Safety of Recombinant Zoster Vaccine: a Retrospective Study of 622 Rheumatology Patients

Rheumatology ◽  
2021 ◽  
Author(s):  
Tiphaine Lenfant ◽  
Yuxuan Jin ◽  
Elizabeth Kirchner ◽  
Rula A Hajj-Ali ◽  
Leonard H Calabrese ◽  
...  
Keyword(s):  
Inflammatory Diseases ◽  
Cox Model ◽  
Patient Portal ◽  
Single Center ◽  
Zoster Vaccine ◽  
Treatment Change ◽  
Immune Mediated ◽  
Recombinant Zoster Vaccine ◽  
Insight Into

Abstract Objectives To provide insight into the safety of Recombinant Zoster Vaccine (RZV) in patients with Immune-Mediated Inflammatory Diseases (IMID). Methods Patients who received RZV in a single center Rheumatology Department were retrospectively included. An IMID flare was defined as a) a documentation of flare in the office notes or patient portal communication or b) new prednisone prescription, in the 12 weeks after each dose. Results Six-hundred twenty-two patients were included (67% female, median age 67 years), 8.5% of them experienced AEs and HZ incidence was 0.6% after median follow-up of 36 weeks. Of 359 IMID patients: 88 had RA (25%), 50 vasculitis (14%), 29 PMR (8%). At vaccination, 35% were on glucocorticoids (GC). Fifty-nine patients (16%) experienced a flare, 18 flares occurred in temporal relation to a treatment change (31%). RA patients had the highest flare rate (n = 21, 24%), 25% of patients who flared required adjustment of immunosuppression. In a multivariate analysis, use of GC at time of vaccination was associated with flare after vaccination (OR 2.31 [1.3-4.1], p = 0.004). A time-to-flare survival analysis (Cox-model) showed that GC was a significant predictor of IMID flare after first RZV dose (HR 2.4 [1.3-4.5], p = 0.0039) and that a flare after the first dose was associated with flaring after the second RZV dose (HR 3.9 [1.7-9], p = 0.0015). Conclusion RZV administration in patients with IMIDs was generally well-tolerated, though mild flares were not uncommon in the first 12 weeks after vaccination. These data may provide useful information for patient education when considering RZV administration.

scholarly journals Prevalence of Hospital PCR Confirmed COVID-19 Cases in Patients with Chronic Inflammatory and Autoimmune Rheumatic Diseases

2020 ◽  
Author(s):  
José L. Pablos ◽  
Lydia Abasolo-Alcázar ◽  
José M. Álvaro-Gracia ◽  
Francisco J. Blanco ◽  
Ricardo Blanco ◽  
...  
Keyword(s):  
Rheumatic Diseases ◽  
Lupus Erythematosus ◽  
Inflammatory Diseases ◽  
Age Distribution ◽  
Reference Population ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Immune Mediated ◽  
Specific Factors

ABSTRACTBackgroundThe susceptibility of patients with rheumatic diseases, and the risks or benefits of immunosuppressive therapies for COVID-19 are unknown.MethodsWe performed a retrospective study with patients under follow-up in rheumatology departments from seven hospitals in Spain. We matched updated databases of rheumatology patients with SARS-CoV-2 positive PCR tests performed in the hospital to the same reference populations. Rates of PCR+ confirmed COVID-19 were compared among groups.ResultsPatients with chronic inflammatory diseases had 1.32-fold higher prevalence of hospital PCR+ COVID-19 than the reference population (0.76% vs 0.58%). Systemic autoimmune or immune mediated diseases (AI/IMID) patients showed a significant increase, whereas inflammatory arthritis (IA) or systemic lupus erythematosus (SLE) patients did not. COVID-19 cases in some but not all diagnostic groups had older ages than cases in the reference population. IA patients on targeted-synthetic or biological disease-modifying antirheumatic drugs (ts/bDMARD), but not those on conventional-synthetic (csDMARD), had a greater prevalence despite a similar age distribution.ConclusionPatients with AI/IMID show a variable risk of hospital diagnosed COVID-19. Interplay of aging, therapies, and disease specific factors seem to contribute. These data provide a basis to improve preventive recommendations to rheumatic patients and to analyze the specific factors involved in COVID-19 susceptibility.

