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For US healthcare professionals only

Prescribing Information

UC

LIBERTY UC TRIAL

ZYMFENTRA maintenance therapy provided significant clinical benefits in patients with moderate to severe UC1

ZYMFENTRA™ achieved significant results at Week 54 in a proportion of patients:

  • 43% clinical remission
  • 36% endoscopic-histologic improvement
  • 37% corticosteroid-free remission

Proportion of patients achieving efficacy endpoints in UC

UC Efficacy Endpoints

Definitions of endpoints: Clinical remission: modified Mayo score with a stool frequency subscore of 0 or 1 point, rectal bleeding subscore of 0 point, and endoscopic subscore of 0 or 1 point. Endoscopic-histological mucosal healing: endoscopic subscore ≤ 1 and a Robarts Histopathology Index score ≤ 3 with no lamina propria neutrophils and neutrophils in epithelium subscore = 0.

Study Design: A randomized, placebo-controlled, double-blind, phase 3 study to evaluate the efficacy and safety of the subcutaneous injection of ZYMFENTRA as maintenance therapy in patients with moderately to severely active UC. Primary outcome measures were Clinical Remission (defined by modified Mayo score which ranges from 0 to 9, including stool frequency subscore, rectal bleeding subscore, and endoscopic subscore but excluding physician’s global assessment subscore from the Total Mayo score).

Corticosteroid-free remission: achieves clinical remission without corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline

CD

LIBERTY CD TRIAL

ZYMFENTRA maintenance therapy provided significant clinical benefits in patients with moderate to severe CD1

ZYMFENTRA achieved significant results at Week 54 in a proportion of patients:

  • 63% clinical remission
  • 50% endoscopic response
  • 35% endoscopic remission
  • 40% corticosteroid-free remission

Co-primary and select secondary endpoints for SC maintenance in CD

Efficacy Endpoints In CD

Definition of endpoints: Clinical remission: absolute CDAI score of <150 points. Endoscopic response: 50% decrease in SES-CD score from the baseline value. Endoscopic remission: SES-CD of 4 and at least 2-point reduction from the baseline value with no segment sub-score of >1.

Study Design: A randomized, placebo-controlled, double-blind, phase 3 study to evaluate the efficacy and safety of ZYMFENTRA as maintenance therapy in patients with moderately to severely active CD. Co-primary endpoints were clinical remission (absolute CDAI score of <150 points) and endoscopic response (≥50% decrease in SES-CD score from baseline).

Corticosteroid-free remission: achieves clinical remission without corticosteroid for at least 8 weeks at Week 54, among the patients who used oral corticosteroids at baseline

CD=Crohn’s disease; CDAI=Crohn’s Disease Activity Index; CI=confidence interval; CV%=coefficient of variation (standard deviation as a percentage of the mean); IFX=infliximab; IV=intravenous; SC=subcutaneous; SD=standard deviation; SES-CD=Simplified Endoscopic Activity Score for Crohn’s Disease; UC=ulcerative colitis; W=week.

Reference: 1. ZYMFENTRA™ Prescribing Information, Celltrion, Inc., 2023.

Important Safety Information

WARNING: SERIOUS INFECTIONS and MALIGNANCY

Contraindications

Warnings and Precautions

Common Adverse Reactions (≥3%)

Drug Interactions

For more information, see full Prescribing Information including BOXED WARNING.