A retrospective cohort study of 203 patients with Takayasu’s arteritis: Experience from a Brazilian tertiary center

doi:10.21203/rs.3.rs-5412116/v1

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A retrospective cohort study of 203 patients with Takayasu’s arteritis: Experience from a Brazilian tertiary center

https://doi.org/10.21203/rs.3.rs-5412116/v1

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Background. Takayasu arteritis (TAK) is a rare form of systemic vasculitis that primarily affects the aorta and its major branches. Despite several epidemiological studies on TAK, only a few descriptive studies have been conducted in our country, which motivated us to conduct this study.

Methods. This single-center retrospective cohort study included Brazilian TAK patients who underwent follow-up at a tertiary outpatient clinic between January 2000 and June 2024. Patient data were extracted from the electronic medical records via standardized and parameterized information.

Results. A total of 203 patients with TAK were included with a predominance of Caucasians (83.7%) and females (79.8%). The median age at disease diagnosis was 28.0 (interquartile range: 20.0-38.0) years, and the median follow-up period was 122.0 (49.0-177.0) months. During the initial or follow-up period, 65.0% of patients used glucocorticoids and 80.0% used immunosuppressive/immunobiological drugs. The three most common Hata classifications were V (46.8%), IV (23.2%), and I (22.7%). There was a high burden of cardiovascular risk factors, including hypertension (72.9%), dyslipidemia (59.1%), and renovascular hypertension (22.7%). When patients were analyzed by age quartile, elderly patients were predominantly without glucocorticoids and immunosuppressants and maintained sustained disease control.

Conclusions. This is the largest cohort study to include Brazilian patients with TAK. Even with higher cardiovascular risk factors than in other series, we observed lower rates of ischemic or cardiovascular events. Moreover, the frequency of disease activity and current treatment was restricted to the patients’ ages.

Disease activity

epidemiology

prevalence

Takayasu’s arteritis

vasculitis.

Takayasu arteritis (TAK) is a rare idiopathic chronic inflammatory disease that affects the aorta, its main branches, and the pulmonary artery. It can lead to vessel wall thickening, fibrosis, stenosis, occlusion, dilatation, or aneurysm formation in the involved vessels [1].

TAK predominantly affects women, with variations in worldwide distribution, and usually has its onset during the second or third decade of life [2].

In recent years, an increasing number of studies on the epidemiological and clinical aspects of TAK have been published in different countries, especially Europe [3], Asia [4–5], and North America [6]. In contrast, little is known about epidemiological data in Latin America, which is even more limited in Brazil. Notably, there are only two Brazilian studies exclusively on TAK with a short sample database, restricting the characterization of clinical aspects and therapeutic approaches [7,8]. In addition, two other studies on vasculitis in general, with a larger number of patients with TAK but little clinical and therapeutic information, were reported from a multicenter southern region perspective [9] and a comparison of two vasculitis referral centers from Brazil and Peru [10].

Therefore, this study aimed to assess the demographic and clinical features, imaging profiles at disease onset, and treatments administered to patients with TAK at a rheumatology outpatient clinic in the largest Brazilian tertiary center.

Study design. This single-center retrospective cohort study included Brazilian patients with TAK who underwent outpatient follow-up at our tertiary institution between January 2000 and June 2024.

Patients. The patients’ medical records were reviewed along with the American College of Rheumatology (ACR) 1990 classification criteria for TAK [11] and the classification criteria for TAK of the ACR/European League Against Rheumatism (EULAR) 2022 [1]. All patients had at least two appointments in the clinic to confirm the diagnosis and reassure their disease status.

Exclusion criteria. Patients with only one visit to the clinic and/or incomplete chart information of interest.

