Severe Cutaneous Adverse Reactions to Drugs in Latin America: The RACGRAD Study.

BACKGROUND AND OBJECTIVE: Severe cutaneous adverse reactions to drugs (SCARs) are associated with high morbidity and mortality and with sequelae. Objective: To characterize patients with SCARs in 8 health care institutions in Latin America. METHODS: We performed a cross-sectional, descriptive, multicenter study of patients diagnosed with SCARs in Latin America between January 2009 and December 2018. The analysis was carried out using a database in BD Clinic. RESULTS: We collected 70 patients, of whom 42 (60%) were women. Mean age was 38.7 years. Forty-two patients (60%) had DRESS-DIHS, 12 (17.1%) TEN, 5 (7.1%) SJS, 6 (8.5%) AGEP, 4 (5.7%) other reactions not classified as SCARs, and 1 (1.4%) overlapping SJS-TEN. The main causative drugs were aromatic anticonvulsants in 31 cases (44.3%), ß-lactam antibiotics in 11 cases (15.7%), and non-ß-lactam antibiotics in 6 cases (8.6%). In all of the cases, the suspected drug was withdrawn at the first sign of a SCAR. Sixty-six patients (94.2%) received anti-inflammatory treatment, mostly systemic corticosteroids. Complications occurred in 53 cases (75.7%), and 3 patients died (4.3%). Thirteen patients (18.6%) had sequelae. CONCLUSIONS: This is the first multicenter report on SCARs in Latin America. DRESS-DIHS was the most frequently reported clinical entity, and anticonvulsants were the main triggers. Most of the patients received systemic corticosteroids. Complications were frequent, and 3 patients died.

Severe Cutaneous Adverse Reactions to Drugs in Latin America: The RACGRAD Study

Background: Severe cutaneous adverse reactions to drugs (SCARs) are associated with high morbidity and mortality and with sequelae. Objective: To characterize patients with SCARs in 8 health care institutions in Latin America. Methods: We performed a cross-sectional, descriptive, multicenter study of patients diagnosed with SCARs in Latin America between January 2009 and December 2018. The analysis was carried out using a database in BD Clinic. Results: We collected 70 patients, of whom 42 (60%) were women. Mean age was 38.7 years. Forty-two patients (60%) had DRESS-DIHS, 12 (17.1%) TEN, 5 (7.1%) SJS, 6 (8.5%) AGEP, 4 (5.7%) other reactions not classified as SCARs, and 1 (1.4%) overlapping SJS-TEN. The main causative drugs were aromatic anticonvulsants in 31 cases (44.3%), ß-lactam antibiotics in 11 cases (15.7%), and non–ß-lactam antibiotics in 6 cases (8.6%). In all of the cases, the suspected drug was withdrawn at the first sign of a SCAR. Sixty-six patients (94.2%) received anti-inflammatory treatment, mostly systemic corticosteroids. Complications occurred in 53 cases (75.7%), and 3 patients died (4.3%). Thirteen patients (18.6%) had sequelae. Conclusions: This is the first multicenter report on SCARs in Latin America. DRESS-DIHS was the most frequently reported clinical entity, and anticonvulsants were the main triggers. Most of the patients received systemic corticosteroids. Complications were frequent, and 3 patients died (AU)

Learnings from real-life experience of using omalizumab for chronic urticaria in Latin America.

BACKGROUND: Updated urticaria guidelines recommend that patients should be assessed for disease activity, severity, control, and quality of life at baseline and follow up. Regarding treatment, guidelines consider second generation antihistamines as the cornerstone in therapy for chronic urticaria (CU), while other drugs, such as omalizumab, are conceived as second-line alternatives. In regards to omalizumab, despite advances in the management of CU, there are still open questions about timing, dosing, and objective measures for clinical response. This study was designed to portray the use of patient-reported outcomes (PROs) in chronic urticaria management, as well as the effectiveness and treatment patterns of omalizumab in CU, as seen in a real-life setting in Latin America. METHODS: This is a retrospective observational study, involving 72 Latin American patients with chronic urticaria treated with omalizumab. Patient reported outcomes and treatment patterns, response, quality of life improvement and discontinuation were analyzed. RESULTS: From the 72 patients, 91.7% (n = 66) were assessed through PROs, where urticaria control test (UCT) was the most used (79.2%; n = 57). Overall, 80.0% (n = 44) responded to omalizumab at some point of the treatment. Omalizumab 300 mg was associated with earlier response compared to lower doses. Regardless of dosage, most patients assessed with CU-Q2oL improved quality of life (80.8%; n = 21). With respect to omalizumab discontinuation, 20.8% (n = 15) patients interrupted omalizumab before the 3rd month of treatment (p = .000). CONCLUSIONS: The present study highlights how the use of PROs and omalizumab in Latin America differ from guidelines' recommendations and clinical trials. Even though most patients were initiated under omalizumab 300 mg, most of them finished with lower doses. Regardless of dosage, most patients responded to omalizumab and improved quality of life at some point during treatment. However, such features were seen earlier with omalizumab 300 mg. Regarding treatment discontinuation, one-fifth of patients interrupted omalizumab before the third month.

