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Background/Aims Rheumatic and musculoskeletal diseases (RMDs) are some of the most common indications for prescribed opioids. It is unclear how opioid prescribing has changed in the UK for RMDs, especially during the COVID-19 pandemic with limited healthcare access and cancelled elective-surgical interventions, which could impact prescribing in either direction. We aimed to investigate trends in opioid prescribing in RMDs and assess the impact of the pandemic in the UK. Methods Adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), systemic lupus erythematosus (SLE), osteoarthritis (OA) and fibromyalgia with opioid prescriptions between 01/Jan/2006-31/Aug/2021 without prior cancer in the UK Clinical Practice Research Datalink (CPRD) were included. We calculated ageand gender-standardised yearly rates of people with opioid prescriptions between 2006-2021, and identified change points in trends by checking whether the rate of change of standardised rates crossed zero. For people with opioid prescriptions, monthly measures of mean morphine milligram equivalents (MME)/day were calculated between 2006-2021. To assess the impact of the pandemic, we fitted regression models to the monthly number of people with opioid prescriptions between Jan/2015-Aug/2021. The time coefficient reflects the trend pre-pandemic and the interaction term coefficient represents the change in the trend during the pandemic. Results We included 1,313,519 patients: 36,932 with RA, 12,649 with PsA, 6,811 with AxSpA, 6,423 with SLE, 1,255,999 with OA, and 66,944 with fibromyalgia. People with opioid prescriptions increased from 2006 to 2018 for OA, to 2019 for RA, AxSpA and SLE, to 2020 for PsA, and to 2021 for fibromyalgia, and all plateaued/decreased afterwards. OA patients on opioids increased from 466.8/10,000 persons in 2006 to a peak of 703.0 in 2018, followed by a decline to 575.3 in 2021. From 2006 to 2021, there was a 4.5-fold increase in fibromyalgia opioid users (17.7 vs.78.5/10,000 persons). In this period, MME/day increased for all RMDs, with the highest for fibromyalgia (>=35). During COVID-19 lockdowns, RA, PsA and fibromyalgia showed significant changes in the trend of people with opioid prescriptions. With a decreasing trend for RA (-0.001,95%CI=-0.002,-0.001) and a decreasing-to-flat curve for PsA (0.0010,95%CI=0.0006,0.0015) prepandemic until Feb/2020, the trends changed by -0.005 (95%CI=-0.008,-0.002) for RA and -0.003 (95%CI=-0.006,-0.0003) for PsA, leading to steeper decreasing trends during the pandemic (Mar/2020-Aug/2021). Fibromyalgia, conversely, had an increasing trend (0.009,95%CI=0.008,0.009) pre-pandemic, and this trend started decreasing by -0.009 (95%CI=-0.011,-0.006) during the pandemic. Conclusion The plateauing/decreasing trend of people with opioid prescriptions in RMDs after 2018 may reflect the efforts to tackle the rising opioid prescribing in UK primary care. Of all RMDs, fibromyalgia patients had the highest MME/day throughout the study period. COVID-19 lockdowns contribute to fewer people on opioids for most RMDs, reassuring there was no sudden increase in opioid prescribing during the pandemic.
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Objectives: To assess the severity of SARS-CoV-2 infection in patients with axSpA from the SAR-COVID registry, comparing them with patients with rheumatoid arthritis (RA), and to determine the factors associated with poor outcomes and death. Method(s): Patients >=18 years of age from the SAR-COVID national registry with diagnosis of axSpA (2009 ASAS criteria) and RA (2010 ACR/EULAR criteria) who had confirmed SARS-CoV-2 infection (RT-PCR or positive serology), recruited from August 2020 to June 2022 were included. Sociodemographic and clinical data, comorbidities, treatment and outcomes of the infection were collected. Infection severity was assessed using the WHO-ordinal scale (WHO-OS): ambulatory (1), mild hospitalizations (2.3 y 4), severe hospitalizations (5.6 y 7) and death (8). Result(s): A total of 1226 patients were included, 59 (4.8%) with axSpA and 1167 (95.2%) with RA. RA patients were significantly older, more frequently female, and had a longer disease duration. 43.9 % presented comorbidities. t the time of SARS-Cov-2 diagnosis, patients with RA used glucocorticoids and conventional DMARDs more frequently than those with axSpA, while 74.6% of the latter were under treatment with biological DMARDs being anti-TNF the most used (61%). 94.9 % of the patients in both groups reported symptoms related to SARS-CoV-2 infection. During the SARS-CoV-2 infection, 6.8% and 23.5% of the patients with axSpA and RA were hospitalized, respectively. All the patients with axSpA were admitted to the general ward, while 26.6%of those with RA were admitted to the intensive care units. No patient with axSpA had complications or severe COVID-19 (WHO-OS> = 5) or died as a result of the infection while mortality in the RA group was 3.3% (Figure 1). In the multivariate analysis adjusted for poor prognosis factors, no association was found between the diagnosis of axSpA and severity of SARS-CoV-2 infection assessed with the WHO-OS (OR-0.18, IC 95%(-0.38, 0.01, p = 0.074). Conclusion(s): Patients with axSpA did not present complications from SARSCoV-2 infections and none of them died due COVID-19.
