Ollier’s disease (enchondromatosis, dyschondroplasia) is a violation of the growth and development of bone structure, manifested by the formation of foci of cartilage tissue in one or more bones of the skeleton. It is accompanied by deformation, shortening and dysfunction of the segments of the bone apparatus involved in the pathological process. Enchondromatosis is a rare disease. At the end of the 20th century, 30 cases of the disease were mentioned in the specialized literature. Taking into account the insufficient familiarity of doctors with this pathology, which causes difficulties in diagnosis, a review of the literature and a description of the clinical case are presented.

The article discusses the pathogenesis and clinical manifestations of cutaneous vasculitis in rheumatoid arthritis (RA) and the role of autoimmune disturbances in the development of micro- and macrovascular thrombosis of the venous and arterial vessels caused by SARS-CoV-2 virus infection. A clinical case is described in which skin necrosis in the elbow joint area developed in a patient with a long-term course of RA after COVID-19. The process subsided against the background of treatment with an interleukin-6 inhibitor.

Relapsing polychondritis (RPC) is a rare disease, its diagnosis presents certain difficulties. This is due to the absence of characteristic clinical manifestations at the initial stages of the disease, late diagnosis and difficulties in selecting adequate therapy.The article presents a review of the literature on the diagnosis and treatment of RPC, as well as a clinical case with tracheobronchial tree and other organ systems involvement in the absence of classical auricular involvement.

Pigmented villonodular synovitis (PVNS) is a rare disease, its diagnosis has certain difficulties. This is due to the absence of characteristic etiological factors and clinical manifestations of PVNS, as well as the insufficient level of knowledge among doctors. The article presents a review of the literature on the diagnosis and treatment of PVNS, as well as a clinical case, which peculiarity is the late diagnosis of this disease, despite the presence of its certain clinical and morphological manifestations.

The need for effective drugs for the treatment of knee osteoarthritis (OA) is constantly growing. Current guidelines recommend the use of symptomatic slow acting drugs for osteoarthritis (SYSADOA) such as glucosamine (GCA) in this disease. Among various drugs containing GCA, high bioavailability and clinical efficacy have been shown only for prescription crystalline GCA sulfate (pGCAS) administration. Several meta-analyses and network meta-analyses have shown that efficacy of pGCAS 1500 mg once daily is superior to other GCA-based products (such as GCA hydrochloride with or without sodium sulfate) and the combination of GCA with chondroitin sulfate (CS) in terms of reducing the intensity of pain and improving the functional state. These studies confirmed the favorable safety profile of pGCAS, which was comparable to placebo in the incidence of adverse events. Pharmacoeconomic studies have also demonstrated greater cost-effectiveness of pGCAS compared to other GCA drugs.A group of Russian experts at a meeting of the advisory committee reviewed the evidence in favor of the use of pGCAS and evidence of its effectiveness in the treatment of knee OA in comparison with other products that include GCA, and the fixed combination of GCA with CS. Taking into account the results obtained, the use of pGCAS at a dose of 1500 mg once a day is recommended as a rational choice for the treatment of knee OA.

Background This article describes an updated stepwise algorithm for the pharmacological management of osteoarthritis (OA) to establish a treatment method for patients with OA. In step 1, background maintenance therapy includes symptomatic slow-acting drugs for OA, especially prescription crystalline glucosamine sulfate product, for which the high-quality evidence base of efficacy is unequivocal, or prescription chondroitin sulfate. Oral nonsteroidal anti-inflammatory drugs (NSAIDs) or paracetamol only as rescue analgesia is given on top of the background therapy. Step 2: For patients with persistent OA symptoms, the use of oral NSAIDs is mandatory for maintaining supportive therapy with symptomatic slow-acting drugs for OA. It is recommended to properly stratify patients and carefully select oral NSAID therapy to maximize the benefit-to-risk ratio. Intra-articular hyaluronic acid and intra-articular corticosteroids are recommended as well in step 2 of the algorithm, especially for patients who do not respond to the previous therapies. Step 3: Duloxetine is considered along with the previous procedures, especially in patients with pain from central sensitization. Step 4: Total joint replacement is recommended for patients with severe symptoms and poor quality of life. Major Conclusions The current guidelines and literature review provide evidence-based recommendations supported by clinical experience on how to organize the treatment process in patients with knee OA applicable in the Russian clinical practice. Future Research Directions International evidence-based guidelines lack consensus on different treatments, including the use of prescription crystalline glucosamine sulfate, NSAIDs, and intra-articular hyaluronic acid. The content of this article needs a further discussion about the clinical evidence and harmonization of recommendations for knee OA management.

