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Background/Aims In December 2019, a new type of novel coronavirus (COVID-19) was identified in Wuhan, China. The likelihood of developing an autoimmune and/or rheumatic diseases in COVID-19 survivors is high and a serious matter. The acute SARS-CoV-2 infection may unmask previously undiagnosed rheumatic conditions. We aimed to study rheumatic autoimmune disease manifestations diseases following COVID-19 infection survival. Methods The study was an observational case series study. The data collection was carried out in Iraqi Kurdistan region between the 1st of July 2021 and 20th of March 2022. Seventy-five patients were included: the patients who previously had confirmed COVID-19 infection who developed symptoms of rheumatic autoimmune diseases post COVID-19 cure. The study was conducted via a rigorous evaluation by two rheumatologists. Patients were investigated by (ESR (mm/h) and CRP (mg/L), some autoimmune screen panel for suspecting rheumatological disease patients were sent for ANA, anti-CCP (U/ML) and rheumatoid factor (IU/M) L. Then, patients were diagnosed according to the classification criteria for suspected autoimmune diseases and those with exacerbation were evaluated clinically and by laboratory;rheumatoid arthritis by DAS28, systemic lupus erythematosus by C3, C4. Results A total of seventy-five participants post-COVID-19 infection were enrolled in this study. Age of the participants was 47.15 +/-16.18 SD, more of the participants were female (69) out of 75. For most of the patients the ESR were high with p value of 0.012, which was statistically significant. ANA was high titre in SLE patients which was (3.05+/-2.4) and in antiphospholipid syndrome p-value was significant at 0.042, Anti-CCP were positive in RA patients and in those with exacerbation of RA (44+/-10, 31.7+/-5.7 respectively), DAS28 was (4.95+/-0.59) moderate and high disease activity in patients with exacerbations. C3, C4 were low in patients with exacerbation of SLE (0.47+/-0.22, 0.03+/-0.01, respectively). Most of the patients developed symptoms post-COVID-19 between 4-10 weeks (37 participants). Conclusion Rheumatic autoimmune diseases presenting post-COVID-19 survival most commonly were systemic lupus erythematous followed by rheumatoid arthritis. and previous autoimmune diseases presented with exacerbation. (Table Presented).
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Background/Aims Baricitinib is the most common Janus Kinase inhibitor (JAKi) used in the treatment of rheumatological conditions. Whilst randomised controlled trials have demonstrated the efficacy and safety profile of baricitinib, real-world data on the experience of JAKi use in clinical practice is lacking. The aim of this analysis was to evaluate baricitinib use in a real-world patient population in South London. Methods We looked at two rheumatology departments in South London (St George's Hospital;a tertiary teaching centre and Kingston Hospital;a district general hospital). All patients prescribed baricitinib between January 2017 to June 2022 were included. A retrospective assessment of electronic patient notes was performed to evaluate disease activity (determined by DAS-28 scores at baseline, 3-6 months and presently);adverse effects including side effects, rates of and reasons for discontinuation;and prescribing practice, including previous use of other biological disease modifying anti-rheumatic drugs (bDMARDs). Baseline data including age, gender, co-morbidities and rheumatological diagnoses were also included. Results 233 patients were included in this evaluation, with seropositive rheumatoid arthritis being the most common diagnosis (58%) and with a significant female population (87%). Baricitinib improved average DAS-28 scores from 5.75 (range 3.57-8.3) at baseline to 3.23 (range 0.28-7.49) at 3-6 months post-baricitinib, with the most recent DAS-28 score of 2.90 (range 0.56-6.77). Rates of adverse effects were low as shown in Table 1. Baricitinib was discontinued in 60/233 patients, with average duration to discontinuation of 9.5 months. The most common reasons for discontinuation were: ineffective disease control (28/60), recurrent bacterial infection (5/60), deranged liver function (3/60) and venous thromboembolism (2/60). Eight patients died whilst taking baricitinib. Where documented, the causes of death were Covid-19 (4/8) and malignancy (1/8). 110 out of 233 patients had received other bDMARDs before starting baricitinib. Documented reasons for baricitinib choice over tumour necrosis factor inhibitors (TNFi) included: previous lack of response to TNFi (89/233), contra-indication to TNFi (11/233) and preference of oral route (10/ 233). Conclusion Our real-world study of JAKi use shows that baricitinib is efficacious in the treatment of rheumatological conditions. Moreover, baricitinib is well tolerated, with low rates of adverse effects and subsequent discontinuation. (Table Presented).
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Background/Aims COVID-19 challenged traditional care models and necessitated introduction of remote consultations. We wanted to understand the experiences of people with rheumatoid arthritis (RA)/adult juvenile idiopathic arthritis (AJIA) on accessing healthcare remotely, and how well people understood their condition and treatment. Methods This collaborative work between the National Rheumatoid Arthritis Society (NRAS) and clinicians in Oxford led to the development of an electronic questionnaire that was disseminated in July 2021 for four weeks through e-newsletters and all NRAS social media platforms. Those living in the UK with RA and AJIA aged 18 and over were eligible. Analyses of data were performed in Microsoft Excel and IBM SPSSv28. Results We analysed 316 responses. There was a middle-aged (ages 46 to 54, 54.1%, n=171), Caucasian (97.5%, n=306), female (92.4%, n=292) preponderance. Most had RA (93%, n=294) followed by another inflammatory arthritis (4.1%, n=13) and AJIA (2.8%, n=9). The majority had their condition for >10 years (43.4%, n=137) but some were diagnosed <12 months ago (3.2%, n=10). Two thirds of participants (66.5%, n=210) did not know their DAS28 score. Of the remaining third, the most commonly reported measure was moderate disease activity (12%, n=38). Those with higher self-reported DAS28 scores were using analgesia more regularly (p<0.01) but we found no difference in NSAID, DMARD or steroid use. Age did not influence steroid usage (p=0.35), but those who had their condition for longer used more steroids and regular analgesia. Only 33.9% (n=107) of responders felt their condition had been managed adequately in the pandemic, with more reporting poor status (40.8%, n=129) rather than good (16.8%, n=53). Those living in the South of England reported statistically better disease control than those from the North, despite having more virtual assessments (p=0.02). Travelling and fear of Covid appeared more important than consultation skills. Just over a fifth (20.3%, n=64) felt greater focus should be given to patient concerns. Of the 9.1% of patients (n=29) with a new diagnosis made during the pandemic, 24.1% (n=7) unable to book a GP appointment easily. Patients experienced a median symptom time of 4-10 weeks before consulting GPs. Once assessed, 31% (n=9) were referred immediately while the median time was 4-8 weeks. We found 58.6% (n=17) of patients received their diagnosis within their initial rheumatology consultation and 76.5% (n=13) of these started a DMARD immediately. Conclusion Despite a greater emphasis on patient education and PROMs influencing clinical decision-making, it is staggering that two-thirds did not know their DAS28 score. Analgesia and steroid use were common in patients with well-established disease which remains a concern. Accessing appointments was a significant barrier to patients and delays in care were experienced at every step in the NHS management pathways. Remote consultations need greater emphasis on patient concerns.