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Objectives: To evaluate vaccination among patients with inflammatory rheumatic diseases initiating disease-modifying antirheumatic drugs (DMARD) Methods: Data from the real-world life PANLAR's register of consecutive patients diagnosed with RA, PsA, and axSpa (2010 ACR-EULAR /2006 CASPAR-2009 ASAS) from Dec 2021 to Dec 2022 were analyzed. Prevalence of recommended vaccinations were compared between different inflammatory rheumatic diseases. Categorical variables were expressed as %. Tables were analyzed with chi2 or Fisher tests, continuous variables (median, IQR)with the Kruskal-Wallis test, according with the variables type. A p value <=0.05 was considered significant. Result(s): 608 patients were included. Among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial Spondyloarthritis (axSpA) are presented in the table. RA and axSpA seemed to have lower vaccination rate of pneumococcal vaccines than PsA. (p = 0.045 for conjugate anti pneumococcal vaccine in RA vs PsA). A large percentage of the population was vaccinated against COVID-19. There was a high rate of influenza vaccination in all three diseases. Conclusion(s): In Latin America, anti-pneumococcal vaccination is low, especially in patients with RA and axSpA. For other vaccines there was an acceptable level of vaccination without differences between diseases.
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Background/Aims The impact of the pandemic on the incidence and management of inflammatory arthritis (IA) is not understood. Routinely-captured data in secure platforms, such as OpenSAFELY, offer unique opportunities to understand how IA was impacted upon by the pandemic. Our objective was to use OpenSAFELY to assess the effects of the pandemic on diagnostic incidence and care delivery for IA in England, and replicate key metrics from the National Early Inflammatory Arthritis Audit. Methods With the approval of NHS England, we used primary care and hospital data for 17 million adults registered with general practices using TPP health record software, to explore the following outcomes between 1 April 2019 and 31 March 2022: 1) incidence of IA diagnoses (rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, undifferentiated IA) recorded in primary care;2) time to first rheumatology assessment;3) time to first prescription of a conventional synthetic DMARD (csDMARD) in primary care, and choice of first csDMARD. Results From 17,683,500 adults (representing 40% of the English population), there were 31,280 incident IA diagnoses recorded between April 2019 and March 2022. New IA diagnoses decreased by 39.7% in the early months of the pandemic. Overall, a 20.3% decrease in IA diagnoses was seen in the year commencing April 2020, relative to the preceding year (5.1 vs. 6.4 diagnoses per 10,000 adults, respectively). Further decreases coincided with rising COVID-19 numbers, before returning to pre-pandemic levels by the end of the study period. No rebound increase in IA incidence was observed as of April 2022. The median time from referral to first rheumatology assessment was shorter during the pandemic (18 days;IQR 8-35 days) than before (21 days;9-41 days). The proportion of patients prescribed csDMARDs in primary care was comparable to before the pandemic;however, fewer people were prescribed methotrexate or leflunomide, and more were prescribed sulfasalazine or hydroxychloroquine. Conclusion IA diagnoses decreased markedly during the early phase of the pandemic;however, the impact on rheumatology assessment times and DMARD prescribing was less marked than might have been anticipated. This study demonstrates the feasibility of using routinelycaptured, near real-time data in the secure OpenSAFELY platform to benchmark care quality on a national scale, without the need for manual data collection.
