and LIBERTY-UC) for ZYMFENTRA™ (infliximab-dyyb) in adult patients with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC) following induction with intravenous (IV) infliximab. These results, presented during 18 oral and poster sessions at the Digestive Disease Week® (DDW) 2024 Annual Meeting in Washington, D.C., from May 18 to 21, reinforce the efficacy and safety demonstrated in earlier pivotal studies.

The presentations covered outcomes of the two-year LIBERTY studies and a post-hoc analysis of the LIBERTY-CD study, which examined the impact of anti-drug antibodies (ADAs) on drug levels and efficacy in ZYMFENTRA-treated patients.

"Establishing the long-term efficacy and safety of ZYMFENTRA represents a significant advancement in addressing the needs of millions worldwide living with Crohn's disease and ulcerative colitis," stated Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "These findings confirm the sustained efficacy and tolerability of ZYMFENTRA as maintenance therapy, underscoring Celltrion USA's dedication to providing diverse treatment options in gastroenterology."

The extension phase of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) spanned 102 weeks (including 10 weeks of IV infliximab induction), extending the initial trials. These studies evaluated the long-term efficacy and safety of infliximab subcutaneous (SC) administration in patients with CD and UC. Results at Week 102 demonstrated generally well-maintained efficacy, including clinical remission, clinical response, and corticosteroid-free remission, compared to Week 54 outcomes.

A post-hoc analysis investigated the influence of ADAs on clinical outcomes in CD patients receiving ZYMFENTRA maintenance treatment. The analysis included 231 patients (ADA-positive: n=150; ADA-negative: n=81) who received infliximab SC. Notably, at Week 54, no statistically significant differences in clinical outcomes were observed between ADA-positive and ADA-negative patients. Although mean trough serum infliximab concentrations were lower in ADA-positive patients (11.7 vs. 19.3 μg/mL; p<0.00001), both groups exceeded the therapeutic target concentration of 5 μg/mL, with comparable discontinuation rates.

"The results from the two-year extension phase of LIBERTY studies, alongside the post-hoc analysis, provide significant support for the efficacy and safety of ZYMFENTRA as a subcutaneous maintenance treatment option for CD and UC patients," noted Hetal Patel, Senior Director, Medical Affairs at Celltrion USA. "The analysis suggests that ADAs did not significantly impact clinical outcomes or discontinuation rates, potentially attributed to the relatively high trough serum infliximab concentrations achieved by ADA-positive patients."

A prospective cohort study assessed SC infliximab persistence, efficacy, and tolerance post-switch from IV infliximab in inflammatory bowel disease patients. Enrolling 426 patients, predominantly with CD, the study revealed notably high drug persistence with SC infliximab at 95.3% up to Week 48.

Digestive Disease Week® (DDW) serves as the premier international gathering of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery professionals. Jointly sponsored by prominent organizations, DDW features presentations on the latest advances in GI research, medicine, and technology.

ZYMFENTRA, a subcutaneous injection prescribed for adult patients, offers maintenance treatment for moderately to severely active UC and CD. Blocking tumor necrosis factor-alpha (TNF-alpha), ZYMFENTRA helps manage immune system responses associated with these conditions.

ZYMFENTRA (infliximab-dyyb) received FDA approval under the 351(a) pathway and boasts patent protection for its dosage form until 2037 and route of administration until 2040.



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