scholarly journals IMMUNOGENICITY AND SAFETY OF 23-VALENT POLYSACCHARIDE PNEUMOCOCCAL VACCINE IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS OF A TWO-YEAR FOLLOW-UP STUDY

2017 ◽  
Vol 54 (6) ◽  
pp. 674-680 ◽  
Author(s):  
M. S. Naumtseva ◽  
B. S. Belov ◽  
E. N. Aleksandrova ◽  
G. M. Tarasova ◽  
A. A. Novikov ◽  
...  

Objective: to investigate the immunogenicity, safety, and clinical efficacy of 23-valent polysaccharide pneumococcal vaccine in patients with rheumatoid arthritis (RA) during a two-year follow-up study.Subjects and methods. The prospective open-label comparative study enrolled 110 people, of them there were 81 (73.6%) women and 29 (26.4%) men at the age of 23 to 76 years, including 79 patients with RA, as well as 31 subjects without systemic inflammatory rheumatic diseases (RD) (a control group). The group of RA patients exhibited a predominance of middle-aged women who had > 3 years’ disease duration and a moderate inflammatory activity (the mean value of DAS28, 4.32). 52 patients received methotrexate (MTX), 14 had Leflunomide (LEF), and 13 were treated with tumor necrosis factor-α (TNF-α) inhibitors + MTX.The 23-valent polysaccharide pneumococcal vaccine Pneumo-23 (Sanofi Pasteur, France) was administered in a single dose of 0.5 ml subcutaneously during continuous MTX or LEF therapy for the underlying disease or 3–4 weeks before the use of TNF-α inhibitors. Clinical examinations of the patient and conventional clinical and laboratory studies were performed during control visits (1, 3, 12, and 24 months after vaccination). Clinical effectiveness and safety were evaluated in all the patients included in the study. The serum levels of anti-pneumococcal capsular polysaccharide antibodies (Ab) were measured in 72 patients with RA and in 30 individuals in the control group during a 12-month follow-up study, including in 25 patients with RA for a 24-month follow-up study by enzyme immunoassay using commercial VaccZymeTM Anti-PCP IgG Enzyme Immunoassay kits (The Binding Site Group Ltd, Birmingham, United Kingdom). Along with this, the post-immunization response coefficient was calculated for each patient as the ratio of postvaccination Ab levels during Visits 2, 3, 4, and 5 to the baseline Ab level.Results and discussion. No clinical and radiological symptoms of pneumonia were recorded in any case during the follow-up period. The patients with RA and the control group showed a more than double significant increase of anti-pneumococcal Ab level during 3 months following vaccination. Despite the decrease in their concentration by month 12, the latter remained at the appropriate level and significantly increased at 24-month follow-up. Vaccination was well tolerated. A favorable course of the postvaccinal period was noted in all cases. There were no adverse reactions to vaccination in 72 (65%) patients; 38 (35%) patients were noted to have pain, skin swelling and hyperemia up to 2 cm in diameter at the site of injection, as well as low-grade fever. There were no episodes of a RD exacerbation or any new autoimmune disorders during the follow-up period.Conclusion. The findings were suggestive of the sufficient immunogenicity and good tolerability of 23-valent pneumococcal vaccine in patients with RD during the two-year follow-up period.

2015 ◽  
Vol 14 (4) ◽  
pp. 67-73
Author(s):  
M. S. Naumtseva ◽  
B. S. Belov ◽  
G. M. Tarasova ◽  
D. E. Karateev ◽  
E. L. Luchikhina ◽  
...  

Objective: to study the clinical efficacy, immunogenicity, and safety of a 23-valent pneumococcal vaccine in patients with rheumatoid arthritis (RA).Subjects and methods. The investigation enrolled 102 patients (78 women and 24 men, aged 23 – 70 years), including 72 patients with RA and 30 people without systemic inflammatory rheumatic diseases (a control group) who had a recent history of 2 and more cases of lower respiratory tract infections (bronchitis, pneumonia). When included, all the patients received anti-inflammatory therapy with methotrexate (MT) (n = 52), leflunomide (LEF) (n = 10), or MT + tumor necrosis factor-α (TNF-α ) inhibitors (n = 10). A single 0.5-ml dose of the 23-valent pneumococcal vaccine was administered subcutaneously during continuous MT or LEF therapy for the underlying disease or 3 – 4 weeks before the use of a TNF-α inhibitor. During control visits (1 and 3 months and 1 year after administration of the vaccine), the patients underwent physical examination and routine clinical and laboratory studies.Results. No clinical and radiological symptoms of pneumonia were recorded in any case during a 12-month follow-up. The RA and control groups showed a more than 2-fold increase in anti-pneumococcal antibody levels 1 year after vaccination. The vaccine was well tolerated by 67 patients. 27 patients were observed to have pain, cutaneous swelling and hyperemia and 8 patients had subfebrility. There were neither episodes of RA exacerbation nor new autoimmune disorders during the follow-up.Conclusion. The findings suggest that 23-valent pneumococcal vaccine shows a good clinical efficacy, adequate immunogenicity, and good tolerability in the patients with RA. 


