[Reduction in the need for glucocorticoids on the background of therapy with biologic disease-modifying antirheumatic drugs and Janus kinase inhibitors in rheumatoid arthritis: evidence from real clinical practice].

BACKGROUND: Clinical guidelines for the treatment of rheumatoid arthritis (RA) recommend reducing the use of glucocorticoids (GCs) due to the high risk of associated complications. AIM: To determine the frequency of GC cancellations and dose reductions in real clinical practice, while taking into account active RA therapy. MATERIALS AND METHODS: The study group consisted of 303 patients with RA reliable according to ACR/EULAR criteria (women 79.9%, age 52.8±13.3, disease duration 9 [4; 16] years, DAS-28-CRP 4.9±1.0, RF seropositivity 77.4%, ACPA seropositivity 70.3%), who were prescribed or changed therapy with disease-modifying antirheumatic drugs (DMARDs), biologic disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (iJAK) due to disease exacerbation and ineffectiveness of previous treatment. All patients initially received GC (7.7±3.8 mg/day equivalent of prednisolone). After adjustment of therapy, 42.9% of patients received methotrexate, 27.6% leflunomide, 2.5% sulfasalazine, hydroxychloroquine, or a combination with an Non-steroidal anti-inflammatory drugs, 63.7% bDMARDs, and 7.2% iJAK. The need for GC intake was assessed by a telephone survey conducted 6 months after the start of follow-up. RESULTS: Telephone survey was possible in 274 (90.4%) persons. There was a significant decrease in pain intensity (numerical rating scale, NRS 0-10) from 6.3±1.4 to 4.3±2.4 (p<0.001), fatigue (NRS) from 6.7±2.3 to 5.2±2.1 (p<0.001), and functional impairment (NRS) from 5.4±2.1 to 3.9±2.0 (p<0.001). A positive PASS index (symptom status acceptable to patients) was noted in 139 (50.7%) patients. GC cancellation was noted in 19.7%, dose reduction in 25.9%, maintaining the same dose in 42.7%, and dose increase in 11.7%. CONCLUSION: Against the background of intensive RA therapy, including combination of DMARDs with bDMARDs or iJAK, complete withdrawal or reduction of GC dose was achieved in less than half (45.6%) of patients after 6 months.

Are the Goals of Therapy Achievable in Patients with Rheumatoid Arthritis Receiving Upadacitinib in Real Clinical Practice?

The aim of the study was to evaluate the effectiveness of UPA in RA patients in real clinical practice after 3 and 6 months of therapy. The study included 63 RA patients with high activity of the disease. Activity was assessed according to the DAS28(ESR), DAS28(CRP), SDAI, CDAI; functional ability to HAQ; quality of life to the EQ-5D; disease activity according to the patient's RAPID-3 index; the level of depression and anxiety to the HADS scale. The effectiveness of therapy was evaluated after 3 (n = 45) and 6 (n = 31) months of UPA therapy. Remission or low activity of the disease by 3 months of therapy was achieved by most patients: remission of 69.8% of patients, low activity of the disease-16.3% of patients. Moderate or high activity persisted in 13.9% of patients. By the 6th month of UPA therapy, the number of remissions reached 90%, low activity 3.3%, moderate activity persisted in 6.7% of patients, high activity of the disease was not in any patient. 20% improvement in function was achieved in 71.8% of patients by the 3rd month of therapy and in 77.8% by the 6th month of treatment; the difference in average HAQ values by the 3rd month of therapy was 0.38 points, by the 6th month-0.58 points. After 3 months of follow-up, 31.1% of patients continued taking GC, by 6 months-24.2%. The dose of GC was reduced from an average of 7.23 to 5.6 mg/s. The percentage of patients requiring NSAIDs decreased from 95.2 to 35.6% and 33.3%, respectively. DMARDs continued to be received by 75.6% of patients by 3 months and 69.7% by 6 months of follow-up. Achieving remission or low activity of the disease in patients with RA receiving UPA in real clinical practice is possible in most patients. A rapid decrease in inflammatory activity is accompanied by a significant improvement in the functional state and quality of life of patients. UPA therapy reduces the need for the use of NSAIDs and reduces the dose of GC in a third of patients.

[Efficacy of combined use of glycosaminoglycan peptide complex for intramuscular administration and oral diacerein in osteoarthritis: evaluation according to an observational multicenter clinical trial].

