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2021 ◽  
Vol 100 (6) ◽  
pp. 143-153
Author(s):  
K.E. Belozerov ◽  
◽  
A.V. Lobacheva ◽  
E.V. Gaidar ◽  
A.A. Yakovlev ◽  
...  

TNF-α inhibitors are used in the treatment of non-systemic variants of juvenile idiopathic arthritis (JIA) in case of ineffectiveness or intolerance to methotrexate. Despite 20 years of experience of using of etanercept in pediatric rheumatology, a long-term study of the efficacy and safety of the drug in real clinical practice remains necessary. Objective of the study: to study the efficacy and safety of etanercept for treatment of various non-systemic JIA subtypes in real clinical practice. Materials and methods of research: data from the case histories of 375 patients (242 girls and 133 boys) with articular forms of JIA for 2010–2020 were included in a retrospective, open, uncontrolled, nonrandomized, continuous multicenter cohort study. The age of debut was 6.3 (2.9; 10.7) years. Demographic characteristics, subtypes of arthritis, indicators of laboratory activity of inflammation, and outcomes were estimated: achievement of remission, exacerbation, and switching from etanercept to another genetically engineered biological drug (GEBD) were assessed. Results: remission was recorded in 78.9% on average after 6 months. The factors that determine the likelihood of achieving remission were the absence of previous therapy with GEBD (p=0.001) and compliance with therapy – OR=2.5 (95% CI: 1.3; 4.7), p=0.006. Exacerbations were recorded in 29.5% and were associated with the presence of the HLA B27 antigen – OR=2.6 (95% CI: 1.1; 6.0), p=0.028, antinuclear factor seropositivity (p=0.060). Change of etanercept to another GEBD was made in 17.4% of children and was associated with a failure to achieve remission – OR=7.7 (95% CI: 4.0–14.3), p=0.000001, with previous exacerbations – OR=14,8 (5.3; 41.2), p=0.0000001 and the development of de novo uveitis – OR=2.4 (95% CI: 1.1–5.3), p=0.038. The arthritis subtype and the presence of concomitant methotrexate therapy did not significantly affect treatment outcomes. Conclusion: achievement of remission, compliance with therapy, history of previous therapy with GEBD, exacerbation of JIA and development of de novo uveitis determined the main outcomes of etanercept therapy. The JIA subtype, as well as concomitant therapy with methotrexate, did not significantly affect the outcomes of the disease, which makes it possible to consider etanercept therapy a very effective and safe method of treating JIA as a genetically engineered first-line therapy of any variants of articular forms of JIA, even in monotherapy with ineffectiveness or intolerance to methotrexate.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3896-3896
Author(s):  
Swe Mar Linn ◽  
Igor Novitzky-Basso ◽  
Elizabeth Shin ◽  
Christopher J. Patriquin ◽  
Ivan Pasic ◽  
...  