Data collection. The following data were collected from electronic medical records with preparametrized and prestandardized information:

Demographic data, age at clinical onset and TAK diagnosis, age at last visit, classification/diagnostic criteria used by the time of disease definition, and outpatient follow-up period;
Comorbidities (systemic arterial hypertension, dyslipidemia, renovascular hypertension, diabetes mellitus, stroke, cardiac insufficiency, pulmonary hypertension, neoplasia), habits (smoker or ex-smoker), and infections (tuberculosis);
Hata’s angiographic classification of TAK [12] at diagnosis, which is based on computed tomographic angiography, magnetic resonance angiography, positron emission tomography, or conventional angiography, made preferable at TAK diagnosis;
Disease activity at the last outpatient visit. Disease activity, measured by the Indian Takayasu’s arteritis activity score (ITAS) 2010, was defined as ITAS 2010 ≥ 2 [13], and remission was considered when there was no use of glucocorticoids or immunosuppressive drugs for more than six consecutive months with ITAS 2010 < 2;
Treatment (glucocorticoid, immunosuppressive, immunomodulators, or immunobiological drugs).

Statistical analysis. The distribution of variables was evaluated via the Shapiro-Wilk test. Continuous variables with nonnormal distribution were expressed as medians (interquartile range: 25th − 75th ), and categorical variables were represented as frequencies (%). Categorical variables were compared via the chi-square test or Fisher’s exact test, according to data distribution and statistical assumptions. Inferential analysis of variables (analyzed by age) with a nonnormal distribution was performed via the Kruskal-Wallis’s test. Patients were also divided into four interquartile groups according to their current age and compared according to the parameterized data described. Statistical significance was set at P < 0.05. All analyses were performed via the SPSS 22.0 software (version 22.0; IL, Armonk, NY, USA).

A total of 225 patients with TAK were evaluated. However, 22 patients were excluded based on the study’s exclusion criteria. Therefore, 203 patients with TAK were included in the present study: 170 (83.7%) were Caucasian, and 162 (79.8%) were female. The median age at disease onset was 28.0 years (20.0–38.0) (Table 1). The median follow-up duration was 122.0 (49.0-177.0) months.

Table 1

General features of the 203 Brazilian patients with Takayasu’s arteritis
Demographic data
Median age at disease diagnosis (years)	28.0 (20.0–38.0)
White ethnicity	170 (83.7)
Female sex	162 (79.8)
Angiographic classification
Hata I	46 (22.7)
Hata IIa	23 (11.3)
Hata IIb	11 (5.4)
Hata II	18 (8.9)
Hata IV	47 (23.2)
Hata V	95 (46.8)
Treatment (initial and cumulative)
None drugs	41 (20.2)
Glucocorticoid	132 (65.0)
Immunosuppressives, immunomodulators or biologicals	162 (80.0)
Data are shown as the median (25th -75th ), or frequency (%).

Regarding angiographic clusters, the most frequent Hata classifications were V (46.8%), IV (23.2%), and I (22.7%) (Table 1).

Approximately one-fifth of the patients did not receive any drug therapy for TAK at diagnosis or during follow-up. Glucocorticoids were administered to 65% of the patients, whereas immunosuppressive, immunomodulator, or immunobiological drugs were administered to 80.0% of the patients during follow-up.

During follow-up and the last outpatient clinical evaluation, methotrexate and azathioprine were administered to 12.8% and 12.3% of the patients, respectively, while infliximab and tocilizumab were the main immunobiological agents used, with 7.9% and 2.5% of the patients receiving them, respectively. No patients were using etanercept or adalimumab. The other drugs that were used are listed in Table 2.