BACKGROUND: The combined use of intramuscular injection glycosaminoglycan peptide complex (GPC) and oral diacerein can increase the effectiveness of treatment of osteoarthritis (OA). AIM: Compare the effectiveness of combination GPC + diacerein and GPC monotherapy in the treatment of OA in clinical practice. MATERIALS AND METHODS: A retrospective evaluation of the results of a 12-week multicenter observational non-interventional study of the effectiveness of GPC (Rumalon, a course of intramuscular injections 3 times a week, №25) in patients with moderate/severe OA (n=2955) requiring regular administration of nonsteroidal anti-inflammatory drugs (NSAIDs). The analysis identified a group of patients (n=414) who received GPC in combination with diacerein 100 mg/day (Diaflex Rompharm). The therapeutic effect was compared in the groups of GPC monotherapy (n=2541) and the combination of GPC with diacerein. These groups did not differ in average age (61.411.8 and 61.911.3 years), both were dominated by women (76.3 and 70.3%), there was approximately equal intensity of pain during movement and impaired joint function: 6.11.8/6.01.6 and 4.92.1/5.11.8 (according to the numerical rating scale 010). The dynamics of pain intensity, the need for NSAIDs, and the frequency of adverse events (AE) were compared 12 weeks after the start of treatment. RESULTS AND DISCUSSION: In the majority of patients with OA both on the background of GPC monotherapy and combined use of GPC and diacerein, there was a significant improvement. The number of patients with pain reduction 50% was 54.3 and 62.8% (p0.001), NSAID administration was completely stopped in 66.7 and 77.5% (p0.001), respectively. The effectiveness of the combination of GPC and diacerein was significantly higher than that of GPC monotherapy in OA of the knee joint, hip joint, and generalized OA. AE from the gastrointestinal tract was observed in 7.8 and 8.9%, arterial hypertension in 6.3 and 4.6%, allergic reactions in 0.3 and 0.5% of patients (not significant). CONCLUSION: The application of the code of civil procedure is an effective treatment for OA. The combination of GPC and diacerein provides a more significant improvement than GPC monotherapy. GPC and diacerein (including in combination) are well tolerated and rarely cause AE.

[Control of pain in the early post-traumatic period in the outpatient practice. Results of the multi-center observational study RAPTOR (Rational Analgesia PostTraumatic: an Observational Research)].

AIM: Evaluate the frequency, nature and course of PTP, as well as the effectiveness and safety of NSAIDs in PTP in real clinical practice. MATERIALS AND METHODS: The assessment of the condition and need for NSAIDs (original meloxicam) in 1115 outpatient patients who suffered a fracture of the radius (32.2%), injury to the knee (35.2%) or ligaments of the ankle (32.6%); women/men 51.5 and 48.5%, average age 46.915.5 years. We evaluated the dynamics of pain intensity (on a numerical rating scale NRS 010) at rest and during movement, the preservation of moderate and severe pain, as well as the development of adverse drugs reactions (ADR) to NSAIDs 48 weeks after injury. RESULTS: The average intensity of pain during movement decreased from 7.031.66 to 2.211.38 (p0.001), at rest from 4.462.07 to 0.710.989 (p0.001). The number of people with pain severity 4 in the NRS in 48 weeks after the radius fracture, injury of the knee and ligaments of ankle was 21.0, 16.9 and 11.9%, with moderate or severe impairment of the injured limb 40.4, 26.2 and 16.3%, respectively. The need for taking NSAIDs up to 7 days was noted in 43.3%, 714 days-in 41.8%, more than 2 weeks or constantly in 14.9% of patients. Weak or moderate ADR were observed in 20.8% of patients, mainly dyspepsia and hypertension. Discontinuation of NSAIDs due to ADR was required in only 2.6% of patients. Pain retention 4 in NRS was associated with initially expressed pain (7 in NRS) OR 2.75 (95% CI 0.834.13; p0.001) and the presence of osteoarthritis of knee and/or hip OR 1.56 (95% CI 1.032.34; p=0.039). CONCLUSION: PTP decreases rapidly in most patients after a radius fracture, injury of the knee, and ankle ligament injury while taking the original meloxicam. However, in a significant part of patients, moderate or severe PTP persists after 48 weeks, which requires prolonged analgesic therapy and active rehabilitation.

