BackgroundThe patients with rheumatoid arthritis (RA) are less physically active than the general population [1]. Physical exercises improve muscle strength, range of movements, aerobic capacity and bone density in patients with RA [2–4]. However, some physicians fear to recommend the intensive exercises.ObjectivesTo compare the efficacy of two exercise programs in patients with early RA during 6 months.Methods51 patients with early RA (92,2% females, age of 18 to 53 years, disease duration of 2 to 17 months) were randomized into 3 groups. At hospital stage 15 patients underwent 10 high-intensity dynamic exercises using gym apparatus Enraf-Nonius for 45–60 min, including aerobic part (En-Cardio) and 18–20 muscle-strengthening exercises (En-Dynamic Track), 18 patients – 10 therapeutic exercises for joints for 45 min under the supervision of a trainer. At outpatient stage the exercises lasted for 6 months 3 times a week. 18 patients received only drug therapy (control). Tender and swollen joint count, pain on 100-mm VAS, erythrocyte sedimentation rate (ESR), DAS28, HAQ, RAPID3, the average powers of knee extension and ankle flexion by EN-TreeM movement analysis were evaluated at baseline and at 6 months.ResultsAfter 6 months in the both exercise groups there were statistically significant differences from the control group in most parameters (p<0,05). Efficacy of the intensive gym exercises was higher than the therapeutic exercises by tender joint count, HAQ, RAPID3 (p<0,05).Table 1ParametersBaseline6 monthsGymTherapeutic exercisesControlGymTherapeutic exercisesControlTender joint count7,9±3,17,6±2,57,8±2,43,0±1,5*#§3,8±1,8*4,6±1,9*Swollen joint count4,8±2,84,5±1,94,9±2,52,1±1,3*#2,5±1,5*#3,8±2,1ESR, mm/h21,9±14,223,4±17,622,3±14,99,9±3,7*#11,5±5,6*#16,0±12,3*Pain on VAS, mm60,5±21,362,4±18,359,7±14,623,8±12,5*#27,2±11,8*#35,4±21,2*DAS284,13±1,284,32±1,534,49±1,423,14±1,23*3,18±1,67*3,47±1,47*HAQ1,35±0,631,38±0,341,30±0,830,44±0,24*#§0,66±0,31*#0,94±0,32*RAPID39,84±3,1710,34±4,2510,11±6,524,62±1,35*#§5,93±2,93*#7,72±2,53*Extension power of a weaker knee joint, W4,54±2,583,99±3,114,27±1,137,93±2,37*#6,87±3,42*6,13±2,53*Flexion power of a weaker ankle joint, W0,39±0,150,44±0,210,41±0,220,67±0,19*#0,62±0,31*#0,43±0,19*Significance of differences from baseline;#significance of differences from control,§significance of differences between two exercise groups, p<0,05.Adherence to the regular therapeutic exercises for 6 months was better (77,8%) then to the gym exercises (60,0%). Predictors of the regular high-intensity gym exercises were the young age (under 40 years) and the very early stage of RA. Most patients, who regularly did exercises, had DAS28 low disease activity (66,7% in the gym group and 57,1% in the therapeutic exercises group vs 36,7% in the control group, p<0,05).ConclusionsThe both 6-month exercise programs reduce pain, increase functional status, quality of life and power of motion without detrimental effect on disease activity.Referencesvan den Berg M.H. et al. J Clin Rheumatol 2007;13(4):181–6.Hurkmans...

