[The efficacy and safety of infliximab in patients with ankylosing spondylitis: results of an open-labeled multicenter study].

AIM: To evaluate the efficacy and tolerability of the anti-tumor necrosis factor-alpha infliximab in patients with active ankylosing spondylitis (AS) in a 54-week multicenter open-label study. SUBJECTS AND METHODS: The study enrolled 42 patients with AS who continued to have an active phase of the disease despite that they had received standard therapy. All but one patient had signs of active spondylitis; peripheral arthritis was noted in 52%; enthesitis was seen in 79%. Infliximab was administered in a dose of 5 mg/kg as 2-hour intravenous infusions; the second and third infusions were injected 2 and 6 weeks after the first one; all further infusions were used at an interval of 6-8 weeks. RESULTS: Thirty-three (78.6%) of the 42 patients completed the trial. There was a considerable, at least 50%, improvement in the ASAS criteria in 84.8% of the patients who completed the trial. A substantial therapeutic effect was observed in the majority of patients just a week after the first infusion of infliximab. There was a statistically improvement in all the analyzed clinical effectiveness indicators, including the Bath AS Disease Activity Index (BASDAI); pain became less in the vertebral column and joints (on an average from 49.6 to 12.4 mm on the 100-mm visual analog scale); the level of C-reactive protein and the number of swollen and tender entheses were decreased. The patients' functional capacity improved considerably (the Bath AS Functional index (BASFI) decreased on average from 59.7 to 16.3 scores). Nine (21.4%) patients were withdrawn from the study ahead of time: 7 and 2 patients because of adverse reactions (AR) and contact loss, respectively. The most common ARs were airway infections (13.6%), hepatic dysfunction (12.0%), and herpes simplex virus infections (10.4%). Four patients developed the severest ARs (pulmonary tuberculosis, generalized psoriasis-like dermatitis, pneumonia, and abscess of the epithelial coccygeal tract); the outcome of all complications was good. CONCLUSION: The results of the study suggest that infliximab has a high, rapidly occurring and stably preserving efficiency in most patients with active AS. The frequency and spectrum of ARs corresponded to the available data on the tolerability of infliximab.

[Comparison of efficacy and tolerability of triple combination therapy (methotrexate + sulfasalazine + hydroxychloroquine) with methotrexate monotherapy in patients with rheumatoid arthritis].

AIM: To compare efficacy and tolerability of combined therapy with methotrexate (MTX), sulfasalazine (SSZ) and hydroxychloroquine (HCQ) with MTX-monotherapy in patients with rheumatoid arthritis (RA). MATERIAL AND METHODS: RA patients (n = 60) who had not been treated with the above drugs were randomized (1:1) to receive either the triple drug combination or MTX alone in a 2-year open study. SSZ was given in a dose of 2.0 g/day, HCQ--200 mg/day. A MTX dose was gradually increased from 7.5 mg/week to 17.5 mg/week in an attempt to achieve remission in all the patients. Basic criterion of the treatment efficacy was achievement of a significant clinical effect (> 50% response according to the American College of Rheumatology--ACR criteria) in stability of the positive effect beginning from the ninth month of the study up to its end with no evidence of serious drug toxicity. RESULTS: 13 of 18 patients treated with the triple therapy (72.2%) and 6 of 20 patients treated with MTX alone (30.0%; p = 0.013) achieved an ACR > 50% response by the end of 18 months of therapy. 11 of 18 patients (61.1%) from the combined therapy group and 5 of 20 patients (25%; p = 0.024) from MTX monotherapy group maintained ACR > 50% response from month 9 to 18 of the study without any evidence of major drug toxicity. Two patients (11.1%) in the combined therapy group and 4 patients (20%) in the MTX group discontinued the treatment because of drug toxicity. CONCLUSION: In patients with RA the triple combination therapy with MTX, SSZ and HCQ given during 1.5 year is more effective than MTX alone. The triple combination of MTX, SSZ and HCQ is well tolerated.

[Undifferentiated spondyloarthropathies].

The article is a review of the various aspects of the undifferentiated spondyloarthropathies. Data on the prevalence denote considerable frequency of undifferentiated spondyloarthropathies in various age groups. Clinical symptoms, evolution and treatment are provided. The special attention is given to a problem of juvenile spondyloarthropathies. Changes of the nomenclature of the spondyloarthropathies are offered, allowing to improve diagnostics and treatment of these diseases.