Table 2

Treatment and disease status at the last clinical evaluation of 203 Brazilian patients with Takayasu arteritis, according to the current age quartile distribution
	44.0 years (34.0–53.0) (N = 203)	28.0 years (24.0–32.0) (n = 51)	40.5 years (38.0–43.0) (n = 51)	49.0 years (46.3–51.8) (n = 51)	60.0 years (55.5–66.0) (n = 50)
Pharmacological treatment
None	133(65.5)	22 (43.1)	29 (56.9)	37 (72.5)	45 (90.0)
Glucocorticoid
Current use	38(18.7)	18 (35.3)	10 (19.6)	7 (13.7)	3 (6.0)
Median dose (mg/day)	10.0 (5.0–25.0)	8.0 (5.0–20.0)	25.0 (13.8–40.0)	0.0 (5.0–60.0)	10.0 (5.0–10.0)
Methotrexate	27(13.3)	7 (13.7)	9 (17.6)	9 (17.6)	2 (4.0)
Azathioprine	25(12.3)	11 (21.6)	8 (15.7)	4 (7.8)	2 (4.0)
Leflunomide	11(5.4)	3 (5.9)	2 (3.9)	4 (7.8)	2 (4.0)
Mycophenolate mofetil	11(4.9)	6 (11.8)	3 (5.9)	0	1 (2.0)
Hydroxychloroquine	2(1.0)	0	2 (3.9)	0	0
Sulphasalazine	1(0.5)	0	0	1 (2.0)	0
Infliximab	17(8.4)	8 (15.7)	2 (3.9)	1 (2.0)	0
Tocilizumab	5(2.5)	2 (3.9)	2 (3.9)	1 (2.0)	0
Abatacept	1(1.0)	2 (3.9)	0	0	0
Disease status
Active (ITAS 2010 ≥ 2)	13(6.4)	8 (15.7)	4 (7.8)	1 (2.0)	0
Inactive (ITAS 2010 < 2)	190(93.6)	43 (84.3)	47 (92.2)	50 (98.0)	50 (100)
Data are shown as the median (25th -75th ), or frequency (%).
ITAS: Indian Takayasu’s arteritis activity score.

Antiplatelet therapy (acetylsalicylic acid) and statins were used in 81.8% and 64.0% of the patients, respectively.

At the last outpatient clinical evaluation, 13 (6.4%) patients reported active disease. Furthermore, 49.3% of the patients remain under follow-up, 3.0% have died, and 47.7% were either lost to follow-up or transferred to other outgoing services.

In an additional analysis, patients were stratified by age quartiles to examine treatment and disease status at the last outpatient clinical evaluation (Table 2). The mean ages within each quartile were 20.8, 40.5, 49.0 and 60.0 years. Azathioprine and methotrexate were the most commonly used immunosuppressive drugs across all quartiles. The proportion of patients without pharmacological treatment increased with age quartiles, with rates of 43.1%, 56.9%, 72.5%, and 90.0%. Biological therapy was not administered in the last quartile. This was directly related to the progressive proportion of inactive disease reported by the ITAS 2010, at 84.3%, 92.2%, 98.0%, and 100% in each quartile, respectively.

With respect to comorbidities and habits, systemic arterial hypertension was highly prevalent (72.9%), followed by dyslipidemia (59.1%) and renovascular hypertension (22.7%), and 16.7% had experience with tobacco, which 12.3% of smokers were abstinent (Table 3).

Table 3

Comorbidities, infections, and habits of the 203 Brazilian patients with Takayasu’s arteritis
Comorbidities
Systemic arterial hypertension	148 (72.9)
Dyslipidemia	120 (59.1)
Renovascular hypertension	46 (22.7)
Diabetes mellitus	31 (15.3)
Stroke	33 (16.3)
Cardiac insufficiency	31 (15.3)
Acute myocardial infarction	20 (9.6)
Pulmonary hypertension	14 (6.9)
Neoplasia	8 (3.9)
Infections
Tuberculosis	25 (12.3)
Habits
Smoker	9 (4.4)
Ex-smoker	24 (12.3)
The data are shown as frequencies (%).

Tuberculosis occurred in 12.3% of patients.

Despite several epidemiological studies on TAK, few descriptive studies have been conducted in our country. In this context, our data support the epidemiological profile and treatment experience of a large sample of patients followed-up in a tertiary outpatient Brazilian service. Notably, our study aimed to understand disease behavior with aging, suggesting lower disease activity with aging and a lower need for pharmacological therapy.