2013 ◽  
Vol 12 (2) ◽  
pp. 135-140 ◽  
Author(s):  
N. A. Shabanova ◽  
O. S. Shubina ◽  
L. A. Ukolova ◽  
N. L. Tov

The relevance of the study is connected with need to expand the arsenal of treatment methods patients with rheumatoid arthritis. The study examined the efficacy of biobehavioral therapy in a comprehensive program of treatment patients with rheumatoid arthritis (medical therapy in combination with biobehavioral therapy). It has been shown when compared with the control group (isolated drug therapy) maintaining  clinical  response  in  short-term  follow-up  study  in  the  intervention  group.  Statistically    significant relationship the volitional control of the alpha rhythm of EEG (increased power of the alpha rhythm) with a reduction in pain intensity in the in neurofeedback program and positive dynamics of the main characteristics of the alpha rhythm have been drmonstrated. Inclusion in the treatment program of arthritis biobehavioral approach has reduced the dose of pain medication, so reducing aggression of pharmacotherapy.


2018 ◽  
Vol 12 (4) ◽  
pp. 85-88 ◽  
Author(s):  
D. V. Bukhanova ◽  
M. S. Sergeeva ◽  
B. S. Belov ◽  
G. M. Tarasova ◽  
M. V. Cherkasova ◽  
...  

The Clinician ◽  
2018 ◽  
Vol 12 (1) ◽  
pp. 25-28
Author(s):  
D. V. Bukhanova ◽  
В. S. Belov ◽  
G. M. Tarasova ◽  
Sh. F. Erdes ◽  
T. V. Dubinina ◽  
...  

Objective: to evaluate the safety and effectiveness of vaccination with trivalent split virion influenza vaccine in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS), estimate the effect of vaccination on rheumatoid disorder (RD) activity and influenza and influenzalike illnesses morbidity.Materials and methods. The study included 86 patients (58 females and 28 males aged 22–82 years) with RDs (52 patients with RA and 34 patients with AS), as well as 40 subjects without RD (control group). At the time of study inclusion, all patients were receiving drug therapy. Duration of RD varied from 2 months to 46 years. The Vaxigrip vaccine containing the currents trains of the flu virus for 2016–2017 season or 2017–2018 season was administered subcutaneously as 1 dose (0.5 ml) with continuing antirheumatic therapy. The main control stages were visits 1, 3, and 6 months after vaccination. During the visits, standard clinical and labtests, clinical examination with disease activity evaluation were performed.Results. In 98 patients, vaccination tolerability was high, no post vaccination reactions were observed. In 20 cases, pain, swelling, and hyperemia of the skin 2 cm in diameter at the point of vaccination were observed; in 8 cases, low-grade fever, myalgia, discomfort, headache were observed. No RD flares or development of new autoimmune disorders were diagnosed during the follow-up period. No cases of influenza or influenza-like illnesses were registered during the follow-up period.Conclusion. The obtained data demonstrate high tolerability, clinical effectiveness of trivalent split virion influenza vaccine in patients with RA and AS.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 5278-5278
Author(s):  
Jeyanthi Ramanarayanan ◽  
Shalu Pahuja ◽  
Myron S Czuczman ◽  
Francisco J. Hernandez-Ilizaliturri

