Psoriatic arthritis (PsA) is a chronic inflammatory disease of the joints, vertebral column, and entesises, which is associated with psoriasis. T helper type 17 cells (Th-17) play a leading role in the development of inflammation in psoriasis and PsA so different biologicals affecting interleukins (IL) 17 and 23 are being intensively investigated. Randomized, placebo-controlled Phase III PSUMMIT 1 (NCT01009086, EudraCT 2009-012264-14) and PSUMMIT 2 (NCT01077362, EudraCT 2009-012265-60) studies were undertaken to evaluate the efficiency and tolerability of ustekinumab (UST) treatment in PsA patients.Subjects and methods. The PSUMMIT 1 study covered 152 Russian patients with active PsA (≥5 tender and ≥5 swollen joints; C-reactive protein ≥3 mg/l) who were randomly (using the dynamic centralized randomization method on the basis of an interactive vocal response algorithm) divided into three groups (at a 1:1:1 ratio): 1) subcutaneous UST 45 mg; 2) UST 90 mg; 3) placebo (PL) at baseline, 4 weeks later, and then every 12 weeks). After 16 weeks the patients showing a less than 5% reduction in the number of tender and swollen joints were given UST 45 mg (if they belonged to the PL group) or 90 mg (if they were in the UST 45-mg group). The PL-receiving patients were given UST 45 mg at weeks 24 and 28 and then every 12 weeks. The treatment duration was 2 years. A therapeutic response was estimated by theAmericanCollege of Rheumatology (ACR) response criteria. The PSUMMIT 2 study enrolled 40 Russian patients who had previously received or were currently receiving disease-modifying anti-rheumatic drugs and/or nonsteroidal anti-inflammatory drugs and tumor necrosis factor-α inhibitors. The patients were randomized to the groups of those receiving UST 45 mg or 90 mg or PL at baseline and at week 4, then once every 12 weeks. The last dose of UST was given at week 40. The follow-up lasted until week 60.Results and discussion. In the PSUMMIT 1 study, 24-week administration of UST 45 mg and 90 mg significantly more frequently ensured a 20% improvement according to the ACR criteria than that of PL (39.2; 44.0, and 15.7%, respectively; p < 0.01); the therapeutic response persisted until week52. In the PSUMMIT 2, following 24 weeks, the UST 45-mg and 90-mg groups considerably more often showed a 20% improvement according to the ACR criteria than the PL group (64.3, 57.1, and 16.7%, respectively; p < 0.01); the therapeutic response persisted until week 52. Among 150 Russian patients taking UST, on the average, for 45.1 weeks in the PSUMMIT 1 study, 62 (41.3%) were observed to have adverse events (AE) that were serious in 6 (4.0%). Among 40 PsA patients who participated in the PSUMMIT 2 study inRussia, AEs were seen in a total of 25 (62.5%) patients, serious AEs being absent.Conclusion. The results of the PSUMMIT 1 and PSUMMIT studies in the Russian population indicated that UST treatment contributed to a significant reduction of PS symptoms and exhibited a good tolerability.DOI: http://dx.doi.org/10.14412/1995-4484-2015-125-133

Objective: to analyze changes of serum calprotectin (CP) concentration, its relationship to the clinical and laboratory parameters of rheumatoid arthritis (RA) activity, and the significance of baseline CP level for predicting therapeutic response in RA patients treated with etanercept (ETC).Subjects and methods. A total of 84 patients with moderate and high RA activity (mean DAS28 6.35±0.92) who had been ineffectively treated with disease-modifying antirheumatic drugs were examined. The patients received ETC 50 mg/week subcutaneously for 34 weeks. To assess RA activity, tender and swollen joint count, pain, patient’s and physician’s assessment of global disease activity on 100-mm visual analogue scale and DAS28 were used. Functional status was evaluated by HAQ and RAPID3. Treatment efficacy was assessed according to the European League against Rheumatism (EULAR) criteria and the American College of Rheumatology (ACR) criteria. Serum concentration of CP was tested before, 12 and 25 weeks after start of therapy.Results and discussion. There was a statistically significant (p < 0.0001) decrease in CP concentrations after 12 weeks of ETC therapy. Later (after 25 weeks) CP level remained essentially unchanged. CP concentration correlated with erythrocyte sedimentation rate, C-reactive protein level, swollen joint count, and DAS28. Baseline CP level was not a predictor for achieving the therapeutic response according to the EULAR and ACR criteria. In a group of patients unresponsive to treatment according to the EULAR criteria, CP levelrose at 25 weeks whereas it fell during clinical improvement. In the patients achieving ACR 50 and 70% response, changes of CP level were significantly better than those in the other patients.Conclusion. ETC therapy caused a considerable reduction of CP level, clinical and laboratory parameters of RA activity. The baseline concentration of CP was not a predictor for achieving the response to ETC treatment.