[What factors affect the effectiveness of long - term analgesic therapy for osteoarthritis? Data analysis of the multi - center 3-month PARACELSUS study].

There are factors that can affect the effectiveness of treatment of osteoarthritis (OA). Aim to identify factors affecting the effectiveness of long - term analgesic therapy in OA. Materials and methods. The study included 6448 patients (70.9% female and 29.1% male), middle age 57.8±10.2 years, with severe pain [≥40 mm on the visual analog scale]. All patients received the preparation of avocado - soybean unsaponifiables (ASU) 300 mg/day. For pain relief at the beginning and during the study, the drug Ketoprofen lysine salt (KLS) 320 mg/day was used. The efficiency criterion was pain reduction ≥50% and satisfaction with treatment ≥4 on a 5-point scale. The influence of a number of factors on the result of treatment was evaluated. Results. For 3 months of treatment, the pain decreased from 63.7±12.0 to 14.2±11.7 mm VAS. The result was evaluated as "good" or "excellent" 81.7% of patients. Adverse reactions were rare. In total, a good response to therapy was noted in 87.4% of patients. Gender, body mass index ≥30 kg/m2, type 2 diabetes mellitus, poor effect of non - steroidal anti - inflammatory drugs (NSAIDs) and Symptomatic Slow-Acting Drugs in Osteoarthritis (SYSADOA) in history did not affect the result. The effect was lower in persons >65 years [odds ratio (OR) 0.418; 95% confidence interval (CI) 0.342-0.509, p2 by Kellgren-Lawrence (OR 0.556; 95% CI 0.298-0.738, p.

[The efficacy of meloxicam in acute back pain: results of an observational non-interventional multicenter study]. / Éffektivnost' meloksikama pri ostroi boli v spine: dannye nabliudatel'nogo neinterventsionnogo mnogotsentrovogo issledovaniia.

AIM: To evaluate the efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) (meloxicam) in acute nonspecific back pain (NSBP) depending on influence of clinical and anamnestic factors. MATERIAL AND METHODS: The studied group included 2078 patients presented with an acute NSBP. All study subjects received meloxicam in a dose of 15 mg/day: 86.1% were given intramuscular meloxicam injections for the first 3-5 days and then switched to an oral meloxicam and 13.9% received an oral meloxicam throughout the therapy. Skeletal muscle relaxants (SMR) and oral or intramuscular group B vitamins were also prescribed to 52.3% and 17.4% of study patients, respectively. Pain was assessed on a 10-point numerical rank scale (NRS). The study assessed the rate of complete pain relief within a 2-weeks NSAID therapy. RESULTS: Complete pain relief was achieved in 75.2% of study patients, mean period of treatment was 8.61±5.53 days. Adverse events were observed in 4.6% of patients. Age <65 years, first NSBP episode and a history of good response to NSAIDs were associated with better treatment outcomes. A severe baseline pain (NRS score ≥7), pain persistence at rest, at nights and, especially, sciatica were associated with poorer treatment outcomes. Co-administration of SMR and group B vitamins did not increase chances for pain relief compared to the NSAID monotherapy. CONCLUSION: Meloxicam in a dose of 15 mg/day is an effective and safe therapy for the treatment of acute NSBP. The analgesic effect of NSAIDs is higher in young patients, patients with the first episode of NBC and a good response to NSAIDs in history. Treatment of patients with NSBP in the presence of severe pain, maintaining pain at rest and at night, and in case of sciatica, requires special control and integrated treatment.

[Russian society and patients with rheumatic diseases]. / Problema revmaticheskikh zabolevanii v Rossii s pozitsii obshchestva i patsienta.

The morbidity, primary morbidity, temporary incapacity for work and disablement due to rheumatoid diseases registered among Russia's population in the recent 3 years are described on the basis of an analysis of Russian statistics. Issues related with mortality, caused by rheumatic diseases, the related expenses and influence on patients' life quality are under discussion. A conclusion is made on a high social-and-medical importance of the above category of diseases as viewed from the standpoint of society (state), patient and his or her family.

[Incidence rate of rheumatic diseases in Russian population: 10-year analysis]. / Zabolevaemost' naseleniia Rossii revmaticheskimi bolezniami (analiz za 10 let).