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Background/Aims There are sporadic reports about the development of new rheumatic immune-mediated inflammatory diseases (R-IMIDs) in adults after receiving SARS-CoV-2 vaccines. This systematic review (SR) aimed to critically review and summarize the clinical profile, patient demographics, treatment, and prognosis of new-onset R-IMIDs following SARS-CoV-2 vaccination. Methods We retrieved English-language articles (Case reports and series and observational studies) on new-onset R-IMIDs following SARS-CoV-2 vaccination, published until June 2022, from standard databases (MEDLINE, Embase, Cochrane). The search strings used during the literature search incorporated 'SARS-CoV-2 vaccination' (along with related MeSH terms) and various key terms for R-IMIDs [which included (but was not limited to) inflammatory arthritis, connective tissue disease (CTD), vasculitis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, systemic sclerosis, idiopathic inflammatory myositis, anti-synthetase syndrome, Adult-onset Stills disease (AOSD), giant cell arteritis (GCA), and polymyalgia rheumatica (PMR)]. The protocol was registered in PROSPERO (CRD42022318561). Results Of the total 2179 articles retrieved, 1986 articles were excluded following the title- screening, and 107 articles that did not meet inclusion criteria. We included the remaining 86 articles (130 cases) upon full-text screening. Furthermore, we added four articles (six cases) based on a manual search, comprising 90 articles (136 cases) for final analysis. These 136 new R-IMID cases were reported from 27 different countries. Of these, more than one-third of the cases were reported from three countries (viz., Italy, Japan, and the USA). The patients had a mean age of 57 (range:17-90) years, and the majority were females (63.0%). Most patients developed R-IMIDs after receiving Pfizer-BioNTech vaccine (76;55%), followed by Oxford AstraZeneca vaccine (35;25%). The mean duration between SARSCoV- 2 vaccination and R-IMIDs development was 9.2 (range:1-90) days. The second dose of the vaccine resulted in more R-IMIDs (74;54%) than the first (53;39%). CTDs (34;25%) and small vessel vasculitis (33;24%) were the commonest R-IMID manifestations, followed by inflammatory arthritis and AOSD, each in 13 (9.5%) cases. Nearly half of the patients with CTDs had Idiopathic Inflammatory Myositis. PMR and GCA accounted for 16 (11.7%) and 5 (3.6%) cases, respectively. However, no cases of axial spondylarthritis were reported. Most (118;86%) R-IMID patients were treated with corticosteroids, with a small number receiving steroid-sparing drugs, such as methotrexate, rituximab and cyclophosphamide. Most (125;91%) went into either disease remission or improvement following the treatment. Only three patients were admitted to the intensive care unit (ICU) to manage their disease;One of them died due to fatal myositis and rhabdomyolysis;two surviving ICU patients had ANCA-associated vasculitis with lung involvement. Conclusion Although rare, this SR highlights the emergence of de novo R-IMIDs following SARS-CoV-2 vaccination. We cannot confirm the causality between the vaccination and the onset of R-IMID. However, further research is warranted in this area.
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The review analyzes data on the course and outcomes of axial spondyloarthritis (axSpA) accumulated over the previous 2.5 years of the COVID-19 pandemic. The issues of clinical and immunological efficacy of vaccination against COVID-19 in this disease are considered. It was noted that the presence of axSpA, as well as treatment with tumor necrosis factor-α inhibitors and non-steroidal anti-inflammatory drugs, did not significantly increase the risk of COVID-19 infection and did not worsen its outcomes, apart from an increase in the incidence of venous thromboembolism. At the same time, it is assumed that anticytokine therapy for SpA may protect against severe COVID-19 course. The data presented suggest that the benefits of vaccination in SpA far outweigh the potential harms associated with the development of adverse events. It has been shown that in patients with SpA, vaccination does not affect the activity of the inflammatory process, and biologic disease modifying antirheumatic drugs have almost no significant effect on the post-vaccination response. © 2023, Ima-Press Publishing House. All rights reserved.
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The review analyzes data on the course and outcomes of axial spondyloarthritis (axSpA) accumulated over the previous 2.5 years of the COVID-19 pandemic. The issues of clinical and immunological efficacy of vaccination against COVID-19 in this disease are considered. It was noted that the presence of axSpA, as well as treatment with tumor necrosis factor-α inhibitors and non-steroidal anti-inflammatory drugs, did not significantly increase the risk of COVID-19 infection and did not worsen its outcomes, apart from an increase in the incidence of venous thromboembolism. At the same time, it is assumed that anticytokine therapy for SpA may protect against severe COVID-19 course. The data presented suggest that the benefits of vaccination in SpA far outweigh the potential harms associated with the development of adverse events. It has been shown that in patients with SpA, vaccination does not affect the activity of the inflammatory process, and biologic disease modifying antirheumatic drugs have almost no significant effect on the post-vaccination response. © 2023, Ima-Press Publishing House. All rights reserved.
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Aims: Rheumatological disease flares may occur after many infections. However, our knowledge of the post-Coronavirus disease-2019 (COVID-19) axial spondyloarthritis (SpA) flares and related factors is limited. Methods: We retrospectively assessed the axial SpA patients who had COVID-19. Demographic and clinical data were collected from the medical records. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was applied via telephone for pre- and post-COVID-19 SpA symptoms. An increase of 2 points in the BASDAI score or any new extra-articular manifestations were defined as SpA flares and SpA patients were grouped as flares and no-flare. Factors predicting SpA flare were also analyzed. Results: A total of 48 axial SpA patients were included in the study [age, mean+or-standard deviation (SD): 42.3+or-8.6 years;male: 65%]. Post-COVID-19 SpA flare was identified in 19 patients (40%), and new extra-articular manifestations were recorded in 6 patients (13%). Although the diagnosis of inflammatory bowel disease was more common in the flare group, the difference was not significant compared with that of the no-flare group. Other features of SpA and COVID-19 disease severity were similar between the flare and no-flare groups. In the flare group, the frequency of back pain (84% vs. 62%, p=0.091) and diarrhea (53% vs. 28%, p=0.080), and headache (84% vs. 52%, p=0.021) were higher than the no-flare group. No risk factor for a post-COVID-19 SpA flare could be identified. Conclusions: Post-COVID-19 flare was common in the axial SpA, and even new extra-articular manifestations could be reported. Although some clinical manifestations of COVID-19 were more common in patients with a flare, any predictive factor could not be identified among the study variables.