The paper gives data on the clinical efficiency and safety profile of long-term use of the infliximab (INF) biosimilar BCD-055 versus the reference drug Remicade® (REM) in a population of patients with active ankylosing spondylitis (AS).Subjects and methods. An international multicenter randomized double-blind Phase III clinical trial was conducted in 199 patients who were randomized into two groups in a 2:1 ratio and who received BCD-055 or REM at a dose of 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Efficiency assessment was made at 14, 30 and 54 weeks in patients who received at least one dose of INF [intent-to-treat (ITT)], as well as at 54 weeks in those who completed the study according to the Protocol (PP) (per protocol). The efficiency endpoints were the proportion of patients who had achieved ASAS20/ASAS40 responses; changes in BASDAI, BASMI, BASFI, MASES, and SF-36 scores. Immunogenicity was assessed by the proportion of patients in each group with identified binding and neutralizing antibodies (BAbs and NAbs) against INF. The safety analysis included the overall rate of adverse events (AEs), including those that met the respective criteria for serous AEs (SAEs), and grade 3–4 toxicity, as well as the number of cases of early termination of the study because of AEs and SAEs.Results and discussion. The ITT population included 199 patients and the PP one consisted of 161 people. The groups were not statistically different in the rate of and reasons for patient withdrawal from the study. A comparable number of patients achieved ASAS20/ASAS40 responses at 14, 30, 54 weeks (р ≥ 0.05). At 54 week, the proportion of patients who received BCD-055 and REM therapy and achieved an ASAS20 response was 67.42 and 52.24% in the ITT population (p = 0.053) and 80.91 and 68.63% in the PP population (p = 0.128). The BCD-055 and drug comparison groups achieved an ASAS40 response in 53.03 and 38.81% in the ITT population (p = 0.081) and in 63.64 and 50.98% in the PP one (p = 0.177). The proportion of persons with identified BAbs and NAbs was comparable: 21.26 and 3.15% in the BCD-055 group (p = 0.920) and 20.63 and 6.35% in the group REM (p = 0.443), respectively. It was found that the presence of NAbs did not affect the therapeutic response. Both groups did not differ in the detection rate and profile of AEs and SAEs or in the rate of patient withdrawal due to AEs. Most identified AEs were mild to moderate.Conclusion. The efficacy of the INF biosimilar BCD-055 used long in patients with AS did not significantly differ from that of the original drug REM; the safety profile of both drugs was comparable.

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BackgroundEquivalent efficacy of BCD-055 and infliximab (INF) innovator has been previously established (the primary endpoint: ACR20 at Wk14)1.ObjectivesThe impact of BCD-055 and INF innovator on RA activity has been analysed within 14 week study period. DAS28-CRP(,4 CDAI and SDAI were evaluated. Additionally, safety data has been collected.MethodsThe study was conducted as international multicenter randomised double-blind placebo controlled study. The study enrolled 426 adults with active RA. Patients were randomised into 2 study arms in 2:1 ratio to receive BCD-055 or INF innovator in dose of 3 mg/kg. In the analysed period of the study, patients received the iv infusions on Wk0, Wk2, Wk6, Wk14.ResultsEfficacy: BCD-055 and INF innovator showed similar impact on RA activity: in both groups significant decline of DAS28-CRP(4 was observed (figure 1). This result corresponds to positive CDAI and SDAI dynamics (table 2). Medians of CDAI/SDAI on screening indicated high RA activity, while on Wk 14 – moderate activity. Analyses of inflammatory markers (ESR and C-reactive protein) revealed pronounced decline in ESR and CRP levels by Wk 2. No further elevation has been observed.Safety: No differences in safety profiles of BCD-055 and INF innovator has been shown. One of the most frequent AEs were arterial hypertension, anaemia, neutropenia and increase of transaminases. Number of patients with binding and neutralising antibodies also did not differ between groups. Babs were detected in 6.83% patients in BCD-055 arm and in 7.81% in INF innovator arm (p=0.888), Nab were observed in 1.61% and 0.78% patients in same arms (p=0.666).Abstract THU0193 – Table 1SDAI, CDAI dynamics.ScreeningWk14p-value SDAIBCD-055 (n=280)42.46 [35.15–51.11]16.22 [8.45–25.03]<0.00000INF innovator (n=138)41.22 [34.21–47.52]16.15 [9.06–27.11]<0.00000CDAIBCD-055 (n=280)39.15 [31.50–46.00]15.40 [8.00–24.00]<0.00000INF innovator (n=138)36.85 [31.90–42.00]15.55 [8.30–25.50]<0.00000Abstract THU0193 – Table 2Summarised safety dataPercentage of patients withArmp-value BCD-055(n=280)INF innovator(n=138) Any AE/SAE53.57% (150)44.93% (62)0.119Therapy-related AEs26.43% (74)24.64%340.784Any SAE2.14%61.45%21.00Grade 3–4 AEs10.00%285.80%80.966Therapy-related grade 3–4 AEs5.71%164.35%60.722Therapy-discontinuation due to AE2.50%72.90%40.757ConclusionsTreatment with BCD-055 and INF innovator leads to significant decline in RA activity and inflammatory markers by Wk14, which corresponds with previous results of ACR20 assessment1. Both drugs are well tolerated with no differences in safety profiles. The frequency of ADA formation is also comparable.Reference[1] Denisov L, Gordeev I, Mazurov V, et al. FRI0208 Comparison of efficacy, safety and pharmacokinetics of infliximab biosimilar (BCD-055) and innovator infliximab Ann Rheum Dis2017;76:560–561.Disclosure of InterestA. Lila: None declared, L. Denisov: None declared, T. Plaksina: None declared, S. Smakotina: None declared, E. Kunder: None declared, N. Soroka: None declared, A. Kastanayan: None declared, O. Nesmeyanova...

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