AIM: To analyze trends in rheumatic diseases (RD) incidence rate in population of Russia for a recent decade. MATERIAL AND METHODS: Medical RD statistics for all regions of Russia for 10 years (1990-1999) have been analysed. RESULTS: Annual number of primary patients with RD has increased for 1990-1999 from 9,147,000 to 12,378,000 (by 35.3%). The percentage of patients with acute rheumatic fever and chronic RD of the heart diminished from 6.5 to 2.9%. Most of the diseases constitute the diseases of osteomuscular system and connective tissue (DOMS). The number of new cases with rheumatic heart diseases (RHD) in adolescents and adults has risen by 50 and 40%, respectively. RHD are especially frequent in the Volga-Vyatka and North-Caucasian regions (2.5 and 2.3 per 1000 against mean Russian 1.7). A total DOMS morbidity has increased for the recent decade by 41%. It is higher in the Central and North regions, in the West Siberia and lower in the North Caucasus, Far East, East Siberia. For the 7 years the above morbidity among children rose 2-fold, among adolescents--2.4-fold. Incidence of rheumatoid arthritis and ankylosing spondylarthritis in adult population of Russia has changed insignificantly while osteoarthrosis total and primary occurrence for 6 years increased by 78 and 58%, respectively. CONCLUSION: RD become a real challenge for health service of Russia. Changes in RD structure require correction of the rheumatic service activities.

[Role of the Institute of Rheumatology in formation and development of State controlling system of rheumatic diseases]. / Rol' Instituta Revmatologii RAMN v stanovlenii i razvitii gosudarstvennoi sistemy bor'by s revmaticheskimi bolezniami.

The paper gives a brief account of the stages of formation and development of rheumatological care in the country, which are closely related to the researches and practical activities of the Institute of Rheumatology.

[Evaluation and prognosis of work capacity in rheumatoid arthritis]. / Otsenka i prognozirovanie trudosposobnosti pri revmatoid artrite.

Assessment of the functional state, social and psychological status of 82 patients with RA was made with the aid of a modified health assessment questionnaire (HAQ) and individual arthritis impact measurement scales (AIMS). A group of disabled persons exhibited a greater markedness of articular destruction, high activity of the disease and a high functional index, all of them being old persons. Patients with working ability underwent prophylactic medical examination, more intensive therapy with basic drugs. The use of a computer for prognostication of capacity for work has been shown.

[A study of the dynamics of a contingent of patients with rheumatic diseases during ambulatory care (based on data from polyclinics in Moscow and the Moscow region)]. / Izuchenie dinamika kontingenta dispansernykh revmatologicheskikh bol'nykh (po materialam poliklinik Moskvy i Moskovksoi oblasti).

The analysis of the contingent of patients with rheumatic diseases taken under dispensary observation (DO) in 1985-1986 (625 persons) showed that in many polyclinics of Moscow and the Moscow region there took place substantial changes in the contingent of these patients and extension of its scope at the expense of inclusion of all nosological forms corresponding to the Regulation of the USSR Ministry of Health. Yet untimely detection and prophylactic medical examination of a great number of patients with rheumatic diseases (RD) was noted. Patients with deforming osteoarthrosis were not given due consideration. The stage of the disease and the functional ability of patients with RD were not always recorded. There were considerable quantitative and qualitative differences in the contingents of patients newly taken under dispensary observation in different polyclinics. The elimination of the above mentioned shortcomings will increase the efficacy of the prophylactic medical examination of patients with RD in polyclinics of Moscow and the Moscow region.

[The use of a modified Health Assessment Questionnaire for evaluating the effectiveness of therapy at a hospital]. / Primenenie modifitsirovannoi ankety otsenki zdorov'ia dlia otsenki éffektivnosti terapii v usloviiakh statsionara.

A study was made of a possibility of estimating the efficacy of hospital therapy of patients suffering from rheumatoid arthritis (RA) using the modified Stanford health assessment questionnaire. The general functional index (GFI) derived on the basis of the questionnaire was found to be in good agreement with a number of the commonly accepted indicators in rheumatology: Richi's articular index, the swelling index, the power of pain in accordance with the visual analog scale, hand force as well as with the psychological and social characteristics. The GFI was shown to decrease significantly after the treatment carried out under hospital conditions together with a decrease of pain and the articular index (p less than 0.001) both in grave RA patients with an unfavorable functional and work fitness prognosis and in patients with milder RA, having a favourable prognosis. It is recommended that the GFI may be used for estimating the efficacy of the treatment in addition to other indicators and measurements.