The strengths of this study include its large cohort size and long follow-up period, which included patients with rare systemic vasculitis. Moreover, we included patients who fulfilled both the 2019 ACR classification criteria [11] and the new 2022 ACR/EULAR classification criteria for TAK [1]. Despite changes in classification criteria and care practices over the study period (2000–2024), this sample still represents the local reality, given the similarities between our results and those of other Brazilian cohorts’ findings.

TAK is estimated to be the first or second most common vasculitis in southeast Brazil [9,10]. However, national and precise measurements are lacking. The country’s size and the mixed population of colonizers and immigrants, especially in the southeastern region, make it difficult to draw conclusions about the real prevalence and genetic, and environmental influences. The only population-based prevalence study of TAK in Brazil by Vieira et al. [8] reported a relatively high prevalence rate of 16.9 cases per million and was limited to the local public and private services of Rio de Janeiro. To our knowledge, there are no other population-based or multicenter studies representative of other locations in the country. For this reason, we assume that the epidemiological profile of the southeastern region tends to be a balance between Asian parameters, where Japan has the highest TAK prevalence (40 cases per million), followed by Turkey (14.7–33 cases per million), and European parameters, as their prevalence rates are intermediate (4.6–10.5 cases per million) [14].

Our study also revealed an early onset of TAK, with a mean age at diagnosis of 28 years, which is consistent with the findings of De Souza et al. [10], who reported a mean diagnosis age of 28,9 year for Brazilian patients, eight years earlier than the mean age of diagnosis of Peruvian patients. There was a female predominance, although there were more men than in previous Brazilian reports [7–10]. A multicenter study by Belem et al. [9] reported a female-to-male ratio of 8.3:1.0, whereas that in the present study was 3.9:1.0. Another unexpected finding, given the high population admixture in the country, is the high prevalence of white ethnicity in 83.7% of cases, which is a higher rate than that reported in other regional studies [9–10].

In Latin America, our epidemiological profile is very similar to that of single-center studies from Mexico [15] and Colombia [16], with no other studies available for comparison.

In our study, the proportion of patients with low disease activity and/or remission increased significantly with age. Notably, all patients in the last age quartile, between 55.5 and 65 years, sustained inactive disease as assessed by the ITAS-2010; 90% of them were off immunosuppressive therapy for over six months, and none were receiving immunobiological therapy. To corroborate our findings in relation to age and disease status, Schmidt et al. [6] concluded that older age at TAK diagnosis is associated with an increased likelihood of sustained remission. Additionally, in a small retrospective cohort of patients with TAK, Oliveira et al. [17] suggested that elderly patients with TAK, compared with younger patients with TAK, have a greater tendency to achieve complete remission without the need for pharmacological treatment, which is consistent with our findings.

Patients with TAK are known to have increased arterial stiffness and thickening, endothelial dysfunction, premature atherosclerosis [18], platelet dysfunction, and activation of procoagulant factors [19,20], leading to increased thrombotic risk. Classical cardiovascular risk factors, particularly smoking, systemic arterial hypertension, elevated LDL-cholesterol, and obesity, are more common in patients with TAK, with a 4.36 fold increased risk of cumulative incidence of cardiovascular events [21]. There is a consensus that there is greater cardiovascular morbidity and that secondary prevention is suboptimal in these patients [22]. Da Silva et al. [23] also showed a greater prevalence of metabolic syndrome in TAK patients than in healthy controls, mostly hypertension, dyslipidemia and overweight/obesity, and TAK was associated with high cardiovascular risk without a clear association with disease status. This may explain the greater risk of ischemic heart disease, peripheral vascular disease, and cerebrovascular disease and therefore, higher mortality, especially in the first three years after diagnosis [24].

