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The COVID-19 pandemic has significantly changed the understanding of the safety profile of therapies for immunoinflammatory rheumatic diseases (IRDs). This is primarily due to the negative impact of a number of basic anti-inflammatory drugs (DMARDs) and biological DMARDs on the course and outcomes of a new coronavirus infection. A number of studies have shown that anti-B-cell therapy (rituximab) gave a statistically significant increase in the risk of severe COVID-19 and an increase in mortality. At the same time, the analysis of real clinical practice data dictated the need to establish a number of restrictions on the use of certain classes of biological DMARDs and to search for alternative therapy programs to maintain control over disease activity. Purpose of the study - to evaluate the efficacy and safety of the drug Artlegia (olokizumab), solution for subcutaneous injection, 160 mg/ml - 0.4 ml, manufactured by R-Pharm JSC, Russia) for the treatment of patients with rheumatoid arthritis in real clinical practice after switching with rituximab during the COVID-19 pandemic. Materials and methods. The study included 14 patients with a confirmed diagnosis of rheumatoid arthritis (RA), who were previously on rituximab therapy at a dose of 1000-500 mg twice with an interval of 2 weeks, who received at least one course of therapy with this drug. As RA worsened, patients were switched to olokizumab against the background of standard DMARDs. At 4, 8, 12 weeks after the switch, the severity of pain was assessed on the VAS scale, the number of painful and swollen joints (TJC28 and TSC28), the level of acute phase markers of inflammation, the DAS28 disease activity index calculated using ESR and CRP, and the CDAI (clinical activity index), functional state index HAQ, as well as assessment of the safety profile of therapy. Results. Data analysis was performed using median values (Me) were used for data analysis. A significant decrease of TJC28 was after the injection of olokizumab (Artlegia) in 8 and 12 weeks (Me baseline = 10;Me 8 weeks = 4;Me 12 weeks = 4;p<0.05) and a decrease of TSC28 in 4, 8 and 12 weeks (Me baseline = 9;Me 4 weeks = 3.5;Me 8 weeks = 2.5;Me 12 weeks = 2.0;p<0.05). Laboratory markers of inflammation showed a decrease in CRP and ESR levels after 4 weeks of treatment (CRP: Me baseline = 21, Me 4 weeks = 1 (p<0.05);ESR: Me baseline = 31, Me 4 weeks = 7 (p<0.05)). Positive dynamics persisted at 8 and 12 weeks (CRP: Me 8 weeks = 1, Me 12 weeks = 0;ESR: Me 8 weeks = 4, Me 12 weeks = 5). The level of CRP by the fourth week 4 became within the normal range, regardless of the initial values. All activity indices improved from the fourth week in each evaluation period compared to baseline: DAS28-ESR: Me baseline = 5.52, Me 4 weeks = 3.59, Me 8 weeks = 3.33, Me 12 weeks = 3.22 (p<0.05);DAS28-CRP: Me baseline = 5.39, Me 4 weeks = 3.71, Me 8 weeks = 3.35, Me 12 weeks = 3.45 (p<0.05);CDAI: Me baseline = 28.5, Me 4 weeks = 18.0, Me 8 weeks = 16.5, Me 12 weeks = 16.0 (p<0.05). All patients showed a reduction in pain (VAS scale) by week 8. The functional status of patients, according to the HAQ index, showed a significant decrease only by the 12th week of the study: Me baseline = 1.62, Me 12 weeks = 1.31 (p<0.05). Conclusion. The study found that switching from rituximab to olokizumab was effective and safe during the COVID-19 pandemic.Copyright © 2023 Ima-Press Publishing House. All rights reserved.
