Non-steroidal anti-inflammatory drugs (NSAIDs) are most popular medications for the treatment of pain in common musculoskeletal diseases such as osteoarthritis (OA) and non-specific low back pain (LBP). However, the factors affecting the effectiveness of these drugs have not been determined fully. Aim: to identify factors affecting the effectiveness of NSAIDs in patients with OA and LBP. Materials and methods. An observational study was conducted to evaluate the effectiveness of a 2-week course of NSAIDs in OA and LBP in real clinical practice. The study group consisted of 3604 patients with OA and LBP (60.6% women and 39.4% men, mean age 55.0±13.4 years). According to the study design, aceclofenac (Airtal) and other NSAIDs used in the ratio 1:1. The main criterion of effectiveness was the frequency of complete pain relief after 2 weeks of therapy. In addition, the decrease of pain and general health were determined on a 10-point numerical rating scale (NRS). We compared the frequency of complete pain relief in patients who had and did not have the studied factors. The value of the studied factors was determined using OR (95% CI). Results and discussion. Most patients received aceclofenac (54.9%), as well as diclofenac (2.0%), ketoprofen (1.9%), lornoxicam (2.2%), meloxicam (13.7%), naproxen (2.1%), nimesulide (5.8%), celecoxib (5.9%), ethicoxib (7.1%) and other NSAIDs (4.4%); 56.2% of patients received muscle relaxants, mainly tolperisone (74.7%), vitamin B (10.4%), and proton pump inhibitors (42.8%). Complete pain relief was achieved in 54.8% of patients. The pain decrease and general health improvement were (for NRS) 63.9±13.4% and 61.7±14.8%, respectively. The efficacy of aceclofenac was slightly higher than in the whole group: complete pain relief was in 59.9% of patients. Adverse events in aceclofenac use were observed in 2.3% of patients, other NSAIDs-from 2.4 to 14.1%. The frequency of complete pain relief was higher in men: OR 1,239 (95% CI 1.08-1.418; p=0.002), who had the first episode of pain - OR 3.341 (95% CI 2.873-3.875; p=0.000), a good" response " to NSAIDs in history - OR 1.656 (95% CI 1.385-1.980; p=0.000) and received NSAIDs in combination with muscle relaxants - OR 1.218 (95% CI 1.067-1.390; p=0.004). The effect of therapy is lower in patients 65 years and older-OR 0,378 (95% CI 0.324-0.442; p=0,000), with body mass index >30 kg/m² - OR 0.619 (95% CI 0.529-0.723; p=0.000), with severe pain (≥7 points NRS) - OR 0.662 (95% CI 0.580-0.756; p=0.002), with pain at rest, - OR 0.515 (95% CI 0.450-0,589; p=0.000), pain at night - OR 0.581 (95% CI 0.501-0.672; p=0.000) and the presence of stiffness - OR 0.501 (95% CI 0.438-0,573; p=0.000). Treatment results are significantly worse in the cases of combination of LBP and joint pain, as well as pain in the trochanter major and pes anserinus area (p
BackgroundBCD-020 is the first Russian rituximab (RTX) biosimilar which was approved for medical use in lymphoma patients in Russia and some CIS countries. Previous preclinical and clinical studies showed that BCD-020 is highly similar to innovator RTX. Since there are several differences in mechanism of action of RTX in NHL and RA it is recommended to conduct separate clinical studies in oncology and autoimmune indications to prove similar efficacy and safety of biosimilar and original medicine.ObjectivesThe primary objective was to evaluate the efficacy and safety of BCD-020 used in combination with MTX in patients with RA with inadequate response or intolerance to other DMARDs including 1 or more TNF inhibitor. The secondary objectives included direct comparison of safety, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of RTX biosimilar and innovator RTX.MethodsThis international multicenter randomized double-blind phase 3 clinical study was conducted in patients with active RA despite DMARD therapy, which included 1 or more TNF inhibitor. After completion of screening all eligible patients were stratified by age (<40 years/40 years), ACCPA positive/ACCPA negative, presence/absence of the need for oral steroids. Then patients were randomized in 1:1 ratio into 2 arms: patients from the main arm received BCD-020 1000 mg as an IV infusion on day 1 and day15, patients from the reference arm received innovator RTX by the same regimen. In this work results of the first 6-months period of observation are presented.ResultsA total of 160 patients were enrolled; 159 patients had data eligible for efficacy analysis. ACR20 at Week 24 was reported in 84.14% patients in BCD-020 arm and 87.01% in reference arm. The 95% CI for the difference in proportion of ACR20 between groups was [-13.95; 8.74%], where the