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Ankylosing spondylitis (AS) is a chronic inflammatory disease of the axial bones, primarily affecting the spine. AS is classified as spondyloarthritis because it affects the spine and other joints. AS has several presentations and, in some cases, can be insidious, making it difficult to diagnose. We encountered a patient on long-term follow-up for rheumatoid arthritis with an appearance of AS. This case suggests that patients with long-term rheumatoid arthritis can develop AS during follow-up and that the seropositivity of rheumatoid factors and anti-cyclic citrullinated peptide antibodies cannot rule out AS. Therefore, the possibility of AS should be considered, even in patients diagnosed with rheumatoid arthritis.
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Objectives: COVID-19 led to rapid uptake of digital health care. We sought to examine digital access, health and digital literacy, and impact on confidence and satisfaction with remote consultations in people with inflammatory rheumatic diseases (IRDs). Methods: People with IRDs (n = 2024) were identified from their electronic health record and invited to participate in a cross-sectional survey, using short message service (SMS) and postal approaches. Data were collected on demographics, self-reported diagnosis, access to and use of internet-enabled devices, health and digital literacy, together with confidence and satisfaction with remote consultations. Ethical approval was obtained (Ref 21/PR/0867). Results: Six hundred and thirty-nine (639) people completed the survey [mean (s.d.) age 64.5 (13.1) years, 384 (60.1%) female]. Two hundred and eighty-seven (44.9%) completed it online. One hundred and twenty-six (19.7%) people reported not having access to an internet-enabled device. Ninety-three (14.6%) reported never accessing the internet; this proportion was highest (23%) in people with RA. One hundred and seventeen (18%) reported limited health literacy. Even in those reporting internet use, digital literacy was only moderate. People with limited health or digital literacy or without internet access were less likely to report confidence or satisfaction with remote consultations. Conclusion: Limited health and digital literacy, lack of digital access and low reported internet use were common, especially in older people with RA. People with limited health literacy or limited digital access reported lower confidence and satisfaction with remote consultations. Digital implementation roll-out needs to take account of people requiring extra support to enable them to access care digitally or risks exacerbating health inequalities.
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Aims: Rheumatological disease flares may occur after many infections. However, our knowledge of the post-Coronavirus disease-2019 (COVID-19) axial spondyloarthritis (SpA) flares and related factors is limited. Methods: We retrospectively assessed the axial SpA patients who had COVID-19. Demographic and clinical data were collected from the medical records. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was applied via telephone for pre- and post-COVID-19 SpA symptoms. An increase of ≥2 points in the BASDAI score or any new extra-articular manifestations were defined as SpA flares and SpA patients were grouped as flares and noflare. Factors predicting SpA flare were also analyzed. Results: A total of 48 axial SpA patients were included in the study [age, mean±standard deviation (SD): 42.3±8.6 years;male: 65%]. Post-COVID-19 SpA flare was identified in 19 patients (40%), and new extra-articular manifestations were recorded in 6 patients (13%). Although the diagnosis of inflammatory bowel disease was more common in the flare group, the difference was not significant compared with that of the no-flare group. Other features of SpA and COVID-19 disease severity were similar between the flare and no-flare groups. In the flare group, the frequency of back pain (84% vs. 62%, p=0.091) and diarrhea (53% vs. 28%, p=0.080), and headache (84% vs. 52%, p=0.021) were higher than the no-flare group. No risk factor for a post-COVID-19 SpA flare could be identified. Conclusions: Post-COVID-19 flare was common in the axial SpA, and even new extra-articular manifestations could be reported. Although some clinical manifestations of COVID-19 were more common in patients with a flare, any predictive factor could not be identified among the study variables. [ FROM AUTHOR]
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Background: Contemporary data on rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritits (SpA) epidemiology in England are lacking. This knowledge is crucial to planning healthcare services. We updated algorithms defining patients with diagnoses of RA, PsA, and axial SpA in primary care and applied them to describe their incidence and prevalence in the Clinical Practice Research Datalink Aurum, an electronic health record (EHR) database covering â¼20% of England. Methods: Algorithms for ascertaining patients with RA, axial SpA, and PsA diagnoses validated in primary care EHR databases using Read codes were updated (to account for the English NHS change to SNOMED CT diagnosis coding) and applied. Updated diagnosis and synthetic disease-modifying anti-rheumatic drug code lists were devised by rheumatologists and general practitioners. Annual incidence/point-prevalence of RA, PsA, and axial SpA diagnoses were calculated from 2004 to 2020 and stratified by age/sex. Findings: Point-prevalence of RA/PsA diagnoses increased annually, peaking in 2019 (RA 0·779% [95% confidence interval (CI) 0·773, 0·784]; PsA 0·287% [95% CI 0·284, 0·291]) then falling slightly. Point-prevalence of axial SpA diagnoses increased annually (except in 2018/2019), peaking in 2020 (0·113% [95% CI 0·111, 0·115]). RA diagnosis annual incidence was higher between 2013-2019 (after inclusion in the Quality and Outcomes Framework, range 49·1 [95% CI 47·7, 50·5] to 52·1 [95% CI 50·6, 53·6]/100,000 person-years) than 2004-2012 (range 34·5 [95% CI 33·2, 35·7] to 40·0 [95% CI 38·6, 41·4]/100,000 person-years). Increases in the annual incidence of PsA/axial SpA diagnosis occurred following new classification criteria publication. Annual incidence of RA, PsA and axial SpA diagnoses fell by 40·1%, 67·4%, and 38·1%, respectively between 2019 and 2020, likely reflecting the COVID-19 pandemic's impact on their diagnosis. Interpretation: Recorded RA, PsA, and axial SpA diagnoses are increasingly prevalent in England, underlining the importance of organising healthcare services to provide timely, treat-to-target care to optimise the health of >1% of adults in England. Funding: National Institute for Health and Care Research (NIHR300826).