Objective – to evaluate efficacy and safety of “Carmolis” fluid and gel in patients with knee osteoarthritis, as well as the gel efficacy combined with ultraphonophoresis.Materials and methods. The study included 200 patients, who were divided into 2 groups depending on the way of application of “Carmolis” forms. Group 1 included 165 patients with knee osteoarthritis (the main group included 90 patients, the control group – 75 patients), who underwent complex local treatment with 2 “Carmolis” forms. Group 2 included 35 patients (20 people in the main group and 15 in the control one). The main group received phonophoresis with “Carmolis” gel, and the control group received “Carmolis” gel locally on the affected knee joint. Patients’ average age in group 1 was 62,7 ± 8,5 years, the average age in the control group was 61.4 ± 8.7 years, the disease duration was 10.1 ± 4.7 and 9.2 ± 6, 0 years, respectively. In group 2 the average age and disease duration were 60.1 ± 12.8 and 5.7 ± 5.4 years, respectively.At the initial stage 90 patients of the main group 1 were rubbed “Carmolis” fluid locally in the joint followed by massage. After the fluid absorbed completely, “Carmolis” gel was applied, followed by massage. In the comparison group (75 patients), standard therapy was combined only with “Carmolis” fluid applied on the II knee joint.Twenty patients of the main group 2 were treated with phonophoresis combined with “Carmolis” gel. Clinical efficacy was assessed by pain dynamics.Results. Treatment with two “Carmolis” local forms significantly decreased average on moving from 61.8 ± 14.2 to 30.7 ± 14.2 (р <0,001), at rest – from 49 ± 19, 9 to 20.4 ± 8.5 (р <0,001), on palpation – from 38.7 ± 10.4 to 18.4 ± 5.7 (р <0,001). A similar dynamics was also revealed during WOMAC assessment (Western Ontario McMaster Universities OA Index). Before the treatment start the average WOMAC pain level in the main group was 240.5 ± 39.8, after the treatment – 114.8 ± 30.4 (р <0,001). The control group also showed pain decrease, but to a much lesser extent than in the main one. At the end of the treatment course, patients of both groups demonstrated a pronounced decrease of synovitis sings, but there were no differences between the groups. The dose of non-steroidal anti-inflammatory drugs in the main group was reduced in 70 (77.8 %) patients, in the control group – in 50 (66.7 %). The tolerability of both forms was very good and good. No adverse events were registered. Data on the effectiveness and safety of “Carmolis” gel combined with ultraphonophoresis are presented in the article.Conclusion. According to the results, combined therapy using “Carmolis” liquid and gel significantly reduces joint pain and synovitis severity, increases joints» functional ability and improves patients» general condition, which allows reducing the dose of non-steroidal anti-inflammatory drugs. Both “Carmolis” forms had excellent and good tolerability.

Background This article describes an updated stepwise algorithm for the pharmacological management of osteoarthritis (OA) to establish a treatment method for patients with OA. Summary In step 1, background maintenance therapy includes symptomatic slow-acting drugs for OA, especially prescription crystalline glucosamine sulfate product, for which the high-quality evidence base of efficacy is unequivocal, or prescription chondroitin sulfate. Oral nonsteroidal anti-inflammatory drugs (NSAIDs) or paracetamol only as rescue analgesia is given on top of the background therapy. Step 2: For patients with persistent OA symptoms, the use of oral NSAIDs is mandatory for maintaining supportive therapy with symptomatic slow-acting drugs for OA. It is recommended to properly stratify patients and carefully select oral NSAID therapy to maximize the benefit-to-risk ratio. Intra-articular hyaluronic acid and intra-articular corticosteroids are recommended as well in step 2 of the algorithm, especially for patients who do not respond to the previous therapies. Step 3: Duloxetine is considered along with the previous procedures, especially in patients with pain from central sensitization. Step 4: Total joint replacement is recommended for patients with severe symptoms and poor quality of life. Major Conclusions The current guidelines and literature review provide evidence-based recommendations supported by clinical experience on how to organize the treatment process in patients with knee OA applicable in the Russian clinical practice. Future Research Directions International evidence-based guidelines lack consensus on different treatments, including the use of prescription crystalline glucosamine sulfate, NSAIDs, and intra-articular hyaluronic acid. The content of this article needs a further discussion about the clinical evidence and harmonization of recommendations for knee OA management.

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.