AIM To study efficacy and tolerance of leflunomide (LF) in patients with polyarticular psoriatic arthritis (PsA). MATERIAL AND METHODS The analysis was made in 58 patients: 35 (60%) females, 23 (40%) males. Mean age of the patients was 44.9 +/- 10.8 years, PsA duration--9.7 +/- 7.5 years. LF was given by a standard scheme: 100 mg/day for 3 days then 20 mg/day for 6 months. PsA activity was assessed by the number of painful and inflamed joints, pain intensity, VAS, Likert quastionnaire data. Functional status of the patients was estimated according to Health Assessment Questionnaire. Skin syndrome was rated by pruritus scale, 5-score Likert scale and PASI (psoriasis Area and Severity Index). PASI was applied in patients with affected area 3% at least. Quality of life was assessed by Dermatology Life Quality Index. Basic criterion of the treatment efficacy was response by PsARC (Psoriatic Arthritis Response Criteria). The additional evaluation was made of the number of patients with improvement by criteria ACR 20, ACR 50 and ACR 75 as well as those with 50 and 75% response by PASI (PASI 50 and PASI 75). RESULTS To the end of the treatment the number of painful and inflamed joints decreased significantly (p < 0.001) as well as pain, VAS and Likert scores. To the treatment month 6 HAQ index diminished by 36%. According to PsARC, of 58 patients 36 (62%) patients responded. Improvement by ACR 20 was observed in 34 (59%) of 58 patients. PASI changes were not significant (p = 0. 144). DLQI diminished by 36% (p = 0.028). As shown by acute phase indices, LF had no effect on ESR (p = 0.45). CRP fell significantly to treatment month 3 (p < or = 0.001) and further changes were insignificant. LF tolerance was satisfactory. Ten patients (17%) withdrew because of side effects which were standard. Severe myelo- and hepatotoxicity were absent. CONCLUSION LF is highly effective in therapy of polyarticular PsA and has satisfactory tolerance. Perspectives of further use of LF in combined treatment of PsA are associated with its potential to inhibit the disease progression.

Objective. To assess efficacy and safety diclofenacol 1% liniment application in comparison with diclo- ran plus. Material and methods. An open controlled 2-weeks trial of diclofenacol 1% liniment on 30 pts with active joint syndrome (group 1) compared with dicloran plus 1% gel on 20 pts (group II). Pts age ranged from 16 to 79 years, mean disease duration was 8,2 1,5 years. Most pts had II activity degree. Results. Diclofenacol 1% liniment applications decreased pain at rest and at movement and circle of aim joints. In pts with RA effect was more prominent. Dicloran plus provided equivalent results. Local effect of diclofenacol appeared in average after 31,5 min. (from 10 to 73 min) and lasted during 118,3 min (from 50 to 240 min.). Diclofenacol allowed to decrease dose of oral NSAIDs in 43,3% of pts and dicloran - in 40% of pts. Diclofenacol safety was good without local and systemic adverse events. Conclusion. Diclofenacol 1% liniment manufactured by Hiperion S.A. (Rumania) can be recommended for wide administration in treatment of joint diseases particularly in pts with concomitant gastrointestinal diseases and hypertension.

Clinical efficiency and safety of nimesil were studied in the multicenter open clinical trial of 52 patients with verified rheumatoid arthritis. Nimesil was given for 12 weeks in a daily dose 200-400 mg in addition to basic therapy. Clinical and laboratory parameters were assessed after 4 and 8 weeks of the treatment and after its end. The treatment produced a significant positive response of the articular syndrome. Marked improvement was registered in 11 (23.4%) patients, improvement--in 33 (79.2%) patients. Side effects were reversible and occurred in 8 (15.3%) patients. In 5 patients the drug was withdrawn. The conclusion is made on high efficiency and good tolerance of nimesil in rheumatoid arthritis patients.