Single center experience with more than 600 drug desensitization in Colombia.

Background: Drug hypersensitivity reactions (DHRs) have a significant impact on both, patient and their treating physicians; it is considered a public health concern. The history of allergy to drugs, limits therapeutic options and will lead to the use of more expensive and potentially less effective options. Drug desensitization (DD) is considered as a procedure with a positive impact on the prognosis of the patient's disease. The objective of this study is to describe the experience with a substantial number of drugs desensitization in a fourth level center in Cali, Colombia. Methods: An observational, cross-sectional and descriptive study was conducted. Patients with DHRs who underwent a standardized institutional DD protocol, between March of 2012 and May of 2023, were included. Results: Two hundred forty-one patients were included. The median age was 47.8 years (4-88). One hundred fifty-six (64.7%) were women, including three who were pregnant. A total of 641 DDs were performed. The most frequent groups of drugs for which the desensitization was performed were monoclonal antibodies in 83 patients (34.4%), chemotherapeutic agents in 53 (21.6%), NSAIDs in 44 (18.2%), and antibiotics in 42 (17.4%). Eighty-seven patients (36.1%) experienced hypersensitivity to the culprit drug on first exposure, while 154 (63.9%) exhibited reactions during subsequent cycles. The main clinical presentation that gave rise to desensitization was anaphylaxis in 125 patients (51.8%), followed by cutaneous symptoms in 106 patients (44%). The predominant observed endophenotype was type 1 in 188 patients (78.3%), followed by mixed type in 46 patients (19.2%). Breakthrough reactions were observed in 50 patients (20.7%). Tolerance to DD was achieved in 636 of the procedures (99.2%), allowing the continuity of treatment of choice for the underlying disease. Conclusions: Most desensitized patients were women with type I reactions. Monoclonal antibodies were the most frequent culprit drugs. DD in patients with DHRs is a useful, safe and effective procedure. The administration of the implicated drug had a positive impact on the course of the disease in these patients.

Multicentric and Observational Study of Omalizumab for Chronic Spontaneous Urticaria in Real-Life in Colombia.

Background: Although chronic urticaria (CU) is a common, cause of medical consulting both in general practitioners and allergist specialists worldwide, there is little information about its behavior and management in Latin America. Currently, national and international guidelines recommend using Omalizumab for cases refractory to management with antihistamines. Despite advances in the knowledge of Omalizumab for the management of CU, although there are few studies in underdeveloped countries, there are many studies evaluating the impact of Omalizumab treatment. There is not clinical information related with CSU-Omalizumab in patient settled in the Caribbean area. This research aims to evaluate the management of CU with Omalizumab in a real-life scenario in Colombia. Methodology: We conducted an observational, descriptive, and retrospective study with patient recruitment between 2014 and 2017 of individuals diagnosed with Chronic Urticaria (CU) treating allergology specialists in five Colombian cities. We included patients with CU who failed to achieve disease control after treatment for 4 weeks with fourfold doses of second-generation H1-antihistamines, as recommended by the EAACI/GA2LEN/EDF/WAO guidelines and who received treatment with Omalizumab. Results: We included 123 patients, 73.1% (n = 90) were women. The mean age was 47.1 years (Standard Deviation, SD: 16.2). The median of the total months of disease evolution was 30 (IQR = 13-58). 81.3 % (n = 100) of patients were diagnosed with chronic spontaneous urticarial (CSU). 4.8% (n = 6) had inducible CU (CIndU), and 13.8% (n = 17) reported mixed urticaria (spontaneous CU with at least one inducible component). Regarding emotional factors, 34.9% (n = 43) of subjects indicated anxiety symptoms, 34.1% (n = 42) had exacerbations associated with stress, and 14.6% (n = 18) manifested episodes of sadness. The percentage of patients with CSU controlled according to medical criteria at 3 months with Omalizumab were 80% (n = 80/100) and at 6 months 87% (n = 87/100). The frequency of adverse events was 29.2% (n = 36), with headache being the most frequent adverse event. Conclusions: This real-life study with Omalizumab at CU describes percentages of effectiveness and safety similar to those observed in pivotal and real-life studies conducted in other regions around the world.

Meloxicam and/or Etoricoxib Could Be Administered Safely in Two Equal Doses during an Open Oral Challenge in Patients with Nonsteroidal Anti-Inflammatory Drug Hypersensitivity.

BACKGROUND: Hypersensitivity reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) are common. These patients require an effective and safe analgesic alternative. OBJECTIVE: The aim of the study was to demonstrate the safety of meloxicam and etoricoxib administered by open oral challenge in 2 equal steps in patients with NSAID hypersensitivity. METHODS: A cross-sectional, descriptive study of patients with a diagnosis of NSAID hypersensitivity who underwent an oral drug provocation test (DPT) with meloxicam or etoricoxib between January 2011 and August 2017 was conducted. The analysis was performed from a database in BD Clinic. RESULTS: Two hundred and twenty-eight oral provocations were performed with an alternative NSAID (203 with meloxicam and 25 with etoricoxib) in 217 patients with hypersensitivity to NSAIDs. The median age was 38 years. Ninety-eight percent of meloxicam and 100% of etoricoxib DPTs were performed in 2 steps (without previous placebo), and 52% and 64% of meloxicam and etoricoxib DPTs, respectively, were performed with 50% of the therapeutic dose in each step. Tolerance to meloxicam was demonstrated in 192 patients (94.5%) and in 100% of patients receiving etoricoxib. CONCLUSIONS: Open oral provocation with meloxicam and etoricoxib carried out in 2 steps without placebo seems to be safe and implies less costs and less time expenditure. Also, it could be performed with 2 equal doses.

Descriptive analysis of a simplified approach to low-risk drug hypersensitivity reactions.

BACKGROUND: Evaluation of drug allergy is intricate because of nonstandardized testing and challenge method variability. OBJECTIVE: To determine the clinical and epidemiologic characteristics of a large group of patients with suspected drug allergies who underwent 1 or more provocation tests (PT), and to establish whether performing this test in fewer steps is safe and effective. METHODS: A cross-sectional descriptive study was conducted in patients with suspected drug allergies who underwent a provocation test at the allergy service of Fundación Valle del Lili, Cali, Colombia, from January 2011 to August 2017. RESULTS: A total of 508 patients underwent 615 PTs; the median age was 34.5 years (range, 1-87 years) and 332 were women (65.3%). The most frequently implicated drugs were nonsteroidal anti-inflammatory drugs in 362 patients (58.9%), followed by beta-lactam antibiotics in 170 (27.6%), and non-beta-lactam antibiotics in 21 (3.4%). The most typically described manifestations were cutaneous urticaria in 282 patients (45.8%) and angioedema in 220 (35.7%). Most patients underwent the PT without performing other previous tests, which were done in only 92 patients (18.3%). Skin prick tests and intradermal reaction tests were performed in 81 patients (15%); all results were negative. In 519 patients (84.3%), the PT was performed in 2 steps without a placebo. Of the PTs performed in 2 steps, 492 (94.8%) had negative results. In addition, PT was performed in 195 patients (37.6%) in whom 2 equal doses of the drug was administered; 186 patients (95.4%) had negative results. CONCLUSION: Performing an open PT (without previous tests) in 2 steps among patients with low-risk drug reactions is safe. However, every case must be analyzed individually in terms of the risk-benefit ratio.