Objective. To assess the efficacy and safety of amtolmetin guacil (AMG) in patients with knee joint osteoarthritis (KJOA) and associated dyspepsia in real clinical practice. Methods . 220 patients with KJOA with severe pain syndrome in KJ ≥ 40 mm in VAS and dyspepsia were included in the observation study. AMG was administered at a dose of 600 mg twice daily for 28 days. Patients had three visits: before starting treatment, on Day 14 ± 3 (visit 2), on Day 28 ± 3 (final visit) to assess the pain dynamics (according to VAS), stiffness and functional activity according to WOMAC index, general health assessment (according to VAS) and a quantitative assessment of dyspepsia (SODA index). Results. Of 219 patients, about 72.5% reported pain reduction from 65 to 27 mm at the end of the study. All indicators of three scales of the WOMAC index decreased statistically significant (р<0,001). There was also a significant decrease of non-pain and pain signs of dyspepsia and an increase in the “treatment satisfaction” index (р<0,001). The patients showed better tolerability of AMG than that of previously taken NSAIDs. Conclusion. AMG proved to be an effective drug with good tolerability and positive effect on associated dyspepsia.

The main goal of management of patients with osteoarthritis (OA) is analgesic and anti-inflammatory therapy, deceleration of the progression of the disease, and improvement of quality of life. Fast-acting symptomatic drugs (analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs)) and sustained-release structure-modifying drugs (chondroitin sulfate, glucosamine sulfate, their combination, piascledine, diacerein) are used to treat OA. The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO)) has analyzed the proposals of a number of expert groups and elaborated a consensus on the management of patients with OA: it has recommended the use of sustained-release drugs just in early OA.The article gives the data of comparative studies of a new Russian chondroprotector, the active ingredient of which is a bioactive extract from small sea fish, which contains alflutop. It evaluates the analgesic and anti-inflammatory effects and acute and chronic toxicity on experimental animal models and the preliminary results of therapy with the new drug in patients with OA in the large and small joints.

Objective. To assess the efficacy and safety of amtolmetin guacil (AMG) in patients with knee joint osteoarthritis (KJOA) and associated dyspepsia in real clinical practice.Methods. 220 patients with KJOA with severe pain syndrome in KJ ≥ 40 mm in VAS and dyspepsia were included in the observation study. AMG was administered at a dose of 600 mg twice daily for 28 days. Patients had three visits: before starting treatment, on Day 14 ± 3 (visit 2), on Day 28 ± 3 (final visit) to assess the pain dynamics (according to VAS), stiffness and functional activity according to WOMAC index, general health assessment (according to VAS) and a quantitative assessment of dyspepsia (SODA index).Results. Of 219 patients, about 72.5% reported pain reduction from 65 to 27 mm at the end of the study. All indicators of three scales of the WOMAC index decreased statistically significant (р<0,001). There was also a significant decrease of non-pain and pain signs of dyspepsia and an increase in the “treatment satisfaction” index (р<0,001). The patients showed better tolerability of AMG than that of previously taken NSAIDs.Conclusion. AMG proved to be an effective drug with good tolerability and positive effect on associated dyspepsia.

The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) treatment algorithm for the management of knee osteoarthritis (OA), published in December 2014, provides practical guidance for the prioritization of interventions. This current paper represents an assessment and endorsement of the algorithm by Russian experts in OA for use in Russian clinical practice, with the aim of providing easy-to-follow advice on how to establish a treatment flow in patients with knee OA, in support of the clinicians’ individualized assessment of the patient. Medications recommended by the ESCEO algorithm are available in Russia. In step 1, background maintenance therapy with symptomatic slow-acting drugs for osteoarthritis (SYSADOA) is advised, for which high-quality evidence is provided only for the formulations of patented crystalline glucosamine sulphate (pCGS) (Rottapharm/Meda) and prescription chondroitin sulfate. Paracetamol may be added for rescue analgesia only, due to limited efficacy and increasing safety signals. Topical non-steroidal anti-inflammatory drugs (NSAIDs) may provide additional symptomatic treatment with the same degree of efficacy as oral NSAIDs but without the systemic safety concerns. To be effective, topical NSAIDs must have high bioavailability, and among NSAIDs molecules like etofenamate have high absorption and bioavailability alongside evidence for accumulation in synovial tissues. Oral NSAIDs maintain a central role in step 2 advanced management of persistent symptoms. However, oral NSAIDs are highly heterogeneous in terms of gastrointestinal and cardiovascular safety profile, and patient stratification with careful treatment selection is advocated to maximize the risk: benefit ratio. Intra-articular hyaluronic acid as a next step provides sustained clinical benefit with effects lasting up to 6 months after a short-course of weekly injections. As a last step before surgery, the slow titration of sustained-release tramadol, a weak opioid, affords sustained analgesia with improved tolerability.