scholarly journals A Brazilian Cohort of Patients With Immuno-Mediated Chronic Inflammatory Diseases Infected by SARS-CoV-2 (ReumaCoV-Brasil Registry): Protocol for a Prospective, Observational Study

10.2196/24357 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e24357
Author(s):  
Claudia Marques ◽  
Adriana Maria Kakehasi ◽  
Ana Paula Monteiro Gomides ◽  
Eduardo Dos Santos Paiva ◽  
Edgard Torres dos Reis Neto ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Inflammatory Diseases ◽  
Progression Rate ◽  
Immune Mediated ◽  
Increased Risk ◽  
Observational Cohort ◽  
And Function ◽  
The Impact ◽  
Brazilian Cohort

Background Patients with immune-mediated rheumatic diseases (IMRD) are at increased risk of infections, including significant morbidity and high mortality. Considering the potential for unfavorable outcomes of SARS-CoV-2 infection in patients with IMRD, several questions were raised regarding the impact of COVID-19 at the start of the pandemic. Objective This paper presents the protocol of a study that aims to prospectively evaluate patients with IMRD and a confirmed COVID-19 diagnosis (using criteria provided by the Brazilian Ministry of Health). Methods The study comprised a prospective, observational cohort (patients with IMRD and COVID-19) and a comparison group (patients with only IMRD), with a follow-up time of 6 months to evaluate differences in health outcomes. The primary outcomes will be changes in IMRD disease activity after SARS-CoV-2 infection at 4 time points: (1) at baseline, (2) within 4-6 weeks after infection, (3) at 3 months after the second assessment (±15 days), and (4) at 6 months (±15 days). The secondary outcomes will be the progression rate to moderate or severe forms of COVID-19, need for intensive care unit admission and mechanical ventilation, death, and therapeutic changes related to IMRD. Two outcomes—pulmonary and thromboembolic events in patients with both IMRD and SARS-CoV-2 infection—are of particular interest and will be monitored with close attention (clinical, laboratory, and function tests as well as imaging). Results Recruitment opened in May 2020, with 1300 participants recruited from 43 sites as of November 2020. Patient recruitment will conclude by the end of December 2020, with follow-up occurring until April 2021. Data analysis is scheduled to start after all inclusion data have been collected, with an aim to publish a peer-reviewed paper in December 2020. Conclusions We believe this study will provide clinically relevant data on the general impact of COVID-19 on patients with IMRD. Trial Registration Brazilian Registry of Clinical Trials RBR-33YTQC; http://www.ensaiosclinicos.gov.br/rg/RBR-33ytqc/ International Registered Report Identifier (IRRID) DERR1-10.2196/24357

scholarly journals Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials

Rheumatology ◽  
2020 ◽  
Author(s):  
Alemnew F Dagnew ◽  
Debora Rausch ◽  
Caroline Hervé ◽  
Toufik Zahaf ◽  
Myron J Levin ◽  
...  
Keyword(s):  
Adverse Events ◽  
Age Groups ◽  
Zoster Vaccine ◽  
Post Dose ◽  
Serious Adverse Events ◽  
Post Hoc Analysis ◽  
Immune Mediated ◽  
Recombinant Zoster Vaccine ◽  
Post Hoc ◽  
Placebo Recipients

Abstract Objective In the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials, the adjuvanted recombinant zoster vaccine (RZV) demonstrated ≥90% efficacy in preventing herpes zoster (HZ) in all age groups ≥50 years. Given the increased HZ risk associated with certain underlying autoimmune diseases or their treatment regimes, we conducted a post hoc analysis of RZV’s efficacy against HZ and safety profile [specifically, the occurrence of serious adverse events (SAEs)] in ZOE-50/70 participants who reported pre-existing potential immune-mediated diseases (pIMDs) at enrolment and were not on immunosuppressive therapies. Methods Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomized to receive two doses of RZV or placebo 2 months apart. In this subgroup analysis of participants with at least one pIMD at enrolment, the efficacy was calculated for two-dose recipients who did not develop confirmed HZ before 30 days post-dose 2. SAE occurrence was evaluated for all participants who received at least one dose. Results Of the 14 645 RZV and 14 660 placebo recipients from the ZOE-50/70 studies, 983 and 960, respectively, reported at least one pre-existing pIMD at enrolment and were included in these analyses. The most frequent pre-existing conditions were psoriasis, spondyloarthropathy and RA. Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70–79-year-old age group. SAEs and fatal SAEs were similar between RZV and placebo recipients. Conclusion In ZOE-50/70 participants with pre-existing pIMDs, RZV was highly efficacious against HZ and SAE incidence was similar between RZV and placebo recipients. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT01165177 (ZOE-50), NCT01165229 (ZOE-70).

