64 Wednesday, 11 June 2014 Scientific Abstracts and EULAR response at week 24 and 48, safety and immunogenicity. Efficacy and safety were evaluated at screening, week 0, 2, 4, 8, 12, 16, 20, and 24. Immunogenicity, efficacy and safety were also evaluated at week 36 and 48. Results: In total, 294 patients were randomized: 147 to HD203 and 147 to Enbrel ® . The proportion of patients achieving ACR20 at week 24 (primary endpoint) was not significantly different for HD203 and Enbrel ® (Table) and equivalence in efficacy was demonstrated within predefined margins. In addition, there were no statistically significant differences between proportions achieving ACR20 at weeks 12 and 48. Similar trends were seen for ACR50 and ACR70, however the proportion of patients achieving ACR50 at week 24 and 48 was higher with HD203 than with Enbrel ® . There were no statistically significant differences between the groups for ACRn, change in DAS28, and EULAR response at week 24 and 48. Table 1. Proportion of patients achieving ACR20 at week 24 and week 48 HD203 Enbrel ® Difference (95% CI) P-value 24-week PPS 83.48% (96/115) 81.36% (96/118) 2.12 (-7.65, 11.89) 0.6706 † FAS 79.10% (106/134) 75.56% (102/135) 3.55 (-6.45, 13.55) 0.4870 † 48-week PPS 86.27% (88/102) 81.90% (86/105) 4.37 (-5.57, 14.31) 0.3905 † CI, confidence interval; PPS, per-protocol set; FAS, full analysis set; † Pearson’s chi-square test. Analysis of the safety set (HD203, n=147; Enbrel ® , n=146) revealed no statistically significant difference in the number of treatment-emergent (all-causality) adverse events (AEs): HD203 76.87% vs. Enbrel ® 78.08% (p=0.8040). Furthermore, no statistically significant differences between HD203 and Enbrel ® were observed with regards to adverse drug reactions, serious AEs, or discontinuations due to AEs. No unexpected AEs were observed, and few patients tested positive for anti-drug antibodies. Conclusions: The study met the primary endpoint of demonstrating equivalence in efficacy of HD203 compared with Enbrel ® . HD203 was well tolerated, with a safety profile comparable to that of Enbrel ® in this population of Korean patients with RA. Disclosure of Interest: S.-C. Bae: None declared, J.-S. Kim Grant/research support: Hanwha Chemical, J.-Y. Choe: None declared, W. Park: None declared, S.-R. Lee Employee of: Hanwha Chemical, Y. Ahn Employee of: Hanwha Chemical, Y. Seo Consultant for: Hanwha Chemical DOI: 10.1136/annrheumdis-2014-eular.3558 OP0012 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR STUDY OF THE EFFICACY AND SAFETY OF BOW015, A BIOSIMILAR INFLIXIMAB, IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON STABLE METHOTREXATE DOSES J. Kay 1 , A. Chopra 2 , S. Chandrashekara 3 , D.J. Olakkengil 4 , K.S. Bhojani 5 , G. Bhatia 6 , G. Rathi 7 , M. Thomas 8 , S. Maroli 9 , E.S. Thomson 10 , L. Shneyer 11 , M.S. Wyand 12 . 1 Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School, Worcester, MA, United States; 2 Center for Rheumatic Diseases, Pune; 3 ChanRe Rheumatology & Immunology Center & Research; 4 St. John’s Medical College Hospital, Bengaluru; 5 Department of Rheumatology, Fortis Hospital, Mumbai; 6 Pentagon Multispeciality Clinic and Research Centre, Pune; 7 Rathi Hospital, Ahmedabad; 8 Health and Research Center, Trivandrum; 9 Reliance Life Sciences, Mumbai, India; 10 Epirus Biopharmaceuticals, Surrey, United Kingdom; 11 Shneyer Statistics LLC, Denville, NJ; 12 Epirus Biopharmaceuticals, Boston, MA, United States Background: Comparative effectiveness trials using suitable endpoints are necessary to demonstrate therapeutic equivalence of biosimilar molecules. Objectives: This phase 3 double-blind, active comparator, clinical trial compared the efficacy and safety of a biosimilar infliximab (IFX), BOW015, to innovator IFX (iIFX). Methods: 189 subjects with active rheumatoid arthritis (RA) diagnosed according to the 2010 ACR/EULAR criteria, on stable doses of oral methotrexate (MTX) 10-20 mg/wk, were randomized 2:1 to receive either BOW015 or iIFX 3 mg/kg iv on wks 0, 2, 6, and 14. Subjects had CRP ≥10 mg/L at screening and were tested for TB by PPD, QuantiFERON-TB Gold, and chest radiographs. The primary endpoint was ACR20 response at Wk 16, within a 23% equivalence margin. Responders to BOW015 were continued on treatment and responders to iIFX were crossed over to BOW015 during an open-label phase in which all subjects are being treated every 8 wks through Wk 46. Efficacy and safety were assessed at each visit and immunogenicity at Wks 0 and 14. Twelve subjects were not included in the per protocol (PP) analysis due to study drug discontinuation prior to Wk 16 (n=9), dosing error (n=2) or missing data (n=1). In serum from each patient, antibodies to IFX were assayed using sensitive bridge ELISAs against BOW015 and iIFX. Results: The ACR20 responses at Wk 16 for BOW015 and iIFX, respectively, were 89.9% and 86.4% in the PP population (95% CI for the difference, -6.9% to 13.7%) and 85.0% and 85.5% in the