Real life study of three years omalizumab in patients with difficult-to-control asthma.

BACKGROUND: Even though there are multiple options for the treatment of asthma, there still exists a fair group of patients with difficult-to-control asthma. We describe for the first time the real-world effects of three-year omalizumab treatment on patients with difficult-to-control asthma, seen in a social security hospital in a Latin American country. METHODS: Difficult-to-control asthmatic patients from the out-patient clinic of a regional hospital were recruited to receive a three-year omalizumab course. Efficacy parameters were asthma control test (ACT) score; FEV1; daily beclomethasone maintenance dose; and unplanned visits for asthma exacerbations (emergency room (ER), hospitalisations, intensive care). RESULTS: 52 patients were recruited, 47 completed the three-year treatment (42 female, 15-67 years, mean age 43.5). Comparing efficacy parameters of the year before omalizumab with the 3rd year of omalizumab: mean ACT improved from 12.4 to 20.5, mean FEV1 from 66.3% (standard deviation (SD) 19.1%) to 88.4% (SD 16.2%) of predicted, while mean beclomethasone dose reduced from 1750 to 766 mcg/day and there was a significant reduction in patients experiencing ER visits (from 95% to 19%, p<0.0001), hospitalisation (38% to 2%, p<0.0001) and intensive care (4% to 0, NS). Five patients discontinued omalizumab, two because of an adverse event (anaphylaxis, severe headache, both resolved without sequelae). CONCLUSION: Omalizumab improved most clinical parameters of Mexican patients with difficult-to-control asthma. Especially the rates of ER visits and hospitalisation were significantly reduced, thus reducing costs. Omalizumab was generally well tolerated.

[Experiencia inicial de Lanadelumab en una paciente mexicana con angioedema hereditario tipo I].

Background: Hereditary angioedema type 1 (HAE1) is an autosomal dominant disorder, characterized by quantitative and qualitative deficiency of C1 inhibitor, excessive production of bradykinin and causing recurrent angioedema in varying degrees of severity that affects quality of life and life itself. from the patients. Lanadelumab is a human monoclonal antibody, a specific inhibitor of plasma kallikrein, approved for long-term prophylaxis of HAE1. Case report: A 59-year-old female patient, diagnosed with HAE 1 since November 1987, without therapeutic response to danazol, fresh frozen plasma, or C1 inhibitor derived from intravenous plasma, requiring 3 to 9 monthly vials of icatibant acetate due to angioedema. laryngeal, cutaneous and visceral with highly altered quality of life indices. Lanadelumab 300 mg subcutaneously every 14 days was started. At the start of treatment, the AECT1 score was 1 point; AE-Qol2: 57 points, AAS3: 32 points, being followed up at 5, 10 and 12 months. After one year of treatment, the records showed an AECT1 of 19 points; AE-Qol2: 36 points and AAS3: 5 points. The requirement for icatibant acetate has been no more than 3 vials per month. Conclusion: In accordance with the literature, lanadelumab offered a significant decrease in angioedema activity and a significantly positive impact on the pa- tient's quality of life, confirming that lanadelumab is an effective option for long-term HAE prophylaxis. .

Antecedentes: El angioedema hereditario tipo 1 (AEH1) es un trastorno autosómico dominante, caracterizado por la carencia cuantitativa y cualitativa del C1 inhibidor, producción excedida de bradicinina y causar angioedema recurrente en diversos grados de severidad que afecta la calidad de vida y la vida misma de los pacientes. Lanadelumab es un anticuerpo monoclonal humano, inhibidor específico de la calicreína plasmática, aprobado para profilaxis a largo plazo del AEH1. Reporte de caso: Paciente femenino de 59 años, con diagnóstico de AEH 1 desde noviembre de 1987, sin respuesta terapéutica a danazol, plasma fresco con- gelado ni C1 inhibidor derivado del plasma intravenoso, requerimiento de 3 a 9 ampolletas mensuales de acetato de icatibant por angioedema laríngeo, cutáneo y visceral con índices de calidad de vida sumamente alterada. Se inició lanadelumab 300 mg cada 14 días subcutánea. Al inicio del tratamiento el puntaje de AECT1 fue de 1 punto; AE-Qol2:57 puntos, AAS3: 32 puntos, realizándose un seguimiento a los 5, 10 y 12 meses. Al año de tratamiento, los registros mostraron un AECT1 de 19 puntos; AE-Qol2: 36 puntos y AAS3: 5 puntos. El requerimiento de acetato de icatibant ha sido a no más de 3 ampolletas por mes. Conclusión: En concordancia a la literatura, lanadelumab ofreció al caso, una importante disminución de la actividad del angioedema y un impacto significativa- mente positivo en la calidad de vida de la paciente, constatando que lanadelumab es una opción eficaz en la profilaxis a largo plazo del AEH.

[Hereditary angioedema. A report of a case and literature review]. / Angioedema hereditario. Comunicación de un caso y revisión de la bibliografía.

Hereditary angioedema is a congenital disorder with recurrent attacks of localized swelling of submucosal and subcutaneous tissue, or both caused by a deficiency of the plasma protein C1 inhibitor. It is caused by heterozygous defects in the C1 inhibitor gene located on chromosome 11q, and it has an autosomal dominant inheritance pattern. This disease afflicts 1 in 10,000 to 1 in 150,000 persons. Hereditary angioedema has been reported in all races, and no sex predominance has been found. Skin and visceral organs may be involved by the typically massive local edema. The most commonly involved viscera are the respiratory and gastrointestinal systems, and it can affect the upper airways resulting in severe life-threatening symptoms, including the risk of asphyxiation. There are three types of hereditary angioedema, which difference lies in the inheritance pattern and in the C1 esterase inhibitor and C4 concentrations. The treatment is complicated and it should be treated with intravenous purified C1 inhibitor concentrate; corticosteroids, antihistamines and epinephrine can be useful adjuncts but they are not effective. We report a patient with hereditary angioedema type 1 and make a review of the medical literature.