In our study, there were more cardiovascular risk factors than ischemic clinical events because of either disease activity or sequelae. A large proportion of patients had renovascular hypertension (22.7%), which usually represents a more severe disease and is consistent with the large proportion of Hata V and IV patients. In addition, 16.7% of patients had current or previous exposure to tobacco, which is within the expected range for the general Brazilian population. Smoking is one of the main traditional cardiovascular risk factors related to mortality and ischemic vascular events in patients with TAK [24,25]. We did not perform this specific subanalysis, but it did not appear to have been a significant factor in our population given the relatively low rate of ischemic events observed.

This may be attributed to the referral of patients to a tertiary facility, where those with more severe disease at diagnosis and prolonged early glucocorticoid exposure are more commonly seen. Notably, 65% of our population used glucocorticoids at some point during follow-up, and Hata type V lesions were the most common, affecting 46.8% of patients. Also, limited primary healthcare coverage and delays in diagnosing and managing cardiovascular morbidities may have influenced these findings. Additionally, the use of aspirin appears to have a protective effect on reducing ischemic events in patients with TAK [22]. In our study, 81.8% and 64.0% of patients used acetylsalicylic acid and statins, respectively, a factor that potentially attenuated cerebral ischemic events and heart failure, even though we has higher rates of hypertension, renovascular hypertension, and dyslipidemia, respectively, than those reported in other studies [6,7,21].

There is a recognized association between TAK and a higher proportion of active tuberculosis cases. In our study, 12.3% of patients required treatment for active tuberculosis during follow-up, consistent with reported prevalence rates between 6.3% and 20% [27]. This may be attributed to endemic tuberculosis in the country or the high rate of glucocorticoid and/or immunosuppressant use among our patients.

The limitations of the present study are that we included only patients from a tertiary referral hospital center in the southeastern region without including local centers of lesser complexity, private clinics, or other regions of Brazil. Another consideration is the loss of follow-up, at 47.7%. We attribute this to either loss to follow-up, outpatient discharge or transfer of care to fewer complex services due to prolonged remission - but, even if we had continued the care of these patients, our remission rates would probably have been maintained or higher. Comparisons with other populations in the country should be made with caution. considering the uniqueness of racial issues, access to health services, and regional disparities.

This is the largest cohort study to include Brazilian patients with TAK. The patients tended to have earlier disease onset, more cardiovascular risk factors, particularly hypertension and renovascular hypertension, and more clinical cardiovascular events than did those in other local studies. Furthermore, older age was associated with a greater probability of sustained remission in the absence of immunosuppressive therapy.

ACR American College of Rheumatology

EULAR European League Against Rheumatism

ITAS Indian Takayasu’s arteritis activity score

TAK Takayasu arteritis

ETHICS APPROVAL AND CONSENT TO PARTICIPATE

This study was approved by the local ethics committee (CAAE 78848324.1.0000.0068).

CONSENT FOR PUBLICATION

Not applicable.

COMPETING INTERESTS

All authors declare that they have no conflicts of interest.

FUNDING

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq): #301500/2022-3

Author Contribution

Conceptualization and supervision: PCA, ANAD, SKS. Data curation: PCA, ANAD, SKS. Formal analysis: PCA, ANAD, ASF, CIE, and SKS. Investigation and methodology: PCA, ANAD, SKS. Writing draft, review and editing: All authors. All the authors approved the manuscript.

AVAILABILITY OF DATA AND MATERIALS

Not applicable.

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No competing interests reported.

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You are reading this latest preprint version

A retrospective cohort study of 203 patients with Takayasu’s arteritis: Experience from a Brazilian tertiary center

Status:

Version 1

Abstract

INTRODUCTION

PATIENTS AND METHODS

RESULTS

DISCUSSION

CONCLUSIONS

Abbreviations

Declarations

ETHICS APPROVAL AND CONSENT TO PARTICIPATE

FUNDING

Author Contribution

AVAILABILITY OF DATA AND MATERIALS

References

Additional Declarations

Status:

Version 1