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In this trial, obinutuzumab, a humanized type II anti-CD20 monoclonal antibody, plus standard therapy provided significantly better renal responses than standard therapy alone in patients with lupus nephritis.

Objective: To define the role of IgA antibodies to cardiolipin (aCL) and IgA antibodies to beta-2 glycoprotein 1 (anti-β2-GP1) in the development of vascular complications in patients with antiphospholipid syndrome (APS) and systemic lupus erythematosus (SLE). Material and methods: A total of 187 patients with one of the following diagnoses: primary APS (PAPS), probable APS, SLE with APS, and SLE without APS. The comparison group consisted of 49 patients with other rheumatic diseases (RD), the control group included 100 relatively healthy individuals (without RD, oncological pathology, and infectious diseases). All patients underwent standard clinical, laboratory, and instrumental examinations before being included in the study and during follow-up. The aPL study included the determination of IgG/IgM aCL, IgG/IgM anti-β2-GP1 by enzyme-linked immunosorbent assay (ELISA), IgG/IgM/IgA aCL, IgG/IgM/IgA anti-β2-GP1 by chemiluminescence analysis (CLA), and lupus anticoagulant (LA). Results: IgA aCL were detected in 75 (40%) of the 187 patients with APS and SLE, in none of the comparison group, and in 2 (2%) of the control one. IgA anti-β2-GP1 were detected in 63 (34%) of the 187 patients with APS and SLE, in none of the patients in the comparison group, and in one (1%) of the control group. The prevalence of IgA aCL and IgA anti-β2-GP1 and their levels were statistically significantly higher in patients with APS (PAPS and SLE + APS) than the levels in patients with SLE and those of the comparison and control groups (p < 0.05). IgA aCL and IgA anti-β2-GP1 were significantly associated with thrombosis in APS (χ2 = 4.96; p = 0.02 and χ2 = 4.37; p = 0.04, respectively). The risk of thrombosis was 2.04 times higher in patients with positive IgA aCL than in patients without these antibodies, as well as in patients with positive IgA anti-β2-GP1; it was twice as high as in patients without antibodies. There was a high specificity of IgA aCL and IgA anti-β2-GP1 for both the diagnosis of APS and its clinical manifestations, despite a low sensitivity. Conclusions: The study revealed a relationship of thrombosis and APS with IgA aCL and IgA anti-β2-GP1. There was a high specificity of IgA aCL and IgA anti-β2-GP1 (95% and 93%, respectively) for the diagnosis of APS with a low sensitivity (54% and 44%, respectively). There were no patients with isolated positivity of IgA aCL and IgA anti-β2-GP1.

Magnetic therapy (MT) is a non-drug method that improves the effectiveness of treatment of musculoskeletal pain, including:acute non-specific back pain (NBP). Objective of our study was to evaluate the results of complex treatment of patients with acute/subacute NBP at home using MT. The study group consisted of 339 patients with severe acute/subacute NBP. All patients received nonsteroidal anti-inflammatory drugs (NSAIDs). 166 patients (Group 1) received a course of MT (ALMAG+ device), 173 patients or a control group (Group 2) who did not receive MT. The dynamics of pain was significantly higher in group 1 than in group 2. So, the intensity of pain during movement (NRS) decreased from 7 [5;8] and 7 [5;8] to 0 [0;13] and 2 [1;3] after 1 month. (p<0.001). Significant differences between Groups 1 and 2 were observed in the dynamics of pain at rest and at night, overall health assessment (OHA), and sleep function and disorders. The average duration of NSAIDs use in Group 1 was 8.8±3.9, Group 2 – 11.8±5.7 days (p<0.001). The use of MT increases the effectiveness of treatment of acute/subacute NBP and reduces the need for NSAIDs use.