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Background: In our country, allergen extracts (AEs) for house-dust mite (HDM) allergen immunotherapy (AIT), were provided by two companies which are Novohelisen Depot and Alutard SQ. During the Covid-19 pandemics, Novohelisen DepotHDM allergens could not be imported due to the unforeseen reasons. In order to ensure the continuity of AIT, consent obtained patients were treated with the AE of the other company. In this study, it was aimed to determine the frequencies of local and systemic side effects (SEs), clinical response, and the effect of AE change on these parameters during the Covid-19 pandemics. Method(s): 59 patients aged >= 5 years, followed up with the diagnosis of allergic rhinoconjunctivitis (ARC) and/or allergic asthma, and clinically related HDM allergy were included in the study. Demographic data of the patients and SEs during the treatment were recorded from the onset of subcutaneous AIT (SCIT) until September 2021. A transition protocol was created in order to maintain maximum effectiveness and minimize potential SEs of AIT after AE switching. After thetransition protocol, the frequency of SEs, and symptoms and medication scores were recorded during each AIT visit. Result(s): Of 59 patients, 38 (64.4%) were male, 27 (45.7%) had ARC and 32 (54.2%) had both allergic asthma and ARC. Age at the onset of AIT was 12 (6-17) years, and duration of the treatment was 30 (8-48) months. In this study 29 patients received Alutard-SQ (group 1) and 30 patients, Novohelisen-Depot (group 2). 19 patients in group 2 switched to AE of Alutard SQ. During the treatment period, 1209 Novohelisen Depot and 1504 Alutard SQ injections were administered and a total of 140 (5.2%) local reactions (LRs), 50 (1.8%) large local reactions (LLRs), and 7 (0.25%) systemic reactions (SRs) were observed. In group 2, 61 (8.3%) LRs and 1 (0.13%) SR were observed before switching, 5 (1.4%) LRs and neither LLR nor SR were observed after switching. Adherence to SCIT has been increased from 49.1% to 79.6% and the decrease in symptom and medication scores in the pre-transition period continued after switching. Conclusion(s): During the Covid-19 pandemics, HDM AEs transition protocol was safe in terms of local and systemic side effects, and AIT was effective.
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Background: One of the most disadvantageous group of people in Covid 19 pandemic are those with chronic diseases who have been unable to reach medical services they should have. The aim of our study was to investigate if our patients receiving either subcutaneous allergen immunotherapy (SCIT) or biologicals had been effected in terms of compliance to their treatment. Method(s): All of our patients that were being followed in our outpatient clinic receiving a regular treatment -either SCIT or a biological agent -before January 2020 were included in the study. The study group consisted of a total of 223 adult patients of whom 128 were on SCIT and 95 on a biological agent. We applied a conversation based survey to each patient by means of a phone call or during an office visit to identify any disruption in their treatment. We also screened our patient files to collect demographic data and data related to the diagnosis and duration of therapy. Patients were also asked if they had past Covid -19 infection or not. Result(s): Out of 128 patients receiving SCIT for an aeroallergen or venom,124 patients (median age 38 (min-max 18-66)) could have the survey completed. Eighty one patients (63.3%) reported that they couldn't continue their treatment while 43 (37.6%) patients could. The most common reasons of noncompliance were the reluctance of patients to go to the hospital with the fear of getting Covid 19 infection (n = 36 ;44.4%) and the difficulties in supplying the allergen immunotherapy product (n = 15;18.5%). Fourteen patients (17.3%) left the treatment as they were already close to the end of the scheduled treatment duration. Ninety one patients (median age 53 (min-max 19-75)) out of 95 who were on a biological treatment-either omalizumab or mepolizumab-had completed the survey. Only nine patients (9.9%) left the treatment while 82 patients (90.1%) did not. The most common reason for noncompliance was similarly the reluctance to go to the hospital in 4 (4.4%) of the patients . Twenty one of the SCIT patients (16.9%) and 22 patients (24.2%) receiving biologicals had documented Covid 19 infection. Conclusion(s): Covid 19 pandemic had a negative effect on our patients'compliance to their treatment. This effect was apparently higher in the patients receiving SCIT who should have their shots only in an allergy clinic under close supervision while patients on biologicals may receive their treatments in other healthcare centers.
