OBJECTIVE: Patients with organ- or life-threatening vasculitis receive high cumulative glucocorticoid (GC) doses during their disease course. GC have diabetogenic effects, but the risk of diabetes mellitus (DM) related to vasculitis therapy is not well characterized. We assessed the DM risk among patients diagnosed with giant cell arteritis (GCA) or granulomatosis with polyangiitis (GPA), i.e., patients with relatively common forms of systemic vasculitis.
METHODS: We used Danish healthcare registries to identify 1682 patients diagnosed with GCA and 342 patients diagnosed with GPA from 1997 to 2015 and to obtain information regarding medication exposures. Each patient with vasculitis was matched with 9 population controls. Date of new-onset DM was defined as date of first claimed prescription for an antidiabetic drug. We used Cox regression analyses to calculate incidence rate ratios (IRR) for DM as a measure of the DM risk among patients relative to population controls. Logistic regression was used to study the association between prednisolone/prednisone (PRED) dose and DM.
RESULTS: Median duration of followup was 6.5 years [interquartile range (IQR) 2.6-10.4] in the GCA cohort and 5.8 years (IQR 1.7-10.6) in the GPA cohort. During the first year after diagnosis of vasculitis, the IRR for DM was 7.0 (95% CI 5.2-9.3) among patients with GCA and 10.4 (95% CI 4.4-24) among patients with GPA. IRR for DM were not significantly increased in either cohort during later followup periods. Within the first year, treatment with high cumulative prednisolone/PRED doses was associated with new-onset DM among the patients with vasculitis.
CONCLUSION: Patients diagnosed with GCA or GPA have a markedly increased risk of new-onset DM during early treatment phases.
AIM: Analysis of the characteristics of very elderly patients with giant cell arteritis (GCA).
METHODS: Patients aged 80 years and older diagnosed with GCA in our department between 1 January 2002 and 31 July 2008 were retrospectively included. For each patient, we recorded general characteristics, reason(s) for hospitalization, specialty of the physician or department that referred the patient to us, medical history, treatment at admission, GCA clinical features, time to diagnosis of GCA, biological screening and GCA treatment.
RESULTS: We analyzed 25 clinical records, 18 women and seven men with a mean age of 83.9 years. General weakness, visual loss and inflammatory syndrome were the principal reasons for hospitalization. Patients were mainly referred by general practitioners or ophthalmological departments. At diagnosis, headache and musculoskeletal disorders were the most frequent signs (52% each), before general weakness and visual disorders. Time to diagnosis was 2.2 months. Inflammatory syndrome was very frequent (92%). Biopsy of the temporal artery confirmed GCA in 16 cases. Corticosteroid therapy (CST) mean dose was 0.9 mg/kg/day. Because of the positive evolution, CST was stopped in nine patients after 22.7 ± 15 months. A total of 22 patients received a preventive osteoporosis treatment. After 3 months of CST, clinical signs and IS vanished in 22 patients. CST complications, mainly infection, appeared in 17 patients.
CONCLUSION: Clinical and biological features of GCA in the very elderly patients of the present study were comparable with those described in the literature in younger patients. However, it must be pointed out that our patients were not compared with a younger population in this study. Geriatr Gerontol Int 2015; ●●: ●●-●●.
BACKGROUND/AIM: To determine the epidemiology and clinical features of biopsy-proven giant cell arteritis (GCA) in South Australia (SA).
METHODS: Patients with biopsy-proven GCA were identified from pathology reports of temporal artery biopsies at SA Pathology laboratories, from 1 January 1992, to 31 July 2011. Epidemiological data were collected through patient questionnaires and standardised case note reviews. Incidence was estimated using Australian Bureau of Statistics population data for SA. Seasonality was analysed by Cosinor analysis, and time-to- event analysis was performed for the duration of steroid use.
RESULTS: There were 314 cases of biopsy-proven GCA (72% female). The mean age at diagnosis of GCA was 78 years (interquartile range 72-82). The estimated population incidence for people over 50 was 3.2 per 100,000 person years. The female : male incidence ratio was 2.3 (P < 0.001), and incidence increased with each age decade. There was evidence of seasonal variation (P = 0.015), with higher rates observed in the summer months. Clinical data were available for 163 patients (68% female, median age 78 years). The most common presenting clinical features were temporal headache (74%), visual disturbance (68.4%), jaw claudication (59.3%) and symptoms of polymyalgia rheumatica (56%). The median initial steroid dose was 60 mg, with median duration of steroid use 4.5 years. Corticosteroid side-effects were common, affecting 89%, with 34% reporting five or more.
CONCLUSIONS: This is the first epidemiological study of Australian biopsy-proven GCA patients. Age at onset and gender associations were similar to other Western populations. There was a high burden of steroid use in these patients.
OBJETIVOS: Evaluar el efecto de la adición de un tratamiento de 10 semanas de adalimumab a un tratamiento estandarizado con corticosteroides sobre la capacidad para disminuir más rápidamente dosis de corticosteroides en pacientes con arteritis de células gigantes recién diagnosticada (ACG).