scholarly journals 19. Completion of Two-Dose Recombinant Zoster Vaccine Series in Adults 50 Years and Older

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S32-S33
Author(s):  
Hung-Fu Tseng ◽  
Lei Qian ◽  
Jun Wu ◽  
Yi Luo ◽  
Lina S Sy ◽  
...  
Keyword(s):  
Health Care ◽  
Influenza Vaccine ◽  
Zoster Vaccine ◽  
Kaiser Permanente ◽  
Factors Associated ◽  
Series Completion ◽  
Race Ethnicity ◽  
Recombinant Zoster Vaccine ◽  
Research Grant

Abstract Background In 2017, the Advisory Committee on Immunization Practices preferentially recommended adjuvanted recombinant zoster vaccine (RZV) for adults ≥ 50 years as a two-dose series 2–6 months apart.1 We evaluated two-dose RZV completion and factors associated with completion. Methods The study included Kaiser Permanente Southern California members ≥ 50 years who received an RZV dose during April-November 2018 and had continuous membership 12 months before to 9 months after the 1st RZV dose (RZV1). Completion was defined as receipt of the 2nd dose ≥4 weeks to 9 months after RZV1 (allowing a 3-month grace period). Characteristics including age at RZV1, sex, race/ethnicity, Medicaid status, neighborhood level income and education, distance from home to medical office, comorbidities, history of herpes zoster, health care utilization before and after RZV1, receipt of influenza vaccine, vaccination month (supply shortage proxy), concomitant vaccine, department administering RZV1, medical center, and medically attended local or systemic reaction, pain, or gout after RZV1 were compared between completers and non-completers. Adjusted odds ratios (aOR) and 95% confidence intervals (CI) for factors associated with completion were estimated by multivariable logistic regression. Results Among 31,120 RZV1 recipients, 67.2% completed the series within 9 months. In adjusted analyses, higher completion was associated with White compared with Black or Hispanic race/ethnicity, higher neighborhood income and education, no chronic pulmonary disease, diabetes, or dementia, more outpatient visits and fewer emergency department visits before or after RZV1, no hospitalizations after RZV1, receipt of influenza vaccine, receipt of RZV1 in June-November rather than April-May 2018, no concomitant vaccine with RZV1, and receipt of RZV1 in Family Practice rather than Internal Medicine. Systemic reactions or pain after RZV1 was not associated with completion. Table 2. RZV Series Completion by Selected Characteristics During Follow-up of Members Aged ≥50 Years Who Received at Least One Dose of RZV at Kaiser Permanente Southern California in April-November 2018 Table 2. RZV Series Completion by Selected Characteristics During Follow-up of Members Aged ≥ 50 Years Who Received at Least One Dose of RZV at KPSC in April-November 2018 Figure 1. Factors Associated with RZV Series Completion of Members Aged ≥ 50 Years Who Received at Least One Dose of RZV at KPSC in April-November 2018 Conclusion Completion of RZV series appears moderate in the early phase of implementation. Despite similar accessibility in a health care system, completion varied by race/ethnicity, socioeconomic status, health status, and care seeking behavior, suggesting areas to target for improvement. Disclosures Hung-Fu Tseng, MPH, PhD, GlaxoSmithKlein (Research Grant or Support) Lei Qian, PhD, GlaxoSmithKlein (Research Grant or Support) Jun Wu, MD, MS, GlaxoSmithKlein (Research Grant or Support) Yi Luo, PhD, GlaxoSmithKlein (Research Grant or Support) Lina S. Sy, MPH, GlaxoSmithKlein (Research Grant or Support) Katia Bruxvoort, PhD, MPH, GlaxoSmithKlein (Research Grant or Support) Bradley Ackerson, MD, GlasoSmithKlein (Research Grant or Support)

scholarly journals 07. Recombinant Zoster Vaccine (RZV) Second-Dose Completion in Adults Age 50‒64 Years in the United States

