Durable Efficacy of Certolizumab Pegol Dosed at 400 mg Every Two Weeks Over 128 Weeks in Patients with Plaque Psoriasis Enrolled in Three Phase 3 Trials (CIMPASI-1, CIMPASI-2 and CIMPACT)

OBJECTIVE• To assess the long-term efficacy of and durability of response to certolizumab pegol dosed at 400 mg every two weeks in patients with moderate to severe plaque psoriasis who achieve PASI 75 after an initial 16 weeks of treatment.OutcomesOutcomes are reported for Week 0 placebo-randomized patients who did not achieve PASI 50 at Week 16, and entered the CZP 400 mg Q2W escape arm (Weeks 16-144).• We report PASI 75, PASI 90, PGA 0/1 and Dermatology Life Quality Index (DLQI) 0/1 responses to Week 144.• Missing data were imputed using Markov Chain Monte Carlo (MCMC) methodology.• Responder rates reflect the simple average response and include patients who did and did not dose adjust during the open-label period. RESULTS• 116 placebo-randomized patients had a PASI <50 at Week 16 and entered the CZP 400 mg Q2W escape arm.• Baseline characteristics of included patients are shown in Table 1.• Patients demonstrated a rapid response during the first 16 weeks of CZP 400 mg Q2W treatment, with 74.7% achieving a PASI 75 response and 48.7% a PASI 90 response.-These responses were durable over 128 weeks of treatment: PASI 75 and PASI 90 responses were 75.5% and 57.6%, respectively, at Week 144 (Figure 2).• Of the patients who achieved PASI 75 after 16 weeks' CZP treatment, 65.9% also achieved PASI 90.-After a further 128 weeks' CZP treatment, 82.4% of these patients maintained PASI 75 and 64.4% achieved PASI 90 (Figure 2).• Similar trends were reported for PGA 0/1 (Figure 3) and DLQI 0/1 (Figure 4). BACKGROUND• Certolizumab pegol (CZP), an Fc-free, PEGylated anti-tumor necrosis factor (anti-TNF), has demonstrated efficacy and safety in moderate to severe plaque psoriasis (PSO).1,2 METHODS Study Design• Pooled data from the CIMPASI-1 (NCT02326298), CIMPASI-2 (NCT02326272), or CIMPACT (NCT02346240) phase 3 studies are reported (Figure 1).• Patient inclusion criteria: -≥18 years of age with PSO for ≥6 months; -Psoriasis Area and Severity Index (PASI) ≥12; -≥10% body surface area (BSA) affected; -Physician's Global Assessment (PGA) ≥3 on a 5-point scale; -Candidates for systemic PSO therapy, phototherapy and/or photochemotherapy.References 1.

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