Quality of life and clinical characterization of patients with vernal keratoconjunctivitis in a pediatric population in Colombia

Vernal keratoconjunctivitis is one of the most serious ocular allergies that have the potential to induce large ocular morbidity and significant visual changes affecting the quality of life of these individuals. Methodology: This study was conducted in two phases. The first phase consisted of the clinical characterization of 32 patients from the Clinical Allergology center of the I.P.S. Universitaria from July 2014 to February 2015. A retrospective analysis of medical records was performed. In the second phase, the evaluation of quality of life was conducted using the questionnaire KIDSCREEN 27, which was validated in our population and evaluated as recommended by the creators of this instrument. Results: A total of 24 patients (75%) were men, mean age of 12.1 (SD 2.6) years. 100% of the patients had clinical evaluation and were monitored by Allergology and Ophthalmology, 12 patients (37.5%) were found in mild level, 5 patients (15.6%) were moderate and 14 patients (43.8%) were severe level. The most common symptoms were pruritus (75%), photophobia (50%), lacrimation (37.5%), and secretions (28.1%). 5.6% had a family history of atopy and 84.4% had an allergic comorbidity. Aeroallergen skin tests were found positive in 25 patients (78.1%). All patients had initiated ocular treatment by the time the survey of quality of life was conducted; but, they still had low quality of life scores in the 5 domains assessed. When the scores were evaluated by gender, the only statistically significant difference was found in the domain of family life and free time, which was lower for women. Conclusion: The vernal keratoconjunctivitis is a disease more prevalent in men. It apparently has an important atopic base in our environment, which due to its severe ocular involvement causes a marked decrease in the quality of life of the children who present it

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Quality of life and clinical characterization of patients with vernal keratoconjunctivitis in a pediatric population in Colombia.

Vernal keratoconjunctivitis is one of the most serious ocular allergies that have the potential to induce large ocular morbidity and significant visual changes affecting the quality of life of these individuals. METHODOLOGY: This study was conducted in two phases. The first phase consisted of the clinical characterization of 32 patients from the Clinical Allergology center of the I.P.S. Universitaria from July 2014 to February 2015. A retrospective analysis of medical records was performed. In the second phase, the evaluation of quality of life was conducted using the questionnaire KIDSCREEN 27, which was validated in our population and evaluated as recommended by the creators of this instrument. RESULTS: A total of 24 patients (75%) were men, mean age of 12.1 (SD 2.6) years. 100% of the patients had clinical evaluation and were monitored by Allergology and Ophthalmology, 12 patients (37.5%) were found in mild level, 5 patients (15.6%) were moderate and 14 patients (43.8%) were severe level. The most common symptoms were pruritus (75%), photophobia (50%), lacrimation (37.5%), and secretions (28.1%). 65.6% had a family history of atopy and 84.4% had an allergic comorbidity. Aeroallergen skin tests were found positive in 25 patients (78.1%). All patients had initiated ocular treatment by the time the survey of quality of life was conducted; but, they still had low quality of life scores in the 5 domains assessed. When the scores were evaluated by gender, the only statistically significant difference was found in the domain of family life and free time, which was lower for women. CONCLUSION: The vernal keratoconjunctivitis is a disease more prevalent in men. It apparently has an important atopic base in our environment, which due to its severe ocular involvement causes a marked decrease in the quality of life of the children who present it.

Health-related quality of life in children and adults with respiratory allergy in Colombia: Prospective study

Background: Allergic diseases are very common, with the estimated cumulative prevalence in Colombia for asthma and allergic rhinitis being 22.7% and 31.3% respectively, and with a clear upward trend. A major social as well as economic impact associated with allergic disease has been described. Because in Colombia there are no studies that assess the Health-Related Quality of Life (HRQOL) in allergic respiratory diseases, our aim is to describe the HRQOL in subjects with respiratory allergy and its association with clinical control variables. Methods: A prospective descriptive study was conducted among 76 Colombian subjects with rhinitis and asthma/allergic rhinitis. In order to evaluate the HRQOL, the instruments Kidscreen-27 and SF-36 were applied. The scores obtained in the HRQOL fields were correlated with the following clinical variables: peak expiratory flow (PEF) and peak nasal inspiratory flow (PNIF). Results: In children, the better HRQL domain is present in the school environment (55.9) and the worst in psychological well-being (39.9). For adults the worst HRQL was found in the emotional function domain (55.6) while the physical function (81.7) had the best. There were no statistical differences between groups of asthma/allergic rhinitis and allergic rhinitis. Subjects with allergic asthma showed a strong correlation between the mental health domain and PEF values (r=−0717, p=0.046). Conclusion: Mental health is more affected than physical health in Colombian subjects with respiratory allergy. There was a strong correlation between the mental health domain and the values of PEF in patients with asthma/allergic rhinitis(AU)

Health-related quality of life in children and adults with respiratory allergy in Colombia: prospective study.

BACKGROUND: Allergic diseases are very common, with the estimated cumulative prevalence in Colombia for asthma and allergic rhinitis being 22.7% and 31.3% respectively, and with a clear upward trend. A major social as well as economic impact associated with allergic disease has been described. Because in Colombia there are no studies that assess the Health-Related Quality of Life (HRQOL) in allergic respiratory diseases, our aim is to describe the HRQOL in subjects with respiratory allergy and its association with clinical control variables. METHODS: A prospective descriptive study was conducted among 76 Colombian subjects with rhinitis and asthma/allergic rhinitis. In order to evaluate the HRQOL, the instruments Kidscreen-27 and SF-36 were applied. The scores obtained in the HRQOL fields were correlated with the following clinical variables: peak expiratory flow (PEF) and peak nasal inspiratory flow (PNIF). RESULTS: In children, the better HRQL domain is present in the school environment (55.9) and the worst in psychological well-being (39.9). For adults the worst HRQL was found in the emotional function domain (55.6) while the physical function (81.7) had the best. There were no statistical differences between groups of asthma/allergic rhinitis and allergic rhinitis. Subjects with allergic asthma showed a strong correlation between the mental health domain and PEF values (r=-0717, p=0.046). CONCLUSION: Mental health is more affected than physical health in Colombian subjects with respiratory allergy. There was a strong correlation between the mental health domain and the values of PEF in patients with asthma/allergic rhinitis.