5-YEAR RESULTS FROM THE RAPID 1 TRIAL AND OPEN-LABEL EXTENSION: LONG-TERM SAFETY AND EFFICACY OF CERTOLIZUMAB PEGOL IN COMBINATION WITH METHOTREXATE IN THE TREATMENT OF RHEUMATOID ARTHRITIS

Background: In the RAPID 1 randomized clinical trial (RCT; NCT00152386), certolizumab pegol (CZP) every 2 weeks (Q2W) plus MTX over 52 weeks (wks) provided rapid improvements in signs and symptoms and inhibition of radiographic damage in patients (pts) with active rheumatoid arthritis (RA). Objectives: To examine the safety and efficacy of CZP plus MTX over 5 yrs in RA. Methods: Eligible pts were treated in the open-label extension (OLE) to RAPID 1 (NCT00175877) with CZP 400mg Q2W, reduced to 200mg Q2W after ≥6 months, plus MTX. Primary objective of the OLE was to monitor safety; secondary objective was to assess efficacy. Combined safety data from RCT and OLE are presented to Wk334 (6.4 yrs) from first dose of CZP for all pts receiving ≥1 dose of CZP in OLE (Safety population, N=846). Pt retention and efficacy data are presented to Wk256 (4.9 yrs) for CZP pts who completed the 52-wk RCT (CZP completers, N=507) and for all pts randomized to CZP 400mg or 200mg in RCT (ITT population, N=783). Efficacy was assessed by ACR20/50/70, DAS28(ESR) and HAQ-DI. Missing categorical data were imputed by non-responder imputation (NRI). Continuous measures were imputed by last observation carried forward (LOCF). Kaplan-Meier analysis was used to estimate pt retention. Results: Overall event rate per 100 pt-yrs (ER) of AEs was 285.6 and SAEs was 18.4 (infections=5.4, malignancies=1.0; total exposure [including 84-day safety follow-up period]: 3,660 pt-yrs). The most common AEs (MedDRA preferred terms) were urinary tract infection (ER=7.8), nasopharyngitis (ER=7.4) and upper respiratory tract infection (ER=7.3). 137 pts (16.2%) experienced an AE leading to withdrawal (incidence rate per 100 pt-yrs [IR]=3.77). 16 (1.9%) experienced an AE leading to death (IR=0.44) (including 4 malignancies, 3 infections, 2 cardiovascular events). ACR20/50/70 response rates for CZP completers and ITT population were sustained to Wk256 (74.6%/57.4%/39.6% and 59.0%/43.7%/28.8%, respectively), as were DAS28(ESR) remission rates (25.2% and 20.3%), improvements in DAS28(ESR) (mean values: 3.43 and 3.83; mean change from baseline: -3.49 and -3.08) and HAQ-DI (mean values: 0.90 and 1.00; mean change from baseline: -0.77 and -0.66). Image/graph: Conclusions: CZP plus MTX provided a favorable risk-benefit profile over 5 yrs of treatment in pts with active RA. No new safety signals were identified. References: 1.Keystone E. Arthritis Rheum 2008;58(11):3319-3329, 2.Keystone E. Rheumatology 2012;51(9):1628-1638 Acknowledgements: The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma. Disclosure of Interest: E. Keystone Grant/research support from: Abbott, Amgen, AstraZeneca, BMS, F. Hoffmann-La Roche, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott, AstraZeneca, Biotest, BMS, F. Hoffmann-La Roche, Genetech, Janssen, Lilly, Merck, Nycomed, Pfizer, UCB Pharma, Speakers bureau: Abbott, Amgen, AstraZeneca, BMS Canada, F. Hoffmann-La Roche, Janssen, Pfizer, UCB Pharma, R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Consultant for: Abbott, Ablynx, Amgen, AstraZeneca, BMS, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, Speakers bureau: Abbott, Amgen, BMS, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, Wyeth, R. van Vollenhoven Grant/research support from: Abbott, BMS, GSK, MSD, Pfizer, Roche, UCB Pharma, Consultant for: Abbott, BMS, GSK, MSD, Pfizer, Roche, UCB Pharma, B. Combe Grant/research support from: Merck, Pfizer, Roche-Chugai, Consultant for: Merck, Pfizer, Roche-Chugai, UCB Pharma, BMS, Celgene, Lilly, Novartis, Speakers bureau: Merck, Pfizer, Roche-Chugai, UCB Pharma, BMS, Celgene, Lilly, Novartis, V. Strand Consultant for: UCB Pharma, P. Mease Grant/research support from: Abbott, Amgen, BiogenIdec, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott, Amgen, BiogenIdec, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Speakers bureau: Abbott, Amgen, BiogenIdec, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, L. Shaughnessy Employee of: UCB Pharma, B. VanLunen Employee of: UCB Pharma, D. van der Heijde Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli Lilly, GSK, Janssen, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli Lilly, GSK, Janssen, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex, Employee of: Imaging Rheumatology bvCitation: , volume 72, supplement s3, year 2013, page Session: Poster session Thursday ( )