MÉTODOS: Los pacientes incluidos en este estudio doble ciego, multicéntrico, controlado fueron asignados al azar para recibir un tratamiento subcutáneo de 10 semanas de adalimumab 40 mg cada dos semanas o placebo además de un régimen de prednisona estándar (dosis inicial de 0,7 mg / kg por día) . El criterio principal de valoración fue el porcentaje de pacientes en remisión con menos de 0,1 mg / kg de prednisona en la semana 26. El análisis se realizó por intención de tratar (ITT).
RESULTADOS: De los 70 pacientes incluidos (adalimumab, n = 34; placebo, n = 36), 10 pacientes no recibieron el tratamiento programado, las siete de la adalimumab y tres en el grupo de placebo. Por ITT, el número de pacientes que alcanzaron el punto final primario fue de 20 (58,9%) y 18 (50,0%) en el grupo de adalimumab y placebo, respectivamente (p = 0,46). La disminución de la dosis de prednisona y la proporción de pacientes que estaban libres de brotes no fue diferente entre los dos grupos. Los eventos adversos graves se produjeron en cinco (14,7%) pacientes tratados con adalimumab y 17 (47,2%) en el grupo placebo, incluyendo infecciones graves en pacientes en tres adalimumab y cinco en el grupo placebo. Dos pacientes murieron en el grupo de placebo (choque séptico y el cáncer) y uno en el grupo de adalimumab (neumonía).
Conclusiones: En los pacientes con diagnóstico reciente de la ACG, la adición de un tratamiento de 10 semanas de adalimumab a la prednisona no aumentó el número de pacientes en remisión con menos de 0,1 mg / kg de corticosteroides a los 6 meses.
CLÍNICA NÚMERO DE PRUEBA DE REGISTRO: NCT00305539.
Giant cell arteritis (GCA) is a relapsing disease. However, the nature, chronology, therapeutic impact, and clinical consequences of relapses have been scarcely addressed. We conducted the present study to investigate the prevalence, timing, and characteristics of relapses in patients with GCA and to analyze whether a relapsing course is associated with disease-related complications, increased glucocorticoid (GC) doses, and GC-related adverse effects. The study cohort included 106 patients, longitudinally followed by the authors for 7.8 ± 3.3 years. Relapses were defined as reappearance of disease-related symptoms requiring treatment adjustment. Relapses were classified into 4 categories: polymyalgia rheumatica (PMR), cranial symptoms (including ischemic complications), systemic disease, or symptomatic large vessel involvement. Cumulated GC dose during the first year of treatment, time required to achieve a maintenance prednisone dose <10 mg/d (T10), <5 mg/d (T5), or complete prednisone discontinuation (T0), and GC-related side effects were recorded. Sixty-eight patients (64%) experienced at least 1 relapse, and 38 (36%) experienced 2 or more. First relapse consisted of PMR in 51%, cranial symptoms in 31%, and systemic complaints in 18%. Relapses appeared predominantly, but not exclusively, within the first 2 years of treatment, and only 1 patient developed visual loss. T10, T5, and T0 were significantly longer in patients with relapses than in patients without relapse (median, 40 vs 27 wk, p < 0.0001; 163 vs 89.5 wk, p = 0.004; and 340 vs 190 wk, p = 0.001, respectively). Cumulated prednisone dose during the first year was significantly higher in relapsing patients (6.2 ± 1.7 g vs 5.4 ± 0.78 g, p = 0.015). Osteoporosis was more common in patients with relapses compared to those without (65% vs 32%, p = 0.001). In conclusion, the results of the present study provide evidence that a relapsing course is associated with higher and prolonged GC requirements and a higher frequency of osteoporosis in GCA.
OBJECTIVE: To assess the occurrence of adverse events in a cohort of patients with polymyalgia rheumatica (PMR), treated with low-dose glucocorticoids (GC).
METHODS: This was a retrospective study by review of medical records.
RESULTS: We identified 222 patients who had a mean duration of followup of 60 ± 22 months and a mean duration of GC therapy of 46 ± 22 months. We found that 95 patients (43%) had at least 1 adverse event after a mean duration of GC therapy of 31 ± 22 months and a mean cumulative dose of 3.4 ± 2.4 g. In particular, 55 developed osteoporosis, 31 had fragility fractures; 27 developed arterial hypertension; 11 diabetes mellitus; 9 acute myocardial infarction; 3 stroke; and 2 peripheral arterial disease. Univariate analysis showed that the duration of GC treatment was significantly associated with osteoporosis (p < 0.0001), fragility fractures (p < 0.0001), arterial hypertension (p < 0.005), and acute myocardial infarction (p < 0.05). Cumulative GC dose was significantly associated with osteoporosis (p < 0.0001), fragility fractures (p < 0.0001), and arterial hypertension (p < 0.01). The adverse events occurred more frequently after 2 years of treatment. Multivariate analysis showed that GC duration was significantly associated with osteoporosis (adjusted OR 1.02, 95% CI 1.02-1.05) and arterial hypertension (adjusted OR 1.03, 95% CI 1.01-1.06); GC cumulative dose was significantly associated with fragility fractures (adjusted OR 1.4, 95% CI 1.03-1.8).
