Synopsis SF-36 is a widely used, general questionnaire to assess HRQoL across 8 mental and physical domains.4 Scores in each domain range from 0–100 and were derived to have a mean score of 50 in the US general population.4 Increased scores represent an improvement in HRQoL. Conclusions Improvements across all SF-36 domains were observed from Week 8 of CZP treatment, and were generally durable through Week 144. The greatest improvements were for bodily pain and social functioning, which were the most affected at baseline. These data complement the three-year DLQI results previously reported.1 Objectives To assess health-related quality of life over 144 weeks using data from two certolizumab pegol phase 3 trials in moderate to severe plaque psoriasis with the 36-item Short Form survey data. Background • The Fc-free, PEGylated anti-tumor necrosis factor (TNF) agent certolizumab pegol (CZP) has shown durable clinical improvements, and a safety profile consistent with the anti-TNF class, over 144 weeks of treatment in patients with moderate to severe plaque psoriasis (PSO).1,2 • PSO can negatively impact health-related quality of life (HRQoL), with links to pain and discomfort, social stigmatisation, and psychological distress.3 Therefore, it is important to understand whether clinical responses translate into long-term improvements in HRQoL. • Durable improvements in HRQoL have been reported over 144 weeks of CZP treatment using the Dermatology Life Quality Index (DLQI).1 • To complement these positive DLQI results, we report results from the 36-item Short Form survey (SF-36).4 Methods • Data were pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase 3 trials (Figure 1).1 • We report mean change from baseline across all SF-36 domains: – For all patients randomized to CZP (combined 200 mg and 400 mg every two weeks [Q2W]) through Weeks 0–144. – At Week 48 separately for patients randomized to CZP 200 mg or CZP 400 mg Q2W. • All data are observed case (OC). Results Patient Population • Baseline demographics (Table 1) and SF-36 values (Table 2) were balanced across treatment groups. All CZP-Randomized Patients to Three Years • Increases in SF-36 domain scores were rapid for patients receiving CZP, with improvements apparent from Week 8 (Figure 2A and Figure 2B). • Improvements at Week 16 were greater for CZP-treated patients compared with placebo across all domains, and were durable to Week 144 (Figure 2A and Figure 2B). CZP Dose Comparison after One Year • At Week 48, greater improvements in all mental SF-36 domains were observed among patients randomized to CZP 400 mg Q2W compared with CZP 200 mg Q2W (Figure 3). • Improvements were also observed across physical domains at Week 48, although differences between the two dose groups were smaller (Figure 3). D. Thaçi,1 A. Blauvelt,2 K. Reich,3 R.B. Warren,4 V. Piguet,5,6 F. Brock,7 F. Fierens,8 V. Ciaravino,9 M. Lebwohl10 BSA: body surface area; CZP: certolizumab pegol; DLQI: Dermatology Life Quality Index; OC: observed case; PASI: Psoriasis Area and Severity Index; PASI 50/75: ≥50/75% improvement from baseline in PASI; Q2W: every two weeks; PGA: Physician’s Global Assessment; PSO: plaque psoriasis; SD: standard deviation; SF-36: 36-item Short Form survey; TNF: tumor necrosis factor. Figure 1 CIMPASI-1 and CIMPASI-2 study design Institutions: 1Institute and Comprehensive Center for Inflammation Medicine, University Hospital of Lübeck, Lübeck, Germany; 2Oregon Medical Research Center, Portland, Oregon, USA; 3Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany; 4Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK; 5Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada; 