Abstract *DB and DK contributed to the work equally Background Prospective randomized controlled data comparing extracorporeal photopheresis (ECP) to other treatments for chronic graft vs host disease (cGvHD) as third-line or later therapy are limited, despite its clinical benefit observed in patients (pts) who failed ≥ 2 lines of previous therapy. Our single-center experience has reported promising results, including 68.3% failure-free survival (FFS) and 85.9% overall survival (OS) at 12 months in 75 heavily pre-treated cGvHD pts treated with ECP (ASH 2021 Abstract ID 152640). The present study compared outcomes, using propensity-score matching (PSM), between ECP ("ECP group", n=74) and a historical cohort treated with best available therapy (BAT) as third-line or later treatment from 2007 to 2021 ("BAT group", n=132). Statistical endpoints such as FFS and OS, as well as steroid dose reduction were evaluated instead of overall response due to limited response assessment data available from retrospective chart review. Patients and methods The BAT group received MMF (n=71, 53.8%), prednisone (n=37, 28.0%), prednisone/cyclosporine (n=7, 5.3%), rituximab (n=7, 5.3%), and others (n=10, 7.6%). There was an imbalance in characteristics between the two groups, as expected; the ECP group had more pts with severe cGVHD (91.1% vs 20.5%; p<0.001), fewer with a previous history of acute GVHD (aGvHD: 60.8% vs 78.0%; p=0.008), and fewer on a prednisone dose ≥0.5mg/kg/day (37.8% vs. 90.5%; p<0.001). PSM analysis was applied to adjust risk factors imbalanced between groups, including cGVHD grade (mild/moderate vs severe), aGVHD history, and baseline prednisone dose (<0.5 vs. ≥ 0.5 mg/kg/day). A total of 54 pts (27 case-control pairs) were selected via PSM within 0.2 of a calliper difference, resulting in the balancing of risk factors between groups: cGVHD severity (p=0.941), aGVHD history (p=0.75) and prednisone dose ≥ 0.5 mg/kg/day (p=0.788). FFS and OS were calculated from the day of starting ECP or BAT, and were compared using Cox's hazard model. Daily prednisone dose at months 0, 3 and 6 were calculated divided by body weight (kg), and the proportions of pts on prednisone ≤ 0, 0.1, 0.2 and 0.5mg/kg/day were compared. Results In the overall cohort (n=206), with a median 29 months of follow-up, 114 treatment failures (55.3%) occurred. While the non-relapse mortality (NRM) was similar in both groups, the ECP group showed a lower rate of resistance requiring therapy switch. Failure was noted in 27 ECP pts (36.4%) due to causes including resistance/intolerance requiring a switch to other therapy (n=15; 20.3%), NRM (n=11, 14.8%), and relapse (n=1; 1.4%), while 87 failures (65.9%) were noted in BAT pts due to resistance requiring a switch to other therapy (n=63; 47.7%), NRM (n=7; 5.3%), and relapse (n=17; 12.9%). In the overall cohort, the 12-month FFS was 68.3% and 32.0% in ECP and BAT groups (p<0.0001; Fig 1A), while OS was 86.2% and 82.2% in ECP and BAT groups, respectively (p=0.333; Fig 1B). In the PSM cohort (n=54), the ECP group showed a survival benefit at 12 months: FFS was 65.8% in the ECP group vs. 30.5% in the BAT group (p=0.00226; Fig 2A), and OS was 76.6% in the ECP group vs. 67.1% in the BAT group (p=0.0977; Fig 2B). Multivariate analysis in the PSM cohort confirmed that ECP was superior to BAT for FFS (p=0.024, HR 0.317 [0.117-0.859]) when adjusted for other risk factors including cGVHD severity, aGvHD history, age, HCT-CI score and prednisone dose ≤0.5mg/kg/day. Prednisone doses were gradually reduced over time; the median doses of prednisone at months 0, 3, and 6 were 0.35, 0.22 and 0.11 mg/kg/day, respectively, in the ECP group vs. 0.96, 0.24 and 0.19mg/kg/day in the BAT group. ECP also showed better kinetics of steroid dose reduction over time; the proportions of pts who discontinued prednisone at months 0, 3 and 6 were 16.2, 17.6% and 32.4% in ECP group vs. 0.8%, 0% and 2.5% in BAT group (Fig 3). The differences in the proportion of pts (delta) who discontinued prednisone in the ECP vs. BAT groups were 15.4%, 17.6% and 29.9% at 0, 3, and 6 months, respectively. Conclusion In the current study using PSM analysis, use of ECP was associated with a superior FFS to BAT when used as third-line or later therapy in cGVHD patients who failed at least 2 lines of previous therapy. Use of ECP also allowed for better steroid tapering in comparison to BAT. Figure 1 Figure 1. Disclosures Patriquin: Alexion: Consultancy, Honoraria, Speakers Bureau; BioCryst Pharmaceuticals: Honoraria; AstraZeneca: Consultancy, Honoraria, Speakers Bureau; Apellis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria. Law: Novartis: Consultancy; Actinium Pharmaceuticals: Research Funding. Lipton: Bristol Myers Squibb, Ariad, Pfizer, Novartis: Consultancy, Research Funding. Mattsson: MattssonAB medical: Current Employment, Current holder of individual stocks in a privately-held company. Kim: Novartis: Consultancy, Honoraria, Research Funding; Paladin: Consultancy, Honoraria, Research Funding; Bristol-Meier Squibb: Research Funding; Pfizer: Honoraria.


2021 ◽  
Vol 59 (5) ◽  
pp. 571-577
Author(s):  
V. N. Amirjanova ◽  
A. E. Karateev ◽  
E. Y. Pogozheva ◽  
A. A. Baranov ◽  
V. I. Mazurov ◽  
...  

