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Objective The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA. Methods RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease. The assessed outcomes included ASAS20, ASAS40, AS DAS (ASDAS), BASDAI, BASFI and BASMI scores, along with selected measures of remission. Further patient-reported outcomes, peripheral arthritis, enthesitis, uveitis and quality-of-life measures are also reported. Results Two hundred and eighteen of 325 patients randomized (AS: 121; nr-axSpA: 97) received certolizumab pegol from week 0. Of these, 65% remained in the study at week 204 (AS: 67%; nr-axSpA: 63%). Across all outcomes, for AS and nr-axSpA, sustained improvements were observed to week 204 [week 204 overall axSpA: ASAS20: 54.1% (non-responder imputation); 83.7% (observed case, OC); ASAS40: 44.0% (non-responder imputation); 68.1% (OC); ASDAS inactive disease: 32.1% (last observation carried forward); 31.4% (OC)]. In the safety set (n = 315), there were 292.8 adverse events and 10.4 serious adverse events per 100 patient-years. No deaths were reported. Conclusion In the first study to evaluate the efficacy of an anti-TNF across both axSpA subpopulations, improvements in clinical and patient-reported outcomes at 24 and 96 weeks were sustained through 4 years of treatment, with no new safety signals. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT01087762.

Background Disease Activity Index for Psoriatic Arthritis (DAPSA) 1 and the minimal disease activity (MDA) criteria 2 are instruments recommended for evaluating disease activity in psoriatic arthritis (PsA). The RAPID-PsA trial (NCT01087788) has demonstrated the sustained efficacy of certolizumab pegol (CZP) across the spectrum of PsA symptoms. 3,4 Objectives To report the proportion of CZP-treated patients (pts) achieving DAPSA remission (REM), DAPSA low disease activity (LDA), MDA (fulfilling ≥5/7 MDA criteria), and very low disease activity (VLDA; fulfilling 7/7 MDA criteria) over 216 weeks (wks) in RAPID-PsA. Methods RAPID-PsA was double-blind and placebo-controlled to Wk24, dose-blind to Wk48, and open-label (OL) to Wk216. Pts had active PsA and had failed ≥1 disease modifying anti-rheumatic drug. Data for pts randomised to CZP at Wk0 (200 mg every 2 wks or 400 mg every 4 wks, following a 400 mg loading dose at Wks0, 2, 4), who continued their assigned dose in the OL period, are presented as observed case and with imputation (figure 1). Outcomes reported are DAPSA (the sum of tender and swollen joint counts [TJC 68; SJC 66], pt global and pain assessment [10 cm visual analogue scale], and C-reactive protein levels [mg/dL]), and pts achieving: 1) DAPSA LDA (DAPSA>4 and≤14); 2) DAPSA REM (DAPSA≤4); 3) MDA (fulfilling ≥5/7 MDA criteria); and 4) VLDA (fulfilling 7/7 MDA criteria), to Wk216. Pts withdrawing from the study between scheduled visits had their final observed assessment values assigned to the next scheduled visit timepoint. Results Of 409 pts randomised; 273 received CZP from Wk0, of whom 248 (90.8%) completed Wk24, 237 (86.8%) completed Wk48, and 183 (67.0%) completed Wk216. The mean (SD) baseline DAPSA was 44.8 (22.9). Of pts completing Wk24, 29.7% (74/249) achieved LDA; 25.3% (63/249) REM; 38.2% (95/249) MDA; and 14.9% (37/249) VLDA. At Wk216, 31.9% (59/185) achieved LDA; 44.3% (82/185) REM; 57.8% (107/185) MDA; and 29.0% (58/183) VLDA (figure 1). Conclusions A substantial proportion of pts who completed the 4 year study achieved disease inactivity targets:~75% achieved DAPSA LDA or REM, almost 60% achieved MDA, and half of those also achieved VLDA. References [1] Schoels MM. Ann Rheum Dis2016;75(5):811–18. [2] Coates LC. Ann Rheum Dis2010;69(01):48–53. [3] Mease PJ. Ann Rheum Dis2016;75:608. [4] FitzGerald O. JAAD2017;76(6):AB264. 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. Editorial services were provided by Costello Medical. Disclosure of Interest D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis, UCB Pharma, Employee of: Director of Imaging Rheumatology B.V., A. Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB Pharma, Consultant for: Eli Lilly, Janssen, Novartis, Pfizer, UCB Pharma, O. FitzGerald Grant/research support from: AbbVie, Bristol-Myers Squibb, Janssen, Pfizer, Consultant for: AbbVie, Celgene, Amgen, Eli Lilly, Janssen, Pfizer, UCB Pharma, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Pfizer, UCB Pharma, R. Fleischmann Grant/research support from: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Eli Lilly, Genentech, Janssen, MSD Pharmaceuticals, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB Pharma, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sanofi-Aventis, D. Gladman Grant/research support from: Abbott, Amgen, Bristol-Myers Squibb, Celgene, Johnson and Johnson, MSD, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott, Bristol-Myers Squibb, Celgene, Johnson and Johnson, MSD, Novartis, Pfizer, UCB Pharma, A. Gottlieb Grant/research support from: Abbott, Aclaris, Actelion, Akros, Amiscus, Amgen, Astellas, Baxalta, Beiersdorf, Bristol-Myers Squibb, Canfite, Catabasis, Celgene, Coronado, Crescendo Bioscience, CSL Behring Biotherapies for Life, Dermipsor, Dermira, Eli Lilly, Genentech, GlaxoSmithKline, Incyte, Janssen, Karyopharm, KinetaOne, KPI Therapeutics, Levia, Meiji Seika Pharma Co., Merck, Mitsubishi Tanabe, Novartis, Novo Nordisk, Pfizer, Reddy, Takeda, TEVA, UCB Pharma, Vertex, Xenoport, Consultant for: Abbott, Aclaris, Actelion, Akros, Amiscus, Amgen, Astellas, Baxalta, Beiersdorf, Bristol-Myers Squibb, Canfite, Catabasis, Celgene, Coronado, Crescendo Bioscience, CSL Behring Biotherapies for Life, Dermipsor, Dermira, Eli Lilly, Genentech, GlaxoSmithKline, Incyte, Janssen, Karyopharm, KinetaOne, KPI Therapeutics, Levia, Meiji Seika Pharma Co., Merck, Mitsubishi Tanabe, Novartis, Novo Nordisk, Pfizer, Reddy, Takeda, TEVA, UCB Pharma, Vertex, Xenoport, L. Coates Grant/research support from: AbbVie, Janssen, Novartis, Pfizer, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Prothena, Sun Pharma, UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Bauer Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, M. Khraishi Grant/research support from: Abbott, Amgen, Pfizer, Consultant for: Abbott, Amgen, Pfizer, P. Mease Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, Sun, UCB Pharma, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, Sun, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer, UCB Pharma