CONCLUSION: Longterm, low-dose GC treatment of PMR is associated with serious adverse events such as osteoporosis, fractures, and arterial hypertension; these adverse events occur mostly after 2 years of treatment.
We conducted the present study to determine the incidence of disease flares (relapses and recurrences) in a series of patients with biopsy-proven giant cell arteritis (GCA). We assessed a series of 174 patients who were diagnosed with biopsy-proven GCA, uniformly treated, and followed at the rheumatology division of Hospital Xeral-Calde (Lugo, Spain), the single rheumatology division for a well-defined population. All of them were followed for at least 1 year after the disease diagnosis. Seventy-one (40.8%) experienced relapses or recurrences of the disease. Patients who had relapses or recurrences did not show clinical differences when compared with the remaining biopsy-proven GCA patients. However, the total duration of corticosteroid therapy was significantly longer in those patients who had relapses or recurrences of the disease. The median dose of prednisone and the median duration of corticosteroid treatment at the time of the first relapse were 5 mg/d and 16 months, respectively. Headache (52%) was the most common feature at the time of the first relapse. Polymyalgia rheumatica manifestations occurred in 30% of the patients at that time. However, none of them developed visual loss. Thirty-two patients experienced recurrences of the disease when prednisone dose had been discontinued. The median time from the disease diagnosis to the time of the recurrence was 23 months. The presence of anemia (hemoglobin <12 g/dL) at the time of disease diagnosis was the best predictor of relapses or recurrences of GCA (odds ratio, 2.17; 95% confidence interval, 1.02-4.62; p = 0.04). The results from the present study confirm that relapses and recurrences are frequent in homogenously treated patients with biopsy-proven GCA. A chronic inflammatory response manifested by anemia at the time of disease diagnosis may predict the development of disease flares.
BACKGROUND: Giant cell arteritis (GCA) is a systemic vasculitis of the elderly that could result in vision loss or even be life threatening. Unlike western countries, this disease is considered exceptional in Tunisia.
OBJECTIVE: The aims of this study were to determine epidemiological and clinical features of GCA in Tunisian population and to identify management difficulties.
PATIENTS AND METHODS: A multicentric study of 96 patients in whom GCA was diagnosed between 1986 and 2003. All patients fulfilled the ACR criteria for classification of GCA.
RESULTS: The majority of cases (77%) were diagnosed since 1994. The male/female ratio was 0.88 and the mean age at the time of diagnosis was 70.8+/-7.7 years. Clinical features were characterized by gradual onset in 64.4% of cases. The most frequent clinical manifestations were headache (91.7%), abnormalities in temporal arteries (85.4%), severe ischemic manifestations (80.2%), constitutional symptoms (75%), and polymyalgia rheumatica (56.3%). Biological inflammatory syndrome was noted in all patients. Temporal artery biopsy established histological diagnosis in 73% of cases. All patients were treated by corticosteroids. Remission was obtained in 45.6%. Relapses occurred in 40.4% of cases and 30 patients were still receiving corticosteroids at the time of study. Four patients died and irreversible ischemic complications were noted in 15.6% of cases. Steroid adverse effects occurred in 56 patients.
CONCLUSION: GCA is not exceptional to Tunisia. It occurs amongst elderly patients with no female predominance noticed. Clinical features are similar to those reported in other series.
Patients with organ- or life-threatening vasculitis receive high cumulative glucocorticoid (GC) doses during their disease course. GC have diabetogenic effects, but the risk of diabetes mellitus (DM) related to vasculitis therapy is not well characterized. We assessed the DM risk among patients diagnosed with giant cell arteritis (GCA) or granulomatosis with polyangiitis (GPA), i.e., patients with relatively common forms of systemic vasculitis.
METHODS:
We used Danish healthcare registries to identify 1682 patients diagnosed with GCA and 342 patients diagnosed with GPA from 1997 to 2015 and to obtain information regarding medication exposures. Each patient with vasculitis was matched with 9 population controls. Date of new-onset DM was defined as date of first claimed prescription for an antidiabetic drug. We used Cox regression analyses to calculate incidence rate ratios (IRR) for DM as a measure of the DM risk among patients relative to population controls. Logistic regression was used to study the association between prednisolone/prednisone (PRED) dose and DM.
RESULTS:
Median duration of followup was 6.5 years [interquartile range (IQR) 2.6-10.4] in the GCA cohort and 5.8 years (IQR 1.7-10.6) in the GPA cohort. During the first year after diagnosis of vasculitis, the IRR for DM was 7.0 (95% CI 5.2-9.3) among patients with GCA and 10.4 (95% CI 4.4-24) among patients with GPA. IRR for DM were not significantly increased in either cohort during later followup periods. Within the first year, treatment with high cumulative prednisolone/PRED doses was associated with new-onset DM among the patients with vasculitis.
CONCLUSION:
Patients diagnosed with GCA or GPA have a markedly increased risk of new-onset DM during early treatment phases.