Upadacitinib (UPA), a JAK inhibitor, is a new therapeutic option that allows patients with insufficient response to therapy with basic anti-inflammatory drugs (DMARDs) or genetically engineered biological drugs (GEBDs) to achieve the goals of therapy for rheumatoid arthritis (RA). Despite the availability of convincing data from international randomized clinical trials, there is insufficient information about the efficacy and safety profile of UPA, the quality of life of patients receiving the drug in real clinical practice.Aim of the study – to assess the efficacy and tolerability of the UPA drug at a dose of 15 mg/day in patients with rheumatoid arthritis with moderate and high disease activity and to assess their quality of life in real clinical practice.Materials and methods. The study included 41 patients with RA with insufficient effect of previous therapy with DMARDs or GEBDs, persisting moderate or high disease activity, who were initiated with UPA therapy in 7 rheumatological centers of the Russian Federation. To assess the activity of the disease, standard indices were used: DAS28- ESR, DAS28-CRP, SDAI, CDAI. Functional ability was assessed according to the HAQ questionnaire, quality of life – according to the EQ-5D questionnaire, the activity of the disease according to the patient’s opinion – according to the RAPID-3 index. The HADS scale was used to identify the states of depression, anxiety and emotional disorder.Results. During the first week of taking the drug, there was a marked decrease in pain from 60 to 30 mm on a visual analogue scale, which lasted until the third month of therapy. There was a statistically significant decrease in morning stiffness, the number of painful and swollen joints, health assessments by the doctor and patient, erythrocyte sedimentation rate and C-reactive protein (p≤0.001). A decrease in disease activity was also noted according to the dynamics of the activity indices DAS28, SDAI, CDAI (p<0.001). The goals of therapy (remission or low disease activity) by the 3rd month of therapy according to the combined indices of activity DAS28-ESR and DAS28-CRP reached 44.8 and 63.4% of patients, respectively, according to the SDAI index – 56.7%, according to the CDAI index – 25.9%. A pronounced improvement in joint function (70% improvement according to the criteria of the American College of Rheumatology) was noted by 33.3% of patients, population indicators of functional state (HAQ≤0.5) had 15.8% of patients. The difference in the HAQ index by the 3rd month of therapy compared to the indicator before treatment was –0.60 points. The quality of life, assessed by patients using the EQ-5D questionnaire, improved in 98.5% of patients, with a 70% improvement noted in more than a third of them (41.7%). The drug was well tolerated, no adverse reactions were registered by the 3rd month of therapy, all patients continued treatment.Conclusions. The first results of the use of UPA in RA patients with insufficient efficacy of previous therapy with DMARDs or GEBDs in real clinical practice indicate its efficacy and safety, an improvement in the functional state and quality of life of patients by the 12th week of the study.


The Breast ◽  
2021 ◽  
Vol 59 ◽  
pp. S50
Author(s):  
Fernando Valencia ◽  
Ronald Limon ◽  
Valeria Colomo ◽  
Henry Gomez

2021 ◽  
Vol 11 ◽  
Author(s):  
Hirofumi Shibata ◽  
Shin Saito ◽  
Ravindra Uppaluri

Neoadjuvant immunotherapy has the potential to enhance clinical outcomes by increasing anti-tumor immune responses in the presence of abundant tumor-derived antigen in an immune microenvironment that has not been exposed to previous therapy. The current mainstay of advanced head and neck squamous cell carcinoma (HNSCC) treatment remains surgery and radiotherapy with/without conventional chemotherapy. Despite this multi-modality treatment, advanced human papillomavirus (HPV)-negative HNSCC shows poor prognosis. Treatment intensification with neoadjuvant (induction) chemotherapies with platinum drugs are insufficient to significantly prolong overall survival. Although only 15-20% of patients benefit, immunotherapies have been approved and widely used for recurrent and metastatic HNSCC. These successes have led to checkpoint blockade therapies being testing in earlier treatment settings. Recent clinical trials of neoadjuvant immunotherapy show promising results and this methodology has the potential to change the treatment algorithm of HNSCC. This overview examines the treatment history of neoadjuvant approaches for HNSCC, and especially focuses on the recent topics of neoadjuvant immunotherapy for HNSCC.


2021 ◽  
Vol 20 (3) ◽  
pp. 28-34
Author(s):  
T. L. Alexandrov ◽  
B. A. Nanaeva ◽  
T. A. Baranova ◽  
I. A. Tishaeva ◽  
D. V. Podolskaya ◽  
...  

AIM: to evaluate the effect of cytomegalovirus (CMV) infection on the course of moderate and severe flare ups of ulcerative colitis (UC).PATIENTS AND METHODS: a prospective cohort single-center study was done in September 2018 — December 2020. The study included patients with moderate and severe flare ups of UC. All patients underwent colonoscopy with biopsy to quantify CMV DNA by polymerase chain reaction (PCR). Subsequently, the patients were divided into subgroups: with the presence of CMV (CMV+) and its absence (CMV–). In the CMV+ subgroup, antiviral therapy was carried out with an assessment of virological, clinical and endoscopic results on the 19th day of therapy, one month after its completion and after 6 months. In the CMV– subgroup these results were evaluated after 6 months only.RESULTS: the study included 126 patients. CMV was detected in 51 (40.5%). At the same time, its presence was not influenced by gender, age, or previous therapy. Laboratory indicators in both subgroups were comparable, as well as the severity of UC. A significant increase in the risk of developing steroid resistance was revealed in CMV+ patients with severe UC attack (OR 1.33, 95% CI: 1.059–19.4). The effectiveness of antiviral therapy was 60.8%. All patients who did not respond to antiviral therapy underwent surgery. At the same time, among patients in whom antiviral therapy was effective (virus eradication was achieved), there was no need for surgery.CONCLUSION: CMV infection significantly increases the likelihood of developing steroid resistance in patients with severe flare up of UC, while all patients who responded to antiviral therapy did not require surgery. Further multicenter randomized trials are needed.