limits of 95% CI lie within the pre-specified equivalence margin. Both drugs caused deep and sustained depletion of B-cells from peripheral blood without any toxicity to other cell populations. Favorable safety profiles were demonstrated in both groups without any significant differences: AEs have been reported in 59.34% patients from BCD-020 arm and 54.12% patients from reference arm. Treatment discontinuation caused by AE/SAE was reported only for 3 (3.30%) patients in BCD-020 arm and 4 (3.53%) patients in the reference arm (p=1.00). SAEs occurred only in the reference group (2.35%). Binding antibodies were revealed in 3 patients from BCD-020 arm and in 7 patients from reference arm (p=0.209). There were 2 events of neutralizing antibodies against RTX, both in the reference arm (p=0.232).ConclusionsEquivalent efficacy of BCD-020 compared to innovator RTX in patients with active RA has been confirmed. Further clinical evaluation of BCD-020 is planned to confirm long-term efficacy and safety.Referencesinterim study report.Disclosure of InterestA. Eremeeva Employee of: CJSC BIOCAD, E. Chernyaeva Employee of: CJSC BIOCAD, R. Ivanov Employee of: CJSC BIOCAD, E. Nasonov: None declared, L. Knyazeva: None declared
За последние годы, наряду с существенным прогрессом в изучении ключевых вопросов патогенеза ревматоидного артрита (РА) и внедрением в клиническую практику новой группы лекарственных средств-генно-инженерных биологических препаратов (ГИБП), способствовавшим расширению возможностей патогенетической терапии заболевания, произошли существенные изменения в понимании стратегии лечения данного заболе
Background:Rituximab (RTX) is successfully used in patients with active rheumatoid arthritis (RA) who previously received biological disease-modifying antirheumatic drugs (bDMARDs) at a dose of 1000 mg. Previous preclinical and clinical studies showed that BCD-020 is highly similar to innovator RTX. ALTERRA study demonstrated that first-line use of 600 mg BCD-020 is very effective in bDMARDs naive patients with RA.Objectives:The goal of ALTERRA study was to evaluate the efficacy and safety of the alternative dosing regimen (600 mg) of BCD-020 in bDMARDs naive patients with RA.Methods:ALTERRA study was conducted as multicenter randomized double-blind placebo-controlled phase 3 study. After the screening patients were stratified by age, anti-CCP level and DAS28 score, randomized (2:1) into 2 arms and received BCD-020 (in combination with methotrexate (MTX)) in a dose 600 mg IV or placebo (in combination with MTX) on day 1 and day 15, then, if the activity of arthritis persisted after 24 wks of study, a second course was provided. Patients were observed up to 52 wks.Results:A total of 159 patients were enrolled in ALTERRA study, 107 patients in BCD-020 arm and 52 patients in placebo arm.Efficacy:ACR20 at wk 24 was reached by 65.69% of patients in BCD-020 arm and 29.41% in placebo arm (p=0.00005, the difference in proportion of registration ACR20 with 95%CI was 29.41 [19.27%; 53.28%], margin 10.5%) in per protocol population, so hypothesis of superiority was confirmed. The performed analysis showed a much more pronounced decrease in the DAS28–4 (ESR) index in BCD-020 arm compared with placebo arm (p=0.0006) at wk 24. A much more significant decrease in change of the HAQ-DI index was also shown in the BCD-020 arm (p=0.008). Analysis of efficacy at wk 52 showed the preservation of the response after 2 courses of therapy with BCD-020, 600 mg (in combination with MTX): ACR20 reached by 84.5%, ACR50 – by 54.6%, ACR70 – by 29.9 % of patients.Safety:BCD-020 showed a favorable safety profile with no significant difference with placebo use (in combination with MTX). After 24 wks patients of both groups developed high similar level of related adverse events: 16.8% of patients in BCD-020 arm and 11.76% in placebo arm (p=0.555). There were only 3 cases of severe adverse events (2.8%) in BCD-020 arm and 2 cases (3.92%) in placebo group. From wk 24 to wk 52: 13.08% of patients (who received 2 courses of BCD-020) and 19.61% of patients (who received one course of BCD-020 after 24 wk) developed related adverse events.Figure 1 ACR 20/50/70 in bDMARDs naive patients with RA after 24-wk treatment of BCD-020/placebo (in combination with MTX).Conclusions:ALTERRA study showed high efficacy and favorable safety profile of RTX biosimilar BCD-020 at a dose of 600 mg in combination with MTX in bDMARDs naive patients with RA.Disclosure of Interest:V. Mazurov: None declared, L. Denisov: None declared, I. Gordeev: None declared, O. Nesmeyanova: None declared, T. Plaksina: None declared, E. Ilivanova: None declared, D. Krechikova: None declared, E...