Abstract BACKGROUND: TNF-α plays a critical role in the regulation of cytokine mediated cancer immunosurveillance. Evidence suggests that depletion of TNF-α may result in abrogated anti-tumor immunity and increase in the risk of malignancies. Anti-TNF-α therapy (infliximab, adalimumab and etanercept) is known to halt the progression of certain inflammatory disorders and has been approved for the treatment of at least five autoimmune/inflammatory conditions. Given the widespread use of these biological agents, it is vital to explore the associated increased risk of malignancies especially lymphoma. OBJECTIVE: Risk of lymphoma associated with anti-TNF-α therapy is controversial in rheumatoid arthritis (RA) and has not been extensively studied in other inflammatory disorders. With the expanding role of anti-TNF-α therapy, we evaluated the risk of lymphoma among all approved indications for which they are currently in use. METHODOLOGY: We conducted a systematic electronic search of MEDLINE using the terms TNF-α, infliximab, adalimumab, etanercept, rheumatoid, psoriasis, arthritis, inflammatory bowel disease, ankylosing spondylitis from January 1998 to December 2007. Studies analyzed were restricted to those in English language, full text published articles, randomized controlled trials (RCT), meta-analysis (MT), review articles, extension studies, reports from national databases (ND) and postmarketing surveillance studies. Risk of lymphoma from ND was obtained as odds ratio with 95% confidence interval. Incidence of lymphoma reported from RCT was analyzed as percentage fraction of the total number of patients enrolled in the study and follow up. RESULTS: Overall 51 studies (2 MT, n=10,370; 4 ND, n=29,099 and 45 RCT, n=54,637) that included anti-TNF-α therapy in inflammatory disorders were analyzed. Treatment/follow up period were variable from 12 weeks to 8 years. Ten patients (0.09%) from MT treated with anti-TNF-α therapy developed lymphoma vs 0 in the non-anti-TNF-α group. Report from one of the 3 ND showed an increased risk (11.5 RR 95% CI 3.7–26.9) of lymphoma among the anti-TN-α exposed group. Among the RCT, 16 patients (0.02%) in the anti-TNF-α group developed lymphoma vs 3 (0.005%) in the control group. CONCLUSION: Existing data suggests that anti-TNF-α therapy in rheumatoid arthritis is associated with an increased risk of lymphoma but this may be attributed to the severity of the disease itself. Among other inflammatory disorders, a rise in lymphoma risk could not be established. Whether anti-TNF-α therapy in the long term can in fact decrease the incidence of lymphoma by altering the disease severity remains to be determined.


Author(s):  
Fatih Öner Kaya ◽  
Yeşim Ceylaner ◽  
Belkız Öngen İpek ◽  
Zeynep Güneş Özünal ◽  
Gülbüz Sezgin ◽  
...  

Aims: The etiopathogenesis of Rheumatoid Arthritis (RA) is not clearly understood. However, the role of the cytokines takes an important part in this mechanism. We aimed to bring a new approach to the concept of 'remission' in patients with RA. Background: RA is a chronic, autoimmune, inflammatory disease that involves small joints in the form of symmetrical polyarthritis and progresses with exacerbations and remissions. Pain, swelling, tenderness and morning stiffness are typical of the joints involved. Although it is approached as a primary joint disease, a wide variety of extra-articular involvements may also occur. It is an interesting pathophysiological process, the exact cause of which is still unknown, with many environmental, genetic and potentially undiscovered possible factors in a chaotic manner. Objective: In this cross-sectional study, sedimentation rate (ESR), C- Reactive protein (CRP), Tumor necrosis factor (TNF)-α, soluble-TNF-α receptor (TNF-R), Interleukin (IL)-1B and IL-10 were measured in three groups which were healthy volunteers, patients with RA in the active period, and patients with RA in remission. Disease activity score-28 (DAS-28) was calculated in active RA and RA in remission. Methods: This study included 20 healthy volunteers, 20 remission patients with RA and 20 active RA patients. Venous blood samples were collected from patients in both healthy and RA groups. Results: RA group consisted 43 (71.6%) female and 17 (28.4%) male. Control group consisted 11 (55%) female and 9 (45%) male. TNF-R was significantly high only in the active group according to the healthy group (p=0.002). IL-10 was significantly high in active RA according to RA in remission (p=0.03). DAS-28 was significantly high in active RA according to RA in remission (p=0.001). In the active RA group, ESR and TNF-R had a positive correlation (r:0.442; p=0.048). In the active RA group, there was also a positive correlation between TNF-R and CRP (r:0.621; p=0,003). Both healthy and active RA group had significant positive correlation between ESR and CRP (r: 0.481; p=0.032 and r: 0,697; p=0,001 respectively). Conclusion: TNF-R can be the main pathophysiological factor and a marker showing activation. TNF-R can be very important in revealing the effect of TNF on the disease and the value of this effect in the treatment and ensuring the follow-up of the disease with CRP instead of ESR in activation.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 625.2-626
Author(s):  
H. Gerasimova ◽  
T. Popkova ◽  
I. Kirillova ◽  
M. Cherkasova ◽  
A. Martynova ◽  
...  

