PASI Changes in Dose Adjusters • Patients who dose reduced to CZP 200 mg Q2W (n=33) achieved at least 75.9% improvement from baseline PASI at the time of first dose adjustment (Table 2). – 19/33 (57.6%) of whom showed 100% improvement from baseline PASI at the time of first dose adjustment. • Following the first dose reduction, 9/33 (27.3%) patients lost PASI 75 response and returned to CZP 400 mg Q2W (Figure 2). – 7/9 (77.8%) of these dose re-adjusters regained PASI 75 within 12 weeks of returning to CZP 400 mg Q2W (Figure 2). – 2/9 (22.2%) dose re-adjusters reduced their dose again from 400 mg to 200 mg Q2W (Figure 2). Conclusions Among patients in the CZP 400 mg Q2W escape arm, the majority of patients did not dose adjust and remained stable on CZP 400 mg Q2W throughout Weeks 48–144. In most patients who reduced the dose to CZP 200 mg Q2W and lost response, their response was regained with return to the 400 mg Q2W dose. The small sample size of this population is a limitation of these analyses, and these data should be interpreted with caution. SynopsisObjective To assess Psoriasis Area and Severity Index (PASI) at the time of, and following, dose adjustment in the open-label extension period of three phase 3 clinical trials of certolizumab pegol in psoriasis. Background • Plaque psoriasis (PSO) is an immune-mediated, inflammatory disease that affects 2−4% of adults.1 • Certolizumab pegol (CZP), an Fc-free, PEGylated anti-tumor necrosis factor biologic, has demonstrated efficacy and safety in moderate to severe PSO.2,3 • Here, we report patterns of dose adjustment between CZP 400 mg and 200 mg Q2W, and changes from baseline PASI, in phase 3 trials. Methods Study Design • Data were pooled from the CIMPASI-1 (NCT02326298), CIMPASI-2 (NCT02326272), and CIMPACT (NCT02346240) trials (Figure 1). Patient eligibility criteria have been reported previously.1,2 • Patients who were randomized to placebo at Week 0 and were PASI 50 non-responders after 16 weeks of placebo treatment entered the open-label escape arm (Weeks 16–48), where they received CZP 400 mg Q2W. • At Week 48, patients in the escape arm entered the open-label extension period, where dose adjustments were possible from Weeks 48–132, per protocol (Figure 1). Statistical Analysis • Proportions of PASI 75 responders and median changes from baseline in PASI at the time of dose adjustments are presented. Results Patient Population and Baseline Characteristics • 116 patients did not achieve PASI 50 after 16 weeks of placebo treatment and entered the open-label CZP 400 mg Q2W escape arm; baseline demographics are shown in Table 1. PASI 75 Response in Dose Non-Adjusters • 97 patients entered the open-label extension at Week 48, and the majority (66.0%; 64/97) remained on CZP 400 mg Q2W throughout the entire period (Figure 2). • 68.8% (44/64) of these patients were PASI 75 responders at Week 144 (Figure 2). A. Blauvelt,1 A.B. Gottlieb,2 F. Fierens,3 F. Brock,4 S. Wiegratz,5 H. Sofen6 BMI: body mass index; BSA: body surface area; CZP: certolizumab pegol; DLQI: Dermatology Life Quality Index; PASI: Psoriasis Area and Severity Index; PGA: Physician’s Global Assessment; PsA: psoriatic arthritis; PSO: plaque psoriasis; Q2W: every two weeks. Figure 1 Study designs Table 1 Demographics and baseline characteristics of included patients aLoading dose of CZP 400 mg Q2W at Weeks 0, 2, and 4; bDose adjustments were mandatory in patients with