[Intravenous high dose glucocorticoids in patients with ankylosing spondylitis].

AIM: To study efficacy and tolerance of 1-3-day intravenous therapy with high dose glucocorticoids in patients with active ankylosing spondylitis (AS). MATERIAL AND METHODS: Methylprednisolone (MP, n = 33) and dexamethason (DM, n = 13) were given to 46 patients with active AS (median BASDAI 47; coxitis was in 37 patients, arthritis of other peripheral joints--in 30 patients). MP and DM were given as 1-3 intravenous infusions, in single doses equivalent to 500-1000 mg of MP. Total doses were 500-3000 mgfor MP and 120-360 mg for DM. Intervals between the infusions were from I to 8 days. RESULTS: An immediate positive effect was seen in all the patients. Significant reduction of AS activity (lowering of BASDAI by 50% and more) was registered in 22 (48%) patients. In accordance with ASAS criteria, 20% improvement occurred in 35 (76%) patients, 50%--in 25 (54%). A significant decrease was seen in the number of joints with inflammation, volume of exudate in hip joints, ESR, C-reactive protein level, functional condition of the patients (BASFI), spinal mobility. Side effects were observed in 26 of 46 (56%) patients. Severe side effects manifested in 17% cases. Efficacy and tolerance of MP and DM were comparable. The immediate response to therapy and side effect rate were unrelated to single and total doses of glucocorticoids. The response persisted for 3 months in 41% patients, a significant effect was observed for 3 months in 9% patients. CONCLUSION: Short-term intravenous therapy with high-dose glucocorticoids is highly effective in the majority of patients with active AS and well tolerated. A short-term effect was seen both for spondylitis and arthritis of peripheral joints, including coxitis, but the effect is not long-lasting.

[The clinical manifestations of polymyalgia rheumatica]. / Klinicheskie proiavleniia revmaticheskoi polimialgii.

The authors describe the results of the follow-up of 59 patients with rheumatic polymyalgia. The observation period lasted from 6 months to 6 years. The clinical manifestations of the disease have been analyzed. The torpid and steroid-independent variants of the disease have been distinguished, 22 patients (37.3%) manifested arthritis of different joints, characterized by an insignificant number of damage joints, little intensity of local inflammation, rapid and steady abatement after the treatment with corticosteroids. 10 patients (16.9%) with rheumatic polymyalgia had the carpal canal syndrome and 5 patients (8.5%) diffuse painless hand edema. The symptoms of Horton's disease were revealed in 19 patients (32.6%).

[Ankylosing hyperostosis of the spine (Forestier's disease). A study of its clinical picture based on the data from a mail questionnaire]. / Ankiloziruiushchii giperostoz pozvonochnika (bolezn' Forest'e). Izuchenie klinicheskoi kartiny po dannym zaochnogo anketirovaniia.

Postal questionnaires were used to study the incidence and intensity of complaints of the spine and peripheral skeleton in patients with ankylosing hyperostosis of the spine. Selection of persons to fill in questionnaires was carried out by means of a preliminary non-randomized analysis of the records of the spinal fluorograms in patients of one of the outpatient clinics of Moscow. Criteria for ankylosing hyperostosis of the spine were the presence of continuous ossification of the anterior longitudinal ligament over a length of not less than 4 successive segments of the spine and the lack of other x-ray alterations in the given part of the spine. It has been established that as compared to the control group (n = 41) without any x-ray alteration in the thoracic part of the spine, the patients with ankylosing hyperostosis of the spine (n = 146) complained of the lumber part and shoulder joints more frequently. The incidence of complaints of other 6 out of 8 parts of the skeleton under analysis was not high in ankylosing hyperostosis of the spine.

[Treatment of patients with gonarthrosis by intra-articular administration of drugs]. / Lechenie bol'nykh gonartrozom vnutrisustavnym vvedeniem lekarstv.

The effectiveness of intra-articular administration of kenalog, hydrocortisone, gordox and polyvinylpyrrolidone to patients with gonarthrosis and concurrent synovitis was studied. Kenalog and hydrocortisone were more effective than placebo, while gordox, polyvinylpyrrolidone and placebo had similar effect. Kenalog and hydrocortisone had nearly the same favourable effect in synovitis. Only one patient treated with gordox had side effects. Signs of synovitis were analysed and its most typical symptoms specified.