Background Certolizumab pegol, an Fc‐free, PEGylated, 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

Objective.The product of physician’s global assessment and body surface area (PGA×BSA) to assess psoriasis severity has previously been investigated in patients with psoriasis, with the aim of assessing PGA×BSA as an alternative to the time-consuming Psoriasis Area and Severity Index (PASI). Here, we investigate PGA×BSA as an alternative to PASI in patients with psoriatic arthritis (PsA).Methods.Analyses used data from the double-blind, placebo-controlled, RAPID-PsA trial (NCT01087788) that investigated the efficacy of certolizumab pegol (CZP) in patients with PsA. Outcomes assessed whether the PGA×BSA and PASI results were comparable, and whether these outcomes correlated with one another or with the Dermatology Life Quality Index (DLQI).Results.For CZP-treated patients, both PGA×BSA and PASI demonstrated similar sensitivities to treatment between baseline and Week 24, with mean improvements of 77.4% and 69.0%, respectively. Similar improvements were also seen with placebo (PGA×BSA: 3.2%, PASI: 6.1%). Achievement of 75% response criterion in PGA×BSA and PASI was attained by similar proportions of patients with CZP (PGA×BSA75: 59.0%, PASI75: 61.4%) and placebo (PGA × BSA75: 15.1%, PASI75: 15.1%). Cross tabulations showed high concordance between achievement of response outcomes in PGA×BSA and PASI (79.6–95.2%). Spearman correlations revealed strong correlations between PGA×BSA and PASI at baseline (r = 0.78; n = 225) and percentage improvement to Week 24 (r = 0.85; n = 186). Both outcomes were only moderately correlated with DLQI (r = 0.41–0.50; n = 179–249).Conclusion.PGA×BSA is sensitive to changes in skin manifestations in patients with PsA treated with CZP. Further, PGA×BSA correlates strongly with PASI, and achievement of 75% improvement was similar for PGA×BSA and PASI.

Background Certolizumab pegol, the only Fc-free, PEGylated anti–tumor necrosis factor biologic, demonstrated clinically meaningful improvements suggestive of a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis. Objective Assess certolizumab efficacy and safety versus placebo in phase 3 studies. Methods Patients with moderate-to-severe chronic plaque psoriasis were randomized 2:2:1 to certolizumab 400 mg, certolizumab 200 mg, or placebo every 2 weeks. At week 16, certolizumab-treated patients achieving a 50% reduction in Psoriasis Area and Severity Index continued treatment through week 48. Coprimary endpoints were week 16 responder rates, defined as a 75% reduction in Psoriasis Area and Severity Index and Physician's Global Assessment 0/1 (clear/almost clear) and ≥2-point improvement. Safety was assessed by treatment-emergent adverse events. Results Week-16 endpoints were significantly greater for both doses of certolizumab versus placebo, and the responses were maintained through week 48. For most measures, improvement was numerically greater for certolizumab 400 mg. No unexpected safety signals were identified. Limitation There was no active comparator. Conclusion Treatment with either certolizumab 400 mg or 200 mg every 2 weeks was associated with significant and clinically meaningful improvements in moderate-to-severe psoriasis. The 400-mg dose could provide additional clinical benefit. The safety profile was consistent with the therapeutic class.

Background Extra-articular manifestations (EAMs) of psoriatic arthritis (PsA) include nail psoriasis, dactylitis, and enthesitis, which can significantly impact patients9 (pts9) quality of life. 1 In the RAPID-PsA trial (NCT01087788), certolizumab pegol (CZP) improved the signs and symptoms of EAMs in pts with PsA over 96 weeks (wks). 2 Objectives To report improvements in EAMs of PsA in pts treated with CZP over 4 years, both with and without prior anti-TNF exposure. Methods The RAPID-PsA trial was double-blind and placebo-controlled to Wk24, dose-blind to Wk48, and open-label (OL) to Wk216. Pts had active PsA and had failed ≥1 DMARD. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks0, 2, 4) continued their assigned dose in the OL period. We present EAM data for those pts originally randomized to CZP, with involvement of the particular EAM at baseline (BL), and both with and without prior anti-TNF exposure. EAMs assessed include nail psoriasis (modified Nail Psoriasis Severity Index [mNAPSI], BL involvement = BL mNAPSI >0), enthesitis (Leeds Enthesitis Index [LEI], BL involvement = BL LEI >0), and dactylitis (Leeds Dactylitis Index [LDI], BL involvement = ≥1 digit affected with a difference in circumference ≥10% compared to the opposite digit). Also presented are the proportions of pts with BL involvement of each EAM who achieved total resolution of the respective EAM on follow-up (a score of 0 for mNAPSI, LEI, or LDI). Observed values are reported, combined for pts receiving either CZP dose regimen. Results A total of 409 PsA pts were randomized; 273 received CZP from Wk0. Among CZP-randomized pts, 197 had nail psoriasis at BL (159 without, and 38 with, prior anti-TNF exposure), 172 had enthesitis (133 without, and 39 with, prior anti-TNF exposure), and 73 had dactylitis (56 without, and 17 with, prior anti-TNF exposure). Although relatively few pts were anti-TNF experienced, a large proportion of pts both with and without prior anti-TNF exposure with BL involvement went on to achieve total resolution of the respective EAM following 48 wks of CZP treatment (Table). Among pts completing the study, the proportions achieving total resolution were maintained or further increased from Wk48 to Wk216 (Table). Mean scores of all EAMs assessed showed improvements by Wk48 of CZP treatment in pts both with and without prior anti-TNF exposure, which were maintained to Wk216 in pts completing the study (Table). Conclusions PsA patients treated with CZP for up to 4 years, both with and without prior anti-TNF exposure, exhibited sustained improvements in the extra-articular manifestations of PsA. References Ritchlin C. Ann Rheum Dis 2009;68:1387–94. FitzGerald O. Ann Rheum Dis 2015;74(2):349. 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. Editorial services were provided by Costello Medical Consulting. Disclosure of Interest O. FitzGerald Grant/research support from: AbbVie, Bristol Myers Squibb, Janssen, Novartis, Pfizer, Consultant for: AbbVie, Celgene, Janssen, Pfizer, Roche, UCB Pharma, Speakers bureau: AbbVie, Celgene, Janssen, Pfizer and UCB Pharma, R. Fleischmann Grant/research support from: Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech, Janssen, MSD Pharmaceuticals, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB Pharma, Consultant for: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Sanofi-Aventis, UCB Pharma, A. Kavanaugh Grant/research support from: Abbott, Amgen, Bristol-Myers Squibb, Janssen, Pfizer, Roche, UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, D. Gladman Grant/research support from: Abbott, Bristol-Myers Squibb, Celgene, Johnson & Johnson, MSD Pharmaceuticals, Novartis, Pfizer, and UCB Pharma, Consultant for: Abbott, Bristol-Myers Squibb, Celgene, Johnson & Johnson, MSD Pharmaceuticals, Novartis, Pfizer, and UCB Pharma

