Changes in health-related quality of life (QoL) due to hip, humeral, ankle, spine, and distal forearm fracture were measured in Russian adults age 50 years or more over the first 18 months after fracture. The accumulated mean QoL loss after hip fracture was 0.5 and significantly greater than after fracture of the distal forearm (0.13), spine (0.21), proximal humerus (0.26), and ankle (0.27). Introduction Data on QoL following osteoporotic fractures in Russia are scarce. The present study evaluated the impact of hip, vertebral, proximal humerus, distal forearm, and ankle fracture up to 18 months after fracture from the Russian arm of the International Costs and Utilities Related to Osteoporotic Fractures Study. Methods Individuals age ≥ 50 years with low-energy-induced humeral, hip, clinical vertebral, ankle, or distal forearm fracture were enrolled. After a recall of pre-fracture status, HRQoL was prospectively collected over 18 months of follow-up using EQ-5D-3L. Multivariate regression analysis was used to identify determinants of QALYs loss.

The aim is to carry out language adaptation and validation on the Russian sample of a special SarQoL questionnaire, designed to assess the quality of life of elderly people with sarcopenia. Material and methods. 100 patients over 65 years, mean age 74.0±6.5 years, observed on an outpatient basis were included. 50 from them had sarcopenia and 50 participants were without it. The diagnosis of sarcopenia was based on criteria developed by the European working group on sarcopenia (EWGSOP, 2010). The validation procedure was carried out in accordance with the Protocol. Results and discussion. There was a significant decrease in the overall quality of life according to SarQoL questionnaire in patients with sarcopenia compared with the control group without sarcopenia (50.65±14.23 and 75.10±14.46, respectively; p<0.001). High internal consistency of the SarQoL (Cronbach's á coefficient 0.924) was revealed. A significant positive correlation of domains with the overall SarQoL index in the range from r=0.37, p=0.0083 to r=0.92, p<0.001 was established. Moderate correlations of SarQoL with some domains SF-36 and the EQ-5D questionnaires were revealed. High internal consistency (ICC) of 0.935 (95% CI 0.91-0.96) was found. Conclusion. The Russian version of the SarQoL questionnaire is valid, consistent and reliable and can be used to assess the quality of life in older patients with sarcopenia.

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Background:Previously, 12-week results of phase 2 clinical study of levilimab (LVL) in patients with active rheumatoid arthritis (RA) have been reported1. The study has met the primary endpoint at W12 confirming that treatment with LVL 162 mg SC + methotrexate (MTX) either QW or Q2W is superior to MTX alone in patients with RA and inadequate response to methotrexate (MTX-IR). Here we report 1-year efficacy and safety data in QW and Q2W arm of the study.Objectives:This study was aimed to assess the efficacy and safety of 2 dosing regimens of LVL in active MTX-IR RA subjects.Methods:This multicenter double-blind placebo-controlled study (NCT03455842) enrolled 105 MTX-IR subjects with active RA (ACR2010). The study design is outlined on Figure 1. Secondary endpoints for the open-label period included ACR20/50/70, LDA, remission rates, and DAS28-CRP(4), among others. The safety was evaluated up to W56.Figure 1.Study designResults:At W12 ACR20 was reached by 77.1% and 57.1% of subjects of QW and Q2W arms respectively. Within open-label (OLE) period further increase in clinical response degree was observed up to W52, more pronounced in ACR50 and even more in ACR70 / RA LDA and Remission rates (Table 1). Figure 1 summarizes the dynamic of DAS28-CRP(4) change throughout the study. QW regimen showed better efficacy results.Table 1.Efficacy results (full analysis set), n (%).QW + MTX(n = 35)Q2W + MTX(n = 35)p-valueACR20 W1227 (77.1)20 (57.1)0.07    W5232 (91.4)25 (71.4)0.03ACR50 W1218 (51.4)11 (31.4)0.09    W5226 (74.3)23 (65.7)0.43ACR70 W1210 (28.6)7 (20.0)0.40    W5223 (65.7)16 (45.7)0.09LDA (DAS28 <3.2) W1220 (57.1)10 (28.6)0.02         W5229 (82.9)24 (68.6)0.16EULAR Remission W244 (11.4)2 (5.7)0.67         W5210 (28.6)10 (28.6)1.00Table 2 shows the main safety endpoints for the entire study (W0 – W56). The most common treatment related AEs (registered >5% of subjects) were laboratory abnormalities (neutrophil count decrease, ALT / AST increase, blood cholesterol/triglycerides increased). SAE occurred within the blinded study period were reported previously1. During OLE, starting from W12, four new serious AE (SAEs) were reported: 3 in LVL QW arm: haemorrhage (gr.3, unrelated), vaginal cyst (gr.3, unrelated) and keratitis (gr.2, unrelated); 1 in LVL Q2W arm: myocardial ischemia with cardiovascular insufficiency (gr.5, unrelated).Table 2.Safety results (full analysis set, W0 – W56), n (%).QW + MTX(n = 35)Q2W + MTX(n = 35)Any TEAEs/SAEs34 (97.1)29 (82.9)Any SAEs4 (11.4)2 (5.7)Any gr. 3-4 AEs16 (45.7)12 (34.3)Gr. 3-4 neutropenia4 (11.4)5 (14.3)AEs of special interest(ALT / AST high; Leucopenia / Neutropenia; Infections; Cholesterol/triglycerides high)28 (80.0)26 (74.3)Treatment discontinuation due to AE04 (11.3)Deaths02 (5.7) (unrelated)Conclusion:Within 1 year of treatment LVL + MTX showed sustained efficacy, with continuous clinical improvement in MTX-IR subjects with active RA. The safety profile of LVL was consistent with other IL6R inhibitors. LVL QW regimen was shown to be safe with better efficacy in terms of time and magnitude and was selected for phase 3 confirmatory clinical study.References:[1]http://dx.doi.org/10.1136/annrheumdis-2019-eular.7220Figure 2.Absolute DAS-28-CRP(4) change (median ± IQR, full analysis set)Disclosure of Interests:V Mazurov: None declared, Evgeniy Zotkin: None declared, Elena Ilivanova Grant/research support from: JSC BIOCAD, Tatyana Kropotina Grant/research support from: JSC BIOCAD, Tatyana Plaksina Grant/research support from: JSC BIOCAD, Olga Nesmeyanova Grant/research support from: JSC BIOCAD, Nikolaj Soroka Grant/research support from: JSC BIOCAD, Alena Kundzer: None declared, Anton Lutskii Employee of: JSC BIOCAD, Ekaterina Dokukina Employee of: JSC BIOCAD, Anna Eremeeva Employee of: JSC BIOCAD, Arina Zinkina-Orihan Employee of: JSC BIOCAD