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S127-S127
Author(s):  
Jessica Leung ◽  
Elizabeth B Gray ◽  
Tara Anderson ◽  
Sarah M Sharkey ◽  
Kathleen L Dooling
Keyword(s):  
The United States ◽  
Administrative Claims ◽  
Completion Rates ◽  
Medicare Beneficiaries ◽  
Medical Provider ◽  
Zoster Vaccine ◽  
National Drug ◽  
Series Completion ◽  
Recombinant Zoster Vaccine

Abstract Background In 2018, CDC recommended a highly efficacious adjuvanted recombinant zoster vaccine (RZV, Shingrix) as a 2-dose series for prevention of herpes zoster (HZ) for immunocompetent persons age ≥50 years, with the 2nd dose recommended 2–6 months after the 1st dose. Among Medicare beneficiaries, 2-dose series completion 6 months and 12 months post initiation was 78% and 86%, respectively. Here we estimate the proportion of adults age 50–64 years who completed the 2-dose RZV series within 6 or 12 months after receiving their 1st dose, by using two administrative claims databases. Methods We used medical and pharmaceutical claims data from October 2017‒March 2020 IQVIA® PharMetrics Plus and October 2017‒October 2020 IBM® MarketScan® databases. RZV vaccination was defined using Current Procedural Terminology and National Drug Codes. We allowed for sufficient follow-up time by examining 1st doses given at least 6 or 12 months prior to the end of the study period in both databases. Place of administration was available in IQVIA data. Results Among persons age 50‒64 years, in IQVIA and MarketScan, 70% and 68% received their 2nd RZV dose within 6 months, respectively, and 79% and 81% received their 2nd dose within 12 months, respectively. The median age of 1st dose of RZV vaccination was 60 years and ~60% were female [Table 1]. When the 2nd dose was administered within 12 months, the median interval between 1st and 2nd doses was 104 and 98 days in the IQVIA and MarketScan databases, respectively. Characteristics by age, sex, or region were similar in persons who received 1 RZV dose vs. 2 RZV doses [Table 1]. Among those who received only 1 RZV dose with at least 12 months of follow-up time, 55% of vaccinations occurred at ambulatory medical provider offices and 40% at pharmacies; among 2 doses recipients, 33% of vaccinations occurred at provider offices and 62% at pharmacies. Conclusion Among 50‒64-year-olds, 2-dose RZV series completion was ~70% within 6 months and 80% within 12 months of initiation. The findings were similar across two administrative claims databases. Availability of RZV at pharmacies has potentially helped to increase RZV 2nd dose completion rates. Disclosures All Authors: No reported disclosures

Design and implementation of a mobile app for the pharmacotherapeutic follow-up of patients diagnosed with immune-mediated inflammatory diseases: eMidCare (Preprint)

2022 ◽  
Author(s):  
Rosa Romero-Jimenez ◽  
Vicente Escudero-Vilaplana ◽  
Esther Chamorro-de-Vega ◽  
Arantza Ais-Larisgoitia ◽  
Maria Elena Lobato Matilla ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthcare Professionals ◽  
Biological Therapy ◽  
Inflammatory Diseases ◽  
Injection Site Reaction ◽  
Mobile App ◽  
Biological Therapies ◽  
Patient Profile ◽  
Immune Mediated