Background The RAPID-PsA trial (NCT01087788) investigated the efficacy and safety of certolizumab pegol (CZP) in patients (pts) with psoriatic arthritis (PsA). It demonstrated that CZP treatment inhibits radiographic progression over 96 weeks (wks). 1 Objectives We report the long-term effect of CZP treatment on radiographic progression in pts with PsA over 4 years. Methods The RAPID-PsA phase 3 trial was double-blind and placebo-controlled to Wk24, dose-blind to Wk48, and open-label (OL) to Wk216. Pts had active PsA and had failed ≥1 DMARD. Pts randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks0, 2, 4) continued their assigned dose in the OL period. Radiographs taken at baseline (BL), and at Wks96, 168, 216, were read in a single reading campaign using the modified Total Sharp Score (mTSS) for PsA by 2 readers, blinded to patient information and time point sequence. The mean of the scores of the 2 readers was used. Outcomes reported are the least squares (LS) mean mTSS score, change from BL (CFB) in mTSS score, and the percentage of pts assessed for radiographic damage who achieved mTSS non-progression (defined either as CFB in mTSS score ≤0.5 or ≤0), for all Wk0 CZP-treated pts, irrespective of dose regimen. mTSS score and CFB were estimated using Mixed Model Repeated Measures (MMRM) estimates; proportions of pts with radiographic non-progression are presented as observed case. Results 409 PsA pts were randomized, of whom 273 received CZP from Wk0. The LS mean BL mTSS score was 16.0 and there was little increase from BL in mTSS score to Wk216 (Table). Amongst those who completed the study to Wk216, the majority of CZP-treated pts achieved radiographic non-progression to Wk216, both with non-progression defined as CFB in mTSS score ≤0.5 or ≤0 (Table). The change in LS mean mTSS score over time for Wk0 CZP-treated pts was consistently low throughout the trial: 0.14 (95% CI: 0.02–0.26) per 48 wks from BL to Wk96, and 0.18 (95% CI: 0.08–0.28) per 48 wks from Wk96 to Wk216. Conclusions There was little radiographic progression in CZP-treated PsA pts, as measured by mTSS, throughout the 4-year RAPID-PsA trial. References Mease P. RMD Open 2015;1:e000119;doi:10.1136/rmdopen-2015–000119. 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. Editorial services were provided by Costello Medical Consulting. Disclosure of Interest D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, UCB Pharma, Employee of: Director of Imaging Rheumatology B.V., R. Fleischmann Grant/research support from: Genentech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, Bristol-Myers Squibb, Eli Lilly, Sanofi-Aventis, MSD Pharmaceuticals, Novartis, AstraZeneca, Janssen, Consultant for: Roche, Abbott, Amgen, UCB Pharma, Pfizer, Bristol-Myers Squibb, Eli Lilly, Sanofi-Aventis, Novartis, AstraZeneca, Janssen, J. Wollenhaupt Grant/research support from: UCB Pharma, Consultant for: UCB Pharma, A. Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB Pharma, Consultant for: Eli Lilly, Janssen, Novartis, Pfizer, UCB Pharma, L. Bauer Employee of: UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, P. Mease Grant/research support from: (Abbott) AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, Sun, UCB Pharma, Consultant for: (Abbott) AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo, Corrona, Dermira, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Sun, UCB Pharma, Zynerba, Speakers bureau: (Abbott) AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo, Genentech Inc, Janssen, Novartis, Pfizer, UCB Pharma

Background Psoriatic arthritis (PsA) is a heterogeneous inflammatory disease that has a substantial impact on patients9 (pts) physical and emotional wellbeing. 1 Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-TNF that has been shown to improve patient-reported outcomes (PROs) in pts with PsA over 96 weeks (wks) of treatment in the RAPID-PsA study (NCT01087788). 2 Objectives To investigate whether initial improvements in PROs observed with CZP treatment were maintained over 4 years in the RAPID-PsA study. Methods RAPID-PsA was double-blind and placebo-controlled to Wk24, dose-blind to Wk48, and open-label to Wk216. Pts were aged ≥18 years, with a diagnosis of active PsA, and had failed treatment with ≥1 DMARD. Pts originally randomized to CZP (400mg at Wks0,2,4 [loading dose] followed by either 200mg every 2 wks [Q2W] or 400mg every 4 wks [Q4W]) continued on their assigned dose during the open-label period. PROs assessed included Patient9s Global Assessment of Arthritis Pain (PtAAP; visual analog scale), fatigue (numeric rating scale), Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 Physical and Mental Component Summary (SF-36 PCS/MCS), Psoriatic Arthritis Quality of Life (PsAQoL), and Dermatology Life Quality Index (DLQI; assessed in the subgroup of pts with ≥3% body surface area affected by psoriasis at baseline [BL]). Data are reported as the mean change from BL (CFB) for pts randomized to CZP at Wk0, with last observation carried forward (LOCF) imputation for Wk24, and LOCF imputation and observed case (OC) values for Wk216. Results Of 273 pts randomized to CZP at Wk0, 248 (91%) completed Wk24 and 183 (67%) completed Wk216. Improvements observed to Wk24 of treatment were generally maintained over 4 years (to Wk216) in all PROs assessed, regardless of prior anti-TNF exposure (Table). Similar improvements were observed in both CZP dose regimens for all PROs examined, including PtAAP (CFB at Wk216 in the 200mg Q2W group [with LOCF imputation]: -30.5, in the 400mg Q4W group: -33.8); fatigue (-2.3, -2.3); HAQ-DI (-0.50, -0.49); SF-36 PCS (8.73, 8.77); SF-36 MCS (3.91, 3.28); PsAQoL (-4.6, -4.4); and DLQI (-8.4, -6.8). Conclusions Early improvements with CZP treatment were maintained over 4 years in all PROs assessed in the RAPID-PsA study. Similar improvements were observed in pts with and without prior anti-TNF exposure, and in both CZP dose regimens. References Rosen C. Rheumatology 2012;51(3):571–6. Gladman D. Value in Health 2014;17(7):A386. 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. Editorial services were provided by Costello Medical Consulting. Disclosure of Interest D. Gladman Grant/research support from: Abbott, Bristol-Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott, Bristol-Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, UCB Pharma, R. Fleischmann Grant/research support from: Genentech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, Bristol-Myers Squibb, Lilly, Sanofi-Aventis, MSD, Novartis, AstraZeneca, Janssen, Consultant for: Roche, Abbott, Amgen, UCB Pharma, Pfizer, Bristol-Myers Squibb, Lilly, Sanofi-Aventis, Novartis, AstraZeneca, Janssen, K. Harris Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, P. Mease Grant/research support from: (Abbott) AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB Pharma, Consultant for: (Abbott) AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo, Corrona, Dermira, Janssen, Lilly, Merck, Novartis, Pfizer, Sun, UCB Pharma, Zynerba, Speakers bureau: (Abbott) AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo, Genentech, Janssen, Novartis, Pfizer, UCB Pharma