Background:In the previous phase 1 study BCD-089 (INN: levilimab) was well-tolerated, had favorable safety profile and low immunogenicity1. Here we report 12-week efficacy and safety results of ongoing phase 2 clinical study of BCD-089 in patients with active RA.Objectives:This study is aimed to assess efficacy and safety of 2 dosing regimens of BCD-089 in patients with MTX-IR active RA.Methods:During this multicenter double-blind placebo-controlled randomized clinical study (NCT03455842) 105 MTX-IR patients with active RA (ACR2010) were assigned (1:1:1) to receive 162 mg of BCD-089 s.c. (QW arm and Q2W arm) or PBO. MTX (10-25 mg/week) was used in all groups. After completion of 12-week blinded period patients from QW/Q2W arms continued the treatment, patients from PBO arm were switched to BCD-089 Q2W until Wk56. The primary efficacy endpoint was the rate of ACR20 at Wk12. Secondary endpoints included ACR50/70 and DAS28-CRP(4). The safety was routinely evaluated.Results:The efficacy analysis showed that 95% confidence interval for BCD-089 treatment effect relative to PBO was [38.45 – 81.55] for QW arm and [16.53 – 63.4] for Q2W arm, which confirms the superiority to PBO of either dosing regimens. Summary of efficacy results is presented in table 1.The majority of adverse events (AE) were laboratory abnormalities. The spectrum of AEs is similar to other IL6R inhibitors (Table 2). Three serious AE (SAEs) were reported: community-acquired pneumonia (QW arm, treatment-related), acute cholecystitis (PBO arm, not related, did not lead to treatment discontinuation), and acute heart failure leading to death (Q2W arm, not related). One case of moderate local reaction (erythema) was reported in QW arm.Conclusion:BCD-089 in combination with MTX had superior efficacy compared with MTX plus PBO in MTX-IR patients with active RA. BCD-089 showed safety profile consistent with other IL6R inhibitors. Further clinical studies are needed.Reference:[1] Khlyabova P, et al. doi: 10.1136/annrheumdis-2018-eular.2410Table 1 Safety results (full analysis set), n (%) Efficacy parameter BCD-089 QW+MTX (n=35) BCD-089 Q2W+MTX (n=35) PBO+MTX (n=35) p-value (Fisher’s exact test) ACR2027 (77.1%)20 (57.1%)6 (17.1%)<0.0001ACR5018 (51.4%)11 (31.4%)2 (5.7%)0.0001ACR7010 (28.6%)7 (20.0%)1 (2.9%)0.0106DAS28-CRP(4) < 3.220 (57.1%)10 (28.6%)1 (2.9%)<0.0001Table 2 Safety results (full analysis set), n (%) Safety parameter BCD-089 QW+MTX (n=35) BCD-089 Q2W+MTX (n=35) PBO+MTX (n=35)Any AE26 (74.29%)23 (65.71%)14 (40.0%)Any SAE1 (2.86%)1 (2.86%)1 (2.86%)Any grade 3-4 AE10 (28.57%)6 (17.14%)2 (5.71%)Grade 3-4 Neutropenia3 (8.57%)3 (8.57%)0 (0.00%)AE of special interest ALT/ AST increased 4 (11.43%)5 (14.29%)1 (2.86%) Leucopenia/ Neutropenia 5 (14.29%)6 (17.14%)1 (2.86%) Infections and infestations 2 (5.71%)1 (2.86%)2 (5.71%) Total cholesterol increased 8 (22.86%)8 (22.86%)2 (5.71%)AEs leading to treatment discontinuation0 (0.00%)1 (2.86%)0 (0.00%)Deaths0(0.00%)1(2.86%)0(0.00%)Disclosure of Interests:V Mazurov Grant/research support from: JSC BIOCAD, Evgeni...