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Background: Vaccination confers relatively short-term protection against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), indicating the need for booster doses. Immunocompromised individuals, including those with immune-mediated inflammatory diseases (IMIDs), may have pronounced immune response waning. Vaccine-boosted humoral and T-cell responses minimize poor coronavirus disease 19 (COVID-19) outcome without increasing adverse events (AE). There is limited evidence of third-dose vaccination in axial spondyloarthritis (AxSpA) patients. We investigated immune-response persistence after primary vaccination and immunogenicity and safety after the BNT162b2 booster vaccination. Methods: This prospective observational study enrolled an AxSpA cohort treated with interleukin-17 (IL-17) and tumor necrosis factor-alpha (TNFα) inhibitors. Serum SARS-CoV-2-specific and virus-neutralizing antibodies for humoral response and flow cytometric detection of intracellular cytokines following SARS-CoV-2-specific peptide-based stimulation for T-cell immune responses were assessed, and safety was evaluated via a clinical questionnaire. Results: Fifteen male AxSpA patients treated with TNFα (73·3%) or IL-17 (26·7%) inhibitors were enrolled and had humoral response persistence at 6 months: 905·6 ( ± 186·1 SD) and 409·1 ( ± 335·7) U/mL. Specific antibody concentrations further increased after booster vaccination to 989·7 ( ± 12·62) and 1000 U/mL and T-cell responders from 53·3% to 80%, with no differences between AxSpA (including "vaccination only" and "hybrid immunity" subgroups) and healthy control (HC) cohorts. No severe AE occurred; the AE spectrum was comparable to that of the general population. Conclusion: Immune-response persistence after primary vaccination and immunogenicity after booster vaccination were unaffected by anti-IL17 or anti-TNFα therapy with similar AE as in the general population.
Subject(s)
Axial Spondyloarthritis , Biological Products , COVID-19 , Antibodies, Neutralizing , Antibodies, Viral , BNT162 Vaccine , COVID-19/prevention & control , Humans , Interleukin-17 , Male , SARS-CoV-2 , Tumor Necrosis Factor-alphaABSTRACT
Patients with inflammatory rheumatic diseases (IRD) have an increased risk for a worse COVID-19 outcome, and impaired immune responses following mRNA COVID-19 vaccines have been observed. In this prospective observational study, we compared the anti-S1 response following vaccination with BNT162b2 and mRNA- 1273 in a large cohort of IRD patients and assessed the effect of different immunomodulatory treatments. Patients from SCQM, the Swiss IRD cohort, who assented to an mRNA COVID-19 vaccine were recruited into the study between 3/2021-9/2021. Participants answered the study questionnaire via the mySCQM patient app and provided self-collected capillary blood samples at baseline, 4, 12, and 24 weeks post second vaccine dose. Samples were tested for IgG antibodies against the S1 domain of the SARS-CoV-2 spike protein using the EUROIMMUN ELISA. We examined differences in antibody titres depending on the vaccine and treatment received, while adjusting for age and history of SARSCoV- 2 infection, by applying mixed effects continuous outcome logistic regression models at each timepoint. Eligible samples were obtained from 564 IRD patients (mean age 53 y (s.d. 12 y), 66% female) with 36% RA, 37%, axSpA, 21% PsA, and 6% UA (undifferentiated arthritis), on no medication (no DMARD & no steroids 15%), csDMARD (9%), TNFi (48%), IL-6/17/23i (14%), JAKi (6%), rituximab (4%), abatacept (3%), and PDE4i (1%) in mono/combination therapy at baseline. 10% of patients had a past SARS-CoV-2 infection, 54% received BNT162b2, 46% mRNA-1273. Independently of the disease, treatment, and history of SARS-CoV- 2 infection, the odds of having higher anti-S1 titres at 4, 12, and 24 weeks post second vaccine dose were, respectively, 3.3, 3.9, and 3.8 times higher with mRNA-1273 compared to BNT162b2 for the average-aged patient of this population (p <0.0001). Moreover, with every year of age, the odds of higher anti-S1 levels increased by 3% to 5% following mRNA-1273 vs BNT162b2 vaccination (p <0.05), indicating an additional benefit for elderly IRD patients. Among monotherapies, rituximab, abatacept, JAKi, and TNFi had the highest odds of reduced anti-S1 responses compared to no medication. Patients on specific combination therapies showed significantly reduced antibody responses compared to respective monotherapies. Our results suggest that in IRD patients, vaccination with mRNA- 1273 vs BNT162b2 results in higher anti-S1 antibody titres, and has an additional benefit in elderly patients.