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Background/Aims Tofacitinib and baricitinib were the first orally available, targeted synthetic Janus kinase (JAK) inhibitors approved for the treatment of rheumatoid arthritis (RA) in the UK. Evidence suggests that JAK inhibitors are as efficacious as biological DMARDs in the treatment of RA. Their safety profile has been demonstrated in long term extension studies and RCTs. However, real-world, long-term data remains as important in bridging the gap between controlled studies and routine practice. We report our initial real-world experience of a cohort of RA patients commenced on JAKi before the SARS-CoV-2 pandemic within a regional centre in the UK. Methods All patients commenced on JAKi for the treatment of RA between February 2018 and March 2020 were identified from our in-house database. Data was retrospectively collected from clinical notes and electronic health records from February 2018 up until April 2022. This included patient demographics, disease duration, serological status, concurrent csDMARD usage, history of bDMARD exposure, duration of use and reason for discontinuation of the drug if appropriate. DAS- 28 scores were recorded at baseline and quarterly. SPSS (version 22.0) was used for data analysis. Results One hundred thirty patients were treated with JAK inhibitors (Tofacitinib 22%, Baricitinib 78%);80% female, mean (S.D.) age 61.5 (12.3) years. 92 (70.8%) patients were seropositive. 70 (53.8%) patients were on concurrent csDMARDs and 23 (17.7%) on concurrent steroids. The mean number of previous bDMARDs was 1.8 +/- 1.7;41 (31.5%) were bDMARD naive. The mean baseline DAS-28 ESR (S.D.) score was 5.96 (0.96). There were significant differences in mean DAS- 28 ESR scores (compared with baseline) of 1.54, 1.96, 2.41, 2.33 and 1.80 at 3, 6, 12, 18 and 24 months respectively (p<0.0001). Mean DAS-28 ESR scores were not statistically significant between bDMARD naive patients and those that had previously received bDMARDs. Overall JAKi retention rate was 66.9% with a mean follow up duration of 27.4+/-13.1 months. Persistence was 88.5%, 76.9%, 73.2% and 68.5% at 6, 12, 18, and 24 months, respectively. Of the 38 patients who stopped JAK inhibitors, 11 stopped due to inefficacy (6, primary inefficacy). 3 patients were lost to follow-up and 6 deceased. Cause of death was sepsis (2), venous thromboembolism (1) and unknown (3). 18 patients stopped because of adverse events (AEs). The most common AEs were recurrent infections (11), gastrointestinal side effects (9), lymphopenia (7), thromboembolic events (6) and herpes zoster (5). In total 6 (4.1%) patients had thromboembolic events which included pulmonary embolism (4) and deep vein thrombosis (1) and central retinal artery thrombosis (1). Conclusion JAK inhibitors in this real-world population of RA patients were effective in reducing disease activity and patients had high persistence rates. Recurrent infections, herpes zoster and thrombo-embolism remain adverse events of concern.
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Background/Aims In our department, patient reported outcome measures (PROMs), including RAPID-3 and PSAID12, were employed during the COVID-19 pandemic in asynchronous consultations for patients with psoriatic arthritis (PsA). We compared pre-pandemic DAS28-CRP with intrapandemic PROMs to assess changes in disease activity since the pandemic. Whilst previous studies have primarily compared PsA PROMs with clinician-assessed scores (e.g. PASDAS), we compare PsA PROMs with clinicians' overall assessment of disease activity;this judgement considers PROMs, serology studies and individual patient feedback. Finally, we assess whether patients with PROMs indicating active disease were followed up appropriately. Methods Clinician-assessed scores were collected between 01/01/2019-01/03/ 2020 (''pre-pandemic''). Between 01/12/2020-31/03/2022 (''intrapandemic''), patient data from electronic surveys were analysed in a secure database for calculation of PROMs. These data, alongside blood results and patient comments, informed clinicians' triage decisions. Clinical outcome data were collected from electronic patient records;>=3 months follow-up appointment allocation was the target for patients with active disease (moderate/high disease activity). Data analysis was performed using r (version 4.2.2). Results In our pre-pandemic cohort (n=393), 79.8% of patients were in remission (per DAS28-CRP). Conversely, the intra-pandemic cohort (n=231) showed remission rates of 14.3% (per PSAID12) and 0% (RAPID-3). Indeed, 33.7% (based on PSAID12) vs 75.8% (RAPID-3) had moderate/ high disease activity. These results were validated in a paired cohort (n=38, score recorded in both windows). Disease activity worsened during the pandemic for 63.2% (PSAID12) and 97.4% (RAPID-3) of patients. PSAID-12 correlated positively with RAPID-3 (r=0.52, p<0.001), especially when RAPID-3 >=6.5 (r=0.75, p<0.001). When comparing PROMs with clinicians' assessment of PsA activity in our paired cohort, PSAID12 and RAPID-3 accurately reflected disease status in 70.6% and 58.8% of patients respectively. 3/9 and 9/27 patients with active disease, based on PSAID12 and RAPID-3 respectively, were seen within three months. Conversely, 7/10 patients who clinicians had deemed to have active disease were seen within three months. Conclusion Despite approximately 80% of patients being in pre-pandemic remission, the majority reported active intra-pandemic PsA. Whilst RAPID-3 skewed patients towards active disease, PSAID12 skewed patients towards remission/low disease activity. PSAID-12 and RAPID- 3 have been previously correlated;however, here we suggest that they could be used interchangeably in patients with high disease activity. PSAID-12 was a better predictor of clinicians' assessment of disease activity, although neither PROM correlated well with >=3 months followup appointment allocation. Although RAPID-3 and PSAID12 helped inform clinicians' decisions, neither alone sufficiently reflects patients' disease states. Remote management is practicable, but future studies should validate these findings across a larger cohort and assess the utility of different PROMs across PsA disease activity categories. Furthermore, multivariate analysis is warranted to ascertain which (combination of) variable(s) (e.g., PROMs, serology results, tender/ swollen joint count) best correlates with clinician judgement.