2021 ◽  
Vol 20 (3) ◽  
pp. 28-34
Author(s):  
T. L. Alexandrov ◽  
B. A. Nanaeva ◽  
T. A. Baranova ◽  
I. A. Tishaeva ◽  
D. V. Podolskaya ◽  
...  

AIM: to evaluate the effect of cytomegalovirus (CMV) infection on the course of moderate and severe flare ups of ulcerative colitis (UC).PATIENTS AND METHODS: a prospective cohort single-center study was done in September 2018 — December 2020. The study included patients with moderate and severe flare ups of UC. All patients underwent colonoscopy with biopsy to quantify CMV DNA by polymerase chain reaction (PCR). Subsequently, the patients were divided into subgroups: with the presence of CMV (CMV+) and its absence (CMV–). In the CMV+ subgroup, antiviral therapy was carried out with an assessment of virological, clinical and endoscopic results on the 19th day of therapy, one month after its completion and after 6 months. In the CMV– subgroup these results were evaluated after 6 months only.RESULTS: the study included 126 patients. CMV was detected in 51 (40.5%). At the same time, its presence was not influenced by gender, age, or previous therapy. Laboratory indicators in both subgroups were comparable, as well as the severity of UC. A significant increase in the risk of developing steroid resistance was revealed in CMV+ patients with severe UC attack (OR 1.33, 95% CI: 1.059–19.4). The effectiveness of antiviral therapy was 60.8%. All patients who did not respond to antiviral therapy underwent surgery. At the same time, among patients in whom antiviral therapy was effective (virus eradication was achieved), there was no need for surgery.CONCLUSION: CMV infection significantly increases the likelihood of developing steroid resistance in patients with severe flare up of UC, while all patients who responded to antiviral therapy did not require surgery. Further multicenter randomized trials are needed.


Author(s):  
Rajesh Hadia ◽  
Krishna Bhavsar ◽  
Riddhi Patel ◽  
Vidhya Shivadas

The precise incidence of drug-induced myopathy is still not known, only few reports with the use of Telmisartan. There are likely around 150 agents that are associated to cause myotoxicity like statins, corticosteroids, anti-retroviral, and immunosuppressants. Therefore, as recommended by the guidelines, therapeutic drug monitoring of Telmisartan is required after the initiation of the therapy. However, the rise in serum creatinine up to 20-30% is accepted. But if serum creatinine level increases >30% then withdrawal of the therapy is recommended. Suspicious with the previous therapy of Tab. Telmisartan as no other pathology could be detected. A causality analysis was done using the Naranjo’s algorithm and WHO-UMC Scale and the present ADR was found to be ‘Probable’ with Telmisartan. Tab. Telmisartan was withdrawn completely and was switched by another Antihypertensive -Tab. Enalapril (5mg). Gradually, the condition of the patient showed improvement in terms of both- the clinical symptoms and laboratory abnormalities. However, re-challenge of the drug was not performed in order to avoid further toxicity. After 15 days, the patient had visited Medicine Outpatient Department (OPD) again the creatinine and uric acid levels where checked which were normal and further advised to follow up every month. To be conclude, adverse drug reaction of myotoxicity associated with telmisartan is rare but quite significant. So, close monitoring is necessary to ensure safety of drug therapy especially in long term use.


2021 ◽  
pp. 52-54
Author(s):  
A. V. Ignatovskiy ◽  
Yu. R. Lasareva

Purpose. To describe a clinical case of penile cancer in a patient with sclerotrophic lichen. Material and methods. Data of anamnesis, medical clinical, histological and instrumental examination. Results. A case of rapidly progressing penile squamous cell carcinoma in a patient with a long history of sclerotrophic lichen and no previous therapy was described. Conclusions.The low level of awareness of primary care physicians about the manifestations of CSAL, as a consequence, the lack of treatment and progression of the disease, expressed in urethral stenosis and malignant transformation draws attention.


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