Search

Objective: to analyze the results of tofacitinib (TOFA) therapy in real clinical practice according to the All-Russian Arthritis Registry (OREL). Subjects and methods. The OREL Registry included 347 patients (286 (82%) women and 61 (18%) men) with rheumatoid arthritis (RA) who initiated TOFA therapy. The male:female ratio was 1:4.7. The patients’ median age at onset of the disease was 42 years; its duration was 8 years. Most of the patients included in the registry had extended- (n=171 (52%)) or late- (n=148 (45%)) stage of RA. Results and discussion. Prior to initiation of TOFA therapy, RA activity according to DAS28 was high and moderate in 91 (64.5%) and 40 (28.4%) patients, respectively; the median DAS28 value was 5.5 [4.6; 6.2]; SDAI – 30.5 [21.4; 42.9], and CDAI – 28.2 [20.0; 37.1]. The use of TOFA was accompanied by significant decrease of disease activity. After 12 weeks, high RA activity was persistent in 32 (22.7%) patients; the number of patients with moderate activity increased to 77 (54.6%), that of those with low activity rose to 15 (10.6%); remission was observed in 17 (12.1%) patients. 216 (62.6%) and 76 (22%) patients received TOFA as first- and second-line therapy, respectively. TOFA was most frequently prescribed when tumor necrosis factor-á inhibitors (19.6%), rituximab (7.8%), tocilizumab (4.3%), and abatacept (5.2%) were insufficiently effective or poorly tolerated. Conclusion. The results of using TOFA in real clinical practice may suggest that the drug has high efficacy in patients with RA. TOFA can be used at a dose of 5 or 10 mg twice daily as both alone and in combination with disease-modifying anti-rheumatic drugs. TOFA showed similar efficacy in patients who had earlier taken biological agents and in those who had not.

The JAK inhibitor tofacitinib (TOFA) blocks the intracellular signaling pathway that activates the synthesis of cytokines and mediators involved in the development of pain and central sensitization (CS), which determines the rapid analgesic effect. However, it is not clear how pain reduction is associated with achieving low activity in rheumatoid arthritis (RA).The aim of the studywas to assess the relationship between the early clinical response to tofacitinib and a decrease in rheumatoid arthritis activity after 3 and 6 months.Material and methods.The study group consisted of 88 RA patients (age – 53±11.5 years; 79.3% of women) who received basic anti-inflammatory drugs (59.5% – methotrexate, 19.8% – leflunomide) and who were prescribed TOFA in a dose 10 mg/day. Seropositivity for rheumatoid factor was 89.8%; the value of the DAS28 index is 5.2±1.2. The severity of pain was assessed using the Brief Pain Inventory questionnaire, the neuropathic component of pain (NCP) – using the PainDETECT questionnaire, signs of CS – using the Central Sensitization Inventory (CSI) questionnaire in the early stages after the administration of TOFA, RA activity – using the DAS28-CRP index after 3 and 6 months.Results.The mean severity of pain at baseline was 5.3±2.0 on the visual analogue scale (VAS); 51.1% of patients had signs of CS (CSI>40), 15.9% had NCP (PainDETECT>18). 7 days after the start of therapy, there was a significant decrease in pain – to 4.1±1.8 according to VAS (pConclusions.The use of the JAK inhibitor TOFA allows achieving a quick analgesic effect and reducing the signs of CS. An early clinical response to TOFA (pain relief) predicts a decrease in RA activity after 3 and 6 months of therapy.

Objective : to assess quality-of-life (QoL) dynamics in patients with rheumatoid arthritis (RA) when initiating therapy with biological agents (BAs) in real clinical practice. Patients and methods . The investigation enrolled patients with RA from the patient cohort participating in the TERMINAL-II multicenter Russian study, who newly initiated BA therapy. In the self-assessment terminal, the patient completed HAQ, EQ-5D, and RAPID-3 questionnaires. DAS28, SDAI, CDAI, and RAPID-3 were used to determine disease activity. The patient's functional status and QoL were assessed using the HAQ index and the EQ-5D questionnaire, respectively. The efficiency of the therapy was analyzed 6 months after the start of the study according to the standard procedures. Results and discussion . The investigation enrolled 156 RA patients: 79.6% females; mean age, 45.8±13.2 years; disease duration, 7.6±5.6 years. The patients had high RA activity (a mean DAS28 of 5.2±1.2, a mean SDAI of 39.5±16.4, a mean CDAI of 27.5±10.4, and a mean RAPID-3 of 15.1±3.6) and previous inefficacy of synthetic disease-modifying antirheumatic drugs (DMARDs) after at least 6 months of therapy. Only 1.2% of patients had a good functional status comparable to the population-based control (HAQ 40.5). 70% of patients needed to take non-steroidal anti-inflammatory drugs (NSAIDs). The first BA was chosen in accordance with the recommendations for administration of BAs and in terms of their availability in a specific region of the Russian Federation. The first prescribed BA was tumor necrosis factor-a (TNF-a) inhibitors in 112 (71.8%)patients, anti-B-cell therapy in 14 (9.0%), an interleukin-6 receptor inhibitor in 16 (10.3%), and a leukocyte costimulatory inhibitor in 14 (9.0%). Comparison of the patients receiving newly initiated therapy with TNF-a inhibitors and drugs with other mechanisms of action showed that the patients who had abatacept received higher doses of methotrexate (MTX), but lower doses of glucocorticoids (GCs) than those who were prescribed rituximab and tocilizumab. A statistically significant decrease in DAS28, SDAI, CDAI, and RAPID-3 scores was achieved after 6 months of therapy. Improvements of functional status and QoL in patients were also noted (p