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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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Aim of the work: To evaluate the frequency of nail ridging (NR) in patients with rheumatoid arthritis (RA) and to study its relation to disease activity. Patients and methods: 230 RA patients and 97 matched controls from Helwan, Ain Shams and Mansoura university hospitals were studied. Disease activity score (DAS28) was assessed. NR has been searched for in all patients. The number of affected fingers was recorded. NR was determined by a magnifying lens, seen by naked eye or seen and felt. Dermoscopic photography of the NR using Dermalite DL4 3Gen dermatoscope has been recorded. Results: The median age of patients was 49 years (42–58 years);they were 221 females and 19 males (F:M 11.1:1) with a disease duration 9 years (5–11 years). Their DAS28 was 3.6 (2.9–4.6). NR was significantly increased in RA cases vs. control;73% vs 20%;p < 0.001. In patients, NR was detected by a magnifying lens in 32.6%, seen in 27% and seen and felt in 13.5%. Joint deformities were significantly higher in those with NR. DAS28 was a significant independent predictor of NR;for every one-point increase in DAS28, there was a 153 times higher odds to exhibit NR at a sensitivity of 93.5%, specificity 80.3% and at a diagnostic accuracy of 90%. Conclusion: NR is a frequent finding in RA. An integrated rheumatological- dermatological clinical evaluation may be helpful and further studies are required to prove the importance of this sign for follow up of RA patients.
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Background and Aim: Since the emergence of COVID-19, tele-rheumatology care has presented as an appealing alternative way for accessing health care. The efficacy of tele-care needs to be evaluated in our setting. This study aimed at assessing the agreement between the tele-visit and the face-to- face clinic-based visit. Methodology: We prospectively recruited patients with rheumatoid arthritis;who were following up in the out-patient department clinics between December 2021 and May 2022. Each patient underwent disease activity assessment by means of disease activity score 28-c- reactive protein (DAS28-CRP) and disease activity score28-erythrocyte sedimentation rate (DAS28-ESR). Within two weeks from the face-to- face visit, we virtually assessed their disease activity, through a telephone-based interview, by applying Routine Assessment of Patient Index Data 3 (RAPID3) score, collecting data on demographics and inquiring about satisfaction with the tele-visit. Disease activity scores were categorized into remission or low disease activity, and moderate to high disease activity. Result(s): In our study, 78 patients were recruited and completed the two-points interview. A total of 62(79.49%) of the participants were female;mean age of 54.73 +/- 13.71 years. Seropositivity for rheumatoid factor and/or anti-citrullinated peptide was found in 51(83.61%) participants. 27% of patients with RAPID3 had remission or low disease activity. While this was 71% and 33% for DAS28-CRP and DAS28-ESR, respectively. Moderate to high disease activity percentage of 73%, 29% and 67% were found in RAPID3, DAS28-CRP and DAS28-ESR, respectively. Furthermore, the correlations of RAPID 3 were relatively moderate but significant with DAS28-CRP (r = 0.6, P-value < 0.001) and DAS28-ESR (r = 0.4, P-value = 0.001), respectively. Satisfaction rates with the tele-visit were at odds with other reported publications. Conclusion(s): Tele-rheumatology assessment of disease activity for patients with rheumatoid arthritis appears to be feasible in our setting. Further studies should aim at assessing patients' satisfaction and the recently implemented video-based tele-clinics.