intention-to-treat (ITT) population (95% CI for the difference, -11.2% to 10.3%). Kinetics of the ACR20 response was similar for both treatments over the first 16 wks of the trial in both the PP and ITT populations. The maximum treatment difference for the PP population was 3.4% and that for the ITT population was 6.4%, each at Wk 2. Overall, 43.3% of BOW015-treated and 50.0% of iIFX-treated subjects had at least one treatment emergent adverse event (AE). There was no significant difference in AE incidence by body system. Infectious AEs occurred in 15.8% of BOW015-treated and 9.7% of iIFX-treated subjects (p=0.368). Anti-IFX antibodies were detected in 22.1% of BOW015-treated and 35.5% of iIFX-treated subjects at Wk 14 (p=0.055). There was high concurrence between the BOW015-specific and iIFX-specific immunoassays among all subjects, regardless of treatment (κ=0.96). Conclusions: This is the first clinical trial of a biosimilar IFX to demonstrate and report the kinetics of response to treatment prior to the plateau phase. The comparable proportion of responders at each of these early time points and at the Wk 16 primary endpoint provides convincing evidence of therapeutic equivalence. The high ACR20 response rates are consistent with those observed in other RA clinical trials in which patients had not failed MTX and were all treated with an active drug. Disclosure of Interest: J. Kay Grant/research support: AbbVie Inc.; Eli Lilly and Company; Roche Laboratories, Inc., Consultant for: Amgen Inc.; AbbVie Inc.; Bristol-Myers Squibb Company; Crescendo Bioscience, Inc.; Epirus Bio- pharmaceuticals, Inc.; Genentech Inc.; Hospira, Inc.; Janssen Biotech, Inc.; Pfizer Inc.; Roche Laboratories, Inc., A. Chopra Grant/research support: Epirus Biopharmaceuticals, Inc., Pfizer Inc., Consultant for: Epirus Biopharmaceuticals, Inc., S. Chandrashekara Grant/research support: Epirus Biopharmaceuticals, Inc., D. Olakkengil Grant/research support: Epirus Biopharmaceuticals, Inc., K. Bhojani Grant/research support: Epirus Biopharmaceuticals, Inc., G. Bhatia Grant/research support: Epirus Biopharmaceuticals, Inc., G. Rathi Grant/research support: Epirus Biopharmaceuticals, Inc., M. Thomas Grant/research support: Epirus Biopharmaceuticals, Inc., S. Maroli Employee of: Reliance Life Sciences Pvt. Ltd., E. Thomson Consultant for: Epirus Biopharmaceuticals, Inc., L. Shneyer Consultant for: Epirus Biopharmaceuticals, Inc., M. Wyand Employee of: Epirus Biopharmaceuticals, Inc. DOI: 10.1136/annrheumdis-2014-eular.1595 WEDNESDAY, 11 JUNE 2014 Managing neck and shoulder pain OP0013 TREATMENT OF EPICONDYLITIS BY ULTRASOUND-GUIDED LOCAL INJECTIONS OF AUTOLOGOUS CONDITIONED PLASMA (ACP ® ): A DOUBLE-BLIND PLACEBO-CONTROLLED RANDOMIZED CLINICAL TRIAL WITH 1-YEAR FOLLOW-UP P. Le Goux 1 , B. Montalvan 1 , J. Leparc 1 , S. Klouche 2 , P. Hardy 2 , M. Breban 1 . 1 Rhumatology; 2 Orthopaedic and traumatologic surgery, Hôpitaux Universitaires Paris Ile-de-France Ouest, Boulogne-Billancourt, France Background: Local injections of corticosteroid represent a standard of care for epicondylitis, albeit it may adversely impair the healing process (1). Recently, local injections of growth factors-containing platelet-rich plasma (PRP) have been proposed as a new therapeutic technique, with the aim of boosting tendon repair (2). Ultrasound guidance of intra-tendinous injections seems to optimize the technical procedure (3). Objectives: The main objective was to assess the efficacy of two local injections of PRP to treat epicondylitis of recent evolution. Methods: A prospective double-blind placebo-controlled randomized trial was conducted during 2011-2012. Inclusion criteria were recent epicondylitis (pain≤3 months), confirmed by MRI and/or ultrasound and written informed consent. Exclusion criterion was previous corticosteroid infiltration. Two ultrasound-guided injections were performed at 4 weeks interval of either PRP (ACP ® , Arthrex) or saline solution. Patients were monitored by an independent clinical evaluator blinded to the treatment at baseline, 1, 3, 6 and 12 months follow-up. The primary evaluation criterion was the relative improvement from baseline to 6 months in pain score (PS) on visual analog scale (0-10). Secondary criteria were the assessment of pain (yes/no) on isometric contraction of the second radial and of the extensor digitorum communis, the Roles-Maudsley score (1 to 4), the proportion of asymptomatic patients (PS ≤1) at 6 and 12 months follow-up and the proportion of patients with persistent pain (PS>2) at 12 months follow-up. Based on a sample size calculation, 21 patients in each group were needed. Results: Fifty patients were included, 25 in each group, 34 men/16 women, mean age 47±9.2 years in the ACP group and 46.4±8.6 years in the control group. Six patients dropped out of the study between baseline and 6 months, 3 in each arm. At 6-month follow-up, no statistically significant difference was View publication stats View publication stats