Objectives Patients with giant cell arteritis (GCA) represent a fragile population with an increased infection risk. In a recent study, older age, a higher number of comorbidities, higher disease activity and prednisolone ≥ 10 mg/day were associated with worse COVID-19 outcome. We aimed to evaluate the frequency and severity of COVID-19 in a well-defined GCA cohort. Methods We reviewed medical records of histologically and/or by imaging-proven GCA patients diagnosed between September 2011 and February 2020 at our secondary/tertiary centre and followed during the COVID-19 pandemic between March 2020 and February 2022 (24 months). Descriptive statistics were used to explore the studied population. Results Of 314 patients with GCA diagnosed for the first time during a 102-month period, 49 patients died before March 2020. Of the remaining 265 patients, 55 (20.8%) patients suffered from a total of 57 SARS-CoV-2 infections. We observed 44 (77.2%) mild and 13 (22.8%) severe COVID-19 episodes (the latter defined as needing hospitalization, death or thrombotic complication). Patients with severe COVID-19 were more likely to have arterial hypertension (12 [92.3%] vs. 25 [56.8%]; p = 0.022), cardiovascular disease (7 [53.8%] vs. 10 [22.7%]; p = 0.043) or obesity (5 [38.5%] vs. 5 [11.4%]; p = 0.038). Neither prednisolone dose 1–5 mg/day ( p = 0.483) nor leflunomide use ( p = 1.000) was associated with COVID-19 course. There were no significant differences in sex, age, GCA type, GCA disease duration and other comorbidities in patients with mild and severe COVID-19 in our cohort. Conclusion More than a fifth of our GCA patients had severe COVID-19. Treatment with leflunomide or low doses of glucocorticoids were not associated with severe course in our cohort. Key Points • Treatment with leflunomide or low doses of glucocorticoids were not associated with worse COVID-19 outcome . • Outcomes of COVID-19 improved as the COVID-19 pandemic, prevention and treatment options evolved . • Arterial hypertension, cardiovascular disease or obesity were associated with severe COVID-19 .

BackgroundThe management of giant cell arteritis (GCA) remains challenging and many patients require prolonged glucocorticoid treatment due to high disease relapse rates. We aimed to evaluate the role of leflunomide as a steroid-sparing agent in GCA.MethodsThis prospective open-label study included patients diagnosed with GCA between July 2014 and August 2020 and followed them for 96 weeks. At the time of diagnosis all patients received treatment following a predefined glucocorticoid regimen. At week 12 of follow-up, 10 mg of leflunomide per day was recommended as an adjunctive therapy. The decision to start with leflunomide treatment was patient-dependent. Follow-up visits were performed adhering to a predetermined protocol. The number of relapses, the cumulative glucocorticoid dose and treatment-related adverse events were recorded and compared between glucocorticoid-only and leflunomide groups.ResultsOf the 215 GCA patients [67.6% female, median (IQR) age 74 (66–79) years], 151 (70.2%) received leflunomide at week 12 (leflunomide group); the others continued with glucocorticoids (glucocorticoid-only group). During the study 64/215 (29.8%) patients relapsed. Of the 51 patients who relapsed after 12 weeks, 22/151 patients (14.6%) and 29/64 patients (45.3%) were in the leflunomide and glucocorticoid-only group, respectively (p = 0.001; NNT 3.3 for leflunomide). Furthermore, 80/151 patients in the leflunomide group managed to stop glucocorticoids at week 48 [with relapses in 6/80 patients (7.5%)]. The cumulative glucocorticoid dose was lower in the leflunomide group (p = 0.009).ConclusionIn our cohort, leflunomide safely and effectively reduced the GCA relapse rate and demonstrated a steroid-sparing effect in over three quarters of patients.

