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Supplemental Digital Content is available in the text., Background: YVOIRE Classic s (YC) and Restylane (RES) have similar rheological properties, which suit mid-dermis injection, while the rheological properties of YVOIRE Volume s (YV) are comparable to those of Perlane (PER), which suit deep dermis injection to treat deep wrinkles. Two similarly designed studies aimed to evaluate the performance and safety of YC and YV injected into the nasolabial folds (NLFs). Methods: These were split-face designed, evaluator-blind, noninferiority studies. Fifty-eight subjects with moderate-to-severe NLFs were enrolled in the first study and treated with YC and RES, and 57 subjects were enrolled in the second study and treated with YV and PER. The Wrinkle Severity Rating Scale ranged from 1 (no visible fold) to 5 (extremely deep and long folds), and subject satisfaction was evaluated. Results: The least squares mean Wrinkle Severity Rating Scale scores (standard error) at week 26 were 2.56 (0.09) for both YC- and RES-treated NLFs and 2.89 (0.08) and 2.91 (0.08) for YV- and PER-treated NLFs, respectively. The difference between the groups was 0 and 0.02, and the lower limit of its 95% confidence interval was −0.0725 and −0.0125, which was greater than the predefined margin (−0.29), proving the noninferiority of YC and YV to RES and PER, respectively. The safety profiles and subject satisfaction of YC and YV were similar to those of RES and PER, respectively. Conclusion: YC is comparable to RES and YV is comparable to PER in terms of performance and safety profiles, with NLF-correcting effects lasting for up to 26 weeks.

ObjectiveTo evaluate the similarities between LBEC0101 (etanercept biosimilar) and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid arthritis despite methotrexate treatment.MethodsThis phase III, multicentre, randomised, double-blind, parallel-group, 54-week study was conducted in Japan and Korea. The primary efficacy endpoint was the change from baseline in the disease activity score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) at week 24. American College of Rheumatology 20% (ACR20) response rate, adverse events (AEs), pharmacokinetics and development of antidrug antibodies (ADAs) were also evaluated.ResultsIn total, 374 patients were randomised to LBEC0101 (n=187) or ETN-RP (n=187). The least squares mean changes from baseline in DAS28-ESR at week 24 in the per-protocol set were −3.01 (95% CI −3.198 to −2.820) in the LBEC0101 group and −2.86 (95% CI −3.051 to −2.667) in the ETN-RP group. The estimated between-group difference was −0.15 and its 95% CI was −0.377 to 0.078, which was within the prespecified equivalence margin of −0.6 to 0.6. ACR20 response rates at week 24 were similar between the groups (LBEC0101 93.3% vs ETN-RP 86.7%). The incidence of AEs up to week 54 was comparable between the groups (LBEC0101 92.0% vs ETN-RP 92.5%), although fewer patients in the LBEC0101 group (1.6%) than the ETN-RP group (9.6%) developed ADAs.ConclusionThe clinical efficacy of LBEC0101 was equivalent to that of ETN-RP. LBEC0101 was well tolerated and had a comparable safety profile to ETN-RP.Trial registration numberNCT02357069.

Aims The present extension study evaluated the long-term safety and efficacy of gemigliptin during a 40-week follow-up period after a 12-week study. Methods The main study was a randomized, placebo-controlled, double-blinded, phase IIIb study in which 50 mg of gemigliptin (N = 66) or placebo (N = 66) was administered to patients with type 2 diabetes mellitus (T2DM) with moderate or severe renal impairment over a 12-week period. Patients with a glycated haemoglobin (HbA1c) level of 7-11% and an estimated glomerular filtration rate (eGFR) of 15–59 mL/min/1.73 m2 were enrolled in the main study. After 12 weeks, the patients in the gemigliptin group continued to receive gemigliptin (N = 50), whereas the patients in the placebo group were transitioned from placebo to linagliptin (N = 52). Each group received the indicated treatment over the subsequent 40-week period. A total of 102 patients consented to participate in the extension study, and 79 patients ultimately completed the study. Results The HbA1c levels of both groups were significantly reduced at week 52 compared with baseline. Specifically, the adjusted mean change ± standard error in the HbA1c level in the gemigliptin and placebo/linagliptin groups was 1.00 ± 0.21% and 0.65 ± 0.22% lower at week 52 than at baseline (P

Table S1. Immunogenicity data. (PDF 55 kb)