BACKGROUND: To date, head-to-head trials comparing the efficacy and safety of biological disease-modifying antirheumatic drugs within the same class, including TNF inhibitors, in patients with active rheumatoid arthritis despite methotrexate therapy are lacking. We aimed to compare the efficacy and safety of two different TNF inhibitors and to assess the efficacy and safety of switching to the other TNF inhibitor without a washout period after insufficient primary response to the first TNF inhibitor at week 12.METHODS: In this 104-week, randomised, single-blind (double-blind until week 12 and investigator blind thereafter), parallel-group, head-to-head superiority study (EXXELERATE), eligible patients from 151 centres worldwide were aged 18 years or older with a diagnosis of rheumatoid arthritis at screening, as defined by the 2010 ACR/EULAR criteria, and had prognostic factors for severe disease progression, including a positive rheumatoid factor, or anti-cyclic citrullinated peptide antibody result, or both. Participants were randomly assigned (1:1) via an interactive voice and web response system with no stratification to receive certolizumab pegol plus methotrexate or adalimumab plus methotrexate. All study staff were kept masked throughout the study and participants were masked until week 12. At week 12, patients were classified as responders (by either achieving low disease activity [LDA] according to Disease Activity Score 28-erythrocyte sedimentation rate [DAS28-ESR] ≤3·2 or DAS28-ESR reduction ≥1·2 from baseline) or as non-responders. Non-responders to the first TNF inhibitor to which they were randomised were switched to the other TNF inhibitor with no washout period. Primary endpoints were the percentage of patients achieving a 20% improvement according to the American College of Rheumatology criteria (ACR20) at week 12 and LDA at week 104 (week 12 non-responders were considered LDA non-responders). This study is registered with ClinicalTrials.gov, number NCT01500278.FINDINGS: Between Dec 14, 2011, and Nov 11, 2013, 1488 patients were screened of whom 915 were randomly assigned; 457 to certolizumab pegol plus methotrexate and 458 to adalimumab plus methotrexate. No statistically significant difference was observed in ACR20 response at week 12 (314 [69%] of 454 patients and 324 [71%] of 454 patients; odds ratio [OR] 0·90 [95% CI 0·67-1·20]; p=0·467) or DAS28-ESR LDA at week 104 (161 [35%] of 454 patients and 152 [33%] of 454 patients; OR 1·09 [0·82-1·45]; p=0·532) between certolizumab pegol plus methotrexate and adalimumab plus methotrexate, respectively. At week 12, 65 non-responders to certolizumab pegol were switched to adalimumab and 57 non-responders to adalimumab were switched to certolizumab pegol; 33 (58%) of 57 patients switching to certolizumab pegol and 40 (62%) of 65 patients switching to adalimumab responded 12 weeks later by achieving LDA or a DAS28-ESR reduction 1·2 or greater. 389 [75%] of 516 patients who received certolizumab pegol plus methotrexate and 386 [74%] of 523 patients who received adalimumab plus methotrexate reported treatment-emergent adverse events. Three deaths (1%) occurred in each group. No serious infection events were reported in the 70-day period after treatment switch.INTERPRETATION: These results show that certolizumab pegol plus methotrexate is not superior to adalimumab plus methotrexate. The data also show the clinical benefit and safety of switching to a second TNF inhibitor without a washout period after primary failure to a first TNF inhibitor.FUNDING: UCB Pharma.

not available. Disclosures: Study sponsored by Dermira. Copyright 2018 SKIN

Background Phase 2 psoriasis studies with the Fc-free, PEGylated, anti–tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity. Objective Assess safety and efficacy of certolizumab in adults with moderate-to-severe chronic plaque psoriasis. Methods Patients were randomized 3:3:1:3 to certolizumab 400 mg, certolizumab 200 mg, or placebo every 2 weeks for 16 weeks or etanercept 50 mg twice weekly for 12 weeks. Certolizumab-treated patients achieving a ≥75% reduction in Psoriasis Area and Severity Index (PASI) at week 16 from baseline PASI were rerandomized to certolizumab or placebo for 32 weeks. The primary endpoint was responder rate (≥75% reduction in PASI from baseline PASI) versus placebo (primary analysis) and etanercept (secondary analysis) at week 12; secondary endpoints included responder rates on various measures versus placebo at weeks 12, 16, and 48. Safety was assessed by treatment-emergent adverse events. Results All endpoints were significantly greater for certolizumab versus placebo with the greatest response seen with 400 mg. Certolizumab 400 mg was superior to and 200 mg was noninferior to etanercept. Adverse events were consistent with the anti–tumor necrosis factor class of drugs. Limitations Etanercept was administered by unblinded study staff or self-administered, but efficacy assessments were performed by a blinded assessor. Conclusion Both certolizumab regimens improved psoriasis symptoms, with a greater response seen with the higher dose. No new safety signals were observed.