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Introduction: Vaccinations are a critical component of routine healthcare, and studies reveal that patients are more likely to receive vaccinations when they are recommended by a medical provider. In the US, annual influenza vaccine rates were 48.4% during the 2019-20 influenza season and 50.2% during the 2020-21 influenza season. The US Healthy People 2030 target goal is 70%. Method(s): As part of a quality improvement program during the COVID-19 pandemic, subcutaneous immunotherapy (SCIT) patients were screened at every injection visit for administration of the 2021-22 influenza vaccine. A sticker was placed in the injection room to remind staff to assess status. Vaccine currency was documented on the patients' injection record. The vaccination rate for the 2020-21 flu season was compared to the vaccination rate for the 2021-22 flu season. Result(s): 175 patients (172 SCIT and 3 biologic) were given injections and screened for the influenza vaccine during the period of September 1, 2021 to May 24, 2022. Of the 175 patients, 87.4% of patients received the influenza vaccination (153 vaccinated and 22 declined). The 2020-21 vaccination rate in the clinic was 91.7%. Conclusion(s): Allergy clinics have a captive audience in their injection rooms with SCIT patients to screen for the influenza vaccine. Our simple screening program resulted in an unprecedented influenza vaccination rate of 87.4% during the 2021-22 influenza season and 91.7% during the 2020-21 influenza season. Each year, our program produced an influenza vaccination rate nearly double the national average. Allergists should consider implementing a similar injection room system for influenza vaccine screening. Copyright © 2022
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In the last few decades, there has been a progressive increase in the prevalence of allergic rhinitis (AR) in China, where it now affects approximately 250 million people. AR prevention and treatment include allergen avoidance, pharmacotherapy, allergen immunotherapy (AIT), and patient education, among which AIT is the only curative intervention. AIT targets the disease etiology and may potentially modify the immune system as well as induce allergen-specific immune tolerance in patients with AR. In 2017, a team of experts from the Chinese Society of Allergy (CSA) and the Chinese Allergic Rhinitis Collaborative Research Group (C2AR2G) produced the first English version of Chinese AIT guidelines for AR. Since then, there has been considerable progress in basic research of and clinical practice for AIT, especially regarding the role of follicular regulatory T (TFR) cells in the pathogenesis of AR and the use of allergen-specific immunoglobulin E (sIgE) in nasal secretions for the diagnosis of AR. Additionally, potential biomarkers, including TFR cells, sIgG4, and sIgE, have been used to monitor the incidence and progression of AR. Moreover, there has been a novel understanding of AIT during the coronavirus disease 2019 pandemic. Hence, there was an urgent need to update the AIT guideline for AR by a team of experts from CSA and C2AR2G. This document aims to serve as professional reference material on AIT for AR treatment in China, thus improving the development of AIT across the world.
ABSTRACT
Allergen immunotherapy (AIT) is a common treatment for patients with allergic asthma and allergic rhinoconjunctivitis. There is evidence that the COVID-19 pandemic could have altered the administration of AIT in patients in some countries, as the pandemic caused major limitations to healthcare access and delivery. The objective of this study was to evaluate the impact of the disruption imposed by the pandemic on the perceptions and administration of AIT therapies in Italy. An online survey was carried out among Italian allergists between 22 February 2021 and 12 April 2021. The results show that Italian physicians (N=66) did not consider that the COVID-19 pandemic presented an added risk to patients with allergic asthma or rhinitis receiving AIT. Although most treatments continued, there were reduced rates of AIT therapy initiations and sublingual AIT was favored over subcutaneous AIT.