Background:Anticardiolipin antibodies (aCL) can be detected in newly diagnosed GCA as reactive antibodies to endothelial lesions. Their prognostic role, as a marker of disease activity, has not been extensively studied in GCA.Objectives:Our aim was to determine whether aCL IgG might represent laboratory marker of active GCA.Methods:We included patients with new clinical diagnosis of GCA supported by histology or imaging between September 2011 and July 2019, who completed at least a 48-week follow-up at our secondary/tertiary rheumatology center. Follow up visits with predetermined clinical and laboratory tests, including aCL IgG, were performed 12, 24, 48, and 96 weeks after diagnosis. GCA relapse was defined as worsening or new disease activity after initial remission. Other reasons for the disease-related symptoms, elevated inflammatory markers (C reactive protein or erythrocyte sedimentation rate) had to be excluded. aCL IgG were determined in the patients’ sera samples at baseline and at follow up visits, using an in-house solid phase enzyme-linked immunosorbent assay1. A value above the 99th percentile of the healthy control population was taken as significant.Results:During the observation period we identified 288 newly diagnosed GCA patients. Two hundred and twelve GCA patients (66.5% females, median (IQR) age 73.9 (67.0–78.7) years) fulfilled the study inclusion criterion, among them 145 patients completed the 96-week follow up visit. At baseline, 129/212 (60.8%) GCA patients had positive aCL IgG. During in total 781 follow up visits, we recorded 77 (9.9%) episodes of active/relapsing GCA (clinical, laboratory or combined in 4 (5.2%), 48 (62.3%), 25 (32.5%) episodes, respectively). aCL IgG were present at 155/781 (19.8%) measurements (at 24/77 episodes of relapsing/active and 131/573 episodes of quiescent GCA). The correlation between active/relapsing GCA and aCL IgG positivity was only weekly positive (r coefficient=0.094; p= 0.015).Conclusion:The role of aCL IgG as a biomarker for GCA activity seems to be rather limited.References:[1]Božič B, et al. Int Arch Allerg Immunol. 1997; 112:19-26. doi.org/ 10.1159/000237426Disclosure of Interests:None declared

BackgroundPolymyalgia rheumatica (PMR) is common in patients over the age of 50 years. Clinical symptoms promptly respond to glucocorticoid therapy, but there are wide variations of dosage tapering, treatment duration and rate of relapses. In Slovenia epidemiology of PMR is unknown.ObjectivesWe aimed to determine the incidence rate of PMR, the clinical characteristics, the relapse frequency and length of glucocorticoid therapy.MethodsA detailed single centre retrospective review of medical records of all patients diagnosed with PMR between 1 January 2014 and 31 December 2016 was performed at the Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia–the only secondary level rheumatology institution in serving the Central Slovenian and Gorenjska regions, which represent ~40% (7×105) of the Slovenian adult population. The outcomes were assessed up to1 October 2021.ResultsDuring the 3-year period 494 patients (460 from Ljubljana and Gorenjska regions) were diagnosed with PMR (64% females, median (IQR) age 75 (69, 80) years), resulting in an annual sex- and age-standardised incidence rate (IR) per 105 adults ≥ 50 years of 46.0 (95% CI 42.0, 50.4), with a female/male ratio of 1.5 (95% CI 1.3, 1.7). The IR peaked between 70–85 years (Figure 1). There was no seasonal variation in IR. The median (IQR) times from symptom onset, and from referral to rheumatology consultation were 6 (4, 11) weeks, and 1 (1, 1) day, respectively. 86% were referred by their GPs, 7% by other internists, and 6% by infectious disease specialists, and the rest by other specialists.At presentation, 96% had morning stiffness (71% lasting >45 minutes), 99% shoulder pain, 94% pelvic girdle pain, 49% weight loss, 13% peripheral arthritis, and 12% body temperature >37°C. Data on US of shoulders and hips was complete, partial, or missing for 38%, 24%, 39%, respectively. Elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) was present in 98% of patients, the median (IQR) ESR was 55 (42, 71) and CRP 49 (26, 79) mg/l, and 58% had anaemia. RF and ACPA were positive in 4% and 3%, respectively. 8/12 had ACPA values less than 2× the reference value. During follow-up ACPA was repeated in 8/12 patients and negativized in 6/8 patients. Among other pre-existing conditions, 51 (10%) had history of malignancy diagnosed a median 7 (3–11) years prior to diagnosis of PMR. EULAR/ACR classification criteria for PMR were fulfilled in 68% and 71% based on clinical and extended ultrasound criteria (missing items were imputed with 0), respectively. 14 (3%) patients had clinically overt concurrent giant cell arteritis (GCA).All patients were treated with methylprednisolone, administered orally in 99.4%, 93% started at 16mg qd. By the end of follow-up, 295 (60%) patients successfully discontinued methylprednisolone after a median of 117 (104, 143) weeks. Steroid sparing leflunomide and methotrexate were used by 66 (13%) and 27 (6%) patients, respectively. During a median follow-up of 150 (98, 244) weeks, 146 (30%) had at least one relapse. Median time to first relapse was 111 (50, 141) weeks. 54% relapsed after glucocorticoid discontinuation after a median time of 4 (2, 18) weeks, 9% presented with GCA, 12% relapsed due to treatment non-adherence. During the follow-up 6% were diagnosed with malignancies.Conclusion(1) With the IR of 46 per 105 adults ≥50 years, PMR is more common as rheumatoid arthritis in Slovenia. (2) A considerable proportion of patients required long-term glucocorticoid treatment, leaving a huge unmet need for safer therapeutic options.Disclosure of InterestsNone declared