Objective To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years’ certolizumab pegol (CZP) treatment in patients with psoriatic arthritis (PsA). Methods RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4). Patients randomised to CZP continued their assigned dose in the OL period. Patients randomised to placebo were re-randomised to CZP 200 mg Q2W or 400 mg Q4W (post-loading dose) at Week 16 (early escape) or after the double-blind phase. We present observed and imputed data; missing values were imputed using non-responder imputation (NRI) for categorical and last observation carried forward (LOCF) for continuous measures. Results 409 patients were randomised; 20% (54/273) of Week 0 patients randomised to CZP had prior anti-tumour necrosis factor (TNF) exposure; 67% (183/273) completed 216 weeks. By Week 48, 60.4% of patients achieved Disease Activity Index for Psoriatic Arthritis low disease activity or remission, which was maintained; 66.3% achieved these outcomes at Week 216 (NRI). At Weeks 48 and 216, 39.2% of patients achieved minimal disease activity (NRI). 75% reduction in Psoriasis Area and Severity Index responses were 65% and 52% at Weeks 48 and 216 (NRI). Total resolution rates for enthesitis, dactylitis and nail psoriasis, at 4 years, were 71%, 81% and 65%, respectively (LOCF). Structural damage progression was low over 4 years’ treatment. No new safety signals were identified after Week 96. Conclusions CZP efficacy in treating PsA was maintained over 4 years, in patients both with and without prior anti-TNF exposure, with no new safety signals identified.

not available. Disclosures: Study sponsored by UCB Pharma. Copyright 2018 SKIN

Not Available Disclosure: Study supported by Dermira.

Not Available Disclosure: Study supported by Dermira.

Not Available Disclosure: Study supported by Dermira.

Not Available Disclosure: Study supported by Dermira.

Background Impaired manual dexterity is common in patients (pts) with rheumatoid arthritis (RA), often resulting in difficulties with drug self-administration when using pre-filled syringes.1,2 Auto-injection devices (AIs) have been shown to provide a number of benefits, including reduced discomfort and greater ease of use compared with manual injections.2,3 A new certolizumab pegol (CZP) device was created, based on pt insights and capitalizing on the benefits of existing AIs. Objectives To compare the usability of a new CZP AI with alternative anti-tumor necrosis factor (anti-TNF) devices (adalimumab, etanercept and golimumab) in patients with moderate to severe RA. Methods Eligible pts had moderate to severe RA (fingers, hands and/or wrists affected) and no prior experience of using an AI for RA. Each pt tested 4 AIs (CZP, golimumab, etanercept and adalimumab) in a randomized order by performing a simulated self-injection on a training skin pad strapped to the upper thigh or lower abdomen. All identifications were removed from the AI devices and respective instructions for use. Pts were provided with instructions for use for each of the AIs, but were not trained on device use prior to testing. Following utilization of all four AIs, pts were asked to rank them in order of preference from 1–4 (1=the most preferred) and to provide feedback on their usability (easy to use, easy to start the injection, easy to tell when injection was finished and willingness to use). Results Overall, 76 pts took part in this study. 67.1% pts ranked the CZP AI as their most preferred device; 23.7% ranked it as their second most preferred (Figure). The preference in the overall ranking of the CZP AI over each of the other devices was statistically significant (p Conclusions In pts with moderate to severe RA, the CZP AI was the preferred choice compared to the golimumab, etanercept and adalimumab AIs, and was associated with a high level of patient satisfaction. References Keininger D. Health Qual Life Outcomes 2011;9:2; Kivitz A. Clin Ther 2006;28:1619–29; Schwarzenbach F. Patient Prefer Adherence 2014;8:199–209 Acknowledgement The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance. Disclosure of Interest B. Domanska Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, I. Mountian Employee of: UCB Pharma, M. Schiff Grant/research support from: UCB Pharma, Consultant for: UCB Pharma

Background The RAPID-PsA trial (NCT01087788) has investigated the efficacy and safety of certolizumab pegol (CZP) for the treatment of patients (pts) with psoriatic arthritis (PsA). Previous reports have demonstrated CZP to be safe and efficacious over 96 weeks (wks) of treatment.1 Objectives To report 4-year efficacy and safety data from the RAPID-PsA trial of CZP in PsA pts. Methods RAPID-PsA was double-blind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label (OL) to Wk216. Pts had active PsA and had failed ≥1 DMARD. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued on their assigned dose in the OL period. Outcomes assessed included: ACR20/50/70 and PASI75/90 responses, minimal disease activity (MDA), HAQ-DI, pain and patient9s global assessment of disease activity (PGADA). Efficacy data are presented for all pts originally randomized to CZP. Data are shown as observed case and with imputation: NRI for categorical and LOCF for continuous measures. The safety set consisted of all pts treated with ≥1 dose of CZP to Wk216. Results 409 pts were randomized, of whom 273 received CZP from Wk0. Of CZP-randomized pts, 91% completed to Wk24, 87% to Wk48 and 67% to Wk216. In the OL period, 17 pts (6.2%) withdrew due to an adverse event (AE) and 5 pts (1.8%) due to loss of efficacy. ACR responses were sustained in both dose regimens from Wk24 to Wk216 (Table A). In those 166 CZP pts (60.8%) with ≥3% body surface area skin involvement at baseline (BL), PASI75/90/100 responses were maintained to Wk216 (Table A). Improvements in patient-reported outcomes were also maintained through Wk216 (Table B). Pts had further improvements from Wk24 to Wk216 in high-threshold outcomes (ACR70, MDA and PASI100) when either observed case or conservative imputation methods (NRI) were used (Table A). Pts in the safety set (N=393) had total CZP exposure of 1321 patient-years (PY) with an AE rate (ER) per 100 PY of 258.0. No new safety signals were identified from Wk96 to Wk204, and no additional deaths were reported. Conclusions CZP efficacy was maintained in PsA pts over 4 years of treatment, with no new safety signals identified. Additional improvements in high-threshold outcomes were seen from Wk24 to Wk216. References Mease P. RMD Open 2015;1:e000119 Acknowledgement The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance. Disclosure of Interest P. Mease Grant/research support from: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant for: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Pfizer and UCB Pharma, R. Fleischmann Grant/research support from: Genetech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, MSD, Novartis, AstraZeneca and Janssen, Consultant for: Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, Novartis, AstraZeneca and Janssen, J. Wollenhaupt Grant/research support from: UCB Pharma, Consultant for: UCB Pharma, A. Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer and UCB Pharma, Consultant for: AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer and UCB Pharma, D. Gladman Grant/research support from: Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, and UCB Pharma, Consultant for: Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, and UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB Pharma, Employee of: Director of Imaging Rheumatology B.V.