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Background: Rheumatoid Arthritis (RA) flare post-COVID- 19 vaccination has been reported and poses a great concern among patients. This study aims to evaluate the prevalence of RA flare post COVID-19 vaccination and its associated risk factors. Method(s): This was a cross-sectional questionnaire-based study assessing RA flare based on patient self-report disease flare or documented physician assessment (physician-reported flare). The study was conducted from May to July 2022 in Hospital Putrajaya and recruited RA patients who received at least one dose of COVID-19 vaccine under the Malaysian National Vaccination Programme. Patient self-reported disease flare was defined as 'a sudden worsening of rheumatology condition or arthritis within 1 month post-vaccination' while physician-reported flare was defined as 'an increment of disease activity score 28-joint (DAS28 CRP/ESR) documented within 3 months post-vaccination' from either a scheduled or unscheduled clinic visit. Demographic data, vaccination history and disease parameters were retrieved from electronic medical records. Statistical analysis included descriptive and univariate analyses were performed using SPSS. Result(s): A total of 186 patients were enrolled. Majority (93%) were female with the mean age of 58 years old (standard deviation, SD 12.2). Most patients were seropositive (66% Rheumatoid factor, 63% anti-citrullinated peptide antibodies) with mean disease duration of 12 years (SD 7.7). Majority were on methotrexate (MTX) (71%), 21.5% were on leflunomide and only 4.8% were on biologics or targeted synthetic disease modifying anti-rheumatic drugs. A small proportion of patients were on steroids (14%). Half of the patients were in remission prior to vaccination. All patients completed 2 doses of vaccination in which 62% received Pfizer-BioNTech vaccine followed by Sinovac (coronaVac) vaccine (24.6%) and Oxford-AstraZaneca vaccine (13.4%). Only 80% received booster dose, of which 88.7% was Pfizer-BioNTech vaccine. A total of 52 patients who were on MTX therapy discontinued the drug post-vaccination for a week duration. The prevalence of flare was only 12.9% (n: 24) in which 14 were self-reported and 10 were physician-reported flares (4 severe flare, 6 mild-moderate flare). Majority of flares occurred during the first and second dose of vaccination with 29.2% respectively, and only 12.5% were reported after booster vaccination. There were no significant differences in the occurrence of flare post-vaccination between age, gender, disease activity prior to vaccination, types of vaccine, usage of MTX and steroids, and discontinuation of MTX post-vaccination. Conclusion(s): Prevelance of RA flare post-COVID- 19 vaccination is low and there were no significant associated risk factors identified in this study.
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Background: Blockade of JAK, preferably JAK1, by upadacitinib is a feasible approach to achieve erosion repair as it (1) is approved for the treatment of rheumatoid arthritis (RA), (2) effectively controls the inflammation and (3) targets pathogenic pathways that influence local bone homeostasis in the joint. To address the question whether inhibition of JAK1 could lead to erosion repair in patients with active RA, we performed a pilot non-randomized study comparing the changes in bone erosions on high-resolution peripheral quantitative computer tomography (HR-pQCT) before and after upadacitinib. Method(s): This is a 24-week, single-centered, prospective, non-randomized pilot study. We enrolled 20 adult patients with active RA (Disease activity score 28-C- reactive protein [DAS28-CRP] > 3.2) and >=1 bone erosion on HR-pQCT. They were given upadacitinib 15mg once daily for 6 months. HR-pQCT of the 2-4 metacarpophalangeal (MCP) head was done at baseline and 6 months. The primary outcome was the change of erosion volume on HR-pQCT. Secondary outcomes included change in RA disease activity and predictors of response to treatment. Erosion regression was defined as decrease in volume exceeding the smallest detectable change. Result(s): The baseline clinical characteristics of the recruited patients were shown in Table 1. Of the 20 patients, 11 (55%) patients failed to respond to 3 or more csDMARDs. At 24-week, there was significant improvement in mean DAS28 (-1.75, P < 0.001). Erosion regression was seen in 8 (40%) patients on HR-pQCT (Figure 1). Although no significant change in overall median erosion volume before and after upadacintinib (0.07 [-0.90 to 0.76 mm3] mm3, P = 0.904) was noted, the deterioration was less obvious compared to a historic cohort of 20 patients with similar age and disease activity on csDMARDs (median erosion volume change in 6 months: 0.67 mm3). When patients were stratified according to whether or not they had failed multiple csDMARDs, significantly high proportion of patients in the non-multiple- DMARDs failure group had volume regression in at least one erosion compared to those in the failure group (75% vs 25%, P = 0.04). There was improvement in mean total erosion volume in the non-failure group (-0.33 +/- 1.33 mm3), whereas mean erosion volume in the failure group worsened (2.09 +/- 7.62 mm3). One patient developed chest infection requiring hospitalization and withdrew from the study. No other serious adverse event was noted. Conclusion(s): The results of the study suggest upadacitinib is clinically efficacious in refractory RA disease and can retard erosion progression. Regression of erosion is possible, particularly in those with limited csDMARDs exposure. Whether early JAK1 inhibition could lead to better structural outcome warrants further investigations. (Figure Presented).
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Objective: To describe the clinical, laboratory and pharmacokinetic features of elderly patients with rheumatoid arthritis (RA), with insufficient response to methotrexate (MTX) therapy for 24 weeks compared with patients with a good response. Material(s) and Method(s): The study included 32 patients with RA, according to the older age category according to WHO criteria, 65 (82%) women and 14 (18%) men, BMI was 27 +/- 4 kg/m2, DAS28 was 5.9 +/- 1. In each case, MTX was administered parenterally, at the rate of 10-15 mg/m2 of body surface. therapeutic drug monitoring was carried out, it was the determination of the concentrations of MTX monoglutamate (initial form) and MTX compounds: polyglutamates and 7-hydroxymethotrexate (7-OH- MT) in erythrocytes (ER) and mononuclear cells (MO) after 4, 12 and 24 weeks. We used high performance liquid chromatography with mass spectrometric detection. The MTX metabolite index was calculated (the ratio of the metabolite concentration to the initial concentration of unchanged MT). Achievement of therapy targets (good response to therapy) was established in accordance with the EULAR criteria. The lack of achievement of therapy goals corresponded to an insufficient response to therapy. Result(s): By week 24, 12 patients (36%, group 1) achieved therapy targets, 17 patients (53%, group 2) did not reach treatment targets, and in 3 more, MTX was discontinued due to Adverse reactions (ARs) and/or the development of COVID-19. A comparison was made of clinical and laboratory parameters before the start of MTX treatment and during MTX therapy. At all stages of the study the groups did not differ in terms of: sex, age, BMI, disease duration, VAS (pain), DAS28 index, creatinine, taking glucocorticoids, statins, the presence and frequency of comorbid pathology (arterial hypertension, diabetes mellitus, chronic autoimmune thyroiditis). The 7-OH- MTX( ER) metabolic index after 12 weeks of treatment was higher in group 1 (1.35 [0.8;2.1] versus 0.35 [0.19;0.73] in group 2). Metabolic indices of other MTX metabolites did not differ. ARs were less common in group 1 (in 1 (18%) versus 6 (35%) in group 2), P = 0.09. Conclusion(s): Clinical and laboratory characteristics of patients of the older age group did not differ in groups with different responses to methotrexate therapy. The 7-OH- MT( ER) metabolism index after 12 weeks of treatment was higher in the group of patients with a good response to therapy, which most likely indicates a more rapid catabolism of MTX in this group of patients.
