The safety and efficacy of Hyruan ONE (test product), an intra-articular cross-linked sodium hyaluronate injection, to treat mild-to-moderate knee osteoarthritis was compared with that of Durolane (comparator) in a prospective, active-controlled, parallel-group, double-blind (masked-observed), multicenter non-inferiority study. European patients (n = 284) were randomized 1:1 (test product:comparator) and received one injection of cross-linked hyaluronic acid (60 mg/3 mL). In total, 280 patients completed the study. The primary endpoint of mean change in Western Ontario and McMaster University (WOMAC)–Likert Pain sub-scores from baseline at week 13 revealed changes of −5.59 and −5.54 for the test and comparator groups, respectively, demonstrating non-inferiority of the test product (difference, −0.05 [95% confidence interval, −0.838 to 0.729]). Secondary endpoint results, which included changes in WOMAC–Likert Pain sub-score from baseline to 26 weeks post-injection and changes in WOMAC–Likert Total score and Physical Function and Stiffness sub-scores, changes in patients’ and investigators’ global assessments, use of rescue medication, and responder rates at 13 and 26 weeks post-injection were similar between the groups. Incidence of adverse events was also similar. In both groups, most treatment-emergent adverse events were mild/moderate. Hyruan ONE was non-inferior to the comparator at 13 weeks post-injection in European patients with mild-to-moderate knee osteoarthritis.

Background: The reduced concentration of hyaluronic acid in the synovial fluid, leading to impairment of joint function and painful symptomatology during knee osteoarthritis (OA), can be restored by using injectable formulations of hyaluronic acid (HA) and chondroitin sulfate (CS), variable for relative composition, HA/CS molecular modifications, and injection protocols. The present study aims to assess the safety and performance of the intra-articular (IA) viscosupplementing agent HYALGO, a formulation combining 40 mg/mL HA (>1700 kDa) and 40 mg/mL CS, in the treatment of patients suffering from knee OA. Methods: 74 patients affected by knee lesions classified as grade II and III according to Kellgren and Lawrence classification were prospectively recruited and treated with three HYALGO injections (2 mL) given one week apart. Visual analogue scale (VAS) pain changes were monitored at each injection and over-time at 6, 14, and 26 weeks of follow-up. Secondary endpoints were: Western Ontario McMaster University Osteoarthritis index (WOMAC), Patient's Global Assessment (PGA) score, Clinical Observer Global Assessment (COGA) score, Outcome Measures in Rheumatology Committee (OMERACT) and Osteoarthritis Research Society International (OARSI) responders rates. Patients were also assessed for changes in their ultrasound joint scores according to the criteria of the OMERACT US Task Force Group. Results: Pain reduction was statistically significant starting from the first IA injection. Mean pain reduction from baseline to week 26 was À90.6%. At 26 weeks, WOMAC Pain was reduced by À62.7%, WOMAC Stiffness by À47.2%, WOMAC Physical Function by À54.1%; Total WOMAC by À53.8%. The VAS PGA change from baseline was À48.0 [mm] and VAS COGA -41.0 [mm]. Responders at week 26 were 78.4%. Ultrasound parameters (joint effusion, synovial thickness, and popliteal cysts) improved or remained stable from baseline to week 6. Conclusions: Three injections of HYALGO were safe and effective to manage symptomatic knee OA, with a beneficial effect that increased progressively over time, peaking 6 months after injection.

Background The risk of infections is increased by patients with RA. There is increasing evidence, that biological agents can contribute to risk of both non serious and serious infections. Vaccination is attractive method to prevent certain infections. Numerous studies have documented good efficacy of vaccinations treated by biologic drugs. ACR and EULAR have developed recommendations for vaccination of adult patients with rheumatic diseases (1). Nevertheless, how it is reflected in clinical practise is not known. Objectives To evaluate, how the patients with rheumatic inflammatory diseases treated by DMARDS and biologics are vaccinated in Czech Republic. Methods Crossectional study using special questionnaire. Study was performed in one academic tertiary centrum and two country private practices not using biologic therapy. Research was performed in second half of 2013. Results 340 patients have been included in study. The diagnosis was RA (220) 65 %, ankylosing spondylitis (77) 22,7 %, psoriatic arthritis (39) 11,5 % and SLE (3) 0,9 %. The mean age was 51,3 ± 14,4 years, duration of disease 13 years and male to female 33,6 % vs. 66,4 %. The proportion of patients in academic centrum to private practises was 231 (108) 68 % vs. 32 %, 31 % of patients were on DMARDs only, 69 % on biologics (ADA 28 %, INF 8 %, GOL 13 %, REM 8 %, ETA 3 %, RIT 4 %, ABA 2 %). Before initiation of immunosuppressive therapy 57 % were vaccinated for tetanus,18,8 % for flue, 9,4 % for hepatitis B, 6,5 % for hepatitis B, 2,9 % for pneunoccoc, 0,9 % for Hemophilus infl. and 0,6 % for Neisseria meningitis. During biologic / DMARD therapy were treated 35 % of patients. The vaccination status has been assessed in initial work–up in 42 % of patients. It was actively offered to 28,5 % of patients only 33 % of patients would have agreed on offer of vaccination and 66 % not. Approximately 50 % of patients agreed of payment for preventive vaccination before biologic therapy. Conclusions Despite EULAR and Czech Rheum Soc. recommendations vaccination status is very low and only 18 % of patients is vaccinated for flue and 3 % for pneumoccocus. Based on these results, we suggest education campaign for both doctors / patients. We also initiate discussion with authorities for better reimbursement of vaccination for patients with inflammatory rheumatic diseases treated by biologic drugs. References Refeences: van Assen S, Agmon-Levin N, Elkayam O, et al. EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 2011;3:414-422 Acknowledgements Key words: vaccination, rheumatic diseases, biologic therapy. Supported by grant of Ministry of Health Czech Republic Nr. NT12437 Disclosure of Interest K. Pavelka Grant/research support from: Ministry of Health Czech Republic Nr. NT12437, E. Moster: None Declared, H. Ptackova: None Declared