Background LBEC0101 is a newly developed biosimilar of etanercept (ETN). As rheumatoid arthritis (RA) treatment is a long-standing process in the clinical practice, the long-term safety and efficacy of anti-TNF inhibitors have been studied and reported.1 Clinical studies have been conducted to evaluate the efficacy and safety of biosimilar after switching from their originator drug.2 Objectives To evaluate the long-term efficacy, safety, and immunogenicity of switching from the ETN reference product (RP) to LBEC0101 or continuing LBEC0101 in patients with RA. Methods This multicenter, single-arm, open-label extension study enrolled patients with RA who had completed the 52 week treatment period of the randomised, double-blind, parallel-group, Phase III study for LBEC0101 (NCT02357069). Patients who were deemed requiring continuous treatment for RA upon the investigator’s discretion and agreed to participate in this study were allowed for participation. All patients received LBEC0101 50 mg/ml once a week for 48 weeks with the stable dose of methotrexate regardless of the randomization group in the Phase III study. Efficacy, safety and immunogenicity were assessed up to Week 100. Data were analysed for patients who continued to receive LBEC0101 for 100 weeks (maintenance group) and for those who had received ETN-RP for 52 weeks and then switched to LBEC0101 for 48 weeks (switch group). Results A total of 148 patients were enrolled in this study; 70 patients continued to receive LBEC0101 and 78 patients switched to receive LBEC0101 from ETN-RP. DAS28-ESR score in the full analysis set were maintained in both groups from week 52 through week 100 (from 3.068 to 3.103 in maintenance group vs. from 3.161 to 3.079 in switch group). Response rates at week 100 for maintenance and switch groups, respectively, were 79.7% vs. 83.3% for ACR20, 65.2% vs. 66.7% for ACR50% and 44.9% vs. 42.3% for ACR70. The incidences of adverse events were comparable between the groups (70.0% for maintenance group and 70.5% for switch group, respectively). The proportion of patients who newly developed antidrug antibodies was similar between the groups (1.4% for maintenance group and 1.3% for switch group, respectively). Conclusions The efficacy and safety of LBEC0101 were comparable in both maintenance and switch groups. The efficacy of LBEC0101 was well sustained over 100 weeks. References [1] Weinblatt ME, Bathon JM, Kremer JM, et al. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken)2011;63:373–82. [2] Emery P, Vencovský J, Sylwestrzak A, et al. Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4. Ann Rheum Dis2017 [Epub ahead of print]. Acknowledgements HanJoo Baek, HoonSuk Cha, JungYoon Choe, ChanBum Choi, InAh Choi, SeungJae Hong, JinWuk Hur, GeunTae Kim, HyunAh Kim, Jinseok Kim, Jisoo Lee, SangHeon Lee, SangIl Lee, SeungGeun Lee, ShinSeok Lee, YunJong Lee, JunKi Min, KyungSu Park, SungHwan Park, Won Park, YongBeom Park, DongHyuk Sheen, SeungCheol Shim, KichulShin, ChangHee Suh, HyungIn Yang, Bin Yoo and WanHee Yoo. Disclosure of Interest Y. W. Song: None declared, H. Matsuno Consultant for: Mochida Pharmaceutical Co., Ltd., AYUMI Pharmaceutical Corporation, Nichi-Iko Pharmaceutical Co., Ltd., Meiji Seika Pharma Co., Ltd., M.-C. Park: None declared, M. Tomomitsu Employee of: Mochida Pharmaceutical Co., Ltd., S. Shin Employee of: LG Chem, Ltd., J. Lee Employee of: LG Chem, Ltd.

Introduction: We undertook a prospective community-based study in North Jakarta, Indonesia, to determine the incidence, clinical characteristics, seasonality, etiologic agent, and antimicrobial susceptibility pattern of enteric fever. Methodology: Following a census, treatment centre-based surveillance for febrile illness was conducted for two-years. Clinical data and a blood culture were obtained from each patient. Results: In a population of 160,261, we detected 296 laboratory-confirmed enteric fever cases during the surveillance period, of which 221 (75%) were typhoid fever and 75 (25%) were paratyphoid fever. The overall incidence of typhoid and paratyphoid cases was 1.4, and 0.5 per thousand populations per year, respectively. Although the incidence of febrile episodes evaluated was highest among children under 5 years of age at 92.6 per thousand persons per year, we found that the burden of typhoid fever was greatest among children between 5 and 20 years of age. Paratyphoid fever occurred most commonly in children and was infrequent in adults. Conclusion: Enteric fever is a public health problem in North Jakarta with a substantial proportion due to paratyphoid fever. The results highlight the need for control strategies against enteric fever.

OBJECTIVE: To inform policy-makers about introduction of preventive interventions against typhoid, including vaccination. METHODS: A population-based prospective surveillance design was used. Study sites where typhoid was considered a problem by local authorities were established in China, India, Indonesia, Pakistan and Viet Nam. Standardized clinical, laboratory, and surveillance methods were used to investigate cases of fever of >or= 3 days' duration for a one-year period. A total of 441,435 persons were under surveillance, 159,856 of whom were aged 5-15 years. FINDINGS: A total of 21,874 episodes of fever were detected. Salmonella typhi was isolated from 475 (2%) blood cultures, 57% (273/475) of which were from 5-15 year-olds. The annual typhoid incidence (per 100,000 person years) among this age group varied from 24.2 and 29.3 in sites in Viet Nam and China, respectively, to 180.3 in the site in Indonesia; and to 412.9 and 493.5 in sites in Pakistan and India, respectively. Altogether, 23% (96/413) of isolates were multidrug resistant (chloramphenicol, ampicillin and trimethoprim-sulfamethoxazole). CONCLUSION: The incidence of typhoid varied substantially between sites, being high in India and Pakistan, intermediate in Indonesia, and low in China and Viet Nam. These findings highlight the considerable, but geographically heterogeneous, burden of typhoid fever in endemic areas of Asia, and underscore the importance of evidence on disease burden in making policy decisions about interventions to control this disease.