Objective: to investigate the efficacy and tolerability of amtolmetin guacil (AMG; Niselat®, Dr. Reddy's Laboratories Ltd, India) versus previous therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with knee osteoarthritis (OA) and signs of dyspepsia.Subjects and methods. The open-label observational study included 220 patients aged 30–65 years who suffered from knee OA and intense pain during NSAID intake and had symptoms of dyspepsia in the absence of contraindications to the use of AMG. Among the comorbidities that generally occurred in 68% of the patients, there was a preponderance of hypertension (42%), lower extremity varicose veins (6.4%), and diabetes mellitus (6%). Treatment efficacy was evaluated using three domains of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), by also taking into account pain intensity and general health assessment on the visual analogue scale. A Severity of Dyspepsia Assessment (SODA) scale was used to rate dyspepsia.Results and discussion. AMG had a marked analgesic effect confirmed by 40% or more pain reduction that occurred in 72.5% of the patients. The high analgesic effect of AMG was confirmed by a statistically significant (p <0.001) reduction in the WOMAC index (pain and stiffness) and by an increase in functional activity. There was a significant decrease in painless and painful signs of dyspepsia, as well as positive changes in the measures “overall assessment of dyspepsia severity” (p < 0.001) and “satisfaction with treatment”. Overall assessment of AMG tolerability was only positive: excellent (33%), good (56%), and satisfactory (11%). There were no serious adverse events (AE). AE were graded as moderate and mild in 8 and 82% of cases, respectively. AE were recorded in 7.7% of the patients. Conclusion. The findings suggest that AMG offers good prospects for knee OA treatment.

The article summarizes the data of two randomized controlled trials (RCTs) Phase III MEASURE 1 and MEASURE 2 investigating the efficacy and safety of secukinumab (SEC) in treating ankylosing spondylitis (AS) and compares the data with the results obtained from Russian patients with active AS, who were enrolled in these RCTs.Subjects and methods. Among 590 patients included in the MEASURE 1 and MEASURE 2 trials, the Russian group totaled 107 patients: 44 and 29 patients took SEC in the MEASURE 1 and MEASURE 2 trials, respectively; 34 patients had placebo in the two trials.Results and discussion. A retrospective analysis of the results for the Russian patient group showed that the efficacy of SEC in treating AS was fully similar to that demonstrated in the entire MEASURE 1 and MEASURE 2 group cohort. At 1 to 16 weeks of SEC therapy, the MEASURE 1 trial Russian patients displayed a rapid clinical improvement in 52.6% (p = 0.043); and in the SEC 150- and 75-mg groups, ASAS20 improvement was achieved by 64% (p = 0.0015), respectively. The SEC 150-mg group in the MEASURE 2 trial exhibited an ASAS20 response in 66.7% of cases (p = 0.0063). The clinical response at 16 weeks in the patients randomized at baseline into SEC treatment groups was sustained for 52 weeks. The proportion of patients achieving ASAS20 response at 52 weeks was 63.2 and 68% in the MEASURE 1 trial (in the SEC 150- and 75-mg groups, respectively) and 73.3% in the MEASURE 2 trial (the SEC 150-mg group). At 52 weeks, ASAS40 reponse was achieved by 52.6% of the patients in the MEASURE 1 trial and by 60% of those in the MEASURE 2 trial (the SEC 150-mg group). In the MEASURE 1 trial, ASAS 5/6 response rates at 16 weeks were 42.1 and 52.0% in the SEC 150- and 75-mg groups (p = 0.0249 and p = 0.0013, respectively). In the MEASURE 2 trial, the proportion of the SEC 150-mg group patients achieving ASAS 5/6 response was 53.3% (p=0.0135). After 52 weeks, these rates were 57.9, 52, and 73.3%, respectively. The adverse reactions observed in both the placebo-controlled and later follow-up periods and in the Russian patient cohort suggest that SEC has an acceptable safety profile and good tolerability in patients with AC.