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Background/Purpose: Rheumatoid arthritis (RA) patients have higher COVID-19 risks [1,2]. Data suggest that some RA biologics, including baricitinib, may be beneficial for COVID-19 outcomes [3,4]. We used data from RA registry to evaluate impact of COVID-19 on RA activity in patients receiving baricitinib. Method(s): Current study is a single center registry of RA patients receiving baricitinib as a part of routine treatment. Study center accumulates most of RA patients who started baricitinib in Moscow (Russia) from July 2020 to data cutoff (January 2022). We analyzed medical records data for demographics, disease history, and change of disease activity indexes. Medical record data were allocated to visit 1 (baseline), closest to 4 and 8 months after baricitinib initiation (visits 2 and 3). Patients, who had no baricitinib interruptions, were divided in strata according to COVID status between visits 1 and 2. Result(s): At the time of data cutoff registry included data from 142 RA patients receiving baricitinib. Median duration of treatment was 14.5 (interquartile range [IQR] 10-29) weeks. Clinical RA indexes measures are compiled in Table 1. Of 142 patients, 52 had COVID-19 between visits 1 and 2 without baricitinib interruption. Swollen joint counts (SJCs) and tender joint counts (TJCs) were comparable across 3 visits except TJC at visit 3 (P < 0.05). Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP), Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR) had comparable change regardless of COVID-19 status (P > 0.05). Simplified Disease Activity Index for Rheumatoid Arthritis (SDAI) and Clinical Disease Activity Index (CDAI) were higher in COVID-19 survivors at visit 3 (P < 0.05). (Table Presented) Conclusion(s): We conclude that, overall, COVID-19 had no significant impact on RA activity during baricitinib treatment. Further follow-up needed to find out reasons for TJC/SDAI/CDAI increase in COVID-19 survivors >=4 months after infection.
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Background: The COVID-19 pandemic accelerated the use telemedicine for rheumatologic patients. Patient reported outcomes (PRO) can provide prioritization criteria for the form of face-to-face care in situations of social restriction, and optimization of early care by identifying high-risk patients. Objectives: Our aim was to demonstrate the main associated factors for a fall or fracture reported by rheumatoid arthritis (RA) patients in an electronic MDHAQ (Multidimensional Health Assessment Questionnaire) during this period. Methods: Patients with RA according to 2010 ACR/EULAR and access to digital platforms were enrolled in the study, from January to august 2021. A weblink was sent to MDHAQ in electronic platform. The study was approved by the ethics committee of Hospital de Clínicas de Porto Alegre-Brazil and all patients agreed with a Term of Informed Consent. Results: A total of 129 RA patients completed the electronic MDHAQ, mean age was 60 years (S.D. 14) and 83% were female. The mean DAS28, SDAI and HAQ were 3.8 (S.D. 1.6), 14.2 (S.D. 11.0) and 1. 2 (S.D. 0.7). Of those 129 patients, 14 reported a fall or fracture in the last 6 months of response and only 16 patients were physically active. Relevant symptoms known as factors associated with risk of fall and its prevalence in this study were: pain (82%), followed by articular pain (68%), fatigue (43%), muscle weakness (37%) and weight gain (22%). Among patients who reported a fall or fracture, 83% had a RADAI ≥ 16 and mean FAST3 (Fibromyalgia Assessment Screening Test) index of 19 (IC95 % 17-21). FAST3 based on MDHAQ and independent RADAI showed positively association with a reported fall or fracture for these patients, with a p value of 0.023 and 0.025, respectively. Other factors, such as high disease activity based on DAS28 or MDHAQ, obesity and age were not statistically signifcant with the reported episode. Conclusion: Maintaining PRO is aligned with patient-centered care, allowing relevant data source and identifcation of high-risk patients-in our study: patients in pain, sedentary and in major risk of fracture. Also, use of combined in like FAST3 or independent articular pain scores such as RADAI, might be helpful to identify those high-risk patients in need for orientation for reinforcement of physical activity, prioritization for in person visits and early clinical adjustments.
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Background: Due to COVID-19 and the reduction of face to face clinic, the rheumatology telephone advice line service has been an integral part in identifying patients that need assessment the most (1). This however means relying on a patient's ability to conduct their own disease activity score (DAS28), which clinicians conduct to help drive patients with rheumatoid arthritis (RA) into remission. Current literature suggests that patient self-assessed joint counts are reliable and when compared to the joint count of the physician, have an acceptable level of accuracy (2-5). We present data from an NHS audit where we incidentally found that patients could conduct their own joint counts. Objectives: Our objective was to compare self-reported DAS28 scores with the clinical opinion of physicians during a face-to-face appointment. Methods: We identifed 10 patients with RA who attended a face-to-face appointment following a call to the helpline where a telephone DAS28 score was undertaken (with guidance from rheumatology specialist nurses). These scores were contrasted against the clinician's assessment of whether synovitis was present or not in a face-to-face consultation. Co-morbidities: fbromyal-gia (FM), osteoarthritis (OA) or both, were also recorded to examine whether these conditions influenced a patient's ability to perform an accurate DAS28 score. Results: There were 10 patient self-reported DAS 28 scores in total. 70% (7/10) of patients DAS 28 scores were over 4.01. In all these cases, clinicians con-frmed evidence of synovitis during their face-to-face consultation. 30% (3/10) of patients self-reported DAS 28 score was <4.01. Of these patients 2/3 have no evidence of synovitis according to their clinician. When considering co-morbidities, one individual also suffered from OA. This individual's self-assessed DAS28 score was over 4.01 and was also evidenced to have synovitis during their consultation with the clinician. Conclusion: This regional NHS audit found that patients who self-reported DAS28 scores over 4.01 accurately identifed a fare up, as confrmed by a diagnosis of synovitis at a face-to-face appointment. This is signifcant as it demonstrates that patients who score above 4.01, can reliably assess their own joint count. This may enable the Rheumatology service to become more patient-driven, empowering patients to accurately assess their condition.