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Background: We recently reported an attenuate immunogenicity in patients with autoimmune rheumatic diseases. However, the effect of spondyloarthritis (SpA) and its treatment on COVID-19 vaccine immunogenicity remains to be determined for this group of patients. We therefore aimed to evaluate humoral immune responses to inactivated SARS-CoV-2 vaccine (CoronaVac) in patients with SpA (axial spondyloarthritis and psoriatic arthritis) taking DMARDs and commonly used targeted biological therapies, compared with a control group(CG). Objectives: Evaluate immunogenicity and safety of CORONAVAC (Sninovac, Beijing) in Spondyloarthritis (SpA) patients. Methods: Prospective observational cohort patients diagnosed with 194 SpA and 183 CG were vaccinated with CoronaVac in two doses with a 28-days interval. 194 patients completed the study and could be paired with CG for immunogenicity analysis. Blood samples were collected in the days 0, 28 and 69 (D69) to evaluate anti-SARS-CoV-2 IgG seroconversion(SC) and presence of neutralizing antibodies (NAb) in participants with negative IgG and NAb at baseline. Results: Patients and GC were comparable regarding age (p=0.93) and sex (p=1.00). Immunogenicity at D69 showed a moderate/high SC (80.2% vs. 95.7%, p<0.0001) and Nab positivity (61.6% vs. 82.7%, p<0.0001) in SpA but lower than CG. Factors associated with lower immunogenicity were older age (56.8 vs. 51.4;p=0.03318) and higher frequencies of prednisone (25.7% vs 4.2%;p=0.0004), methotrexate (51.4% vs 40.1%, p=0.0016) and TNF inhibitor (TNFi) (62.9% vs 34.5%, p=0.0035). Likewise, prednisone (17.6% vs. 2.8%, p=0.0013) and TNFi (50% vs 33.9%;p=0.0408) were associated with diminished NAb positivity. Sulfasalazine was associated with higher SC rates (8.6% vs. 26.8%, p=0.0246) and NAb positivity (13.2% vs. 29.4%, p=0.0168). The multivariate analysis revealed that older age (p=0.037), prednisone (p=0.001), TNFi (p=0.016), and methotrex-ate(p=0.017) were independently associated with lower SC while prednisone (p=0.006) and TNFi (p=0.027) were also associated with reduced NAb response. Conclusion: Our fnding of an excellent safety and moderate/high SC rate in SpA supports the recommendation of CoronaVac vaccination. The impaired immune response in the minority of patients under immunosuppressive and biological therapy requires novel strategies to enhance antibody response in this subgroup of patients.
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Background: Rheumatological disease fares may be seen after many infections. However, our knowledge for the post-COVID axial spondyloarthritis (SpA) fares and its related factors is limited. Objectives: We aimed to evaluate disease activity and factors that may be associated with disease activity in axial SpA patients in post-COVID period. Methods: We retrospectively assessed the axial SpA patients who have had COVID-19 disease confrmed by a positive SARS-CoV-2 polymerized chain reaction (PCR) test result. Demographics, comorbid diseases, active medical treatments for SpA and information regarding COVID-19 clinical courses were collected from medical records. PCR positive patients were reached via telephone and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scored for pre-and post-COVID SpA symptoms. An increase of ≥2 points in the BASDAI score was defned as fare, and SpA groups with and without fare were compared. Factors predicting SpA fare were also analyzed by the logistic regression analysis. Results: A total of 48 axial SpA patients were included in our study, 65% of them male and the mean±SD age was 42.3±8.6 years. Post-COVID SpA fare was seen in 38% patients. Demographic, clinical, medical features of the SpA patients and COVID-19 disease severity were similar between Flare and No fare groups. In comparison of the COVID-19 symptoms, although most of the COVID-19 related symptoms were similar between two groups, the frequency of the back pain and diarrhea were higher in the Flare group than No fare group. But in multivariate analysis, only history of the infammatory bowel disease had an increased risk for post-COVID SpA fare (Table 1). Conclusion: The presence of infammatory bowel disease statistically signifcant related post-COVID SpA fares. In addition, diarrhea and back pain symptoms in COVID-19 disease may be stimulating factors for SpA fares but we found no effect of rheumatological therapies.