Subject(s)
Asthma , COVID-19 , Sublingual Immunotherapy , Asthma/therapy , COVID-19/epidemiology , COVID-19/therapy , Desensitization, Immunologic/methods , Humans , PandemicsABSTRACT
BACKGROUND: Allergen-specific immunotherapy (AIT) is accepted as the only disease-modifying therapy for IgE-mediated allergic airway diseases and hymenoptera venom allergy. AIT requires repeated contact between patient and physician or nurse in the hospital. Because it is a long-term treatment, compliance is essential issue to obtain maximal efficacy. Coronavirus disease 2019 (COVID-19) pandemic reshaped doctor-patient interaction and pattern of hospital admissions. OBJECTIVE: We aimed to determine the possible changes in the administration of AIT and associated factors, in addition to the characteristics of patients diagnosed with COVID-19 infection. METHODS: Adult patients who underwent AIT for hymenoptera venom allergy, allergic rhinitis or allergic asthma between 11 March 2020 and 31 January 2021 were included in our retrospective study. Perennial and preseasonal AIT practices were evaluated. We identified patients with COVID-19 infection among the ones who received AIT. RESULTS: The mean age of 215 patients was 37.8±11.9 years and 52.1% of the patients were female. In our study, 35.4% of perennial AIT patients did not continue treatment after the COVID-19 pandemic, and the cause was patient-related in 66.7% of the cases. Compliance was 70.7% in patients receiving perennial AIT. The highest compliance rate for AIT was for venom allergy (86.5%). Thirty-four patients (15.8%) were diagnosed with COVID-19 infection. No mortality due to COVID-19 infection was observed in those who underwent AIT. CONCLUSION: COVID-19 pandemic has reduced compliance to AIT. Compliance was higher in venom immunotherapy than in aeroallergens. Severe COVID-19 infection and COVID-19 related death were not observed in patients receiving AIT.
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Background: Allergen-specific immunotherapy (AIT) is the only treatment that cures allergic diseases. Subcutaneous immunotherapy (SCIT) is a conventional treatment which introduced more than 100 years ago. Novel oral formulation sublingual immunotherapy (SLIT) has shown equal efficacy to SCIT, while it is safe without life-threatening allergic reaction. Amid a pandemic of COVID-19, patients are advised to avoid hospital visits. SLIT might be the right choice because patients can take the tablets at home and no need to go to the hospital for weekly injections like SCIT. However, no recent report on the efficacy of changing the route of immunotherapy from SCIT to SLIT. The study aims to assess the efficacy of switching SCIT to SLIT in patients with house dust mite (HDM) allergy. Method: A randomized controlled study was undertaken in 40 patients with allergic rhinitis with/without asthma and receiving maintenance phase of HDM SCIT (TCTR20200606002). HDM SLIT tablet was given daily for 12 weeks and compared to patients with continue SCIT. The principle outcome measure was symptom-medication score (SMS) and asthma control test (ACT) score. immunologic changes in fresh whole blood to monitor T cell subsets, including regulatory T cells (tregs), dysfunctional tregs, and T helper 2 cells were investigated by the flow cytometry method and Der p2-specific IgE, Der p2-specific IgG4 and Der p2-specific IgE/IgG4 were investigated by ELISA method at baseline and 12 weeks after switching treatment. Results: Of 40 patients, 19 patients in the SLIT group and 20 patients in the control group achieved the study. There were no significant differences in SMS and ACT scores between the SLIT group and SCIT group during 12 weeks of treatment. Significantly reduced SMS after 8 weeks compared to baseline (17.6 ± 2.9 to 14 ± 2.4, p = 0.028) was demonstrated in the patients with SLIT. T cell subsets' frequency, specific IgE, IgG4 and IgE/IgG4 ratio did not change significantly in both groups at the end of the study. No severe adverse drug reactions were reported.