6Division of Dermatology, Department of Medicine, Women’s College Hospital, Toronto, Ontario, Canada; 7UCB Pharma, Slough, UK; 8UCB Pharma, Brussels, Belgium; 9UCB Pharma, Colombes, France; 10Icahn School of Medicine at Mount Sinai, New York, New York, USA Long-Term Improvements in Health-Related Quality of Life of Patients with Moderate to Severe Plaque Psoriasis Treated with Certolizumab Pegol: Results from the CIMPASI-1 and CIMPASI-2 Phase 3 Trials Presented at Winter Clinical 2021 Virtual Congress | January 16–24 References: 1Gordon K. Br J Dermatol 2020; doi.org/10.1111/bjd.19393; 2Blauvelt A. Br J Dermatol 2020; doi.org/10.1111/bjd. 19314; 3Bhosle MJ. Health Qual Life Outcomes 2006;4:35; 4Optum. SF-36v2 Health Survey. Available at www.optum.com/solutions/life-sciences/answer-research/patient-insights/sf-health-surveys/sf-36v2-health-survey [Accessed 25th March 2020]. Author Contributions: Substantial contributions to study conception/design, or acquisition/analysis/interpretation of data: DT, AB, KR, RBW, VP, FB, FF, VC, ML; Drafting of the publication, or revising it critically for important intellectual content: DT, AB, KR, RBW, VP, FB, FF, VC, ML; Final approval of the publication: DT, AB, KR, RBW, VP, FB, FF, VC, ML. Author Disclosures: DT: Honoraria for participation on advisory boards, as a speaker and for consultancy from AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, DS Biopharma, Eli Lilly, Galapagos, Janssen, LEO Pharma, Morphosis, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi Genzyme, and UCB Pharma; research grants received from Celgene, LEO Pharma, and Novartis. AB: Scientific adviser and/or clinical study investigator for AbbVie, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Forte, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma; paid speaker for AbbVie. KR: Served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Covagen, Dermira, Eli Lilly, Forward Pharma, Fresenius Medical Care, Galapagos, GSK, Janssen, Kyowa Kirin, LEO Pharma, Medac, MSD, Miltenyi Biotec, Novartis, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB Pharma, Valeant/Bausch Health, and Xenoport. RBW: Consulting fees from AbbVie, Almirall, Amgen, Arena, Avillion, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB Pharma; research grants from AbbVie, Almirall, Amgen, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, and UCB Pharma. FB, FF, VC: Employees of UCB Pharma. ML: Employee of Mount Sinai which receives research funds from AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen, LEO Pharma, Ortho Dermatologics, Pfizer, and UCB Pharma; consultant for Aditum Bio, Allergan, Almirall, Arcutis, Avotres, BirchBioMed, BMD Skincare, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant, Evelo, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi Pharma, Neuroderm, Pfizer, Promius/Dr. Reddy’s Laboratories, Serono, Theravance, and Verrica. Acknowledgements: This study was funded by UCB Pharma. We thank the patients and their caregivers in addition to the investigators and their teams who contributed to this study. The authors acknowledge Mylene Serna, PharmD, UCB Pharma, Smyrna, GA, USA and Susanne Wiegratz, MSc, UCB Pharma, Monheim am Rhein, Germany for publication coordination, Ruth Moulson, MPH, Costello Medical, London, UK and Joe Dixon, PhD, Costello Medical, Cambridge, UK for medical writing and editorial assistance, and the Costello Medical Design Team for design support. All costs associated with development of this poster were funded by UCB Pharma. Previously presented at EADV 2020 Virtual Congress | October 29–31 Table 1 Demographics and baseline characteristics aDose adjustments were mandatory