BCD-055 is a biosimilar of innovator infliximab (IFX). Here we present the 54-week results from phase 3 clinical study in patients with rheumatoid arthritis (RA). The aim of this study was to demonstrate the equivalent efficacy and safety of BCD-055 and IFX in patients with active rheumatoid arthritis. 426 adults with active RA were enrolled. Patients were randomized into 2 study arms in 2:1 ratio to receive BCD-055 or IFX innovator in dose of 3 mg/kg at week 0, 2, 6 and then every 8 weeks up to week 54. Primary efficacy endpoint was the rate of American College of Rheumatology (ACR) 20 response at week 14. The equivalence margin was set as 15%. Immunogenicity and safety were also assessed. Rate of ACR20 at week 14 in PP (Per-Protocol) population was 71.2% in BCD-055 group and 67.9% in IFX group. Difference in ACR20 rates between groups was 3.2% with 95% CI [− 7.0%; 13.5%] (р = 0.587). Throughout 54-week study period, both groups were characterized by similar rates of ACR20/50/70 response at all timepoints without significant differences (p > 0.05). The rates of adverse events (AE) were similar in groups (74.64% in BCD-055 arm vs 66.67% in IFX arm, p = 0.111). Antibodies to infliximab were detected in 28.46% patients for BCD-055 arm and 26.56% for IFX arm (p = 0.786). BCD-055 and IFX were comparable in efficacy (including radiographic progression), safety and immunogenicity throughout the 54-week study.Trial registration ClinicalTrials.gov ID, number NCT02762838.

Background The real-world effectiveness of intravenous (IV) belimumab in treating systemic lupus erythematosus (SLE) has been demonstrated in various countries through the OBSErve (evaluation Of use of Belimumab in clinical practice SEttings) program. Here we describe the clinical effectiveness of IV belimumab for treating SLE in real-world clinical practice in the Russian Federation. Methods In the retrospective, observational OBSErve Russia study (GSK Study 215349), eligible physicians enrolled adults with SLE receiving IV belimumab as part of their standard care. De-identified data were collected from patient medical records from September 2021 to March 2022. The primary outcome was the physician-assessed overall clinical response at 6 months post-index versus index (belimumab initiation) among patients receiving belimumab for ≥6 months. Other endpoints included change in Safety of Estrogens in Lupus Erythematosus National Assessment – SLE Disease Activity Index (SELENA-SLEDAI) score and glucocorticoid use. Results Overall, 59 patients initiated IV belimumab, mainly due to the previous regimen not being effective and to decrease glucocorticoid use (76.3% each); 15.3% of patients started belimumab within the first year of SLE diagnosis. Only 13.6% of patients discontinued belimumab within the first 6 months, mainly due to loss to follow-up and loss of insurance/reimbursement. At 6 months post-index, among patients who completed ≥6 months of belimumab therapy (full analysis set, n  = 53), 90.6% and 60.4% had an overall clinical improvement of ≥20% and ≥50%, respectively. Mean (standard deviation, SD) change in SELENA-SLEDAI score from index to 6 months post-index was −5.9 (4.3). Mean (SD) glucocorticoid dose decreased from 12.2 (7.3) mg/day at index to 8.6 (5.1) mg/day at 6 months post-index ( n  = 50). Conclusions Patients with SLE receiving IV belimumab for 6 months in real-world settings in the Russian Federation experienced overall clinical improvements and reductions in glucocorticoid use, which is an important long-term strategy of SLE treatment.