Background Previous reports of the RAPID-PsA trial (NCT01087788) have demonstrated the efficacy of certolizumab pegol (CZP) in improving joint outcomes of psoriatic arthritis (PsA) over 96 weeks (wks) of treatment in patients (pts) with and without prior anti-TNF exposure. 1,2 Objectives To report the efficacy of CZP over 4 years for the treatment of joint outcomes in PsA pts with and without prior anti-TNF exposure. Methods The RAPID-PsA trial was double-blind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label (OL) to Wk216. Pts had active PsA, had failed ≥1 DMARD, and ≤40% pts could have received 1 prior anti-TNF. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued on their assigned dose in the OL period. Joint disease activity was assessed in all pts using tender joint count (TJC), swollen joint count (SJC) and DAS28(CRP), as well as the composite disease activity measures ACR20/50/70. Data are shown as observed case (OC) and with imputation: NRI for categorical and LOCF for continuous measures. Data are presented for all pts originally randomized to CZP with and without prior anti-TNF exposure. Results 409 pts were randomized and 273 received CZP from Wk0 (54/273 pts had prior anti-TNF exposure). Of pts randomized to CZP at baseline, 91% completed to Wk24, 87% to Wk48 and 67% to Wk216. CZP treatment was associated with improvements in all measures of joint disease activity to Wk24. Improvements in outcomes including TJC, SJC and DAS28(CRP), as well as the composite measures ACR20/50/70, were sustained through to Wk216 of the trial and were similar in pts with and without prior anti-TNF exposure (Figure). Greater improvements were observed in those pts completing to Wk216, as expected (Figure, OC data). Pts experienced further improvements from Wk24 to Wk216 in the high-threshold outcome ACR70 when either OC or NRI was used (Table). At Wk216, ACR20 responses were similar regardless of dose regimen in pts with and without prior anti-TNF exposure (pts with anti-TNF exposure [OC]: 200mg Q2W: 81.8%; 400mg Q4W: 83.3%; pts without prior anti-TNF exposure [OC]: 200mg Q2W: 75.0%; 400mg Q4W: 85.3%). Conclusions Improvements in measures of joint disease activity were observed in PsA pts to Wk24 and efficacy was sustained over 4 years. Efficacy remained similar in pts with and without prior anti-TNF exposure in all joint outcomes assessed. References Mease P. RMD Open 2015;1:e000119; Gladman D. Arthritis Rheum 2015;67(S10) Acknowledgement The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance. Disclosure of Interest P. Mease Grant/research support from: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant for: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Pfizer and UCB Pharma, R. Fleischmann Grant/research support from: Genetech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, MSD, Novartis, AstraZeneca and Janssen, Consultant for: Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, Novartis, AstraZeneca and Janssen, J. Wollenhaupt Grant/research support from: UCB Pharma, Consultant for: UCB Pharma, A. Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer and UCB Pharma, Consultant for: AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer and UCB Pharma, D. Gladman Grant/research support from: Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, and UCB Pharma, Consultant for: Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, and UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB Pharma, Employee of: Director of Imaging Rheumatology B.V.

Background The RAPID-axSpA trial (NCT01087762) investigated the efficacy and safety of certolizumab pegol (CZP) for the treatment of patients (pts) with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS; also termed radiographic-axSpA) and non-radiographic (nr)-axSpA pts. Previous reports have shown CZP to be safe and efficacious over 96 weeks (wks) of treatment. 1 Objectives To report 4-year efficacy and safety data from the RAPID-axSpA trial. Methods RAPID-axSpA was double-blind and placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label (OL) to Wk204. Pts fulfilled ASAS criteria and had active axSpA with positive sacroiliac joint MRI and/or raised CRP (>7.9mg/L). Pts originally randomized to CZP (200mg Q2W or 400mg Q4W) continued on their assigned dose in the OL period. Outcomes assessed included: ASAS responses, ASDAS, BASDAI, BASFI, BASMI-linear and enthesitis. Efficacy data are presented for pts originally randomized to CZP (combined doses) as observed case and with imputation: NRI for categorical and LOCF for continuous measures. The safety set consisted of all pts treated with ≥1 dose of CZP to Wk204. Results 325 pts were randomized, of whom 218 received CZP from Wk0. Of CZP-randomized pts, 93% completed to Wk24, 88% to Wk48 and 65% to Week 204 (AS: 67%; nr-axSpA: 63%). In the OL period, 9.2% of pts withdrew due to an adverse event (AE) and 1.4% due to lack of efficacy. The proportion of pts achieving ASAS20/40 and partial remission (PR) responses at Wk24 was maintained over 4 years (to Wk204) in pts remaining in the study (Table). Efficacy, expressed as ASDAS ID rates (LOCF: Wk24: 30.3%; Wk204: 32.1%), mean ASDAS score (baseline: 3.84; LOCF: Wk24: 2.07; Wk204: 1.98), and all other outcomes reported, was maintained to Wk204. Similar improvements were seen in AS and nr-axSpA pts (Figure/Table) and in both CZP dose regimens (data not shown). Function (BASFI) was also improved in both subpopulations, with nr-axSpA pts having a particularly low mean score by Wk204 (Table). Pts in the safety set (N=315) had a total CZP exposure of 981 patient-years (PY), with an AE rate (ER) per 100 PY of 292.9. No new safety signals were identified from Wk96 to Wk204, and no deaths were reported over 4 years. Conclusions CZP efficacy was maintained in axSpA pts over 4 years with no new safety signals. Treatment responses to CZP were similar in AS and nr-axSpA pts. References Sieper J. Arthritis Rheum 2015;67:668–77 Acknowledgement The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance. Disclosure of Interest D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB Pharma, Employee of: Director of Imaging Rheumatology bv, M. Dougados Grant/research support from: UCB Pharma, Abbvie, Pfizer, Lilly, Merck and Novartis, Consultant for: UCB Pharma, Abbvie, Pfizer, Lilly, Merck and Novartis, R. Landewe Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, Consultant for: Abbott, Ablynx, Amgen, Astra-Zeneca, Bristol Myers Squibb, Centocor, Glaxo-Smith-Kline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, Speakers bureau: Abbott, Amgen, Bristol Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma and Wyeth, J. Sieper Consultant for: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly and Janssen, Speakers bureau: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly and Janssen, W. Maksymowych Grant/research support from: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma, Consultant for: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma, Speakers bureau: Abbott, Amgen, Bristol Myers Squibb, Eli-Lilly, Janssen, Merck, Pfizer, Synarc, Sanofi and UCB Pharma, M. Rudwaleit Consultant for: Abbott, BMS, Janssen, MSD, Pfizer, Roche and UCB Pharma, F. van den Bosch Consultant for: Abbvie, Bristol Myers-Squibb, Celgene, Janssen, Merck, Novartis, Pfizer, UCB Pharma, Speakers bureau: Abbvie, Bristol Myers-Squibb, Celgene, Janssen, Merck, Novartis, Pfizer, UCB Pharma, J. Braun Grant/research support from: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma, Consultant for: Abbott, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Johnson & Johnson, MSD, Novartis, Pfizer, Roche and UCB Pharma, P. Mease Grant/research support from: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant for: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Pfizer and UCB Pharma, O. Davies Shareholder of: UCB Pharma, Employee of: UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, A. Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB Pharma, Consultant for: AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB Pharma