This article presents results from two clinical trials of infliximab biosimilar, BCD-055, including comparative data on the pharmacokinetics (PK), efficacy and safety of BCD-055 and innovator infliximab (IFX) in patients with ankylosing spondylitis (AS). Objective : The purpose of phase I clinical study ASART-1 was to evaluate the pharmacokinetic and safety profile of BCD-055 and to prove its equivalence with Remicade®, phase III study ASART-2 was conducted to evaluate the efficacy and tolerability of BCD-055 in comparison with Remicade® in patients with active AS. Patients and methods : Both studies were conducted as international multi-center randomized double-blind studies in direct comparison with innovator IFX. Inclusion and exclusion criteria, main examination methods, and drug regimens were the same in both trials. A total of 199 patients were enrolled in the studies. After the screening, the patients were stratified by CRP and BASDAI score, randomized (1:1 ratio in ASART-1; 2:1 ratio in ASART-2) into 2 arms and received BCD-055 or innovator IFX at a dose 5 mg/kg IV at 0, 2, 6 and then every 8 weeks (up to week 54). The primary endpoint for PK profile evaluation was the area under the concentration-time curve (AUC(0-tau)), maximum serum concentration of infliximab at steady state Cmax,ss. Efficacy was assessed by achieving ASAS20 at week 30, the endpoints for safety profile were the incidence of adverse events and serious adverse events during the maintenance-dosing phase and withdrawals from the study due to the safety reasons. Results : A total of 81 patients (ASART-1 study) were included in PK analysis, 199 patients were in efficacy and safety analysis. AUC(0-tau) value were 25,420,996.25±11,635,015.74 (ng/ml) Cmax,ss for BCD-055 and 26,114,705.71±12,102,376.9 (ng/ml)⋅h for INF innovator (p>0.05). Cmax,ss for BCD-055/Remicade® was 122,752 [99,401–151,553] ng/ml and 119,844 [98,120–132,772] ng/ml, respectively (p>0.05). ASAS20 was achieved at week 30 by 81.30% of the patients in the BCD-055 group, and 67.74% in the INF innovator group (p=0.061). The analysis of secondary endpoints (BASDAI, BASMI, BASFI, MASES, quality of life, chest excursion, and number of pathologically changed joints) showed no difference between the biosimilar and innovator groups. BCD-055 and innovator IFX showed highly similar safety profiles in both studies without cases of unexpected toxicity. The rates of AEs were equivalent for both drugs and were 48.48% and 58.21% of patients in the BCD-055 and Remicade®, respectively. Conclusion : BCD-055 is found to be equivalent in terms of PK, and showed the similarity in efficacy and safety profile compared with innovator IFX in patients with active AS.

The Russian biotechnological company «BIOCAD» has designed a chimeric monoclonal antibody against CD20 (BCD-020, Acellbia®) that is a biosimilar of rituximab (RTM; MabThera®, F. Hoffmann-La Roche Ltd., Switzerland). In recent years, there has been evidence that RTM can be used at lower doses than those given in the standard recommendations and instructions for the use of this drug. This serves as the basis for the BCD-020-4/ALTERRA (ALTErnative Rituximab regimen in Rheumatoid Arthritis) trial, the objective of which was to investigate the efficiency and safety of using Acellbia® (at a dose of 600 mg twice at a 2-week interval) as the first biological agent (BA) for methotrexate (MTX)-resistant active rheumatoid arthritis (RA). The investigation enrolled 159 patients aged 18 to 80 years with active RA. After 24 weeks 65.7 and 29.4% of patients achieved 20% improvement by the American College of Rheumatology (ACR) criteria in the Acellbia® + MTX and placebo (PL) + MTX groups, respectively (p<0.0001). The differences in the ACR20 response rate in the two groups were 36.3% (95% CI, 19.27–53.28%). There were significant differences between the groups in the ACR50 response rates: 28.4% and 5.9% (p=0.001) and in the ACR70 ones: 12.8% and only 2.0%, respectively (p=0.036). Analysis of all recorded adverse events (AE) frequency showed no significant differences between the patients in the study and control groups and demonstrates its equivalence with that of RTM (MabThera®); all the AE were expectable. It is noted that antibodies to RTM with binding and neutralizing activities had no impact on the efficiency and safety of therapy.