ObjectivesTo present a clinical case of two patients with resistant thromboangiitis obliterans, as a manifestation of antiphospholipid syndrome (APS), successfully treated with rituximab.MethodsTwo patients (men, aged 44 and 40, one of whom had been a long-time smoker) with high triple aPL positivity, occlusive artery disease and ischemia of the distal lower extremities received anticoagulants, aspirin, hydroxychloroquine, statins and a prostaglandin E1 analog (alprostadil). A 44-year-old man had a history of heart attack that had been treated with thrombolysis. The patients met the diagnostic criteria for APS. They underwent balloon angioplasty of the lower extremities, which was performed to treat peripheral arterial disease. Blood flow was restored above the level of the feet, but remained reduced in the foot area. Rituximab was prescribed to patients with good efficacy and tolerability because the previous treatment had not worked.ResultsOne of the patients had dry gangrene of the terminal phalanx of the second toe of the right foot. The finger was amputated and the wound healed without complications. In addition to rituximab, antibiotics and intravenous immunoglobulin of 100 mg per kg of body weight were added to the therapy. The second patient had no recurrence of ischemia after rituximab therapy. Figure 1 shows the results of computed tomography angiography of the lower extremities of one of the patients before balloon angioplasty, with uneven stenosis of the celiac trunk (figure 1a) and occlusion of peripheral arteries (figure 1b) and the second toe of the right foot before (figure 1c) and after amputation (figure 1d) due to dry gangrene.Abstract PO:01:015 Figure 1[Image Omitted. See PDF.]ConclusionsPatients with definite high triple positive antiphospholipid syndrome may have an inflammatory component that is resistant to standard anticoagulant therapy and requires treatment with rituximab with good effect.

ObjectivesAs systemic lupus erythematosus(SLE) is an autoimmune disease characterised by the formation of autoantibodies, diagnostic immunology laboratory tests for detecting and quantifying autoantibodies are used for the diagnosis of SLE. These include antinuclear antibodies, anti-dsDNA and anti-Sm, together with other antibodies such as antiphospholipid(aPL) or complement proteins C3andC4. By contrast, although antibodies that recognize RNA-binding proteins are also common in patients with SLE, they are not part of the classification criteria and have a wider distribution among diseases. The aim of the study was to determine the frequency of different spectrum of antibodies in patients with SLE from the Russian cohortMethodsThis observational retrospective-prospective study included 140patients (88% women, median aged 34[26;41]years (median [interquartile range 25;75%]), with SLE(SLICC 2012). Baseline demographics, disease characteristic, organ system involvement/damage were analysed descriptively according to SLEDAI-2k, Systemic Lupus International Collaborating Clinics damage index(SDI).ResultsThe median disease duration was 3,4 [0,4;12,0]years, SLEDAI-2k at the time of inclusion–6,5 [4,0;10,5]score, SDI–0 [0;2]score.At the time of inclusion, the main clinical manifestations of SLE were: hematological disorders-46%, cutaneous lupus-34%, inflammatory arthritis-33%, lupus nephritis-29%, non-scarring alopecia-23%, serositis-17%, mucosal ulcers-7%, nervous system involvement-7%. Among ‘non-criteria’ symptoms the most common were: livedo-24%, Raynaud’s phenomenon-14%, interstitial lung diseases-10%, lymphadenopathy-7%, ulcerative necrotising vasculitis-3%, myocarditis-1%. Concomitant antiphospholipid syndrome(APS) and Sjögren’s syndrome(SS) were detected in 11% and 36% of patients, respectively.Hypocomplementemia for C3 and/or C4 was detected in 64% of patients, the most common autoantibodies were positive anti-dsDNA-69%, anti-C1q -43%, anti-Ro/SSA-39% and aPL-30%, the rarest were positive anti-La/SSB-9%, anti-RNP-70 -10%, anti-Sm-11% and rheumatoid factor(RF) -14%.In patients with SLE, when SS was excluded, the frequency of diagnostic antibodies for SS decreased: RF from 14% to11%, anti-Ro/SSA from 39% to22%, anti-La/SSB from 9% to1%.When APS was excluded, the frequency aPL decreased from 30% to14%ConclusionsHypocomplementemia is as common as positive anti-dsDNA in most SLE cases. Second most common is positive anti-C1q, which is not included in either the 2012 or 2019 SLE classification criteria or the SLE activity indices. Third most common is positive anti-Ro/SSA, even when excluding SS. Other autoantibodies:anti-La/SSB, anti-RNP-70, RF, aPL(without APS) are rare, occurring in no more than 1-14%.