ABSTRACT
Background: According to 2019 updated EULAR recommendations, therapy of Early Rheumatoid Arthritis (ERA) with biological disease-modifying antirheu-matic drugs(bDMARDs) is adviced in presence of poor prognostic factors,I.e. persistently moderate/high disease activity, high acute phase reactants, high swollen joint count, autoantibody positivity, presence of early erosions, failure of two/more conventional synthetic DMARD. Objectives: To evaluate over time prevalence of bDMARD therapy and factors associated to rapid initiation in our EA Clinic (EAC), comparing two different periods: from 2004 to 2012 and from 2012 to 2020. The last two years were not considered because of the adverse influence of COVID19 pandemia on early access to EAC and on timely scheduled visits. Methods: A total of 281 ERA patients with less than 12 months of disease duration (53.9 years mean age, 75% female, 77% seropositive), followed according to the treat-to-target (T2T) strategy, were enrolled in the study. At baseline, and every three months, the ACR/EULAR core data set variables were recorded. At baseline and every year, hand and foot radiographs were examined according to modifed Total Sharp score (mTSS). At each visit, clinical improvement and remission were evaluated according to EULAR criteria. The achievement of Comprehensive Disease Control (CDC) (28-joint Disease Activity Score using C reactive protein <2.6, Health Assessment Questionnaire <0.5 and change from baseline in mTSS ≤0.5) was assessed every year. Results: We examined 164 patients from 2004 to 2012 and 117 subjects from 2012 to 2020. In the frst group 72 patients (43.9%) initiated bDMARDs during the 8-year FU, with a mean delay of 41.8 months. In the second group 37 patients (31.6%) started biotechnological drugs over time, with a mean delay of 50.4 months. Analyzing the period from 2004 to 2012, ERA patients starting bDMARDs were younger (p<0.0001), had longer disease duration (p=0.02) and higher body mass index (BMI) (p=0.01) compared to subjects not undergoing to biological therapy. Moreover, ERA patients in bDMARDs were in higher percentage anti-citrullinated peptide antibody (ACPA) positive (80.6%) and reached to a lesser extent CDC at 12months of FU (26.1%) compared to patients that didn't initiate bDMARDs (60.9% ACPA positive, p=0.01;63% achieving CDC, p<0.0001, respectively). Examining the period from 2012 to 2020, bDMARD-treated ERA patients were younger (p=0.06),in higher percentage ACPA positive (81.1%) and erosive at baseline (35.1%) compared to patients that didn't initiate bDMARDs (64% ACPA positive, p=0.02;17.5% erosive, p=0.04, respectively). As previously, patients in bDMARD reached to a lesser extent CDC at 12 month of FU (35.1%) compared to subjects not undergoing to biological therapy (55% achieving CDC, p=0.05). On multivariate analysis, ACPA positivity was associated with initiation of bDMARD in both patient groups (p=0.02), whereas older age at onset and reaching CDC at 12 month were inversely associated (p=0.001;p<0.0001, respectively). Conclusion: Despite the widest choice of bDMARDs currently available in the last 8 years, we did not observe an increase in the prescription of these drugs from 2012 to 2020. As in other ERA cohorts, bDMARD initiation is associated to poor prognostic factors, in particular ACPA positivity, presence of erosions at baseline and not achieving CDC at 12 months of FU. In the last 8 years, the decreased influence of disease duration at onset and of BMI could be a consequence of the improvement in strategies of early referral and control of modifable risk factors.
ABSTRACT
Background: Pausing methotrexate (MTX) for two to four weeks, improved immunogenicity of infuenza vaccination in patients with rheumatoid arthritis (RA), albeit a risk of disease fare (1). This guided the framing of guidelines on MTX withdrawal for COVID-19 vaccination (2). However, evidence for MTX withdrawal for COVID-19 vaccination is limited to observational studies only. Objectives: To compare the efficacy and safety of holding MTX after each (MIVAC 1) and only after the second dose (MIVAC II) of the ChAdOx1 vaccine versus continuation of MTX in two randomized controlled trials (RCTs). Methods: Two single centre, investigator-blinded, RCTs were conducted in patients with RA or Psoriatic arthritis (PsA) on stable doses of MTX without prior COVID-19 (CTRI reg. no. MIVAC I: CTRI/2021/07/03463 & MIVAC II: CTRI/2021/07/035307). In MIVAC I, unvaccinated patients were randomised (1:1) to hold or continue MTX for two weeks after each dose of the vaccine. MIVAC II included patients who had continued MTX during the frst dose of ChA-dOx1 and were randomised (1:1) to hold or continue MTX for 2 weeks after the second vaccine dose. The primary outcome for both the trials was the anti-Receptor Binding Domain (RBD) antibody titres measured four weeks after the second vaccine dose (per protocol analysis). Secondary outcome was the fare rate, defned as an increase in disease activity scores (DAS28/cDAPSA) or physician intent to hike DMARDs. Results: 250 patients were randomized for MIVAC 1 and 178 for MIVAC II and after due exclusions, 158 and 157 were eligible for analysis respectively (Figure 1). In MIVAC I, median anti-RBD titres were signifcantly high in the MTX hold group [2484 (1050-4388) versus 1147(433-2360), p=0.001] but the fare rate was higher in the hold group [20 (25%) versus 6(8%) p=0.005] compared to continue group. In MIVAC II median anti-RBD titres were signifcantly high for the MTX hold group [2553 (1792-4823) versus 990 (356-2252), p=0.001] when compared to continue group but there was no difference in the fare rate between the groups [9(11.8%) and 4(7.9%), p=0.15] (Table 1). Since both were parallel studies in similar population, MTX hold arms across both the trials were compared for anti-RBD titres and fare. There was no difference in the anti-RBD titres [p=0.2] between the groups. In MIVAC I, 29(36.25%) patients had reported fare (19 in either frst or second dose, 10 for both doses) when compared to MIVAC II where only 9(11.84%) patients had reported fare after the second dose (P <0.001). Conclusion: Holding MTX after both the doses or only after the second dose of ChAdOx1 yields higher anti-RBD antibody titres as compared to continuing MTX. Comparing across the trials, holding MTX only after the second dose appears to be non-inferior to holding MTX after both doses of the vaccine with a lesser risk of fare.