This article presents results from two clinical trials of infliximab biosimilar, BCD-055, including comparative data on the pharmacokinetics (PK), efficacy and safety of BCD-055 and innovator infliximab (IFX) in patients with ankylosing spondylitis (AS).Objective: The purpose of phase I clinical study ASART-1 was to evaluate the pharmacokinetic and safety profile of BCD-055 and to prove its equivalence with Remicade®, phase III study ASART-2 was conducted to evaluate the efficacy and tolerability of BCD-055 in comparison with Remicade® in patients with active AS.Patients and methods: Both studies were conducted as international multi-center randomized double-blind studies in direct comparison with innovator IFX. Inclusion and exclusion criteria, main examination methods, and drug regimens were the same in both trials. A total of 199 patients were enrolled in the studies. After the screening, the patients were stratified by CRP and BASDAI score, randomized (1:1 ratio in ASART-1; 2:1 ratio in ASART-2) into 2 arms and received BCD-055 or innovator IFX at a dose 5 mg/kg IV at 0, 2, 6 and then every 8 weeks (up to week 54). The primary endpoint for PK profile evaluation was the area under the concentration-time curve (AUC(0-tau)), maximum serum concentration of infliximab at steady state Cmax,ss. Efficacy was assessed by achieving ASAS20 at week 30, the endpoints for safety profile were the incidence of adverse events and serious adverse events during the maintenance-dosing phase and withdrawals from the study due to the safety reasons.Results: A total of 81 patients (ASART-1 study) were included in PK analysis, 199 patients were in efficacy and safety analysis. AUC(0-tau) value were 25,420,996.25±11,635,015.74 (ng/ml) Cmax,ss for BCD-055 and 26,114,705.71±12,102,376.9 (ng/ml)⋅h for INF innovator (p>0.05). Cmax,ss for BCD-055/Remicade® was 122,752 [99,401–151,553] ng/ml and 119,844 [98,120–132,772] ng/ml, respectively (p>0.05). ASAS20 was achieved at week 30 by 81.30% of the patients in the BCD-055 group, and 67.74% in the INF innovator group (p=0.061). The analysis of secondary endpoints (BASDAI, BASMI, BASFI, MASES, quality of life, chest excursion, and number of pathologically changed joints) showed no difference between the biosimilar and innovator groups. BCD-055 and innovator IFX showed highly similar safety profiles in both studies without cases of unexpected toxicity. The rates of AEs were equivalent for both drugs and were 48.48% and 58.21% of patients in the BCD-055 and Remicade®, respectively.Conclusion: BCD-055 is found to be equivalent in terms of PK, and showed the similarity in efficacy and safety profile compared with innovator IFX in patients with active AS.

The 16th Annual European Congress of Rheumatology, which is indubitably the central event of international rheumatology, took place in Rome on 10–13 June 2015. It was attended by around 14,000 delegates (physicians, healthcare workers, patients) from more than 100 countries of the world. A total of 4,300 theses were considered; 82% of them were selected to be published. The program of the congress was extremely diverse; it included discussion of new data on the diagnosis and treatment of the most common rheumatic diseases, their etiology and pathogenesis, personified therapy, and many other problems. This communication presents in more detail materials reflecting current trends in the treatment of rheumatoid arthritis.

Apremilast (AP) is a new phosphodiesterase 4 inhibitor for the treatment of psoriasis and psoriatic arthritis (PsA). Treatment with AP reduces the level of proinflammatory cytokines and the activity of inflammatory changes.The positive impact of AP treatment on the course of psoriasis has been proven in a number of clinical trials, for example ESTEEM 1 (Efficacy and Safety Trial Evaluating the Effects of apreMilast in psoriasis), in which the treatment with AP has led to a decrease in PASI scores in patients with moderate and severe psoriasis en plaque: after 16 weeks, a 75% PASI improvement was significantly more common in patients taking AP 30 mg twice daily (33%) than in those who used placebo (PL) (5%) (p = 0.0001). In the PALACE 1 trial, the PsA patients were given AP at a dose of 20 or 10 mg twice daily. At 16 weeks, the patients who used AP at doses 20 and 30 mg twice daily, more frequently showed a 20% improvement according to the American College of Rheumatology (ACR) response criteria (ACR20) than those who received PL (in 30.4, 38.1, and 19% of cases; p = 0.0166 and p = 0.0001, respectively). Following 52 weeks of AP treatment, ACR20 was achieved by 63.0% of the patients who took the drug at 20 mg twice daily, and by 54.6% of those who used 30 mg twice daily. The PALACE 1, PALACE 2, and PALACE 3 trials demonstrated that the most common adverse events (AE) were diarrhea, nausea, headache, upper respiratory tract infections, and nasopharyngitis. Most AE were mild and moderate; and the rate of therapy discontinuation due to AE was low.These PALACE trials covering 1493 patients have provided evidence for the efficacy and safety of AP in treating moderate PsA activity.