BACKGROUND Pharmacotherapeutic management of immune-mediated inflammatory diseases (IMID) has become more complex due to the development of new treatments, such as biological therapies. Mobile health, especially apps, can provide IMID patients with greater autonomy and facilitate communication with healthcare professionals. OBJECTIVE Our objective was to design and implement an app for remote monitoring and communication with IMID patients. We also assessed the usability of and satisfaction with the app. METHODS A multidisciplinary group comprising pharmacists, dermatologists, rheumatologists, gastroenterologists, and nurses was created to design and develop an app for IMID patients in a tertiary hospital. The app functionalities were identified through a focus group with IMID patients and through an observational, cross-sectional, descriptive study of all available apps for IMID patients at App Store and Play Store platforms. Once the app was designed and developed, we started offering the app to all IMID patients who initiated a new biological therapy. We performed an observational, longitudinal study of patients followed using the app to assess the tool's impact on safety, communication, satisfaction, and usability. The inclusion period was from December 2020 to August 2021. The inclusion criteria were age ≥ 18 years, diagnosis of an IMID, and ownership of a Smartphone. Patients with language barriers were excluded. RESULTS We designed an app (eMidCare®) with the following modules: My Medication, My Questionnaires, Adverse Events, Useful Information, Messages, and Patient Profile. A total of 86 patients were installed with the app (the median age was 48.3 [18.1-79.4] years and 62.4 were female). The median (range) follow-up time for app use was 123 (5-270) days. In the My Medication module, 100% of patients registered their biological therapy and 25.9% also used this module to record each dose of medication administered. A total of 82 adverse events (AEs) were registered. Thirty-two percent of the patients registered at least 1 AE. The most frequent AEs were fatigue, injection site reaction, headache, and nausea. Fifty-two percent of patients used the Messages module to communicate with healthcare professionals. The most frequent messages concerned doubts about managing AEs (26.2%) and drug interactions (18.9%). The satisfaction survey yielded a median (range) score of 9.1 (7-10) out of 10. The app sections that patients browsed for the longest time were Messages (21.9%), Start screen (20.9%), My questionnaires (20.4%), My medication (8.8%), and Adverse events (7.1%). CONCLUSIONS We developed an app, eMidCare®, which reminds patients to take their medication, enables them to record AEs, and helps them communicate with healthcare professionals. Approximately one-third of the patients registered the administration of the biological therapies and registered at least 1 AE. The most used and most satisfactory functionality was communication with health professionals. Patient satisfaction and retention were very high.

AB0884-HPR PERSONALISED TREATMENT GOALS IN PATIENTS WITH IMMUNE MEDIATED INFLAMMATORY DISEASE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1465.1-1466
Author(s):  
S. Fadaei ◽  
H. Van Os-Medendorp ◽  
A. Sloeserwij ◽  
V. Sigurdsson ◽  
J. M. Van Laar ◽  
...  
Keyword(s):  
Inflammatory Diseases ◽  
Personalised Medicine ◽  
Clinical Information ◽  
Daily Functioning ◽  
Personal Goals ◽  
Treatment Goals ◽  
Emotional Wellbeing ◽  
Record System ◽  
Immune Mediated

Background:Immune mediated inflammatory diseases (IMIDs) often have a chronic character and large impact on daily life of patients. In order to provide patient-centred care, insight in personal goals is a key issue.Objectives:The aim of this study was to evaluate treatment goals of patients with IMIDs over time.Methods:Patients with IMIDs were invited to complete a self-designed questionnaire about lifestyle, personal treatment goals and perceived care at their first visit to our centre and one year after referral. Clinical information was collected through the electronic patient record system.Results:41 (30%) patients of the 137 invited, completed both questionnaires. Participants had a mean age of 45.6 years (SD 13.4), N=35 (83%) was female, mean disease duration was 12.7 years (SD 12.7). Patients were diagnosed with connective tissue disease (CTD, n=19; 45%), antiphospholipid syndrome (APS, n=10; 24%), inflammatory arthritis (n=7; 17%) and psoriasis (n=7; 17%). We identified six categories of treatment goals: disease related, daily functioning, lifestyle, emotional wellbeing. Figure 1 shows the reported treatment goals at baseline and follow-up. Most frequently mentioned were goals related to disease, lifestyle and daily functioning. At follow-up we observed a vast increase in reported goals related to psychological wellbeing (from 5% to 16%). At baseline patients with APS chose lifestyle-related goals more often than other patients (RR=3.2; p=0.015). At follow-up patients with CTDs reported disease related-goals less often than other patients (RR=0.4; p=0.002). Patients did not report significant progress in reaching their goals on a Likert scale of 1-10. However, in 90% at first visit and in 83% of patients at follow-up, patients reported that the provided care was addressing issues they personally prioritized.Conclusion:IMID patients’ most frequent treatment goals relate to disease activity, lifestyle and daily functioning. Patients frequently change their treatment goals during the first year of treatment. Better understanding of personal goals can help physicians providing targeted and personalised medicine.Figure 1.themes of treatment goals at baseline and follow-upAcknowledgements:The researchers would like to thank all patients participating in this study and acknowledge the UMC Utrecht research program Infection and Immunity for supporting this initiative.Disclosure of Interests:None declared

scholarly journals Prevalence of hospital PCR-confirmed COVID-19 cases in patients with chronic inflammatory and autoimmune rheumatic diseases