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Background: During the COVID-19 pandemic, the number of hospital admissions has significantly decreased, due to both the risk of transmission and the restrictions imposed. The most adversely affected ones are patients who need to admit to a hospital due to their chronic diseases, such as those receiving allergen immunotherapy. We aimed to investigate the effect of the SARS-CoV-2 pandemic on adherence to treatment of the patients receiving AIT due to allergic diseases in our clinic, to determine the reasons why patients are coming late/not coming for treatment and to reveal the effect of SARS-CoV-2 pandemic on the anxiety of this patient group. Method: Files of the patients who were administered subcutaneous immunotherapy (SCIT) regularly, were retrospectively reviewed. At first outpatient clinic visits during the period of so-called normalization process (June-July-August 2020), the patients were asked to fill a mini questionnaire and validated coronavirus anxiety questionnaire. Results: A total of 151 patients receiving SCIT were included in the study. The most common government-related factors hindering outpatient clinic visits of the patients were travel restrictions (40.6%) and the most common patient-related factors were fear of contracting SARS-CoV-2 (39.7%). Overall adherence to treatment during the 3-month period from March to April-May 2020 was determined to be 54.3%. The duration of immunotherapy, increased allergic symptoms, the need for additional treatment and treatment switch in SCIT because of the pandemic were significantly higher in patients non-adherent to SCIT treatment compared to adherent ones (p: 0.031, p: 0.001, p: 0.001 and p: 0.001, respectively). Conclusion: Access to allergen immunotherapy, applicability, and maintenance of the immunotherapy should be a priority during the COVID-19 pandemic. Considering both patient-related and government-related factors in the administration of immunotherapy, the process of immunotherapy should be continued, minimizing the risk of SARS-CoV-2 transmission. Furthermore, patients' worry and anxiety levels may be reduced with these measures and their adherence to treatment may be promoted.
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Case Report Background: The pediatric population represents 35% of all atopics (Chad et al. 2001). SCIT has been shown to be effective in pediatrics in the management of Allergic Rhino-Conjuncitvitis (ARC), (Kim et al. 2013). Debate continues in dosing regimes (Arasi et al. 2018) and the true reporting of pediatric SCIT induced Systemic Reactions (SR). As SR's, mild to severe bronchospasm ranges from 1-30% and unspecified systemic reactions between 3-34% (Kim et al. 2013). This retrospective study aimed at illustrating the frequency of aeroallergen SCIT induced adverse reactions in a pediatric population. Method: Data was obtained from pediatric patients (PP) attending a community allergy clinic for aeroallergen SCIT. Recorded data included the following: demographics, diagnosis, allergen, administered dose and occurrence of adverse reactions over the last 5 years. SCIT doses were administered in accordance with Canadian Society of Allergy and Clinical Immunology guidelines and SR were graded as per World Allergy Organization guidelines (Cox et al. 2010). Patients on Vespid immunotherapy were excluded. Results: SCIT data was reviewed over 5 years. Out of a total of 97 SCIT patients, 23 were pediatric (mean age of 11.2 years 95% CI, 10.12 to 12.28). Of all pediatric patients, 9% received single allergen immunotherapy, 91% received multi-allergen immunotherapy. Ten of the 23 PP sustained adverse reactions to SCIT. Clinically significant large local reactions requiring dose reduction were reported in 3 PP (13%), while SR were noted in 7 PP (30%), 4 classified as Grade 1 and 3 as Grade 2. SR occurred in 4/7 (57%) PP on a build-up regime and 3/7 (43%) on maintenance dosing. Six PP with SR continued on SCIT with modified dosing regimes, 1 discontinued therapy because of current COVID-19 concerns. Two of the 23 PP completed the duration of therapy with no reactions and were discharged from follow up care. During the same time period, SR occurred in 6/74 (8.1%) adult patients. In comparison to adults undergoing SCIT, the rate of SCIT induced SR in the pediatric population was three times higher. Conclusion: In general, the rate of SCIT-associated SR of varying severity is low (James et al. 2017). However, in PP, our study reported a significantly higher occurrence of SR compared to adults on SCIT over the same time period. Additional research is required to tailor conventional build-up and dosing to a pediatric population to address higher rates of SR in this population.