Background Previous reports of RAPID-PsA (NCT01087788) have demonstrated the efficacy of certolizumab pegol (CZP) in patients (pts) with psoriatic arthritis (PsA) to Week (Wk) 96 of treatment. 1 Objectives Here we report the efficacy of CZP for the treatment of psoriatic skin manifestations in PsA pts over 96 wks, including pts with and without prior anti-TNF exposure and pts with severe skin involvement at baseline (BL). Methods RAPID-PsA 1 was double-blind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label to Wk216. Pts had active PsA, had failed ≥1 DMARD and ≤40% of pts could have received 1 prior anti-TNF. Pts were randomized at BL to either placebo or CZP (200mg Q2W/400mg Q4W, following 400mg loading dose at Wks 0, 2, 4). Primary clinical endpoint was Wk12 ACR20 response. 2 Here we present skin data for pts originally randomized to CZP and with BL skin involvement ≥3% body surface area (BSA). Outcomes presented are psoriasis area and severity index (PASI) responses, physician9s global assessment of psoriasis (PGA) and dermatology life quality index (DLQI). Data are shown as both observed and imputed values. Non-responder imputation (NRI) was used for categorical outcomes; last observation carried forward (LOCF) for continuous outcomes. Outcomes are presented for pts with or without prior anti-TNF exposure, or for pts with severe BL skin involvement (BL PASI ≥10). Results 409 pts were randomized and 273 received CZP from Wk0. CZP pts with ≥3% skin involvement at BL (166 pts, 60.8%) had a mean of 24.2% BSA affected by psoriasis and a mean PASI of 12.0 at BL. The primary endpoint of RAPID-PsA was met (ACR20[NRI]: 58.0%, 51.9% vs 24.3%; for CZP 200mg Q2W, 400mg Q4W vs placebo) and ACR responses were maintained to Wk96 (ACR20[NRI]: 60.1% at Wk24 and 64.1% at Wk96, combined CZP doses). Improvements in skin outcomes were observed to Wk96 of CZP treatment (Table A), with similar efficacy seen with both dose regimens (PASI90[NRI]: Wk24: 46.7% and 35.5%; Wk96: 48.9% and 38.2%, for 200mg Q2W and 400mg Q4W, respectively). Efficacy was also maintained in pts with severe skin involvement at BL (PASI ≥10) (PASI90[NRI]: Wk24: 59.5% and 47.1%; Wk96: 45.9% and 47.1%, for 200mg Q2W and 400mg Q4W, respectively). In these pts, greater improvements were observed in PASI responses, as well as the patient-reported measure DLQI, when compared to all pts analyzed (Table A). Similar improvements in skin outcomes were observed in patients with and without prior anti-TNF exposure (Table B). Conclusions Improvements in skin outcomes, observed in PsA patients treated with CZP to Wk24, were maintained to Wk96 of treatment in patients with and without prior anti-TNF exposure. Patients with severe skin involvement at BL showed greater improvements in skin outcomes. Similar efficacy was observed with both CZP dosing regimen. References Mease P. J. Ann Rheum Dis 2014;73(S2):90. Mease P. J. Arthritis Rheum 2013;65(10):S132–133 Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma. Disclosure of Interest M. Khraishi Grant/research support from: Abbott, Amgen and Pfizer, B. Hoepken Employee of: UCB Pharma, O. Davies Shareholder of: UCB Pharma, Employee of: UCB Pharma, T. Arledge Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, P. Mease Grant/research support from: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Speakers bureau: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Pfizer, UCB Pharma.