or at the investigator’s discretion, based on PASI response; bLoading dose of CZP 400 mg Q2W at Weeks 0, 2, and 4 or Weeks 16, 18, and 20. Adults with PSO ≥6 months (PASI >12, BSA affected ≥10% and PGA ≥3 on a 5-point scale) were enrolled. At Week 48 patients entering the open-label period from blinded treatment received CZP 200 mg Q2W, with subsequent dose adjustments permitted. Patients not achieving PASI 50 at Week 16 entered the escape arm for treatment with CZP 400 mg Q2W; at Week 48 these patients continued to receive CZP 400 mg Q2W or, if they achieved PASI 75, could have had their dose reduced at the investigator’s discretion. Figure 2 Mean change from baseline in SF-36 domain scores (OC) A) Mental domains Table 2 Baseline SF-36 scores across all domains (OC) aCZP 200 mg Q2W patients received CZP 400 mg Q2W at Weeks 0, 2, and 4. B) Physical domains C) Patient numbers with available SF-36 data The All CZP group includes all patients initially randomized to CZP 200 mg Q2W or CZP 400 mg Q2W. Patient numbers reflect those for whom SF-36 data were available at both baseline and the timepoint in question, from which change from baseline could be calculated. Placebo data are not shown past Week 16. Figure 3 Mean change from baseline in SF-36 domain scores at Week 48 by dose (OC) Data are shown as observed for patients randomized to either CZP 200 mg or 400 mg Q2W, including those that entered the open-label CZP 400 mg Q2W escape arm at Week 16. Patient numbers reflect those for whom data were available at both baseline and Week 48, from which change from baseline could be calculated. Mean ± SD unless stated CZP 200 mg Q2W (n=186)a CZP 400 mg Q2W (n=175) All CZP (n=361) Placebo (n=100) Demographics Age, years 45.6 ± 13.2 45.0 ± 12.9 45.3 ± 13.0 45.7 ± 13.8 Male, n (%) 125 (67.2) 103 (58.9) 228 (63.2) 61 (61.0) BMI, kg/m2 32.0 ± 7.8 31.2 ± 7.9 31.6 ± 7.8 31.2 ± 7.4 Baseline characteristics Disease duration, years 17.7 ± 12.9 18.5 ± 12.6 18.1 ± 12.7 16.9 ± 12.6 PASI 19.2 ± 7.2 19.6 ± 7.3 19.4 ± 7.3 18.6 ± 6.6 DLQI 14.3 ± 7.4 13.7 ± 6.9 14.0 ± 7.1 13.4 ± 7.8 BSA (%) affected 23.5 ± 14.9 23.6 ± 14.3 23.5 ± 14.6 23.1 ± 13.6 PGA, n (%) 3: moderate 128 (68.8) 126 (72.0) 254 (70.4) 72 (72.0) 4: severe 58 (31.2) 49 (28.0) 107 (29.6) 28 (28.0) Prior anti-TNF-use, n (%) 44 (23.7) 40 (22.9) 84 (23.3) 19 (19.0) Mean ± SD CZP 200 mg Q2W (n=183) CZP 400 mg Q2W (n=173) All CZP (n=356) Placebo (n=97) SF-36 Domain Vitality 48.5 ± 9.8 47.6 ± 10.0 48.1 ± 9.9 47.2 ± 9.7 Social functioning 45.4 ± 11.1 45.1 ± 11.0 45.2 ± 11.0 45.0 ± 11.7 Role emotional 46.8 ± 10.4 46.1 ± 10.8 46.4 ± 10.6 46.7 ± 10.3 Mental health 46.8 ± 10.7 46.3 ± 10.1 46.5 ± 10.4 44.9 ± 12.0 Physical functioning 47.7 ± 9.6 49.1 ± 9.4 48.4 ± 9.5 48.5 ± 8.8 Role physical 46.7 ± 9.5 47.3 ± 10.0 47.0 ± 9.7 47.1 ± 8.8 Bodily pain 45.3 ± 10.4 46.6 ± 11.1 45.9 ± 10.7 45.5 ± 10.7 General health 47.1 ± 10.1 47.5 ± 9.3 47.3 ± 9.7 46.4 ± 10.4 Study Week 0 8 12 16 24 32 48 72 96 120 144 All CZP 356 339 340 339 319 307 295 275 256 238 221 Placebo 97 92 88 87 - - - - - - - Physical domainsMental domains 8 7 6 5 4 3 2 1 Physical functioning Role physical Bodily pain General healthVitality Social functioning Role emotional Mental health CZP 200 mg Q2W (n=149) CZP 400 mg Q2W (n=146) M e a n c h a n g e f ro m b a se lin e Week 168 4832 72 12096 144 All CZP Placebo Bodily pain Role physical General health Physical functioning 0 8 6 4 2 0 Open-label period with possible dose adjustment 6 4 2 0 8 -1 M e a n c h a n g e f ro m b a se lin e Week 160 8 4832 72 12096 144 All CZP Placebo Role emotional Social functioning Mental health Vitality 6 4 2 0 8 Open-label period with possible dose adjustment -1