CT-P39 COMPARED TO REFERENCE OMALIZUMAB IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA; 40-WEEK RESULTS

Abstract

Introduction

CT-P39 is the first biosimilar to reference omalizumab (ref-OMA) approved in the European Union. Therapeutic equivalence and comparable safety, pharmacokinetics, and pharmacodynamics of CT-P39 to ref-OMA have been shown in patients with chronic spontaneous urticaria through 24-week results. Here, additional efficacy and safety data up to 40 weeks are presented.

Methods

Patients were randomized to receive 300 mg of CT-P39 (N=204) or ref-OMA (N=205) every 4 weeks. From Week 12, patients who received CT-P39 were continued on CT-P39 (N=187), and patients who received ref-OMA were re-randomized in a 1:1 ratio to switch to CT-P39 (N=96) or to continue ref-OMA (N=97). From Week 24, patients were followed up until Week 40 without dosing.

Results

The mean weekly itch-severity-scores and urticaria-activity-scores gradually decreased from the baseline during the treatment period, with similar levels among the treatment groups, and increased towards baseline during the off-dose follow-up period (Figure). The number of patients experiencing ≥1 treatment-emergent-adverse-events (TEAEs) up to Week 40 was similar across the treatment groups (84 [44.9%] in CT-P39 maintenance group, 48 [50.0%] in switched to CT-P39 from ref-OMA group, and 47 [49.0%] in ref-OMA maintenance group). Most TEAEs were grade 1 or 2 in intensity. The proportion of patients with positive anti-drug antibody results at each visit in each group was below 8%, and no clinical impact was observed.

Conclusion

CT-P39 showed comparable efficacy and safety to ref-OMA during both treatment and off-dose periods. A switch from ref-OMA to CT-P39 from Week 12 showed comparable efficacy and safety to continuing treatment with ref-OMA.