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Background: Quality Improvement (QI) methods have been used in healthcare since the late 1980s across a wide range of healthcare settings. However, in the UK they have not been applied widely within rheumatology including axial Spon-dyloarthritis (axial SpA). In 2017, the UK healthcare regulator, NICE, produced a national clinical guideline for axial SpA, but there was no mechanism to encourage uptake of its recommendations. The National Axial Spondyloarthritis Society created a programme to use QI approaches to help encourage uptake of the Guidelines and act as a catalyst for wider improvement in axial SpA care. Objectives: To encourage service improvement in axial Spondyloarthritis care through the use of quality improvement theory and methods. Methods: In late 2019 six rheumatology departments were selected to participate in the frst cohort. The programme design was underpinned by: A framework for management grounded in systems theory1 A learning system that brings healthcare organisations together2 A set of tools to develop, test and implement changes: the Model for Improvement3. The teams met four times for training in QI methods, plus team-based online coaching. They had time to develop their projects and networking opportunities to share their data and experiences of implementation. We conducted a qualitative review of the programme in year one. We interviewed 31 programme participants and reviewed programme documentation. Results: The review found that: A proven QI framework provides a strong basis to build improvement A competitive programme helps foster motivation and accountability The programme provides the time to use tools to understand the problem and construct improvement aims Measurement is key to understand improvement and to create a story of change Collaboration and engagement is key within the team and with other stakeholders. The teams have: • Trained community-based physiotherapists, leading to improved rheumatology referrals Implemented an infammatory back pain pathway from primary care Introduced an MRI spine IBP protocol to reduce variation in imaging Established a tertiary referral service which has improved time to diagnosis Implemented mental health interventions for patients and reduced the percentage of patients with abnormal scores Established a pathway for physiotherapy self-referral and reduced Did Not Attend rates Used audit to make the business case for an extended scope practitioner Conclusion: Despite the challenges of posed by the Covid-19 pandemic, a structured QI programme has enabled clinicians to stay engaged and implement projects to reduce diagnostic delay and improve care.
ABSTRACT
Background: To our knowledge, no published work has described precisely the severity and evolution of SARS-CoV-2 infection in patients with spondyloarthritis (SpA). Data on COVID-19 from cohorts of patients with immune-mediated infam-matory diseases concern small samples of SpA. Objectives: Our objective was to describe the severity and course of COVID-19 in a large cohort of patients with SpA, including axial SpA (axSpA) and psoriatic arthritis (PsA), and to identify factors associated with severe forms. Methods: Patients: individuals with Spondyloarthritis (SpA) from the French RMD COVID-19 cohort (observational, national, multicenter cohort) with a diagnosis of COVID-19 (clinical, PCR, CT or serology) were included. Data collected: demographics, type of SpA, comorbidities, treatments, severity of COVID-19. Severity of COVID-19 was graded according to care needed: mild = outpatient care;moderate = non-intensive hospital treatment;severe = intensive care unit admission or death;severe = moderate or severe. Statistical analyses: Logistic regression models were used to identify factors associated with these severe forms. All variables with p <0.20 in the univariate analysis were proposed in the multivariate model. Treatment variables (non-ste-roidal anti-infammatory drugs (NSAIDs), methotrexate (MTX), sulfasalazine (SLZ), TNF inhibitors (TNFi), IL-17 inhibitors (IL-17i) and IL-23p19/p40 inhibitors (IL-23p19/p40i)) were included in the models, even if p≥0.20. Results: Between March 2020 and April 2021, 626 SpAs reported COVID-19 with a mild course in 508 cases (81.1%), moderate in 93 cases (14.8%), and severe in 25 cases (3.9%), including 6 deaths. The cohort analyzed included 349 women (55.8%), mean age 49.3 ± 14.1 years, mean BMI 27.1 ± 5.4 with 403 axSpA (64.4%), 187 PsA (29.9%) and 36 other SpA, duration of disease 11.3 ± 9.8 years;352 (56.2%) had at least one comorbidity, of which obesity (23.6%), hypertension (15.5%), and smoking (10.4%) were the most frequent. Among them, 104 were treated with NSAIDs (16.6%), 186 with conventional synthetic disease-modifying antirheumatic drugs (DMARDs) including 156 MTX, and 460 (73.5%) with biological DMARDs (379 TNFi, 57 IL-17i, 15 IL-23p19/p40i, 9 others). The following variables were associated with severe COVID-19 outcomes: age, body mass index, chronic obstructive lung disease, cardiovascular disease, diabetes, hypertension, interstitial lung disease, renal failure, and corticosteroids intake. The factors independently associated with severe COVID-19 outcomes were cor-ticosteroid intake (3.15 [CI95%: 1.46-6.76], p 0.004), and age (OR=1.06 [CI95%: 1.04-1.08], p <0.001] while anti-TNF (OR=0.26 [CI95%: 0.09-0.78], p=0.01]) was protective. NSAIDs intake (OR=0.97 [CI95%: 0.48-1.98]), SLZ (OR=7.9 [CI95%: 0.60-103]), or anti-IL17 (OR=0.37 [CI95%: 0.10-1.31]) was not associated with infection severity. Conclusion: The course of COVID-19 was mild for the majority of SpA patients (81.1%). Corticosteroid intake was associated with more severe COVID-19 outcomes, whereas TNFi were found to be protective.
