Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: Effect of Demographics and Baseline Disease Characteristics on Efficacy

Abstract

Introduction: We present certolizumab pegol (CZP) efficacy data across patient demographic and baseline disease characteristic subgroups from a phase 2/3 trial investigating CZP treatment in Japanese patients with moderate to severe plaque psoriasis (PSO; ClinicalTrials.gov identifier: NCT03051217).

Methods: Patients were randomised 1:2:2 to placebo once every 2 weeks (Q2W), CZP 400 mg Q2W and CZP 200 mg Q2W (400 mg weeks 0, 2 and 4) for 16 weeks. Patients who achieved ≥ 50% reduction in their baseline Psoriasis Area and Severity Index (PASI 50) score at week 16 continued therapy to week 52. PASI 75/90 (75% and 90% reduction, respectively) and Physician's Global Assessment (PGA) 0/1 responder rates at weeks 16 and 52 were reported for patient demographic and baseline disease characteristic subgroups, including body mass index (BMI), PASI, disease duration and prior biologic use. Non-responder imputation was used.

Results: Of the randomised patients, 2/26 patients in the placebo group, 47/53 patients in the CZP 400 mg Q2W group and and 39/48 patients in the CZP 200 mg Q2W group completed week 52. In the subgroups evaluated, week 16 efficacy was generally maintained through week 52. At week 52, PASI 75 was achieved by 84.2, 85.7 and 80.0% of patients receiving CZP 400 mg Q2W in the low (15.0-23.7 kg/m2)/intermediate (> 23.7-27.4 kg/m2)/high (> 27.4-47.0 kg/m2) BMI subgroups, respectively, and by 77.8, 70.6 and 69.2%, respectively of patients treated with CZP 200 mg Q2W. PASI 75 at week 52 was achieved by 92.9, 75.0 and 84.2% of patients receiving CZP 400 mg Q2W in the low (12.0-18.0)/intermediate (> 18.0-27.0)/high (> 27.0-67.2) baseline PASI subgroups, respectively, and by 85.0, 58.3 and 68.8% of patients receiving CZP 200 mg Q2W, respectively. Similar responses were observed across other subgroups evaluated for both CZP doses in PASI 75/90 and PGA 0/1.

Conclusion: Clinically meaningful improvements in signs and symptoms of PSO were maintained through week 52 for CZP dosed at 400 mg Q2W or 200 mg Q2W, across patient subgroups. In general, a numerically greater response was observed for patients receiving CZP 400 mg Q2W versus those receiving CZP 200 mg Q2W across patient subgroups.

Trial registration: ClinicalTrials.gov identifier, NCT03051217.

Keywords: Anti-tumour necrosis factor; BMI; Certolizumab pegol; Japan; Plaque psoriasis.

© 2021. The Author(s).

Figures

Fig. 1

Response by baseline BMI. Non-responder imputation. Escapers were treated as non-responders from the time of escape onwards. Statistical significance between groups was not tested. n = number of patients in the subgroup at baseline. Patients were classified into tertiles based on baseline BMI values: 15.0–23.7, > 23.7–27.4 and > 27.4–47.0 kg/m2. Only 2 patients continued placebo treatment to week 52; therefore placebo data are not shown for week 52. BMI Body mass index, CZP certolizumab pegol, PASI Psoriasis Area and Severity Index, PASI 75/90 at least 75%/90% improvement from baseline PASI, PGA Physician’s Global Assessment, Q2W once every 2 weeks

Fig. 2

Response by baseline PASI. Non-responder imputation. Escapers were treated as non-responders from the time of escape onwards. Statistical significance between groups was not tested. n = number of patients in the subgroup at baseline. Patients were classified into tertiles based on baseline PASI values: 12.0–18.0, > 18.0–27.0 and > 27.0–67.2. Only 2 patients continued placebo treatment to week 52; therefore placebo data are not shown for week 52

Fig. 3

Response by baseline disease duration. Non-responder imputation. Escapers were treated as non-responders from the time of escape onwards. Statistical significance between groups was not tested. n = number of patients in the subgroup at baseline. Patients were classified based on the baseline median disease duration: ≤ 10.7 years and > 10.7 years. Only 2 patients continued placebo treatment to week 52; therefore placebo data are not shown for week 52

Fig. 4

Response by prior biologic exposure at baseline. Non-responder imputation. Escapers were treated as non-responders from the time of escape onwards. Statistical significance between groups was not tested. n = number of patients in the subgroup at baseline. Patients were grouped based on prior biologic exposure: never used/No or used/Yes (≥ 1 therapy). Only 2 patients continued placebo treatment to week 52; therefore placebo data are not shown for week 52