2020 ◽  
Vol 79 (9) ◽  
pp. 1170-1173 ◽  
Author(s):  
Jose L Pablos ◽  
Lydia Abasolo ◽  
Jose M Alvaro-Gracia ◽  
Francisco J Blanco ◽  
Ricardo Blanco ◽  
...  
Keyword(s):  
Rheumatic Diseases ◽  
Lupus Erythematosus ◽  
Inflammatory Diseases ◽  
Age Distribution ◽  
Reference Population ◽  
Disease Modifying Antirheumatic Drugs ◽  
Immune Mediated ◽  
Synthetic Dmards ◽  
Specific Factors

BackgroundThe susceptibility of patients with rheumatic diseases and the risks or benefits of immunosuppressive therapies for COVID-19 are unknown.MethodsWe performed a retrospective study with patients under follow-up in rheumatology departments from seven hospitals in Spain. We matched updated databases of rheumatology patients with severe acute respiratory syndrome coronavirus 2-positive PCR tests performed in the hospital to the same reference populations. Rates of PCR+ confirmed COVID-19 were compared among groups.ResultsPatients with chronic inflammatory diseases had 1.32-fold higher prevalence of hospital PCR+ COVID-19 than the reference population (0.76% vs 0.58%). Patients with systemic autoimmune or immune-mediated disease (AI/IMID) showed a significant increase, whereas patients with inflammatory arthritis (IA) or systemic lupus erythematosus did not. COVID-19 cases in some but not all diagnostic groups had older ages than cases in the reference population. Patients with IA on targeted-synthetic or biological disease-modifying antirheumatic drugs (DMARDs), but not those on conventional-synthetic DMARDs, had a greater prevalence despite a similar age distribution.ConclusionPatients with AI/IMID show a variable risk of hospital-diagnosed COVID-19. Interplay of ageing, therapies and disease-specific factors seem to contribute. These data provide a basis to improve preventive recommendations to rheumatic patients and to analyse the specific factors involved in COVID-19 susceptibility.

scholarly journals Short-term absolute B-cell counts monitoring in systemic sclerosis patients treated with rituximab

2020 ◽  
Vol 58 (4) ◽  
pp. 395-400
Author(s):  
L. P. Ananieva ◽  
L. A. Garzanova ◽  
O. V. Desinova ◽  
O. A. Koneva ◽  
M. N. Starovoytova ◽  
...  
Keyword(s):  
B Cell ◽  
Peripheral Blood ◽  
Inflammatory Diseases ◽  
Inverse Correlation ◽  
Peripheral Circulation ◽  
Cell Counts ◽  
Immune Mediated ◽  
Group 2 ◽  
One Year

Objective. To evaluate B-cell counts in circulation of SS patients prior to initiation and one year after completion of RTM therapy.Subjects and methods. The study included 71 patients. Median follow up was 13,2±2,0 months (11-18 Mo.). Average cumulative RTM dose during the follow up period was 1,43±0,60 g, with 48 patients receiving < 2 g RTM (Group 1, mean dose 1,1±0,1 g) and 23 patients receiving ≥ 2 g RTM (Group 2, mean dose 2,2±0,6 g). CD19+ lymphocyte counts in peripheral blood were determined using flow cytometry in PSS patients and 20 healthy volunteers matched by sex and age. In SS patients B-cell counts were obtained before initiating RTM, within first month after first administration, then after 6 months and at the end of this study.Results. Baseline absolute and proportional В-lymphocyte counts in peripheral blood was almost similar in SS patients and healthy subjects. Highest counts were observed in SS patients with <3 years disease duration, showing inverse correlation between baseline absolute (R – 0,36, р=0,003) and proportional (R – 0,48, р=0,001) B cell counts and duration of the disease. Complete B-cell depletion from peripheral circulation was documented one month after RTM administration. It persisted in 79% 6 months later, although initiation of B- cell repopulation was documented in some patients. In one year after RTM initiation В-cell counts were significantly lower than at baseline. Complete or partial depletion was still there in the majority of patients with normal counts achieved only in 10% of SS patients. Inverse correlation was found between absolute B-cell count and cumulative RTM dose (R=-0,237, p=0,048).Conclusion. Higher RTM doses resulted in more pronounced В-lymphocytes depletion and more evident improvement of lung function. Current state of practice requires further research to identify most optimal regimens in the context of personalized therapy for SS and other immune-mediated inflammatory diseases. 

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