Background:N-terminal pro-brain natriuretic peptide (NT-proBNP) is a recognized predictor of congestive heart failure (CHF) and cardiovascular death. Rheumatoid arthritis (RA) patients (pts) were shown to have higher NT-proBNP concentrations than in general population, but it remains unclear, whether NT-proBNP levels are related to RA duration, activity or treatment.Objectives:To investigate the effect of interleukin 6 receptor inhibitor - tocilizumab (TCZ) and JAK inhibitor - tofacitinib (TOFA) on NT-proBNP levels in RA pts during a 12-month (m) follow-up period.Methods:The study enrolled 60pts (50women/10men) with the lack of efficacy/resistance and/or intolerance of basic anti-inflammatory drugs (DMARDs); median age was 55[42;61] years, median disease duration 55[29;120]m, with moderate to high activity (DAS28-5,1[4,6;6,1], serum positivity for rheumatoid factor (RF)(85%)/ anti-cyclic citrullinated peptide antibodies (ACCP)(80%). The study did not include RA pts with CHF and clinically overt cardiovascular disease (CVD). Twenty nine RA pts received TCZ(8mg/kg) every 4 weeks: 61% received TCZ in combination with methotrexate (MTX), 35% - with low-dose glucocorticoids (GCs). Thirty one RA pts were prescribed oral TOFA at 5 mg BID with dose escalation to 10 mg BID in 8 (26%)pts. TOFA was used in combination with MTX in 90% pts, with GCs – in 29% pts. Pts treated with TCZ and TOFA were comparable in terms of age, sex, body mass index. RA activity rates (DAS28, SDAI, ESR, CRP) were higher in pts on TCZ -therapy compared with pts treated with TOFA. Echocardiography data and NT-proBNP levels using electrochemiluminescence method Elecsys proBNP II (Roche Diagnostics, Switzerland) were obtained at baseline and after 12m.Results:Significant positive changes in major disease activity, clinical and laboratory parameters were found in RA pts after 12 m of TCZ infusion and TOFA intake: remission (DAS28<2,6) was achieved in 54% and 39% pts, low activity levels (DAS28<3,2) – in 46% and 51% pts, respectively.The NT-proBNP levels were significantly higher in RA pts than in the control group (median 69,1 (37,9;105,8) pg/mL vs 55,3 (36,6;67,3) pg/mL,p<0.05).Six pts (10%) (three in each pts group) had NT-proBNP levels over 125pg/ml, but were asymptomatic and had unremarkable echocardiography.There was a good correlation between NT-proBNP level at baseline with age (r=0,55,p<0,001), SDAI (r=0,5, h=0,01), ACCP (r=0,23,p=0,01).Decrease of median NT-proBNP levels was documented after 12m of TCZ therapy (81,5[43,0;102,0]vs41,6[25,4;64,2]pg/ml (p<0,01) and after 12m TOFA therapy (66,1[30,5;105,0]vs16,8 [5,0;81,0]pg/ml,p=0,001).After 12m of TCZ correlations of ΔNT-proBNP were established with ΔESR (R=0,43;p<0,05], ΔСRP (R=0,46;p<0,05], ΔEe left ventricle (LV) (r=0,88,p=0,03).In the group of pts treated with TOFA ΔNT-proBNP level significantly correlated with the percentage change in DAS 28 (r=0,41,p=0,038), there was no direct correlation with changes in the parameters of the LV diastolic function.Conclusion:TCZ and TOFA treatment for 12 m reduced NT-proBNP levels in RA pts without clinically manifest CVD and CHF. Falling NT-proBNP concentrations are associated with positive dynamics of RA activity (DAS 28) and inflammatory markers (CRP, ESR), therefore allowing to suggest that increased NT-proBNP levels should be considered as a component of disease activity. Correlation between ΔNT-proBNP and ΔEeLF may be indicative as possible impact of these biomarkers on the LV diastolic function’s development in RA pts.Disclosure of Interests:None declared


Life ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 527
Author(s):  
Lucero A. Ramon-Luing ◽  
Ranferi Ocaña-Guzman ◽  
Norma A. Téllez-Navarrete ◽  
Mario Preciado-García ◽  
Dámaris P. Romero-Rodríguez ◽  
...  

Immune reconstitution inflammatory syndrome (IRIS) is an exacerbated immune response that can occur to HIV+ patients after initiating antiretroviral therapy (ART). IRIS pathogenesis is unclear, but dysfunctional and exhausted cells have been reported in IRIS patients, and the TIM-3/Gal-9 axis has been associated with chronic phases of viral infection. This study aimed to evaluate the soluble levels of TIM-3 and Gal-9 and their relationship with IRIS development. TIM-3, Gal-9, TNF-α, IFN-γ, IL-6, TNFR1, TNFR2, E-cadherin, ADAM10, and ADAM17 were measured to search for IRIS-associated biomarkers in plasma samples from 0-, 4-, 8-, 12-, and 24-weeks after ART initiation of 61 HIV+ patients (15 patients developed IRIS, and 46 did not). We found that patients who developed IRIS had higher levels of TIM-3 [median 4806, IQR: 3206–6182] at the time of the IRIS events, compared to any other follow-up time evaluated in these patients or compared with a control group of patients who did not develop IRIS. Similarly, IRIS patients had a higher TNF-α level [median 10.89, IQR: 8.36–12.34] at IRIS events than any other follow-up time evaluated. Other molecules related to the TIM-3 and TNF-α pathway (Gal-9, IL-6, IFN-γ, TNFR1, TNFR2, ADAM-10, and ADAM-17) did not change during the IRIS events. In conclusion, our data suggest that a high level of soluble TIM-3 and TNF-α could be used as an IRIS biomarker.


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