ABSTRACT
Background: Rheumatologists recommend vaccination in rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) patients, but there are few studies on the occurrence of adverse events (AEs), particularly worsening disease related activity and unrelated immune reactions in these groups. Objectives: To evaluate the uptake of COVID vaccination in RA and axSpA patients, compare the frequency of AEs, and identify risk factors associated with vaccine AEs in two prospective cohorts comprised of these patients. Methods: The IMPACT study is a monthly survey of two prospective cohorts of established RA and axSpA patients in northern Alberta, Canada from November 2020-2021 who answered at least one or more Redcap surveys through de-iden-tifed email link surveying demographics, disease characteristics, COVID symptoms, treatment of RA and axSpA, health care utilization, vaccination status, vaccine AEs and use of cannabis. Univariate analyses evaluated independent variables associated with the dependent variables of (1) any AE, (2) any severe AE, (3) any arthritis fare, and (4) any severe arthritis fare, followed by multi-variate analyses of these four dependant variables using all clinically relevant variables from the univariate analysis. Results: 773/2167 patients (RA 574, axSpA 197) responded to at least one survey. 32/663 (5%) were single vaccinated, 631 (95%) double vaccinated and 230 (54%) triple vaccinated with 80% receiving Pfzer, 24% Moderna, 28% Astra-Zeneca and 30% 'other'. 456 (69%) reported at least one AE (Figure 1) with 21 (3%) patients seeing a physician for their AE. Increased age was associated with all AEs. RA patients had lower reported AEs versus axSpA patients for all AE defnitions except for severe arthritis fares. Generally, males reported worse AEs (Table 1). 'Any arthritis fare' was lower in patients reporting cannabis use. Conclusion: RA and axSpA patients showed high uptake of COVID vaccination with largely minor AEs. Older age and male gender were associated with more general and arthritis specifc AEs. The association of any AE and/or arthritis-spe-cifc AEs in SpA versus RA patients is a novel fnding which may correlate with the male predominance of SpA. The association of cannabis with fewer arthritis AEs may refect the nociceptive properties of cannabis.
ABSTRACT
Background: Throughout the pandemic, there has been ongoing concern that people with autoimmune diseases such as rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) will have more severe COVID-19 disease due to immune dysfunction associated with autoimmune diseases and their treatment. Objectives: We aimed to compare the severity of COVID-19 in patients with RA versus axSpA and characterize the predictors of COVID-19 severity during the pre-Omicron pandemic phases. Methods: The IMPACT (IMPact of infammatory Arthritis on COVID Outcomes STudy) study is a monthly survey of two established northern Alberta, Canada prospective cohorts of RA and axSpA patients from November 2020-2021 who answered Redcap surveys through de-identifed email link surveying patient demographics, disease characteristics, COVID-19 symptoms, treatment of RA and axSpA, health care utilization, vaccination status and vaccine adverse events. Descriptive and univariate analyses (dependent variable = severe COVID-19) were performed followed by multivariate analyses of all signifcant and clinically relevant independent variables from the univariate analysis. Infection severity was defned as any patient with COVID-19 symptoms who visited a doctor, ER or required hospital admission. Results: 773 of 2167 (36%) patients (RA n=574, axSpA n=197) registered in both cohorts answered at least one baseline survey, 28 (4%) reporting positive COVID-19 tests (24 positive once). Of 442 reporting COVID-19 symptoms during the survey, 11 (3%) were admitted for a mean of 4 days, 2 requiring ICU or blood clot treatment and 1 requiring advanced therapy. 116 (26%) visited a physician for Covid symptoms. Univariate analysis showed that the use of steroids, NSAIDs and increased disease activity were associated with having less severe infection but these associations were not signifcant in the multivariate analysis (Table 1). There were no signifcant impacts of RA vs axSpA, age, gender, treatment, disease activity, or smoking. Conclusion: Possible disease related risk factors for increased COVID-19 severity in RA and axSpA patients preceding the onset of the Omicron variant including use of steroids or DMARDs were not associated with severe infection. These fndings are consistent with other international studies whereby other non-rheumatic disease comorbidities played a greater role in infection severity.