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BACKGROUND: Allergen immunotherapy (AIT) must be continued for 3 years, to achieve a long-term modifying effect. Adherence is a key to ensure effectiveness. The objective of this study was, first of all, to evaluate the adherence with subcutaneous immunotherapy (SCIT) and to identify the main causes of SCIT withdrawal in real-life practice in our clinic. Secondly, we also aimed to investigate to what extent the COVID-19 pandemic altered our SCIT receiving patients' treatment adherence behaviors and the factors that affected their decisions. METHODS: Retrospective analysis of the medical records of patients ages ≥18 years, who had started SCIT in January 2014 or later until September 2020 in our department for the diagnosis of allergic rhinitis, allergic asthma or venom allergy, were included in the study. Adherence was determined as the accomplishment of 3 years of SCIT. RESULTS: A total of 124 patients (72 female [58.1%]; median age, 35 [19-77] years) were included. The adherence rate to SCIT in our tertiary center's real-life setting was 56.25% with a follow-up duration of 3 years before COVID-19 pandemic. Dose modification, defined as reducing patient's planned SCIT dose due to a systemic allergic/large local reaction or missed injection, and its frequency, which is the number of dose adjustments done throughout the SCIT, was found to be the only factor related to nonadherence. But with the pandemic only in 6 months, among 63 patients receiving SCIT, 15 patients (23.81%) dropped out, and the most common reason was fear of being infected with COVID-19 virus during receiving SCIT in hospital (93.33%). The only independent predictor of drop-out during the COVID-19 pandemic was short duration of AIT (p = 0.012). When we compare the dropped-out cases before and after the start of pandemic, AIT duration was significantly shorter in pandemic period (p = 0.005). CONCLUSION: Adherence rate to SCIT in our real-world setting study was 56.25% before the COVID-19 pandemic. Our results indicated that patients requiring dose modification were more prone to be non-adherent. Approximately one quarter of patients dropped-out with the start of pandemic, almost all due to fear of being infected during receiving SCIT in hospital. Since short SCIT follow-up time was found to be the only risk factor for drop-out during the COVID-19 pandemic, we believe that patients who are in the early phases of their treatment should be observed more closely and their concerns should be answered by their doctors.
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BACKGROUND: The success of subcutaneous immunotherapy (SCIT) mostly depends on regular injections. Our aim was to investigate adherence to SCIT with aeroallergens during the COVID-19 pandemic and demonstrate clinical consequences of treatment disruptions in real life. METHODS: Visual analogue scale for quality of life (VAS-QoL), VAS for symptom scores (VAS-symptom), medication scores (MSs), and total symptom scores (TSS-6) were recorded during the pandemic in 327 adult allergic rhinitis and/or asthmatic patients receiving maintenance SCIT, and these scores were compared with the pre-pandemic data. Patients were grouped according to SCIT administration intervals; no delay (Group 1), <2 months (Group 2), and ≥2-month intervals (Group 3). RESULTS: A total of 104 (31.8%) patients (Group 3) were considered as nonadherent which was mostly related to receiving SCIT with HDMs and using public transportation for reaching the hospital. Median MS, VAS-symptom, and TSS-6 scores of Group 3 patients during the pandemic were higher than the pre-pandemic scores (p = 0.005, p < 0.001, p < 0.001, respectively), whereas median VAS-QoL scores of Group 3 during the pandemic were lower than the pre-pandemic scores (p < 0.001). Median TSS-6 and VAS-symptom scores were the highest in Group 3 compared with other groups (p < 0.001 for each comparison). Median VAS-QoL scores were the lowest in Group 3 compared with Group 1 and Group 2 (p < 0.001, p = 0.043, respectively). CONCLUSION: When precautions in allergy clinics are carefully applied, adherence to SCIT can be high during a pandemic. Patients must be encouraged to regularly adhere to SCIT injections since delays in SCIT administration can deteriorate clinical symptoms.