Background Previous reports of RAPID-PsA (NCT01087788) have demonstrated the clinical efficacy of certolizumab pegol (CZP) in patients (pts) with psoriatic arthritis (PsA) over 96 weeks (wks), but have not yet investigated the long-term improvements in extra-articular manifestations (EAMs) of PsA. 1 Objectives To report the efficacy of CZP for the treatment of EAMs in PsA including nail psoriasis, enthesitis, dactylitis, and psoriasis, over 96 wks of the RAPID-PsA trial. Methods RAPID-PsA 1 was double-blind and placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label to Wk216. Pts had active PsA and had failed ≥1 DMARD. Pts were randomized 1:1:1 to either PBO or CZP 400mg loading dose at Wks 0, 2, 4 followed by 200mg Q2W or 400mg Q4W. We present efficacy data for all pts originally randomized to CZP. The primary clinical endpoint was Wk12 ACR20 response. 2 EAMs were assessed in pts with baseline (BL) involvement and included nail psoriasis (modified nail psoriasis severity index [mNAPSI], BL involvement = BL mNAPSI >0; for some pts the nail analyzed was changed once or more to Wk96), enthesitis (Leeds enthesitis index [LEI], BL involvement = BL LEI >0), dactylitis (Leeds dactylitis index [LDI], BL involvement = at least 1 digit affected and with a difference in circumference ≥10%) and psoriasis (body surface area affected [BSA], BL involvement = BL BSA ≥3%). We also present data for pts with total resolution of each EAM, ie. the percentage of pts with BL involvement achieving complete clearance (a score of 0 for mNAPSI, LEI or LDI, or 0% BSA). Data shown are observed values. Results Of 409 pts randomized, 273 received CZP from Wk0. At BL, 197 of these pts had nail psoriasis, 172 enthesitis, 73 dactylitis and 166 psoriasis. Rapid reductions in scores were seen in all EAMs assessed and were maintained to Wk96 of the study. Improvements were observed in nail psoriasis, enthesitis, dactylitis and psoriasis, for pts with BL involvement (Table). These improvements were observed in pts treated with either CZP dose regimen. A large proportion of pts with BL EAM involvement went on to achieve total resolution. For pts with nail psoriasis at BL, 38.5% had achieved total resolution at Wk24 and 65.2% at Wk96. Similar results were seen for pts with enthesitis, dactylitis, or psoriasis at BL (pts with enthesitis at BL achieving total resolution: 65.2% at Wk24 and 71.0% at Wk96; pts with dactylitis at BL achieving total resolution: 73.8% at Wk24 and 89.5% at Wk96; pts with psoriasis at BL achieving total resolution: 26.8% at Wk24 and 48.5% at Wk96). Conclusions Improvements in EAMs of PsA were observed following CZP treatment and were maintained to Wk96 of RAPID-PsA. These improvements were seen in all EAMs measured, including nail psoriasis, enthesitis, dactylitis and psoriasis. Similar improvements were observed with both CZP dose regimens. References Mease P. J. Ann Rheum Dis 2014;73(S2):90. Mease P. J. Arthritis Rheum 2013;65(10):S132–133 Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance, which was funded by UCB Pharma. Disclosure of Interest O. FitzGerald Grant/research support from: Abbvie, Roche, MSD, BMS, Speakers bureau: Janssen, Pfizer, Abbvie, UCB Pharma, Cellgene, R. Fleischmann: None declared, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, D. Gladman Consultant for: Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, UCB Pharma

Background Previous reports of RAPID-PsA (NCT01087788) demonstrated efficacy and safety of certolizumab pegol (CZP) over 48 weeks (wks) in psoriatic arthritis (PsA) patients (pts), including pts with prior anti-TNF therapy.1 Objectives To report the clinical efficacy and safety of CZP in PsA from a 96-wk interim data cut of RAPID-PsA. Methods RAPID-PsA1 is double-blind and placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label to Wk216. Pts had active PsA and had failed ≥1 DMARD. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose [LD] at Wks 0, 2, 4) continued on their assigned dose in the OLE; PBO pts entering dose-blind phase were re-randomized to CZP LD followed by CZP 200mg Q2W or CZP 400mg Q4W after Wk24 or, for non-responders, Wk16. We present efficacy data for all pts originally randomized to CZP (combined dose regimens). Primary clinical endpoint was ACR20 response at Wk12 [1]. Other endpoints included ACR20/50/70 and PASI75/90 responses, HAQ-DI, pain and minimal disease activity (MDA) [2] at Wk96, and ACR responses in pts with or without prior anti-TNF exposure. Data are shown as observed case and with imputation. NRI was used for categorical measures, LOCF for continuous measures. Safety set consists of all pts treated with ≥1 dose of CZP to Wk96. Results 409 pts were randomized, of whom 273 received CZP from Wk0. 54 (19.8%) CZP pts had prior anti-TNF exposure with similar baseline (BL) characteristics to pts without. Of CZP-randomized pts, 91% completed Wk24, 87% Wk48 and 80% Wk96. ACR20/50/70 and MDA responses were maintained in both dosing regimens from Wk24 to Wk96 (Table). ACR responses were similar in pts with or without prior anti-TNF exposure (Figure). Pts originally randomized to PBO who switched to CZP at Wk 16 or 24 displayed rapid clinical improvements which were maintained through Wk96. In pts with ≥3% skin involvement at BL (60.8% CZP pts), PASI75 and PASI90 responses were maintained to Wk96 (Table). Improvements in PROs were maintained through Wk96 (Change from BL at Wk24 and Wk96: HAQ-DI: -0.48 vs -0.52; pain: -28.5 vs -31.3). In the safety set (N=393) total exposure to CZP was 606 pt-yrs. Adverse events (AEs) occurred in 345 pts (87.8%; event rate [ER] per 100 pt-yrs=329.8) and serious AEs (SAEs) in 67 (17.0%; ER=14.5). SAEs included malignancies in 4 pts (1.0%; ER=0.7) (including 2 cases of breast cancer, and 1 each of lymphoma and in situ cervix carcinoma) and serious infections in 16 pts (4.1%; ER=3.3). 6 deaths were reported in the overall 96-wk period (1.5%) (2 cardiac disorders, 1 sudden death, 1 infection and 1 case each of breast cancer and lymphoma). Conclusions The clinical efficacy of CZP was maintained through both the dose-blind and open-label phases of RAPID-PsA. Efficacy was maintained in both dosing regimens and in both TNF-naive and TNF-experienced pts. The safety profile was in line with that previously reported from the RAPID-PsA trial, with no new safety signals observed with increased exposure. References Mease P.J. Arthritis Rheum 2013;65(10):S132-S133; Coates L. Ann Rheum 2010;69(1):48-53 Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma. Disclosure of Interest P. Mease Grant/research support: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Vertex, Consultant for: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Vertex, Speakers bureau: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Crescendo, Genentech, Janssen, Lilly, Pfizer, UCB Pharma, R. Fleischmann Grant/research support: Genetech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, MSD, Novartis, BiogenIdec, Astellas, AstraZeneca, Janssen, Consultant for: Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, Novartis, Astellas, AstraZeneca, Janssen, J. Wollenhaupt Grant/research support: UCB Pharma, Consultant for: UCB Pharma, A. Deodhar Grant/research support: UCB Pharma, Abbott, Amgen, Janssen, Novartis, Consultant for: UCB Pharma, Abbott, D. Gladman Grant/research support: Abbvie, Amgen, Celgene, Janssen, Pfizer, UCB Pharma, Consultant for: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Pfizer, Novartis, UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, D. van der Heijde Consultant for: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex DOI 10.1136/annrheumdis-2014-eular.1652