Background:Tofacitinib is an oral Janus Kinase inhibitor for the treatment of rheumatoid arthritis (RA).Objectives:To evaluate the three-year effectiveness of tofacitinib in RA conventional synthetic (cs) DMARDs non-responders.Methods:Data from 374 patients from Russian national register OREL of patients with RA treated with tofacitinib not less than 3 years after failure of conventional DMARDs were included in the statistical analysis. Clinical and laboratory data from 4 consecutive visits with an interval of 12 months between the visits (± 28 days) were analyzed. Treatment with any biologics ever was an exclusion criteria. Demographical (age, sex) and disease-related characteristics of RA (symptoms duration, RF- and ACCP positivity, presence of joint erosions, DAS28, CDAI, number of tender and swollen joints (NTJ, NSJ), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP)) collected. Statistical analysis performed with statistical programs SPSS2017 and GraphPadPrizm. p-value < 0.05 considered as significant.Results:Baseline characteristics of RA patients, involved in the analysis are presented in table 1.Table 1.Baseline characteristics of the patients with RA (n=374).ParameterCharacteristicsMale, n (%)92 (24.5)Age, years (mean±SD)53.4±13.38Symptoms duration, month (mean±SD)140±137Positive rheumatoid factor (RF), n (%)123(32.8)Positive antibodies to cyclic citrullinated peptide (ACCP), n (%)329(87.9)Erosions of hand joints (X-rays), n (%)372 (99.4)BMI, kg/m2(mean ±SD)26.8 ± 6.14Smokers (current and in the past), n (%)54 (14.4)Changes in the diseases activity parameters in patients with RA, treated with tofacitinib not less than 3 years after cs DMARD failure are presented in table 2, figure 1, and figure 2.Figure 1.DAS28 of patients with RA, treated with tofacitinib (n=374) – 3-years follow-up (time-points are presented in years ± 28 days).Figure 2.DAS28 of patients with RA, treated with tofacitinib (n=374) – 3-years follow-up (time-points are presented in years ± 28 days).Table 2.Changes in RA parameters in patients treated with tofacitinib, n=374 (M±SE).Disease characteristicsBaselineYear 1#Year 2#Year 3#C-RP, mg/L30.1±35.08.3±12.87.6±10.79.4±13.5ESR, mm/h35.2±21.222.7±17.221.9±17.722.3±17.3NTJ from 2811.2±6.54.6±4.94.8±5.03.9±3.8NTJ from 287.6±5.12.4±3.21.7±3.11.4±2.8*difference with baseline is significant with p<0.000.#- ±28 daysConclusion:According to the real world data treatment with tofacitinib may provide good response rates in RA patients, refractory to the previous csDMARDs treatment in long-term perspective.Acknowledgments :PfizerDisclosure of Interests: :Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: Pfizer, Novartis, AbbVie, JSC BIOCAD, Сelgene, MSD, Sanofi, V Mazurov: None declared, Alexander Lila: None declared, Andrey Baranov Grant/research support from: Bayer, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Evgeniy Zhilyaev Speakers bureau: Novartis, UCB, Pfizer, Biocad, Abbvie, MSD, Roche, Ekaterina Koltsova: None declared, Evgeniya Shmidt Speakers bureau: MSD, Novartis, Pfizer, Oxana Fomina: None declared, Irina Bondareva: None declared, Olga Anoshenkova: None declared, Aleksey Vasilenko: None declared, Elizaveta Vasilenko: None declared, Natalya Yudina: None declared, Larisa Knyazeva: None declared, Vyacheslav Poncratov: None declared, Ekaterina Gaydukova: None declared, Evgeny Nasonov Speakers bureau: Lilly, AbbVie, Pfizer, Biocad, R-Pharm
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