ABSTRACT
Background: Many measurement tools are designed to assess disease activity for Rheumatoid Arthritis (RA) patients. One of the most used tools is the Disease Activity Score-DAS28 which assesses the number of painful joints, erythrocyte sedimentation, and a patient's global assessment. The assessment is performed by a clinician and requires laboratory exams. Unfortunately, from March to August 2019, Colombia had one of the strictest responses to the COVID-19 pandemic according to the COVID-19 stringency Index(1). One of the main restrictions was the preventive isolation of older populations, especially those with comorbidities. These restrictions challenged the rheumatology practice because face-to-face consultations were not possible. Due to the above, measurements like the PAS-II score should be used to assess disease activity during the pandemic. Objectives: To describe disease activity according to the Patient Activity Score-PAS-II score patients with RA and compare its results to the most recent DAS28 assessment before the COVID-19 pandemic. Methods: We conducted a descriptive study;patients were followed during the COVID-19-lockdown in a video consultation. The PAS-II score was applied to assess disease activity as an alternative to the DAS28 assessment. The patients were part of an educational program, clinical charts were reviewed to collect the study variables. We collected demographic data and DAS28 before the pandemic started. We present a descriptive analysis of DAS28 severity and the results obtained by the PASS-II score. Results: The educational program enrolled 250 participants;196 patients had complete data. 93% of participants were women, mean age was 64 years IQR (54-67). 43% of participants were married or had a civil union, 26% were single, 20% divorced, and 11% were widowed. Regarding educational level, 25% had fnished elementary school and 39% high school;the remaining 36% had higher education. When we compared the last DAS28 assessed by a rheumatologist between January, and March 2019, 67% of patients were in remission, while in July 2019, the PASS-II score reported that 7% of patients were in remission and 75% had low or minimal activity. Figure 1-Table 1. Conclusion: The PASS score is a helpful tool to assess disease activity in patients with RA, especially in situations where the patient cannot see a rheumatologist in a face-to-face consultation;however, patients in severe disease activity should not delay the consultation with a clinician. As other studies have demonstrated, patient-reported outcome measures should be adopted in clinical practice as an alternative for treat-to-targe strategies(2). Further studies should be conducted to assess the impact of the pandemic in countries with high levels of restrictions in the course of RA.
ABSTRACT
Background: Patients with rheumatoid arthritis (RA) are considered a high-risk population to develop severe COVID-19 [1] and therefore vaccination is strongly recommended. Previous reports have shown a high hesitancy rate to receive a COVID-19 vaccine among RA. Objectives: This study aimed to evaluate the attitude of patients with RA to vaccination against SARS-CoV-2, explore the factors which may influence it, and assess adverse events of SARS-CoV-2 vaccines. Methods: This is a cross-sectional study including 106 patients with RA diagnosed according to the ACR/EULAR 2010 classification criteria and followed in the Rheumatology Department, over a period of 10 months from March to December 2021.Demographic and disease parameters were collected: age, gender, educational status, disease duration, erythrocyte sedimentation rate (ESR), disease activity score (DAS28), and treatments being used. All patients responded to a questionnaire on their perceptions and concerns about the covid-19 vaccine, and the adverse effects for those who got vaccinated. Results: Among the 106 patients, 90 (84,9%) were females and 16 (15,1%) were males. The mean age was 54 ±13 years old [23-77]. Sixty-four percent were from urban areas and 36 % were from rural areas. Thirty-three percent of patients were illiterate. The mean disease duration was 9.54 ±5.76 years [2-22]. The mean DAS28 ESR was 3,88 ±1.34 [1.2-7.58]. All of our patients were taking conventional synthetic DMARDs. Seventeen percent of patients were on biological DMARDs. The majority of the patients (90%) reported that they respected the preventive measures. Twenty-two percent of patients had stopped their treatment because they were afraid of the covid-19. Twenty-eight patients had contracted the SARS-CoV-2. Seventeen percent of the patients reported that they didn't get vaccinated against covid-19. The reasons given by these patients were: presumed adverse events (53,3%), presumed inef-fciency (25%), no recommendation from their doctor (46,7%), fear that the vaccine would make RA worse (64,7%). For the vaccinated patients, the vaccines administered were: 63,6 % Pfzer BioNTech, 6,8% Oxford/AstraZeneca, 5,7% Moderna, 4,5% Janssen/Johnson & Johnson, 2,3% Sinovac-Coro-naVac and 17% unspecifed. The majority of the patients (72,7 %) received two doses,14,8 % one dose and 12,5% 3 doses. After vaccination, 73,9% of patients reported adverse events, such as pain at the site of injection (88,1%), fatigue (35,8%), headache (14,9%), fever (13,4%) and muscle/joint pains (4,5%). Only 1 patient had experienced rheumatic disease fare. Hesitancy about the COVID-19 vaccination was associated with low intellectual level (p=0.004) and rural origin (p=0.001).RA disease duration, DAS28-ESR, and treatments have no influence on the attitude of patients towards COVID-19 Vaccination (p > 0,05). Conclusion: The acceptance of COVID-19 vaccination by RA patients in our study is quite promising. The majority of patients tolerated their vaccination well, with rare RA fares up. These results should reassure rheumatologists and patients. Education and outreach efforts need to be continued, especially for illiterate people and those who live in rural areas.