[Safety and efficacy of specific sublingual immunotherapy in patients with asthma and allergy to Dermatophagoides pteronyssinus]. / Inocuidad y eficacia de la inmunoterapia sublingual específica en pacientes con asma y alergia a Dermatophagoides pteronyssinus.

BACKGROUND: First reports on sublingual immunotherapy were published in 1980. OBJECTIVE: To compare safety and effectiveness of sublingual immunotherapy, as compared with placebo, in asthmatic patients. MATERIALS: In a blinded randomized controlled trial asthmatic patients with positive skin prick tests to Dermatophagoides pteronyssinus, and with serum IgE at least 200 UI were included. According to GINA, asthma severity was mild persistent and moderate. All patients improved their baseline FEV1 at least by 14% after inhaled albuterol. Spirometry was performed again after three and six months after initiating treatment. Patients were randomized to receive for six months either sublingual immunotherapy with Der p 1 standardized allergens (IPI-ASAC, México) at a total dose of 10,469 UBE or identically looking and tasting placebo. Both groups received conventional pharmacological therapy. RESULTS: Sixty four patients enter the study; four were excluded because of systemic oral steroid therapy. Sixty patients underwent randomization. Both groups (30 patients in each one) were similar in their baseline characteristics. After six months, patients that received sublingual immunotherapy had less exacerbations than those in the control group (61 vs 123, T 2.61, p<0.001, IC 1.8-7.2), better FEV1 as compared with baseline values (25% vs 9%, Z=0.66, p=0.03), and less need of albuterol (50% of initial dose, vs 21% (Z=1.4, p=0.03, IC 1.39-1.49). CONCLUSION: Sublingual immunotherapy improves patient symptoms and pulmonary functional tests, makes exacerbations less frequent, and reduces albuterol needs. It may improve asthma related quality of life.

[Transfer factor as specific immunomodulator in the treatment of moderate-severe atopic dermatitis]. / Factor de transferencia como inmunomodulador específico en el tratamiento de la dermatitis atópica moderada a severa.

BACKGROUND: Atopic dermatitis is a skin inflammatory disease which has been associated to high levels of IgE, eosinophiles and change of T lymphocytes. The transfer factor is an immunomodulator active substance and decreases the number of inflammatory cells and the severity of the symptoms of atopic dermatitis. OBJECTIVE: To determine the efficacy of the transfer factor as treatment of moderate and severe atopic dermatitis. MATERIAL AND METHODS: Articles related to treatment with transfer factor in the atopic dermatitis were looked up in Medline and EMBASE, and the ones referring to controlled studies in patients with moderate and severe atopic dermatitis in accord to SCORAD. RESULTS: We found seven articles with 121 patients and 88 controls demonstrating significant decrease in the symptoms of the SCORAD index, decreased IgE, and eosinophils in patients treated with transfer factor. CONCLUSIONS: The transfer factor is a choice treatment for moderate and severe atopic dermatitis.

[Hypersensitivity to medications]. / Hipersensibilidad a medicamentos.

drug hypersensitivity is an adverse reaction provoked by an immunologic response due to the consumption of a drug, or else, by reaction to one of their metaboliteS. Currently, it is considered that 10% of general population has susceptibility to a drug hypersensitivity to a drug or biological product. These reactions obey a pattern of factors of the individual and the medicine, that define the degree of sensitivity to the drug, and according to their characteristics it is possible to develop any type of immunologic reaction (Gel & Coombs), Nevertheless, it should be established that still there are mechanisms of drug hypersensitivity of drugs that have not been totally known, so they are not integrated to this classification and they are catalogued as an undefined type of reaction. On the other hand, there are drugs that provoke drugs reactions by non-immunologic mechanisms corresponding to the drug's different aggressive effects. According to the indicated concepts, we will show some basic concepts of the diverse mechanisms of drug hypersensitivity immunologic and non-immunological, thus as some therapeutic and diagnostic concepts needed for the management of drug hypersensitivity.

[Skin tests with high and minor determinants in patients with doubtful allergy to penicillin]. / Pruebas cutáneas con determinantes mayores y menores en pacientes con alergia dudosa a la penicilina.

BACKGROUND: Currently, the skin tests are the most accepted methods for the diagnosis of allergy to penicillin. OBJECTIVE: To evaluate the efficacy and diagnosis security of the skin tests with high and minor determinants of penicillin, crystalline and penicillin, in patients with hypersensitivity reaction to penicillin. METHODS: Patients with doubtful antecedents of reaction to penicillin (problem group) and healthy patients (control group) were included. Both groups were submitted at the following tests: 1) Skin tests with high and minor determinants of penicillin, and crystalline penicillin, by prick and intradermoreaction methods. 2) In case of negativity, tests of direct challenge with penicillin were practiced. The formation of wheal with or without erythema 3 mm related to the negative control or systemic reaction, was considered positive test. RESULTS: 47 patients were included (24 for problem group, and 23 for control group), 50% of the group problem showed positive reactions with the method of prick, none patient of the control group (p < 0.001); with the intradermoreaction method, 79% in the problem group and only 13.4% in the control group showed positive reaction (p < 0.001). Cutaneous tests showed local adverse effects. Clinical history showed a sensitivity or 88%, method of prick, 50%, and intradermoreaction method, 95%.