Objective: to assess the long-term safety and efficiency of tocilizumab (TCZ) therapy in patients with early rheumatoid arthritis (RA) of moderate and high activity, who have completed the basic WA19926 study, as well as the rate of sustained drug-free remission.Subjects and methods. A long-term open-label multicenter Phase III extension study (ML28124) was conducted using a group of 49 patients (36 (73.5%) women and 13 (26.5%) men; mean age 53.3±10.8 years) with early RA of moderate and high activity. All the patients received an intravenous infusion of TCZ 8 mg/kg every 4 weeks for 104 weeks (a total of 27 infusions). The safety assessment criteria were the rate and severity of all adverse events (AE), serious AE (SAE), and AE of particular interest; the rate of AE causing drug dosage changes or withdrawal from the study; the frequency of clinically significant laboratory abnormalities. The analysis of efficiency (secondary end points) included changes of DAS8, which was calculated using erythrocyte sedimentation rate (ESR) (DAS28-ESR) and SDAI, the of tender joint count (TJC) and swollen joint count (SJC); the number of patients who had achieved drug-free remission; and the time to a RA exacerbation in patients who had achieved non-drug remission.Results and discussion. The total rate of AE was found to be 69.4%; that of SAE was 10.2%; SAE were 6.9% of the the total number of AE; AE of particular interest were 17.2% of the total number of AE. More than one-third (35.6%) of the AE caused drug dose changes or therapy discontinuation or complete cessation. The laboratory clinically significant abnormalities included those in complete blood cell counts (blood alanine aminotransferase, aspartate aminotransferase, total and direct bilirubin, creatinine, and glucose). The evaluation efficiency analysis showed that the main disease activity measures (DAS28-ESR, SDAI, SJC, and TJC) decreased at 104-week follow-up versus at baseline. The rate of drug-free remission was 71.4%; that of recurrence was 40.0% (the median time to recurrence was 23 weeks). The findings suggest that the safety profile of TCZ is acceptable in the long-term treatment of early RA and correspond to earlier results.

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

The literature virtually lacks the results of investigations aimed to study the clinical picture of ankylosing spondylitis (AS) in the real practice of rheumatologists in Russia. At the same time, these investigations may give information on not only the epidemiological aspects of the disease, but also a variety of its clinical presentation, its social importance, allow evaluation of the efficiency of therapy, and plan a system of further health care costs. Subjects and methods. In early 2015, the cross-sectional multicenter non-interventional trial EPICA2 was conducted to refine the clinical picture of AS in the real practice of a rheumatologist. The trial involved 402 patients with AS from 10 centers of Russia. The patients were examined using the international standards accepted for this disease. Results and discussion. 180 out of the 402 patients were treated in hospital; the others were examined during outpatient visits. The patients' mean age was 40.8±11.5 years; there were 292 (72.6%) men; 82.6% were HLA-B27 positive. The average age of onset was 27.6 years; the interval between symptom onset and diagnosis was 85.2 months. The rheumatologists established the diagnosis in 87.3% of the cases. BASDAI and BASFI averaged 4.3±2.1 and 4.1±1.8, respectively. At the trial, there was peripheral arthritis in 33.1% of the patients, enthesitis in 37.1%, and dactylitis in 1.2%. Joint endoprosthesis was carried out in 4.7% of the patients. The most common comorbidities were hypertension (25.1%), gastric ulcer (9.7%), coronary heart disease (4.0%), and diabetes mellitus (3.0%). Conclusion. AS is diagnosed in real practice more than 7 years after its onset mainly by rheumatologists.The delay of the diagnosis is mostly associated with the fact that specialists of other medical specialties are unaware of the clinical presentation of the disease. The examined group of patients with AS shows a relatively high activity and obvious functional impairments, which is primarily related to the specific features of patient selection in this trial.