Certolizumab pegol for the treatment of patients with moderate‐to‐severe chronic plaque psoriasis: pooled analysis of week 16 data from three randomized controlled trials

Abstract

Background Certolizumab pegol, an Fc‐free, PEG ylated, anti‐tumour necrosis factor ( TNF ) biologic, has demonstrated favourable results in three ongoing, phase 3, randomized, double‐blinded, placebo‐controlled trials in adults with psoriasis. Objective Data were pooled from the ongoing trials to investigate efficacy in selected subgroups and add precision to estimates of treatment effects during the initial 16 weeks of treatment. Methods In each trial, patients ≥18 years with moderate‐to‐severe chronic plaque psoriasis for ≥6 months were randomized to receive certolizumab 400 mg, certolizumab 200 mg or placebo every 2 weeks for 16 weeks. Coprimary endpoints for the pooled analysis were responder rates at Week 16, defined as ≥75% reduction in psoriasis area and severity index ( PASI 75) and physician global assessment ( PGA ) of 0/1 (‘clear’/‘almost clear’ with ≥2‐category improvement). Safety was assessed by treatment‐emergent adverse events. Results A total of 850 patients treated with certolizumab 400 mg ( N = 342), certolizumab 200 mg ( N = 351) or placebo ( N = 157) were included in the pooled analysis. At Week 16, PASI 75 and PGA 0/1 responder rates were 80.1% and 63.7% in the certolizumab 400 mg group, 74.5% and 54.6% in the certolizumab 200 mg group, and 7.5% and 2.8% in the placebo group ( P < 0.0001 for each dose versus placebo). In patients with and without prior biologic therapy, both doses of certolizumab resulted in substantially higher responder rates versus placebo. The incidence of adverse events was generally similar between the 400 mg and placebo groups, and somewhat lower in the 200 mg group versus placebo. No new safety signals were identified. Conclusion Certolizumab pegol 400 mg or 200 mg every 2 weeks for 16 weeks was associated with statistically significant and clinically meaningful improvements in signs and symptoms of psoriasis in patients with and without prior biologic therapy, and a safety profile consistent with the anti‐ TNF class in psoriasis.

Prevalence of Advanced Liver Fibrosis in Patients With Severe Psoriasis

“…The strengths of this study are the systematic evaluation of clinical factors associated with advanced fibrosis in a population with severe psoriasis that has been accurately phenotyped. Demographics in our cohort are comparable with those of a reference population (BSTOP study; N = 3722) but also with phase 3 trial populations in North America and Europe, 16 supporting the generalizability of our findings. This study had low levels of missing data.…”

“…We suggest that clinicians managing patients with severe psoriasis, cognizant of psoriasisassociated complications, engage with their management to improve outcomes for patients. Waist circumference, mean (SD), cm 99.5 (15) 101 (16) .09…”

Certolizumab Pegol for the Treatment of Moderate to Severe Plaque Psoriasis: 16-Week Results from a Phase 2/3 Japanese Study

“…Three phase 3 trials, conducted in North America and Europe, have evaluated CZP in moderate to severe PSO over the long-term (CIMPASI-1 [NCT02326298], CIMPASI-2 [NCT02326272], and CIMPACT [NCT02346240]). In these 3-year trials, with a combined total of 1020 randomized patients, CZP has demonstrated favorable efficacy, and a safety profile consistent with the anti-TNF class, with data currently reported through 48 weeks [ 26 – 28 ]. Here, we report efficacy and safety results from the initial 16 weeks of a 52-week phase 2/3 trial of CZP in Japanese patients with moderate to severe PSO (NCT03051217); this study is the first to evaluate CZP for the treatment of psoriasis in this patient population.…”

Certolizumab for the treatment of psoriasis and psoriatic arthritis: a real‐world multicentre Italian study

“…15 In a pooled analysis of these three phase III trials (CIMPASI-1, CIMPASI-2 and CIM-PACT), which included 850 patients who received treatment with certolizumab or placebo, both doses of certolizumab gave statistically significant and clinically meaningful improvements in PASI75 and PGA responder rates compared with placebo after 16 weeks' treatment (75-80% vs. 8% and 55-64% vs. 3%, respectively; all P < 0.0001). 24 The rapid and sustained efficacy of certolizumab in our patient cohort can reassure clinicians that many of their patients are likely to experience improvements with 'real-world' use of the drug at a rheumatologic dose (i.e. 400 mg every 2 weeks for the first 4 weeks and 200 mg every 2 weeks thereafter) and that its efficacy is not limited to the dosage regimens used in the clinical trials mentioned above.…”