ABSTRACT
Background: The management of patients with rheumatoid arthritis (RA) and novel coronavirus infection (NCI) is a signifcant problem due to the insufficient evidence base on this topic. Objectives: To study the features of the transferred NCI in patients with RA and its influence on the course of RA. Methods: From March 2020 to January 2022, 105 patients with RA who underwent NCI with a confrmed SarsCoV2 PCR result and/or X-ray computed tomography (CT) of the lungs were followed up. The age of the patients was 62 [55;68] years, among them females-84.7% (89 patients). The duration of RA at the time of NCI was 11 [6.5;17.5] years. RA activity before NCI was low in 14 (13.3%) patients, moderate in 70 (66.6%), and high in 21 (20%) patients. The results of clinical and laboratory examinations were evaluated during the COVID-19, 1 and 3 months after it. Results: The symptoms of NCI in patients with RA were comparable in frequency and severity to the course of infection in the population. 30 (28.6%) patients had a mild course of COVID-19, 74 (70.5%) had a moderate course, and 1 had a severe course. Bilateral polysegmental pneumonia was detected in 75 (71.4%) patients. The outcome of COVID-19 in all patients is recovery. Analysis of the course of RA showed a signifcant increase in activity 1 and 3 months after NCI: DAS28 from baseline to COVID-19 3.59±1.13 to 4.87±1.27 points after 3 months, respectively. Of the total number of recovered patients, 38.0% of patients showed an increase in activity due to clinical and laboratory parameters. 90.4% of patients noted the persistence or appearance of symptoms after undergoing NCI after 3 months, 45.7% had a combination of more than 3 different symptoms. The most common manifestations of asthenia in the form of a decrease in the quality of life (QOL) and working capacity. in 90.4% of patients: signifcant in 58.0% of people, insignifcant in 32.4% of people. There was no signifcant correlation between RA activity and NCI severity. The second most frequent was the increase/appearance of pain in the joints-in 86.6% of respondents: signifcant in 72.3%, insignificant-14.2%. Strengthening/appearance of muscle pain and/or headache and/or dysautonomia occurred in 44.7%. Appearance/intensifcation of shortness of breath and a decrease in exercise tolerance were noted by 36.1% of respondents: signifcant in 19.0% of people, insignifcant in 17.1% of people. Among them, 64.8% (24) people with moderate severity, 35.2% (13) people with asymptomatic or mild NCI. Appearance/intensifcation of chest pain and/or palpitations was noted by 44.7% of people. Conclusion: The prevalence and course of COVID-19 in patients with RA did not differ from that in the general population. However, coronavirus infection has led to an increase in pain and an increase in RA activity, a long-term persistence of post-COVID manifestations in the form of musculoskeletal pain and asthenic symptoms with a deterioration in the quality of life. There was no signifcant correlation between RA activity and NCI severity. At the same time, specifc respiratory symptoms occurred only in a third of patients.
ABSTRACT
Background: Patients with rheumatoid arthritis (RA) on methotrexate have reduced vaccine responses. Temporary discontinuation has improved immuno-genicity of anti-infuenza vaccine, but this strategy has not been evaluated in anti-SARS-CoV-2 vaccines. Objectives: To evaluate the effect on immunogenicity and safety of 2-week methotrexate (MTX) discontinuation after each dose of the Sinovac-CoronaVac vaccine versus MTX maintenance in rheumatoid arthritis (RA) patients. Methods: This was a single-center, prospective, randomized, investigator-blinded, intervention study (#NCT04754698, CoronavRheum), including adult RA patients (stable CDAI≤10, prednisone ≤7.5mg/day), randomized (1:1) to withdraw MTX (MTX-hold) for 2 weeks after each vaccine dose or maintain MTX (MTX-maintain), evaluated at D0, D28 and D69. Co-primary outcomes were anti-SARS-CoV-2 S1/S2 IgG seroconversion(SC) and neutralizing antibody (NAb) positivity at D69. Secondary outcomes were geometric mean titers (GMT) and fare rates. For immunogenicity analyses, we excluded patients with baseline positive IgG/NAb, and, for safety reasons, those who fared at D28 (CDAI>10) and did not withdraw MTX twice. Results: Randomization included 138 patients with 9 exclusions (5 COVID-19, 4 protocol violations). Safety evaluation included 60 (MTX-hold) and 69 (MTX-maintain) patients. Further exclusions: 27 patients [13 (21.7%) vs. 14 (20.3%), p=0.848] with positive baseline IgG/NAb and 10 patients (21.3%) in MTX-hold with CDAI>10 at D28. At D69, MTX-hold (n=37) had a higher rate of seroconversion than MTX-maintain (n=55) group [29 (78.4%) vs 30 (54.5%), p=0.019], with parallel augmentation in GMT [34.2 (25.2-46.4) vs 16.8 (11.9-23.6), p=0.006]. No differences were observed for NAb positivity [23 (62.2%) vs 27 (49.1%), p=0.217]. At D28 fare, rates were comparable in both groups (CDAI, p=0.122;DAS28-CRP, p=0.576), whereas CDAI>10 was more frequent in MTX-hold at D69 (p=0.024). Conclusion: We provide novel data that 2-week MTX withdrawal after each Sinovac-CoronaVac vaccine dose improves anti-SARS-CoV-2 IgG response. The increased fare rates after second MTX withdrawal may be attributed to the short-term interval between vaccine doses. This strategy requires close surveillance and shared decision making due to the possibility of fares.